Proposed Rule2023-04591
Requirements for Tobacco Product Manufacturing Practice
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
March 10, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, we, or Agency) is proposing to establish tobacco product manufacturing practice requirements for manufacturers of finished and bulk tobacco products. This proposed rule, if finalized, would set forth the requirements with which finished and bulk tobacco product manufacturers must comply in the manufacture, preproduction design validation, packing, and storage of finished and bulk tobacco products, to assure that the public health is protected and that tobacco products are in compliance with chapter IX of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Full Text
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[Federal Register Volume 88, Number 47 (Friday, March 10, 2023)]
[Proposed Rules]
[Pages 15174-15263]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-04591]
[[Page 15173]]
Vol. 88
Friday,
No. 47
March 10, 2023
Part III
Department of Health and Human Services
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Food and Drug Administration
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21 CFR Part 1120
Requirements for Tobacco Product Manufacturing Practice; Proposed Rule
Federal Register / Vol. 88 , No. 47 / Friday, March 10, 2023 /
Proposed Rules
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 1120
[Docket No. FDA-2013-N-0227]
RIN 0910-AH91
Requirements for Tobacco Product Manufacturing Practice
AGENCY: Food and Drug Administration, Health and Human Services (HHS).
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA, we, or Agency) is
proposing to establish tobacco product manufacturing practice
requirements for manufacturers of finished and bulk tobacco products.
This proposed rule, if finalized, would set forth the requirements with
which finished and bulk tobacco product manufacturers must comply in
the manufacture, preproduction design validation, packing, and storage
of finished and bulk tobacco products, to assure that the public health
is protected and that tobacco products are in compliance with chapter
IX of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
DATES: Either electronic or written comments on the proposed rule must
be submitted by September 6, 2023. Submit written comments (including
recommendations) on the collection of information under the Paperwork
Reduction Act of 1995 (PRA) by April 10, 2023 (see section ``VI.
Paperwork Reduction Act of 1995'' of this document). See section V of
this document for the proposed effective date of a final rule based on
this proposed rule.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of September 6, 2023. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2013-N-0227 for ``Requirements for Tobacco Product Manufacturing
Practice.'' Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: <a href="http://www.fda.gov/regulatoryinformation/dockets/default.htm">http://www.fda.gov/regulatoryinformation/dockets/default.htm</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
Submit comments on information collection issues to the Office of
Management and Budget (OMB) in the following ways:
<bullet> Fax to the Office of Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or email to
<a href="/cdn-cgi/l/email-protection#6807011a09371b1d0a05011b1b0107062807050a460d0718460f071e"><span class="__cf_email__" data-cfemail="dfb0b6adbe80acaabdb2b6acacb6b0b19fb0b2bdf1bab0aff1b8b0a9">[email protected]</span></a>. All comments should be identified with the
title, ``Requirements for Tobacco Product Manufacturing Practice.''
FOR FURTHER INFORMATION CONTACT: Matthew Brenner, Office of
Regulations, or Rear Admiral Emil Wang, Office of Compliance and
Enforcement, Center for Tobacco Products, Food and Drug Administration,
Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335,
Silver Spring, MD 20993, 877-287-1373, <a href="/cdn-cgi/l/email-protection#3071435b736460625557455c5144595f5e43705654511e5858431e575f46"><span class="__cf_email__" data-cfemail="d998aab29a8d898bbcbeacb5b8adb0b6b7aa99bfbdb8f7b1b1aaf7beb6af">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Executive Summary
A. Purpose of the Proposed Rule
B. Summary of the Major Provisions of the Proposed Rule
C. Legal Authority
D. Costs and Benefits
II. Table of Abbreviations/Commonly Used Acronyms in This Document
III. Background
A. Legal Authority
B. Rationale for the Proposed Regulation
C. Development of the Proposed Regulation
IV. Description of the Proposed Regulation
A. General Provisions
B. Management System Requirements
C. Buildings, Facilities, and Equipment
D. Design and Development Controls
E. Process Controls
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F. Packaging and Labeling Controls
G. Handling, Storage, and Distribution
H. Recordkeeping and Document Controls
I. Small Tobacco Product Manufacturers
J. Exemptions and Variances
V. Proposed Effective and Compliance Dates
VI. Preliminary Economic Analysis of Impacts
VII. Paperwork Reduction Act of 1995
VIII. Analysis of Environmental Impact
IX. Federalism
X. Consultation and Coordination With Indian Tribal Governments
XI. References
I. Executive Summary
A. Purpose of the Proposed Rule
This proposed regulation--proposed part 1120 (21 CFR part 1120)--
sets forth requirements for tobacco product manufacturing practice
(TPMP) and provides a framework for manufacturers of finished or bulk
tobacco products to follow that would include: (1) establishing tobacco
product design and development controls to prevent or minimize certain
risks; (2) ensuring that finished and bulk tobacco products are
manufactured in conformance with established specifications; (3)
minimizing the likelihood of the manufacture and distribution of
nonconforming tobacco products; (4) requiring investigation and
identification of nonconforming products, including those that have
been distributed in order to institute appropriate corrective actions,
such as conducting a recall as needed; (5) requiring manufacturers to
take appropriate measures to prevent contamination of tobacco products;
and (6) establishing traceability to account for all components or
parts, ingredients, additives, and materials, as well as each batch of
finished or bulk tobacco product, to aid in investigations of
nonconforming tobacco products. Therefore, this proposed regulation
would establish requirements for the control of tobacco product
manufacturing activities and the treatment of contaminated or otherwise
nonconforming tobacco products, including the investigation,
evaluation, and corrective and preventive actions (CAPA) necessary to
protect the public health.
These provisions are generally similar to many existing industry
practices and are drafted to provide tobacco product manufacturers with
flexibility in the manner they comply with the proposed requirements
while assuring the protection of public health. This proposal is
intended to ensure that tobacco products conform to established
specifications and to help prevent the manufacture and distribution of
contaminated or otherwise nonconforming products, thereby assuring that
the public health is protected and that tobacco products comply with
the requirements in chapter IX of the FD&C Act.
B. Summary of the Major Provisions of the Proposed Rule
The proposed regulation is divided into 10 subparts. This proposed
regulation is intended to provide a framework that requires all
finished and bulk tobacco product manufacturers subject to the rule
(including specification developers, contract manufacturers, and
repackagers/relabelers) to establish and maintain procedures for
various aspects of the manufacturing, preproduction design validation,
packing, and storage processes, while allowing flexibility to establish
procedures that are unique to the manufacturer's facilities and
activities, and appropriate for a given tobacco product. The proposed
requirements are written in general terms to allow manufacturers to
establish procedures appropriate for their specific products and
operations. The extent of the procedures necessary to meet the
regulation requirements may vary with the size and complexity of the
design and manufacturing operations. Tobacco product manufacturers who
have a complex manufacturing process would likely need to establish
more detailed procedures to comply with the rule, while tobacco product
manufacturers who have a less complex manufacturing process may need
less extensive procedures.
1. Subpart A--General Provisions
Subpart A contains two proposed sections: scope and definitions.
The scope section describes the purpose of this proposed regulation and
the products and activities to which it applies. This proposed
regulation would apply to manufacturers (foreign and domestic) of
finished and bulk tobacco products. The definitions section defines the
terminology applicable to the proposed requirements laid out in this
notice of proposed rulemaking (NPRM). The proposed rule would define
``tobacco product manufacturer'' to mean ``any person(s), including a
repacker or relabeler, who: manufactures, fabricates, assembles,
processes, or labels a tobacco product, or imports a finished or bulk
tobacco product for sale or distribution in the United States. The
manufacture of a tobacco product includes establishing the
specifications of or the requirements for a tobacco product.''
2. Subpart B--Management System Requirements
Subpart B contains three proposed sections: organization and
personnel; tobacco product complaints; and CAPA. The organization and
personnel section would require finished and bulk tobacco product
manufacturers to establish and maintain an organizational structure;
have sufficient personnel; designate personnel with appropriate
responsibility, including management with executive responsibility;
train personnel; and maintain certain records of these activities. The
tobacco product complaints section would require finished and bulk
tobacco product manufacturers to establish and maintain complaint
handling procedures for the receipt, evaluation, investigation, and
documentation of all complaints. The CAPA section would require
finished and bulk tobacco product manufacturers to establish and
maintain procedures for implementing CAPA and to maintain records of
the activities required under this subpart.
3. Subpart C--Buildings, Facilities, and Equipment
Subpart C contains four proposed sections: personnel practices;
buildings, facilities, and grounds; equipment; and environmental
controls. The personnel practices section would require finished and
bulk tobacco product manufacturers to establish and maintain procedures
related to personnel practices to reduce the risk of contamination with
filth biological materials, chemical hazards, or other deleterious
substances, including rocks or metal shavings. The buildings,
facilities, and grounds section would require such manufacturers to
ensure that buildings and facilities are of suitable construction,
design, and location to facilitate cleaning and sanitation,
maintenance, and proper operations. In addition, manufacturers would be
required to ensure that facility grounds are maintained in a condition
to prevent contamination and to control the water used in the
manufacturing process. The proposed requirements would also require
such manufacturers to establish and maintain procedures for proper
cleaning and sanitation and animal and pest control, and maintain
records of these activities to demonstrate compliance with this
proposed rule. The equipment section would provide requirements for
design, construction, and maintenance of equipment as well as certain
additional requirements (e.g., calibration) for testing, monitoring,
and measuring equipment used in the tobacco product manufacturing
processes and for major
[[Page 15176]]
equipment and processing line identification. Lastly, the environmental
controls section would require that environmental control systems be
maintained and monitored to verify that environmental controls,
including necessary equipment, are adequate and functioning properly.
This subpart would also require manufacturers to maintain certain
records to demonstrate compliance with this proposed rule.
4. Subpart D--Design and Development Controls
Subpart D contains two proposed sections: design and development
activities and master manufacturing record (MMR). The design and
development activities section would require finished and bulk tobacco
product manufacturers to establish and maintain procedures to control
the design and development of tobacco products, including the control
of risks associated with the product, production process, packing, and
storage, as well as procedures for design verification and validation.
These requirements would include developing a process for
identification, analysis, and evaluation of known and reasonably
foreseeable risks associated with the tobacco product and its packaging
as well as taking appropriate measures to reduce or eliminate risks
using recognized tools for risk management. Manufacturers would also be
required to maintain records of all activities required under this
section.
The proposed MMR section would require manufacturers to establish
and maintain an MMR for each finished and bulk tobacco product they
manufacture for distribution. The proposed section would require each
MMR to include tobacco product specifications, the manufacturing
methods and production process procedures, and all packaging, labeling,
and labels approved for use with the product. Additionally, the
proposed MMR section includes requirements for the review and approval
of the MMR, including any changes after initial approval.
5. Subpart E--Process Controls
Subpart E contains nine proposed sections: purchasing controls;
acceptance activities; production processes and controls; laboratory
controls; production record; sampling; nonconforming tobacco product;
returned tobacco product; and reprocessing and rework. The purchasing
controls section would require finished and bulk tobacco product
manufacturers to establish and maintain procedures for ensuring that
purchased or otherwise received products and services related to the
manufacture of a finished or bulk tobacco product are from qualified
suppliers and conform to established specifications. The acceptance
activities section would require finished and bulk tobacco product
manufacturers to establish and maintain procedures for incoming and for
in-process and/or final acceptance activities, including acceptance
criteria, to ensure that products meet established specifications. The
production processes and controls section would require finished and
bulk tobacco product manufacturers to establish and maintain procedures
for production processes, including process specifications and process
controls, process validation, and manual methods and manufacturing
material. The laboratory controls section would require finished and
bulk tobacco product manufacturers to demonstrate laboratory competency
to perform laboratory activities associated with the manufacture of
finished and bulk tobacco products and to establish and maintain
laboratory control procedures for any laboratory activities conducted
under proposed part 1120. The production record section would require
finished and bulk tobacco product manufacturers to establish and
maintain procedures for ensuring that a production record is prepared
for each batch of finished or bulk product to demonstrate conformity
with the requirements established under the MMR. The sampling section
would require finished and bulk tobacco product manufacturers to
establish and maintain an adequate sampling plan that uses
representative samples based on a valid scientific rationale for any
sampling performed under proposed part 1120. The nonconforming tobacco
product section would require finished and bulk tobacco product
manufacturers to establish and maintain procedures for control and
disposition of nonconforming tobacco product, including specific
requirements for identification and segregation, investigation, and
disposition and followup. The proposed returned tobacco product section
would require procedures for the control and disposition of returned
tobacco product, including specific requirements for identification,
segregation, evaluation, and disposition. The reprocessing and rework
section would require procedures for reprocessing and reworking tobacco
products, including specific requirements for evaluation of the tobacco
product to determine that it is appropriate for reprocessing or rework,
authorization of the reprocessing or rework, and production processes,
including process controls, to ensure that reprocessed and reworked
tobacco product conforms to MMR specifications. Manufacturers also
would be required to maintain records of all activities required under
this subpart.
6. Subpart F--Packaging and Labeling Controls
Subpart F contains four proposed sections: packaging and labeling
controls; repackaging and relabeling; manufacturing code; and warning
plans. The packaging and labeling controls section would require
finished and bulk tobacco product manufacturers to establish and
maintain procedures for ensuring that the correct packaging and
labeling is used to prevent mixups and that all packaging and labeling
is approved for use by the manufacturer and complies with all
requirements of the MMR as well as other applicable requirements of the
FD&C Act, the Comprehensive Smokeless Tobacco Health Education Act
(CSTHEA), and the Federal Cigarette Labeling and Advertising Act
(FCLAA) and their implementing regulations. The section would also
require the packaging and labeling control procedures to ensure that
labels are indelibly printed on or permanently affixed to finished and
bulk tobacco product packages; and that the packaging, labeling,
storage, and shipping cases do not contaminate or otherwise render the
tobacco product adulterated or misbranded. The repackaging and
relabeling requirements would require finished tobacco product
manufacturers to establish and maintain procedures for repackaging and
relabeling operations. The manufacturing code section would require
finished and bulk tobacco product manufacturers to apply a
manufacturing code that contains the manufacturing date and batch
number to the packaging or label of all finished and bulk tobacco
products. The warning plans section would require manufacturers of
finished tobacco products that are required to comply with a warning
plan for tobacco product packaging, to establish and maintain
procedures for implementing the requirements of such plan.
Manufacturers would also be required to maintain records of all
activities required under this subpart.
7. Subpart G--Handling, Storage and Distribution
Subpart G contains two proposed sections: handling and storage and
distribution. The handling and storage
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section would require finished and bulk tobacco product manufactures to
establish and maintain procedures to ensure that tobacco products are
handled and stored under appropriate conditions to prevent
nonconforming products as well as mixups, deterioration, contamination,
adulteration, and misbranding of tobacco products. The distribution
section would require finished and bulk tobacco product manufacturers
to establish and maintain procedures to ensure that tobacco products
are distributed to the initial consignee under appropriate conditions
and that only those finished and bulk tobacco products approved for
release are distributed. The distribution section would also require
finished and bulk tobacco product manufacturers to maintain
distribution records and a list of direct accounts.
8. Subpart H--Recordkeeping and Document Controls
The recordkeeping and document control requirements section
establishes certain requirements for documents and records required by
this rule. This section would require that all documents and records be
maintained at the manufacturing establishment or another location that
is readily accessible to responsible individuals of the manufacturer
and to FDA and that they be written in English or an English
translation be made available upon request. Documents and records
required under this section that are associated with a batch of
finished or bulk tobacco product must be retained for a period of not
less than 4 years from the date of distribution of the batch or until
the product reaches its expiration date if one exists, whichever is
later. Documents and records required under this section that are not
associated with a batch of finished or bulk tobacco product must be
retained for a period of not less than 4 years from the date they were
last in effect. FDA is soliciting comment on whether the timeframe for
manufacturers to retain the documents and records under this section is
sufficient for FDA's inspections and compliance activities or if it
should be extended for an additional 1 or 2 years after the tobacco
product reaches its expiration date if one exists. They also must be
made readily accessible to FDA during the retention period for
inspection and photocopying or other means of reproduction. This
section also would require finished and bulk tobacco product
manufacturers to ensure that all records are attributable to a
responsible individual, legible, contemporaneously recorded, original,
and accurate and to establish and maintain procedures for the approval
and distribution of documents and for making changes to documents.
9. Subpart I--Small Tobacco Product Manufacturers
Subpart I explains that small tobacco product manufacturers of
finished and bulk tobacco products would not have to comply with the
TPMP regulation until 4 years after the effective date of the final
rule.
10. Subpart J--Exemptions and Variances
Subpart J consists of five sections, and it sets forth the proposed
procedures and requirements for petitioning for an exemption or
variance from a TPMP requirement. Pursuant to section 906(e)(2)(B) of
the FD&C Act (21 U.S.C. 387f), this subpart also would establish that a
petition for an exemption or variance may be referred to the Tobacco
Products Scientific Advisory Committee (TPSAC) and describe how FDA
would make a determination on a petition for an exemption or variance.
Finally, pursuant to section 906(e)(2)(E) of the FD&C Act, this subpart
would provide that the petitioner has an opportunity for a hearing
after the issuance of an order denying or approving a petition for an
exemption or variance.
C. Legal Authority
Section 906(e) of the FD&C Act (21 U.S.C. 387f) states that in
applying manufacturing restrictions to tobacco, FDA shall prescribe
regulations requiring that the methods used in, and the facilities and
controls used for, the manufacture, preproduction design validation
(including a process to assess the performance of a tobacco product),
packing, and storage of a tobacco product conform to current good
manufacturing practice (cGMP) or hazard analysis and critical control
point (HACCP) methodology as prescribed in such regulations to assure
that the public health is protected and that the tobacco product is in
compliance with chapter IX of the FD&C Act (21 U.S.C. 387 through
387u). The proposed requirements flow from this authority and serve
these goals of protecting public health and assuring compliance with
chapter IX of the FD&C Act.
The proposed rule is also being issued based upon: FDA's
authorities related to adulterated and misbranded tobacco products
under sections 902 and 903 (21 U.S.C. 387c); FDA's authorities related
to records and reports under section 909 (21 U.S.C. 387i); and FDA's
rulemaking and inspection authorities under sections 701 (21 U.S.C.
371), 704 (21 U.S.C. 374), and 905(g) (21 U.S.C. 387e(g)) of the FD&C
Act.
D. Costs and Benefits
The proposed rule, if finalized, would establish requirements for
manufacturers of finished and bulk tobacco products on the methods used
in, and the facilities and controls used for, the manufacture, pre-
production design validation, packing, and storage of tobacco products.
The TPMP requirements described in the proposed rule are expected to
ensure that tobacco product manufacturers control the design and
specifications of finished and bulk tobacco products, providing a level
of assurance of conformity in the production of tobacco products to
established and required specifications that does not occur in the
existing market for tobacco products, to prevent the adulteration and
misbranding of finished and bulk tobacco products, and establish
controls for traceability purposes.
Estimated quantified benefits of the proposed rule arise from the
value of reduced adverse events due to nonconforming finished and bulk
tobacco products and from the reduction of costs associated with
reduced product recalls and market withdrawals. We estimate the mean
present value of benefits annualized over ten years using a seven and
three percent discount rate to be $27.2 million and $29.9 million.
There are other potential benefits associated with the proposed
rule which we have not quantified. First, the proposed recordkeeping
provisions would support FDA's regulatory compliance activities and
help FDA implement and enforce other provisions of the FD&C Act which
will likely generate government cost savings. Second, the proposed
rule, if finalized, may further reduce losses to health and property
for users and nonusers associated with nonconforming tobacco products,
beyond those estimated in the quantified benefits. Third, the proposed
rule's risk assessment, CAPA, tobacco product complaints, and related
provisions will facilitate investigation and identification of causes
and root causes of consumer complaints and other reports of adverse
events. Other benefits include avoided spillover costs to capital
markets.\1\
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\1\ Estimated quantified benefits of avoided recalls include
reduced external costs in the supply chain of the recalled or
withdrawn products (or they exclude reduced recall costs to
manufacturers). Estimated external costs of conducting a recall or
market withdrawal include lost sales to retailers and wholesalers,
expenses associated with notifying tobacco retailers (for
wholesalers) and consumers, removal and storage of inventory costs
collection and shipping costs, disposal costs, and legal costs,
among others. Estimated quantified benefits do not include avoided
spillover costs to capital markets.
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[[Page 15178]]
Initial and recurring costs from this proposed rule arise from
conducting tasks associated with establishing and maintaining
procedures for various aspects of the manufacturing, preproduction
design validation, packing and storage processes. We estimate the mean
present value of costs annualized over ten years using a seven and
three percent discount rate to be $27.0 million and $28.2 million.
II. Table of Abbreviations/Commonly Used Acronyms in This Document
------------------------------------------------------------------------
Abbreviation/acronym What it means
------------------------------------------------------------------------
AAMI......................... Advancement of Medical Instrumentation.
ALCOA........................ Attributable, Legible, Contemporaneously
Recorded, Original, and Accurate.
ANSI......................... American National Standards Institute.
ASTM......................... American Society for Testing and
Materials.
ASQ.......................... American Society for Quality.
CAPA......................... Corrective and Preventive Actions.
CDC.......................... Centers for Disease Control and
Prevention.
cGMP......................... Current Good Manufacturing Practice.
CoA.......................... Certificate of Analysis.
CORESTA...................... Cooperation Centre for Scientific
Research Relative to Tobacco.
CSTHEA....................... Comprehensive Smokeless Tobacco Health
Education Act.
Deeming Rule................. Deeming Tobacco Products To Be Subject to
the Food, Drug, and Cosmetic Act, as
Amended by the Family Smoking Prevention
and Tobacco Control Act; Regulations
Restricting the Sale and Distribution of
Tobacco Products and Required Warning
Statements for Tobacco Product Packages
and Advertisements.
EA........................... Environmental Assessment.
E. coli...................... Escherichia coli.
EIS.......................... Environmental Impact Statement.
ENDS......................... Electronic Nicotine Delivery Systems.
E.O.......................... Executive Order.
FCLAA........................ Federal Cigarette Labeling and
Advertising Act.
FCTC......................... Framework Convention on Tobacco Control.
FDA or Agency................ Food and Drug Administration.
FD&C Act..................... Federal Food, Drug, and Cosmetic Act.
FR........................... Federal Register.
HACCP........................ Hazard Analysis and Critical Control
Point.
HHS.......................... Health and Human Services.
HVAC......................... Heating, Ventilation, and Cooling.
IARC......................... International Agency for Research on
Cancer.
IEC.......................... International Electrotechnical
Commission.
ISO.......................... International Organization for
Standardization.
MITC......................... Manufacturer Detected Methyl
Isothiocyanate.
MMR.......................... Master Manufacturing Record.
MRTPs........................ Modified Risk Tobacco Products.
MRTPA........................ Modified Risk Tobacco Product
Application.
NNK.......................... 4-(methylnitrosamino)-1-(3-pyridyl)-1-
butanone.
NNN.......................... N-nitrosonornicotine.
NPRM......................... Notice of Proposed Rulemaking.
NTRMs........................ Nontobacco Related Materials.
OMB.......................... Office of Management and Budget.
OOS.......................... Out-Of-Specification.
SE........................... Substantial Equivalence.
PMTA......................... Premarket Tobacco Product Application.
PRA.......................... Paperwork Reduction Act of 1995.
PRIA......................... Proposed Regulatory Impact Analysis.
QMS.......................... Quality Management System.
QSR.......................... Quality System Regulation.
RYO.......................... Roll-Your-Own.
Tobacco Control Act.......... Family Smoking Prevention and Tobacco
Control Act.
TPMP......................... Tobacco Product Manufacturing Practice.
TPSAC........................ Tobacco Products Scientific Advisory
Committee.
TSNAs........................ Tobacco-Specific Nitrosamines.
UPC.......................... Universal Product Code.
USB.......................... Universal Serial Bus.
U.S.C........................ United States Code.
WHO.......................... World Health Organization.
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III. Background
A. Legal Authority
The Family Smoking Prevention and Tobacco Control Act (Tobacco
Control Act) was enacted on June 22, 2009, amending the FD&C Act and
providing FDA with the authority to regulate tobacco products (Pub. L.
111-31). Specifically, section 101(b) of the Tobacco Control Act
amended the FD&C Act by adding chapter IX, which provides FDA with the
authority to regulate tobacco products and imposes certain obligations
on tobacco product
[[Page 15179]]
manufacturers (including importers), distributors, and retailers.
Section 901(b) of the FD&C Act establishes FDA's immediate
authority over cigarettes, cigarette tobacco, roll-your-own (RYO)
tobacco, smokeless tobacco, and tobacco products containing nicotine
that is not made or derived from tobacco,\2\ and permits FDA, by
regulation, to deem additional tobacco products subject to chapter IX
of the FD&C Act. In the Federal Register of May 10, 2016 (81 FR 28973),
FDA published a final rule entitled ``Deeming Tobacco Products To Be
Subject to the Food, Drug, and Cosmetic Act, as Amended by the Family
Smoking Prevention and Tobacco Control Act; Regulations Restricting the
Sale and Distribution of Tobacco Products and Required Warning
Statements for Tobacco Product Packages and Advertisements'' (Deeming
Rule) deeming all tobacco products meeting the statutory definition of
``tobacco product,'' except accessories of deemed tobacco products, to
be subject to chapter IX of the FD&C Act. FDA intends for this proposed
rule to apply to manufacturers of all finished and bulk tobacco
products that are subject to chapter IX of the FD&C Act, except
finished and bulk accessories of cigarettes, cigarette tobacco, RYO
tobacco, smokeless tobacco, and tobacco products containing nicotine
that is not made or derived from tobacco.
---------------------------------------------------------------------------
\2\ See Consolidated Appropriations Act, 2022, Public Law 117-
103, div. P, tit. I, subtit. A, sec. 111(b) (March 15, 2022).
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Section 906(e) of the FD&C Act provides that in applying
manufacturing restrictions to tobacco, FDA shall prescribe regulations
requiring that the methods used in, and the facilities and controls
used for, the manufacture, preproduction design validation (including a
process to assess the performance of a tobacco product), packing, and
storage of a tobacco product conform to cGMP or HACCP methodology, as
prescribed in such regulations to assure that the public health is
protected and that the tobacco product is in compliance with chapter IX
of the FD&C Act. The requirements in proposed part 1120, including
management system requirements; buildings, facilities, and equipment
requirements; design and development controls; process controls;
packaging and labeling controls; handling, storage, and distribution
requirements; and recordkeeping and document controls, are derived from
this authority. Section 902(7) of the FD&C Act provides that a tobacco
product shall be deemed to be adulterated if the methods used in, or
the facilities or controls used for, its manufacture, packing, or
storage are not in conformity with applicable requirements under
section 906(e)(1) of the FD&C Act or an applicable condition prescribed
by an order under section 906(e)(2) of the FD&C Act. As a result, a
product will be adulterated if a manufacturer fails to comply with the
requirements prescribed in this proposed regulation. Violations
relating to section 906(e) of the FD&C Act are subject to regulatory
action by FDA, including seizure and injunction.
In addition, section 909 of the FD&C Act authorizes FDA, by
regulation, to require manufacturers and importers of tobacco products
to establish and maintain records, make reports, and provide
information to assure that such tobacco products are not adulterated or
misbranded, and to otherwise protect public health. Section 909 thus
provides additional legal authority for the proposed rule's
recordkeeping, reporting, and related requirements. In addition, under
section 701(a) of the FD&C Act (21 U.S.C. 371(a)), FDA has the
authority to issue regulations for the efficient enforcement of the
FD&C Act. The proposed rule will help assure that tobacco products are
not adulterated or misbranded under other provisions of the FD&C Act
and will assist in the efficient enforcement of those other provisions.
For example, section 902 of the FD&C Act provides that a tobacco
product is adulterated in several circumstances including: (1) if a
tobacco product consists in whole or in part of any filthy, putrid, or
decomposed substance, or is otherwise contaminated by any added
poisonous or added deleterious substance that may render the product
injurious to health; (2) it has been prepared, packed, or held under
insanitary conditions whereby it may have been contaminated with filth,
or whereby it may have been rendered injurious to health; or (3) its
package is composed, in whole or in part, of any poisonous or
deleterious substance which may render the contents injurious to
health. (Section 902(1)-(3) of the FD&C Act.) The proposed rule will
help ensure that tobacco products are not adulterated in these ways,
and that appropriate records, reports, and information will be
available to enforce section 902's adulteration provisions. To similar
effect, section 903 provides that a tobacco product is misbranded if,
for example, its labeling is false or misleading in any particular or
if the product does not bear labeling that is required by an applicable
tobacco product standard established under section 907 (section
903(a)(1) and (a)(9) of the FD&C Act). The proposed rule's labeling
requirements will help prevent tobacco products from being misbranded
in violation of section 903.
Further, section 801(a) of the FD&C Act gives FDA authority to
refuse admission of tobacco products imported or offered for import
into the United States in situations where it appears such products:
(1) have been manufactured, processed, or packed under insanitary
conditions; (2) are forbidden or restricted in sale in the country in
which they were produced or from which they were exported; or (3) are
adulterated or misbranded. As noted earlier, section 701(a) of the FD&C
Act (21 U.S.C. 371(a)) authorizes FDA to issue regulations for the
efficient enforcement of the FD&C Act. The proposed rule will assist in
the efficient enforcement of the FD&C Act's import requirements under
section 801(a) by requiring manufacturers of finished and bulk tobacco
products to implement certain controls over their product
manufacturing, preproduction design validation, packing, and storage
activities, including recordkeeping, to prevent the import of tobacco
products that appear to be adulterated or misbranded.
Finally, the proposed rule will assist in the performance of FDA
inspections under section 704 (21 U.S.C. 374) and 905(g) (21 U.S.C.
387e(g)) of the FD&C Act.
B. Rationale for the Proposed Regulation
While all tobacco products have inherent risks to the public
health, FDA is proposing TPMP requirements to minimize or prevent
product problems, as well as health issues not normally associated with
use of a tobacco product. For example, these requirements would help
minimize or prevent the manufacture and distribution of tobacco
products contaminated with foreign substances (e.g., nontobacco related
materials (NTRMs) such as metal, glass, nails, pins, wood, dirt, sand,
stones, rocks, fabric, cloth, and plastics) which have been found in
finished tobacco products as will be discussed further below. These
requirements also would help minimize or prevent the manufacture and
distribution of nonconforming electronic nicotine delivery systems
(ENDS) e-liquids that contain nicotine concentration levels that vary
from the labeled amount and vary from one ENDS product to another
within the same brand (Ref. 1, Ref. 178). As explained elsewhere in
this document, this potential variability in nicotine concentration, in
which an e-liquid product contains significantly higher
[[Page 15180]]
levels of nicotine than what is stated on the label, could be
misleading to consumers concerned about nicotine delivery levels,
potentially intensifying or prolonging their addiction and potentially
exposing users to increased toxins (Refs. 4 and 5). Tobacco products
may introduce preventable harms not normally associated with use of
tobacco products due to inadequate design or manufacturing controls;
for example, defective solder joints from an ENDS cartomizer (atomizer
plus replaceable fluid-filled cartridge) may cause respiratory distress
due to metallic particles in the aerosol (Ref. 2). This proposed
regulation would help to assure that the public health is protected
from these, and other, types of hazards and that tobacco products
comply with chapter IX of the FD&C Act.
FDA is proposing a TPMP regulation under section 906(e) of the FD&C
Act that employs a Quality Management System (QMS) approach. QMS
approaches are well established and have been required (e.g., 21 CFR
part 820) or utilized by FDA (e.g., ``FDA Guidance for Industry--
Quality Systems Approach to Pharmaceutical CGMP Regulations'') in other
product categories. A QMS can protect the public health in several
ways. First, a QMS can enable the manufacturer to demonstrate its
ability to consistently produce products that meet applicable statutory
and regulatory requirements. Second, a QMS can enable a manufacturer to
establish and maintain a robust design and development process for its
product and to adequately identify and control nonconforming products
to prevent their distribution and related potential harm. Finally, if
nonconforming products are discovered, a QMS can provide the
manufacturer with a recognized framework to effectively investigate and
identify the nonconforming products in order to institute appropriate
corrective actions such as conducting a recall as needed. If a firm is
manufacturing a tobacco product that is contaminated or inconsistent
with the specifications identified in an application under which it has
received marketing authorization, the tobacco product may be
adulterated or misbranded pursuant to section 902 or section 903 of the
FD&C Act and subject to regulatory action. Thus, the proposed
regulation based on a QMS approach, if finalized, would help assure
that the public health is protected and that tobacco products are in
compliance with chapter IX of the FD&C Act.
1. Assuring That the Public Health Is Protected
The proposed regulation would help assure that the public health is
protected by, among other things, minimizing the likelihood of the
manufacture and distribution of nonconforming tobacco products. A
``nonconforming tobacco product'' is proposed to be defined as any
tobacco product that: (1) does not meet a product specification as set
by the MMR (see proposed Sec. 1120.44(a)(1)); (2) has packaging,
labeling, or labels other than those included in the MMR (see proposed
Sec. 1120.44(a)(3)); or (3) is a contaminated tobacco product
(proposed Sec. 1120.3). Nonconforming products occur for many
different reasons, including inadequate sanitation practices, design
issues, failures of or problems with purchasing controls, inadequate
process controls, improper facilities or equipment, inadequate
personnel training, inadequate manufacturing methods and procedures,
the introduction or presence of hazards, or improper handling or
storage of the tobacco product. A tobacco product that does not conform
to established specifications, has incorrect packaging, labeling, or
labels, or is contaminated could increase the product's risk compared
to what would normally be associated with use of the product.
Tobacco products with contaminants that could have been prevented
with the implementation of this proposed TPMP rule have been
identified. For example, consumer complaints of foreign metal material,
including sharp metal objects, in a manufacturer's smokeless tobacco
(e.g., chewing) products ultimately led the manufacturer to issue a
voluntary recall of certain products on January 31, 2017 (Ref. 3). In
other instances, smokeless tobacco products have contained rocks or
metal shavings as well as other NTRMs (e.g., glass, nails, pins, wood,
dirt, sand, fabric, cloth, and plastics) in finished tobacco products.
These NTRMs can cause cuts or lacerations to the lips and gums or
result in broken teeth. This proposed regulation includes measures that
will help avoid such contamination, in addition to provisions for how
manufacturers would be required to handle complaints in similar
situations, as well as the subsequent investigation, evaluation, and
CAPA they would need to take to address such issues.
Consumers have reported additional substances not ordinarily
contained in tobacco products such as biological materials (e.g., mold,
mildew, hair, fingernails) and chemical hazards (e.g., ammonia,
cleaning agents, and kerosene). Caustic cleaning chemicals may cause
vomiting, nausea, allergic reactions, dizziness, numbness, or
headaches.
Even when nonconforming tobacco products are not contaminated with
foreign objects or substances, they may contain higher levels of a
constituent than the consumer is expecting, which can have negative
health effects not normally associated with the tobacco product. For
example, researchers have reported on the variability of nicotine in
certain ENDS e-liquids and that the labeling of these products did not
accurately reflect the actual nicotine levels. For example, there have
been reports of wide variability in e-cigarette manufacturing,
including nicotine concentrations in e-liquid, that were inconsistent
with the information contained on the product label (Ref. 178). In one
study, researchers found that actual nicotine amounts differed from
label amounts by more than 20 percent in 9 out of 20 original e-
cigarette cartridges tested, and in 3 out of 15 refill cartridges
tested (Ref. 1). In a second study, 9 of 21 samples had nicotine levels
that deviated from the labeled value by more than 10%, with
inconsistencies ranging from -21 percent to +22.1 percent (Ref. 4).
Nicotine delivery varies not only across brands, but also within brands
(Refs. 178-180). A finished ENDS that contains a nicotine concentration
higher than the established specification can be more addictive.
Similarly, a cigarette that does not conform to its pH specification
can affect the amount of nicotine that is delivered to the user and its
rate of absorption that can increase the tobacco product's toxicity and
addictiveness (Ref. 6).
Nonconforming products may also occur because of design issues,
which can cause the tobacco product to be more harmful. For example, an
ENDS product, as designed, may have a design feature that contributes
to an increased risk of fire and/or explosion. The ENDS product, during
use or foreseeable misuse, can expose consumers to increased harm if
the product catches fire or explodes resulting in serious burns that
would not be expected from use of the product (e.g., Ref. 7).
Given the dangers associated with contaminated and otherwise
nonconforming tobacco products, FDA is proposing this regulation to
help assure that the public health is protected by requiring that
finished and bulk tobacco product manufacturers establish and maintain
certain controls to prevent the manufacture and distribution of
nonconforming products
[[Page 15181]]
that may have an adverse effect on public health.
2. Ensuring Compliance With Chapter IX of the FD&C Act
The proposed regulation would help assure that tobacco products are
in compliance with the requirements of chapter IX of the FD&C Act
pursuant to section 906(e) of the FD&C Act. In particular, by requiring
controls over the manufacturing process, the proposed regulation would
help assure that tobacco products are manufactured in accordance with
the specifications provided in their applications authorized by FDA.
Specifications generally are included in four types of applications:
<bullet> Substantial equivalence (SE) report--To request marketing
authorization for a new tobacco product, manufacturers may submit a
report pursuant to section 905(j) of the FD&C Act (21 U.S.C. 387e) to
demonstrate that the new tobacco product has the same characteristics
as a predicate tobacco product, or has different characteristics than
the predicate tobacco product but the information submitted
demonstrates that it is not appropriate to regulate the product under
section 910 because the product does not raise different questions of
public health.
<bullet> Exemption from SE--To request marketing authorization for
a new tobacco product that is modified by adding or deleting a tobacco
additive, or increasing or decreasing the quantity of an existing
tobacco additive, manufacturers may request an exemption from
demonstrating SE under certain circumstances (see 21 CFR 1107.1 and
section 905(j) of the FD&C Act).
<bullet> Premarket tobacco product application (PMTA)--To request
marketing authorization for a new tobacco product, manufacturers may
submit a PMTA, which must include, among other things, a full statement
of the components, ingredients, additives, and properties of the
product as well as a full description of the methods used in, and the
facilities and controls used for, the manufacture, processing, and when
relevant, packing and installation of the product. This pathway
requires the applicant to demonstrate that marketing the new tobacco
product is appropriate for the protection of public health pursuant to
section 910 of the FD&C Act.
<bullet> Modified risk tobacco product application (MRTPA)--To
request that a product be sold or distributed for use to reduce harm or
the risk of tobacco-related diseases associated with commercially
marketed tobacco products, manufacturers may submit an MRTPA, which
must include, among other things, a description of the product and the
formulation of the product. Applicants must demonstrate that, among
other things, the product will or is expected to benefit the health of
the population as a whole.
If a firm is manufacturing a tobacco product that is inconsistent
with the specifications identified in the application under which it
has received marketing authorization, the tobacco product may be
adulterated or misbranded pursuant to section 902 or section 903 of the
FD&C Act and subject to regulatory action. Such a product could have
negative effects on public health. For example, a cigarette that does
not meet its specifications for ventilation such that ventilation is
reduced can pose public health risk through the resulting higher
delivery of harmful and potentially harmful constituents (HPHCs)
including nicotine (Refs. 8-9, 106, 173, and 183). FDA believes that
the proposed TPMP rule (if finalized) would help ensure that tobacco
products conform to the specifications in their authorized marketing
applications and do not provide a more addictive or toxic product to
consumers.
Pursuant to section 910(a)(1) of the FD&C Act, tobacco products
that were commercially marketed (other than exclusively in test
markets) in the United States as of February 15, 2007 (``pre-existing
products''), are not considered ``new tobacco products'' and thus are
not subject to the premarket requirements of the FD&C Act. These
products are subject to other provisions of the FD&C Act, including
proposed TPMP requirements. The proposed rule would help manufacturers
ensure that pre-existing tobacco products are manufactured to their
original specifications, and thus do not undergo any modification that
would render them ``new'' and in violation of the requirements of
chapter IX of the FD&C Act because they lack proper marketing
authorization. It would also help FDA identify and determine if any
changes to established specifications or manufacturing methods and
procedures result in a modification that would render the tobacco
product ``new.''
Manufacturers must also ensure that their tobacco products are in
compliance with tobacco product standards under section 907 of the FD&C
Act. Tobacco product standards may reduce the death and disease caused
by tobacco use, encourage cessation, decrease initiation, or reduce the
harms not normally associated with tobacco use, such as nicotine
poisoning. The proposed requirements would help a finished or bulk
tobacco product manufacturer to ensure that, and FDA to review whether,
the tobacco products conform to applicable tobacco product standards.
In addition to helping assure that tobacco products are
manufactured in accordance with the specifications provided in their
marketing applications authorized by FDA and that products are
manufactured in accordance with applicable product standards, the
proposed TPMP rule would help tobacco product manufacturers assure
compliance with other requirements in chapter IX of the FD&C Act. For
example, tobacco product manufacturers must submit a listing of
ingredients, additives, and harmful and potentially harmful
constituents to FDA under section 904 and applicable regulations under
section 915 of the FD&C Act. The proposed TPMP recordkeeping
requirements, including the MMR and production record requirements,
could help FDA verify that the ingredients of these products are
consistent with the listing of ingredients reported to FDA under
section 904(a)(1) of the FD&C Act.
Similarly, under section 905(i) of the FD&C Act, copies of all
labeling, and section 910(b)(1)(F) of the FD&C Act, specimens of
labeling, must be submitted by tobacco product manufacturers to FDA.
This helps the Agency determine if a manufacturer has included
unauthorized modified risk claims on product labels or labeling or if
product labeling is false or misleading or otherwise renders the
product misbranded under section 903 of the FD&C Act. The recordkeeping
requirements in the proposed regulation related to packaging and
labeling would help the Agency make similar assessments, as well as
identify variations between the submitted labeling and actual packaging
and labeling.
Finally, the proposed contamination and risk management controls
would help prevent products from becoming contaminated. Finished or
bulk tobacco products that contain substances such as physical,
chemical, and/or biological hazards may be adulterated under sections
902(1) to (3) of the FD&C Act. The proposed requirements for facilities
and controls covering the manufacture, packing, and storage of tobacco
products would help minimize the occurrence of these kinds of hazards
and would therefore help ensure that products are in compliance with
the requirements of chapter IX of the FD&C Act.
[[Page 15182]]
C. Development of the Proposed Regulation
FDA's development of this proposed regulation reflects its
experience in regulating tobacco products, including the inspections
and facility visits of tobacco manufacturing facilities it has
conducted, recommendations for good manufacturing practice requirements
for ENDS submitted by tobacco product manufacturers, and public
comments filed in response to these recommendations (Docket No. FDA-
2013-N-0227). FDA is also drawing on its experience with cGMP and HACCP
regulations for other regulated products, such as foods, medical
devices, drugs, and dietary supplements.
FDA's experience with biennial inspections of tobacco products has
informed this proposal. Pursuant to section 905(g) of the FD&C Act, FDA
has conducted hundreds of inspections of establishments engaged in the
manufacture of regulated tobacco products, including cigarettes,
cigarette tobacco, RYO tobacco, and smokeless tobacco since October 1,
2011. FDA believes that this experience is also relevant to
establishments that manufacture deemed products, which engage in many
similar activities and processes. Beginning in 2017, the Agency also
began inspecting manufacturing establishments of deemed tobacco
products, including ENDS products.
In August 2012, FDA issued a notice in the Federal Register
announcing an invitation to participate in its Tobacco Product
Manufacturing Facility Visits program (77 FR 48992, August 15, 2012).
The purpose of the program was to provide an opportunity for tobacco
product manufacturing facilities, including facilities related to
laboratory testing, to invite FDA staff to visit these facilities and
observe their manufacturing operations. As part of this program, FDA
staff visited tobacco product manufacturers, including small tobacco
product manufacturers, of cigarettes, smokeless tobacco products, and
cigarette papers, as well as facilities that conduct laboratory testing
services for the tobacco industry. In response to a similar notice
issued in 2016 (81 FR 39053, June 15, 2016), FDA staff also visited
manufacturing facilities of domestic and foreign manufacturers,
including small tobacco product manufacturers, of deemed tobacco
products including cigars, ENDS, and e-liquids. FDA's experiences
during these visits have helped to inform this proposal.
In addition, on January 10, 2012, 13 tobacco companies and a trade
association of tobacco product manufacturers submitted to FDA their
recommendations for regulations on cGMP. This group of industry
stakeholders included manufacturers of a variety of tobacco products
including cigarettes, smokeless tobacco, and snus. On May 2, 2012,
representatives of the tobacco companies met with the Agency to present
an overview of the recommendations and their approach to developing
them. FDA established a public docket requesting public comment on
these industry recommendations (78 FR 16824, March 19, 2013). These
industry GMP recommendations included proposed requirements for an
extensive range of manufacturing practices including: qualification of
personnel; complaints and recordkeeping; procedures for nonconforming
product; contamination prevention; buildings, facilities, and
equipment; MMR; acceptance activities; supplier evaluation;
manufacturing records; packaging and labeling; handling and storage;
and general recordkeeping and document control procedures. We received
comments on the industry recommendations from a variety of stakeholders
including manufacturers of cigarettes, cigars, smokeless tobacco, and
snus, as well as from public health advocates.
Further, on June 7, 2017, a group of 13 tobacco companies, a trade
coalition representing small tobacco product manufacturers, and a
standards organization representing vaping manufacturers and retailers
submitted updated supplemental industry recommendations in order to
provide additional cGMP recommendations for ENDS products. The
supplemental industry GMP recommendations were generally similar to
industry manufacturing practices that the Agency has observed through
its biennial inspections. Among the cGMP requirements that industry
recommended for ENDS products were specific ENDS design process and
procedures, process qualification requirements to ensure that products
consistently meet specifications, procedures to validate and approve
test methods, and requirements for stability testing, reserve samples,
and sampling plans.
FDA established a public docket requesting comment on these updated
industry recommendations for good manufacturing practice requirements
for ENDS (82 FR 55613, November 22, 2017). FDA received additional
comments from manufacturers of a variety of tobacco products, public
health advocates, and individuals sharing their experiences with ENDS.
In developing this regulation, FDA reviewed and considered the
recommendations from both industry proposals, as well as the comments
submitted to the public docket.
FDA is proposing many requirements similar to those included in the
industry GMP recommendations, particularly in the areas of personnel;
contamination prevention; requirements for buildings, facilities, and
equipment; development of an MMR; purchasing controls; process
controls; production records; procedures for nonconforming tobacco
product; complaints; packaging and labeling; distribution; and document
control procedures.
However, FDA's proposal deviates from the industry GMP
recommendations in several ways. First, the proposed TPMP regulation
generally includes more robust provisions for procedures and records
than provisions in the industry GMP recommendations. For example, the
industry recommendations do not propose requirements for design and
development activities generally, returned tobacco product, and warning
plans, as discussed throughout this preamble. Such provisions are
critical for the efficient enforcement of the FD&C Act.
Second, FDA's proposal includes additional provisions that are
necessary to assure that the public health is protected and that
manufacturers' tobacco products are in compliance with chapter IX of
the FD&C Act. As noted, the industry GMP recommendations do not propose
requirements for returned tobacco product and warning plans (see
sections IV.E and IV.F.3 for a discussion of these FDA proposals and
why FDA believes they will help assure the protection of the public
health). In addition, to ensure that tobacco product manufacturers can
demonstrate that their tobacco products consistently conform to
established specifications, an important public health objective, the
proposed rule includes additional requirements for environmental
controls, process validation, laboratory controls, and sampling.
Moreover, this document includes proposed requirements for design and
development activities, as well as complaint, CAPA, and nonconforming
product investigations. To address risks not normally associated with
use of tobacco products, FDA is also proposing manufacturing code and
distribution record requirements to facilitate the traceability of
nonconforming products and enable tobacco product manufacturers and FDA
to take appropriate corrective actions to protect the public health.
[[Page 15183]]
FDA also has chosen not to propose certain requirements in the
industry cGMP recommendations which, in some cases, would have been
more burdensome than FDA's proposed requirements. For example, FDA
considered industry recommendations stating that TPMP requirements
should be modified for ENDS given that they are different from other
tobacco products. FDA's proposed rule, instead, utilizes an
``umbrella'' approach with flexible requirements, similar to other cGMP
regulations, that would apply to the wide variety of tobacco products
offered for sale or distribution. For example, the scope of covered
tobacco products in the 2017 supplemental industry cGMP recommendations
covers manufacturers and suppliers of ENDS components and parts and
included an additional requirement for stability tests to determine
appropriate storage conditions and expiration dates for finished ENDS
products. However, FDA believes that such requirements are unnecessary
and that the FDA proposal to cover bulk tobacco product manufacturers
and the proposed requirements for design and development controls,
process controls, and handling and storage requirements are sufficient
to address the design, manufacture, and storage of ENDS products.
Further, the industry GMP recommendations include a requirement for
a HACCP analysis for ENDS and e-liquids. While the Agency considered
requiring HACCP plans in this proposal, as discussed in section IV.D.1,
FDA determined that use of a risk management process would be more
flexible for manufacturers while still assuring that the public health
was protected.
FDA also did not include the industry's proposed GMP recommendation
to require reserve samples of the e-liquid-containing component/product
from each lot or batch of finished ENDS products, similar to the
reserve samples that are required for medical products. While reserve
samples could be useful for determining a root cause for any
nonconforming products or addressing any customer complaints, we
believe that the proposed documentation and recordkeeping requirements
are sufficient to address any investigation required under the proposed
rule. For example, for a released product found to be nonconforming
because of its nicotine concentration, under the proposed rule, the
manufacturer and/or FDA could review the MMR and the purchasing,
acceptance activities, and production records to determine the nicotine
concentration of the released product as well as who conducted the
testing and signed off on the release of the product. FDA's request for
comments includes comments both on industry GMP recommendations that
FDA is proposing in these requirements, and industry GMP
recommendations that FDA is not proposing.
In addition to the industry GMP recommendation, FDA considered its
existing cGMP regulations for other regulated products and evaluated
them for their suitability and applicability to tobacco products.
Specifically, FDA considered the medical device quality system
regulation (QSR) (part 820), and the food, dietary supplement, and drug
cGMP regulations (21 CFR parts 110, 111, 210, and 211, respectively).
In addition, FDA examined its regulations on HACCP systems, such as
preventive controls for human foods, juice HACCP regulations, and fish
and fishery products HACCP regulations (21 CFR parts 117, 120, and 123,
respectively).
FDA also considered voluntary industry cGMP and quality system
standards in developing this proposal. For example, FDA evaluated the
American E-Liquid Manufacturing Standards Association's voluntary E-
Liquid Manufacturing Standards (Ref. 10). The Agency also considered
the International Organization for Standardization (ISO) ISO
9001:2015--Quality management systems--Requirements (Ref. 11); ISO
31000: 2018--Risk Management--Principles and Guidelines (Ref. 12).
FDA considered the quality systems and QMS requirements in FDA's
medical device QSR and pharmaceutical cGMP for the 21st century (Ref.
13) in designing the proposed rule. The Agency believes certain aspects
of those regulations are informative but not wholly applicable to
tobacco products because of certain key differences between tobacco
products and medical products regulated by FDA. For example, marketing
applications for medical products are evaluated to determine whether
they are ``safe and effective.'' Unlike medical products, tobacco
products cannot be ``safe and effective'' even if used as intended and,
therefore, the FD&C Act requires that marketing applications for
tobacco products be evaluated under different standards (see, e.g., the
``appropriate for the protection of the public health'' standard under
section 910 of the FD&C Act). FDA has taken these differences into
account in developing the proposed rule. For example, while the Agency
has included requirements for CAPA, it has decided not to propose
continuous process improvement requirements as part of this rule.
The Agency's proposed rule utilizes an ``umbrella'' approach to the
regulation of all types of finished and bulk tobacco products, which is
similar to the approach taken by the other cGMPs and voluntary
standards considered in the development of this proposal. Because this
regulation would apply to many different types of tobacco products, the
proposal does not prescribe in detail how a manufacturer must produce a
specific tobacco product. Rather, the proposed regulation provides the
framework that all manufacturers would follow by requiring that
manufacturers establish and maintain procedures and fill in the details
that are appropriate to a given tobacco product.
V. Description of the Proposed Regulation
A. General Provisions
1. Scope
The Tobacco Control Act gave FDA immediate authority over
cigarettes, cigarette tobacco, RYO tobacco, and smokeless tobacco. In
addition, the Tobacco Control Act gave FDA the authority to promulgate
regulations deeming other tobacco products subject to its authorities
in chapter IX of the FD&C Act. In the Federal Register of May 10, 2016,
FDA issued the Deeming Rule deeming all other products meeting the
statutory definition of tobacco product to be subject to FDA's
regulatory authority under chapter IX of the FD&C Act, except
accessories of deemed products. 81 FR 28974. That rule became effective
on August 8, 2016.
As discussed in proposed Sec. 1120.1(a), FDA is proposing TPMP
requirements that would apply to manufacturers of all finished and bulk
tobacco products that are subject to chapter IX of the FD&C Act (e.g.,
cigarettes, cigarette tobacco, RYO tobacco, smokeless tobacco, ENDS, e-
liquids, pipe tobacco, cigars, hookah tobacco, nicotine gels, and
dissolvable tobacco products) but not their related accessories.
FDA proposes to define a ''finished tobacco product'' as a tobacco
product, including any component or part, sealed in final packaging
(e.g., a pack of cigarettes, a can of moist snuff). For the purposes of
the ``finished tobacco product'' definition, a ``package'' is a pack,
box, carton, or container of any kind or, if no other container, any
wrapping, including cellophane, in which a finished tobacco product is
offered for sale, sold, or otherwise distributed to consumers. As
discussed in more detail below, the proposed
[[Page 15184]]
definition of finished tobacco product also includes components or
parts of tobacco products sealed in final packaging (e.g., rolling
papers, filters, filter tubes, or e-liquids sold separately to
consumers or as part of kits). FDA intends for this TPMP rule to cover
manufacturers of finished tobacco products to help assure that the
public health is protected and that those products are in compliance
with chapter IX of the FD&C Act.
FDA proposes to define a ``bulk tobacco product'' as any tobacco
product that is not sealed in final packaging but is otherwise suitable
for consumer use as a tobacco product (e.g., bulk cigarettes, bulk RYO
tobacco, bulk pipe tobacco). As discussed in more detail below, the
proposed definition of bulk tobacco product also includes components or
parts of tobacco products that are not sealed in final packaging but
are otherwise suitable for consumer use as tobacco products (e.g., bulk
filters, bulk e-liquids). Products that are suitable for consumer use
as tobacco products are those products that do not require further
processing by a tobacco product manufacturer, such as mixing, cutting,
curing, blending, or adding components or parts, ingredients, additives
and materials, before they can be used by a consumer. For example, an
e-liquid not sealed in final packaging is suitable for consumer use as
a tobacco product because it requires no additional processing by a
tobacco product manufacturer before it can be used by a consumer in an
ENDS device; it requires only final packaging and labeling to be a
finished tobacco product. A product can be suitable for consumer use as
a tobacco product even if it could undergo additional processing by a
manufacturer, such as blending, as long as it does not require further
processing by a manufacturer before use by a consumer. For example,
coconut and pineapple e-liquids not sealed in final packaging would be
considered bulk tobacco products because they are suitable for consumer
use as tobacco products, even if they might later be blended together
by a manufacturer to make pi[ntilde]a colada e-liquid.
FDA is including bulk manufacturers within the scope of this
proposed rule in order to cover critical regulatory gaps that would
occur if the rule were to only cover manufacturers of finished tobacco
products. Bulk manufacturers provide bulk tobacco products, such as
bulk cigarettes, bulk RYO or pipe tobacco, and bulk e-liquids, to
finished tobacco product manufacturers who merely package and/or label
the products for consumer use. Bulk tobacco products are suitable for
consumer use as tobacco products with no additional processing by a
tobacco product manufacturer and, therefore, should be regulated in the
same manner as finished tobacco products. If the scope of the rule were
limited to finished tobacco product manufacturers, then entities that
perform key manufacturing steps other than final packaging and labeling
for consumer use, such as design and development, blending, mixing,
cutting, processing, assembling, and compounding, might not be subject
to any TPMP requirements. Inadequate controls in earlier stages of
manufacturing could result in contaminated or otherwise nonconforming
bulk tobacco products that would not be detected by a finished tobacco
product manufacturer during packaging and labeling operations. In
addition, a finished tobacco product manufacturer that packages or
labels a bulk tobacco product may not be able to conduct adequate
investigations of product complaints and implementing CAPA for issues
related to product design or production processes.
As noted above, the proposed definitions of finished and bulk
tobacco products would include finished and bulk components or parts of
tobacco products. FDA proposes to define ``component or part'' for
purposes of proposed part 1120 consistent with the definition of
``component or part'' in the Deeming Rule, codified at 21 CFR 1143.1.
Accordingly, a component or part would mean any software or assembly of
materials intended or reasonably expected: (1) to alter or affect the
tobacco product's performance, composition, constituents, or
characteristics, or (2) to be used with or for the human consumption of
a tobacco product; but would exclude anything that is an accessory of a
tobacco product. The requirements of proposed part 1120 would apply to
manufacturers of finished and bulk components or parts of tobacco
products. This would include manufacturers of finished or bulk RYO
tobacco, papers, and filters, ENDS e-liquids, atomizers, batteries
(with or without variable voltage), and cartomizers (atomizer plus
replaceable fluid-filled cartridge).
In determining whether software or an assembly of materials might
be ``intended or reasonably expected'' to alter or affect a tobacco
product's performance, composition, constituents, or characteristics,
or to be used with or for the human consumption of a tobacco product
(and, therefore, whether the software or assembly of materials is a
``component or part''), the manufacturer's subjective claims of intent
are not controlling. Rather, FDA considers all relevant evidence,
including direct and circumstantial objective evidence, which
encompasses a variety of factors, such as circumstances surrounding the
distribution of the product or the context in which it is sold, sales
data, and how the product is used by consumers.
The requirements of proposed part 1120 would also apply to
manufacturers of finished or bulk products for general consumer use
(i.e., products not specifically designed for use with tobacco
products) that meet the definition of finished or bulk tobacco products
(including finished or bulk components or parts). For example, the
requirements of proposed part 1120 would apply to manufacturers of
finished or bulk batteries who intend them to be used in an ENDS
device, for example by labeling or co-packaging the batteries with an
ENDS device. Similarly, the rule would apply to manufacturers of
finished or bulk food grade flavors who intend the flavors to be used
with e-liquids. Likewise, the rule would apply to the manufacturer of a
screen sold at a hardware store for a variety of general uses if that
manufacturer labels the screen for use with a tobacco product, such as
an ENDS, or co-packages the screen with a tobacco product.
The proposed rule would not apply to manufacturers of accessories
of finished or bulk tobacco products. FDA proposes to define an
``accessory'' as any product that is intended or reasonably expected to
be used with or for the human consumption of a tobacco product; does
not contain tobacco and is not made or derived from tobacco; and meets
either of the following: (1) is not intended or reasonably expected to
affect or alter the performance, composition, constituents, or
characteristics of a tobacco product or (2) is intended or reasonably
expected to affect or maintain the performance, composition,
constituents, or characteristics of a tobacco product but (i) solely
controls moisture and/or temperature of a stored tobacco product; or
(ii) solely provides an external heat source to initiate but not
maintain combustion of a tobacco product. This proposed definition is
the same as the definition of ``accessory'' under 21 CFR 1100.3 and
under 21 CFR 1143.1. Examples of accessories of finished and bulk
tobacco products include ashtrays, spittoons, hookah tongs, cigar clips
and stands, and pipe pouches, because they do not contain tobacco, are
not derived from tobacco, and do not affect or alter the performance,
composition, constituents, or characteristics of a
[[Page 15185]]
tobacco product. Examples of accessories also include humidors or
refrigerators that solely control the moisture and/or temperature of a
stored product and conventional matches and lighters that solely
provide an external heat source to initiate but not maintain combustion
of a tobacco product. An electric heater or charcoal used for prolonged
heating of waterpipe tobacco is not an accessory because it is
maintaining the combustion of the tobacco. Accessories of deemed
products are not currently subject to chapter IX of the FD&C Act. At
this time, FDA believes that the proposed requirements of this rule
assure that the public health is protected and that tobacco products
are in compliance with chapter IX of the FD&C Act without applying the
requirements to manufacturers of accessories of cigarettes, cigarette
tobacco, RYO tobacco, smokeless tobacco, and deemed tobacco products.
2. Umbrella Approach
This proposed rule utilizes an ``umbrella'' approach to the
regulation of all types of finished and bulk tobacco products, which is
similar to the approach taken by the other cGMPs and voluntary
standards considered in the development of this proposal. Thus, the
proposed regulation provides the framework that requires all finished
and bulk tobacco product manufacturers subject to the rule (including
specification developers, contract manufacturers, and repackagers/
relabelers) to establish and maintain procedures that are unique to the
manufacturer's facilities and activities, and appropriate for a given
tobacco product. The proposed requirements are written in general terms
to allow manufacturers to establish procedures appropriate for their
specific products and operations. The extent of the procedures
necessary to meet the regulation requirements may vary with the size
and complexity of the design and manufacturing operations. Tobacco
product manufacturers who have a complex manufacturing process would
likely need to establish more detailed procedures to comply with the
rule, while tobacco product manufacturers who have a less complex
manufacturing process may need less extensive procedures.
3. Specification Developers
As discussed in proposed Sec. 1120.1(a), manufacturers of finished
and bulk tobacco products include specification developers, contract
manufacturers, and repackagers and relabelers. If a specification
developer designs and establishes tobacco product specifications of a
finished or bulk tobacco product and provides the specifications to a
contract manufacturer to physically manufacture the product, both the
specification developer and the contract manufacturer would be engaged
in the manufacture and/or preproduction design validation of finished
or bulk tobacco products for purposes of this rule and would be
required to comply with this proposed rule. This approach is similar to
other cGMP and HACCP regulations that have been applied to other FDA-
regulated products, such as part 820, QSR for medical devices, and part
211, cGMP for finished pharmaceuticals.
A specification developer is a person who controls the design and
development of a tobacco product and/or initiates or creates the
specifications for the product. Such activities are important steps in
the manufacture and preproduction design validation of a tobacco
product. A specification developer is, in concept, like an architect
who creates a ``blueprint'' of a tobacco product. A specification
developer may be the same party that physically manufactures the
tobacco product or a separate entity that only provides specification
development services to another manufacturer, who then physically
manufactures the tobacco product. FDA is aware that some tobacco
product manufacturers have established an organizational structure that
places the specification development functions in an entity separate
from the entity in charge of physically manufacturing the finished or
bulk tobacco product; these entities develop and usually control
changes to the specifications of the tobacco product. Such entities are
specification developers under the proposed rule.
A tobacco product manufacturer may utilize a specification
developer to initiate or create the specifications of a finished or
bulk tobacco product when the manufacturer lacks knowledge or expertise
in product design and development. Specifically, a manufacturer may
want to produce a tobacco product with certain features but lack the
knowledge needed to design such a product and translate the desired
features into particular product specifications. For example, a
cigarette manufacturer who wants to manufacture a cigarette with
certain constituent yields and consumer sensory qualities may use a
specification developer to create appropriate specifications for the
product, such as the specific tobacco blend, paper type and grade,
filter ventilation, additives, and other features. A tobacco product
manufacturer who intends to manufacture a dissolvable lozenge, orb, or
strip smokeless tobacco product may similarly involve a specification
developer to create appropriate product specifications such as tobacco
mixtures, pH, additives, colorants, size and shape, and packaging
materials. A tobacco product manufacturer who wants to commercially
market an e-cigarette with certain performance features such as
particular power levels, aerosol particle size, pressure drop, airflow,
and puff count may similarly use a specification developer who can
design a product with such features and translate them into appropriate
specifications, including cartridge, atomizer, heating element,
battery, and circuit board/software specifications.
FDA proposes to regulate specification developers under this rule
because product design and the development of product specifications
are integral parts of the manufacturing and preproduction design
validation process. Product design and specification development are
important because these can affect the level of risk or harm (e.g.,
toxicity, addictiveness) a tobacco product consumer may be exposed to
when using tobacco products, and, in the absence of proper controls,
can also result in harm not normally associated with the use of a
tobacco product.
FDA has authority to include requirements about product design in
its TPMP regulation. Specifically, section 906(e) of the FD&C Act
provides, in part, that FDA shall prescribe regulations requiring that
the methods used in and the facilities and controls used for tobacco-
product manufacture and preproduction design validation (including a
process to assess the performance of a tobacco product) conform to
current good manufacturing practice, or HACCP methodology. Requiring
specification developers to comply with TPMP provisions is consistent
with that authority.
FDA believes that it is necessary to apply the proposed TPMP
regulation to specification developers because of their key role in the
manufacture and preproduction design validation of finished and bulk
tobacco products and because, under certain circumstances, a
specification developer may be the most appropriate party or even the
only capable party, to adequately perform certain activities required
under the proposed regulation. Design and development frequently
involve knowledge of trade secrets and/or other confidential commercial
information, and a specification developer may not
[[Page 15186]]
share such information with the entity that physically manufactures the
finished or bulk tobacco product.
Such activities include, for example, conducting adequate
investigations of product complaints and implementing CAPA for issues
related to product design. For example, if complaints are received that
users are experiencing respiratory distress from the aerosol of an ENDS
product, only a specification developer may be able to conduct an
adequate investigation to determine the cause of problems and implement
the necessary actions to correct and prevent the problems. The finished
or bulk ENDS manufacturer who physically manufactures the product may
be able to rule out a manufacturing problem (e.g., defectively
manufactured solder joints), but it may not be able to determine the
cause of the problem if the issue relates to design (e.g., metallic
particles that result from improper material selection for the
cartomizer wires). In that case, only the specification developer may
have the unique knowledge regarding the product's design and history of
specification development necessary to determine the cause of the
problem and how to address it.
Similarly, if complaints are received that the software of an ENDS
product that controls the heat and temperature functions is being
altered or hacked by users and causing malfunctions that result in
overheating, fires, or explosions, the specification developer--not the
manufacturer who physically manufactures the product--would have the
expertise to conduct a thorough investigation and initiate a CAPA to
redesign the software to prevent this user misuse.
Specification developers are also the only party capable of
adequately performing certain activities included in the proposed
product development control requirements, such as identifying known or
reasonably foreseeable risks associated with the design of the tobacco
product and/or package as well as design verification and validation
activities. With product design and development knowledge, the
specification developer would be in the best position to identify and
take appropriate measures to treat risks associated with the design of
the tobacco product and package that are not normally associated with
the use of the tobacco product and package, or that it determines
constitute an unacceptable level of risk. For example, a specification
developer of a dissolvable tobacco product (e.g., a tobacco lozenge)
would have the knowledge to address possible misuse of the product by a
child that could cause choking or inadvertent exposure and to take
appropriate measures to redesign the size and shape of the tobacco
product or redesign the packaging. As another example, a specification
developer of a heat-not-burn tobacco product would have the knowledge
to assess whether the product could reach temperatures that could cause
burns and to take appropriate measures to reduce this risk.
Accordingly, FDA believes that requiring specification developers
to comply with the proposed TPMP requirements is essential to ensure
that the proposed TPMP regulation operates as intended.
4. Foreign Manufacturers
Further, FDA is proposing that foreign manufacturers of finished or
bulk tobacco products that are imported or offered for import into the
United States be covered under this TPMP rule. In accordance with
section 906(e) of the FD&C Act, FDA believes that covering foreign
manufacturers is necessary to assure the protection of the public
health. The risks associated with the tobacco product, production
process, packaging, and storage are the same for all tobacco products
covered by this proposed rule, regardless of where they are
manufactured, and all can be addressed by the same types of controls.
For example, the proposed design and development controls (proposed
subpart D) would address these risks, including risks associated with
the design of ENDS products that are primarily designed and
manufactured in China and for which there have been numerous reports of
battery fires and explosions (e.g., Ref. 7).
In addition, having the proposed rule apply to foreign
manufacturers of finished or bulk tobacco products would be necessary
to ensure that imported tobacco products comply with chapter IX of the
FD&C Act. For example, the proposed controls (e.g., design and
development controls, MMR, acceptance activities, and production record
requirements) would help to ensure that imported tobacco products meet
all applicable tobacco product standards, and thus avoid being
adulterated or misbranded. A tobacco product which is subject to a
tobacco product standard is adulterated under section 902(5) of the
FD&C Act unless the product is in all respects in conformity with the
standard. Similarly, a tobacco product subject to a tobacco product
standard is misbranded under section 903(a)(9) of the FD&C Act unless
it bears such labeling as may be prescribed in the standard.
5. Vape Shops Engaged in the Manufacture of Tobacco Products
Vape shops are establishments that generally, among other things,
sell a variety of products including ENDS, replacement pieces,
hardware, custom mixed e-liquids, and other related accessories. Sales
of such products, standing alone, would not constitute finished or bulk
tobacco product manufacturing. However, some vape shops are also
tobacco product manufacturers under the Deeming Rule, 81 FR at 29044,
because they also (for example) mix or prepare e-liquids or create or
modify aerosolizing apparatuses for direct sale to consumers for use in
ENDS. Under the proposed regulation, vape shops engaged in these
additional activities would be manufacturers of finished or bulk
tobacco products. When such vape shops are engaged in the manufacture,
preproduction design validation, packing, and storage of finished or
bulk tobacco products within the meaning of the proposed rule, they
would be subject to the requirements in this proposed TPMP rule.
Requiring such manufacturers to comply with TPMP requirements, as
proposed, is important for protecting the public health because
products manufactured at the retail level pose many of the same public
health risks as those manufactured upstream, and possibly additional
risks related to the lack of standard manufacturing practices and
controls. A vape shop that does not engage in the activities described
above would not be a finished or bulk tobacco product manufacturer
subject to the requirements of this proposed part 1120. In addition, as
set out immediately below, proposed Sec. 1120.1(b) would require a
finished and bulk tobacco product manufacturer to comply only with
requirements applicable to its finished and bulk tobacco product
manufacturing operations. Therefore, smaller tobacco product
manufacturers (such as vape shops that engage in some but not all of
the activities described above) would be able to tailor their
procedures to suit their smaller operations while still complying with
the proposed TPMP requirements.
6. Compliance With Requirements Applicable to Operations
Proposed Sec. 1120.1(b) clarifies that if a tobacco product
manufacturer engages in some operations subject to the requirements of
proposed part 1120, but not others, the manufacturer need only comply
with those requirements applicable to the operations in which it is
engaged. This is the same approach
[[Page 15187]]
used in the drug cGMP regulation at Sec. 210.2(b) and the device QSR
at Sec. 820.1(a)(1).
For example, a manufacturer of finished e-liquids would not need to
comply with the warning plan requirements in proposed Sec. 1120.98
because e-liquids are only required to bear a single warning.
Similarly, a finished cigarette manufacturer who does not engage in
repackaging or relabeling operations would not need to comply with the
repackaging and relabeling requirements in proposed Sec. 1120.94.
Likewise, a specification developer who only designs/creates the MMR
for another manufacturer's tobacco product and does not engage in any
physical manufacturing would not be subject to, for example, the
proposed requirements in subparts C (Buildings, Facilities, and
Equipment), E (Production Processes and Controls), and G (Handling,
Storage, and Distribution). If manufacturers believe a requirement is
not appropriate or necessary to ensure that the public health is
protected and that the tobacco product will be in compliance with this
chapter, they may petition for an exemption or variance from all or
part of the regulation pursuant to proposed Sec. 1120.142.
Proposed Sec. 1120.1(c) clarifies the term ``where appropriate,''
which appears several times in proposed part 1120. As discussed in
proposed Sec. 1120.1(c), when a requirement is qualified with ``where
appropriate,'' it is deemed to be appropriate unless the tobacco
product manufacturer documents in writing (on paper or electronically)
an adequate justification prior to abstaining from implementing the
requirement. An adequate justification would address why abstaining
from the requirement would not result in a nonconforming tobacco
product or in the manufacturer not being able to carry out necessary
corrective actions. In this circumstance, the manufacturer need not
petition for or receive an exemption or variance under Sec. 1120.140.
Proposed Sec. 1120.1(d) notes that requirements in proposed part 1120
are intended to protect the public health and assure that tobacco
products are in compliance with the relevant provisions of the FD&C Act
and explains that the failure to comply with any applicable provision
in proposed part 1120 would render the tobacco product adulterated
under section 902(7) of the FD&C Act.
7. Other Manufacturers and Request for Comment
At this time, FDA is not proposing to apply these proposed TPMP
requirements to manufacturers of tobacco products other than finished
and bulk tobacco products. In particular, the proposed regulation will
not reach manufacturers of components or parts that are not offered for
sale, sold, or otherwise distributed to consumers, i.e., components or
parts for further manufacture. For example, the rule would not apply to
manufacturers of filter tow material and cigarette tipping paper that
are intended or reasonably expected to be used to manufacture a
cigarette, because those products are not sold to consumers. The
proposed rule's current scope does not reach such components or parts
directly, but rather requires incoming tobacco product components or
parts, ingredients, additives, and materials to be subject to
purchasing controls and acceptance activities implemented by finished
and bulk tobacco product manufacturers to ensure that they meet
established specifications. In addition, FDA is not currently proposing
to apply these proposed requirements to manufacturers of accessories.
FDA is soliciting comment on the scope of the proposed rule, as
well as whether the scope of this regulation should be expanded to
reach more than finished and bulk tobacco products. If you believe that
FDA should expand the scope of this proposed rule to reach additional
tobacco products, please explain why you believe FDA should take that
approach; which proposed requirements, if any, should apply to other
manufacturers; whether the regulation should cover manufacturers of all
regulated tobacco products, including all components or parts, or only
manufacturers of certain products; as well as any public health data
and information that would support what you believe would be the
appropriate scope of this rule. Alternatively, if you believe that FDA
should limit the scope of the proposed regulation, please explain why
you believe the scope of the rule should be more limited than finished
and bulk tobacco product manufacturers and provide any data or
information that would support that such a limited scope would still
assure that the public health is protected and that tobacco products
are in compliance with chapter IX of the FD&C Act.
8. Definitions
Proposed Sec. 1120.3 sets forth the meaning of terms used in
proposed part 1120.
<bullet> Accessory. We propose to define ``accessory'' as any
product that is intended or reasonably expected to be used with or for
the human consumption of a tobacco product; does not contain tobacco
and is not made or derived from tobacco; and meets either of the
following: (1) is not intended or reasonably expected to affect or
alter the performance, composition, constituents, or characteristics of
a tobacco product or (2) is intended or reasonably expected to affect
or maintain the performance, composition, constituents, or
characteristics of a tobacco product but (i) solely controls moisture
and/or temperature of a stored tobacco product; or (ii) solely provides
an external heat source to initiate but not maintain combustion of a
tobacco product. Examples of accessories are ashtrays, spittoons,
hookah tongs, cigar clips and stands and pipe pouches, because they do
not contain tobacco, are not derived from tobacco, and do not affect or
alter the performance, composition, constituents, or characteristics of
a tobacco product. Examples of accessories also include humidors or
refrigerators that solely control the moisture and/or temperature of a
stored product and conventional matches and lighters that solely
provide an external heat source to initiate but not maintain combustion
of a tobacco product. An electric heater or charcoal used for prolonged
heating of waterpipe tobacco is not an accessory because it is used to
maintain the combustion of the tobacco.
<bullet> Additive. We propose to define ``additive'' as any
substance the intended use of which results or may reasonably be
expected to result, directly or indirectly, in its becoming a component
or otherwise affecting the characteristic of any tobacco product
(including any substances intended for use as a flavoring or coloring
or in producing, manufacturing, packing, processing, preparing,
treating, packaging, transporting, or holding), except that such term
does not include tobacco or a pesticide chemical residue in or on raw
tobacco or a pesticide chemical. An additive can be a type of
ingredient in a tobacco product; an example is methyl salicylate in
smokeless tobacco, which can serve as an absorption enhancer and affect
the characteristics of the tobacco product by changing the rate of
absorption into the body.
<bullet> Batch. We propose to define ``batch'' as a specific
identified amount of tobacco product produced in a unit of time or
quantity and that is intended to have the same specifications. FDA
proposes to give tobacco product manufacturers flexibility to determine
what unit of time or quantity is appropriate for their product, and how
batches would be designated. For example, manufacturers likely would
define a batch for cigarette production, which is almost continuous,
differently
[[Page 15188]]
than a batch for smokeless tobacco, which likely would be defined based
on the amount processed in a vat through the fermentation process.
<bullet> Brand. We propose to define ``brand'' as a variety of
tobacco product distinguished by the tobacco used, tar content,
nicotine content, flavoring used, size, filtration, packaging, logo,
registered trademark, brand name, identifiable pattern of colors, or
any combination of such attributes.
<bullet> Bulk tobacco product. We proposed to define ``bulk tobacco
product'' as a tobacco product not sealed in final packaging but
otherwise suitable for consumer use as a tobacco product. Products that
are suitable for consumer use as a tobacco product are those products
that do not require further processing by a tobacco product
manufacturer before they can be used by a consumer, such as mixing,
cutting, curing, blending, and adding components or parts, ingredients,
additives and materials. A tobacco product can be suitable for use even
if it could undergo additional processing by a manufacturer as long as
it does not require further processing by a manufacturer before use by
a consumer. Examples of bulk tobacco products include bulk RYO tobacco,
bulk pipe tobacco, bulk RYO filters, and bulk e-liquids. However,
cigarette paper that is supplied on a bobbin roll would not be
considered a bulk tobacco product because it would need to be cut into
rolling paper sizes or combined/glued with filters to make cigarette
tubes. The terms ``bulk tobacco product'' and ``finished tobacco
product'' are distinguishable because bulk tobacco products are not
sealed in final packaging, whereas finished tobacco products are sealed
in final packaging.
<bullet> Characteristic. We propose to define ``characteristic'' as
the materials, ingredients, design, composition, heating source, or
other features of a tobacco product.
<bullet> Component or Part. We propose to define ``component or
part'' as any software or assembly of materials intended or reasonably
expected: (1) to alter or affect the tobacco product's performance,
composition, constituents, or characteristics or (2) to be used with or
for the human consumption of a tobacco product. Component or part
excludes anything that is an accessory of a tobacco product.
<bullet> Contaminated tobacco product. We propose to define
``contaminated tobacco product'' as a tobacco product that contains a
substance not ordinarily contained in that tobacco product. ``Not
ordinarily contained'' refers to a substance that is not intended or
expected to be in that tobacco product. As stated in proposed Sec.
1120.3, an example of a contaminated tobacco product is a smokeless
tobacco product with metal fragments in the tobacco filler.
<bullet> Design. We propose to define ``design'' as the form and
structure concerning and the manner in which components or parts,
ingredients, additives, and materials are integrated to produce a
tobacco product.
<bullet> Direct accounts. We propose to define ``direct accounts''
as all persons who are customers of the tobacco product manufacturer
that receive finished or bulk tobacco products directly from the
manufacturer or from any person under control of the manufacturer.
Direct accounts may include wholesalers, distributors, and retailers.
Direct accounts do not include individual purchasers of tobacco
products for personal consumption.
<bullet> Establish and maintain. We propose to define ``establish
and maintain'' as to define, document in writing (on paper or
electronically), implement, follow, and update. Multiple requirements
in the proposed regulation direct manufacturers to ``establish and
maintain'' certain procedures. For example, proposed Sec.
1120.12(e)(1) would require tobacco product manufacturers to establish
and maintain procedures for identifying training needs and establishing
training frequency for personnel based on the work the employee
performs. Therefore, to comply with proposed Sec. 1120.12(e)(1), a
manufacturer would be required to create written procedures for
identifying and meeting training needs, implement and follow the
written procedures, and update the procedures as needed.
<bullet> Equipment. We propose to define ``equipment'' as any
machinery, tool, instrument, utensil, or other similar or related
article, used in the manufacture, preproduction design validation,
packing, or storage of a tobacco product. Equipment used during testing
and laboratory activities conducted as part of the manufacturing
process would be covered under this proposed definition.
<bullet> Finished tobacco product. We propose to define ``finished
tobacco product'' as a tobacco product, including any component or
part, sealed in final packaging. Additional examples of finished
tobacco products include a pack of cigarettes, a can of moist snuff,
and rolling papers, filters, filter tubes, or e-liquids sold to
consumers. One finished tobacco product may contain others. For
example, a carton of cigarette packs (which are finished tobacco
products) is also a finished tobacco product, because, like a cigarette
pack, a carton is a tobacco product sealed in final packaging. As noted
below, final packaging means a pack, box, carton, or container of any
kind or, if no other container, any wrapping (including cellophane), in
which a finished tobacco product is offered for sale, sold, or
otherwise distributed to consumers. (See definition of packaging).
<bullet> Ingredient. We propose to define ``ingredient'' as
tobacco, substances, compounds, or additives contained within or added
to the tobacco, paper, filter, or any other component or part of a
tobacco product, including substances and compounds reasonably expected
to be formed through chemical action during tobacco product
manufacturing.
For example, an ingredient may be a single chemical substance, leaf
tobacco, or the product of a reaction, such as a chemical reaction, in
manufacturing. Examples of substances and compounds (ingredients)
reasonably expected to be formed through a chemical reaction during
tobacco product manufacturing include the following:
--The reaction of sugars with amines to form families of compounds with
new carbon-nitrogen bonds, including Maillard reaction products and
Amadori compounds;
--the reaction of sodium hydroxide with citric acid to form sodium
citrate;
--the production of ethyl alcohol, a residual solvent, from ethyl
acetate during production of tipping paper adhesive;
--products of thermolytic reactions,
--such as the production of carboxylic acids from sugar esters;
--products of enzymatically or nonenzymatically catalyzed reactions,
such as the hydrolytic production of flavor or aroma precursors from
nonvolatile glucosides; and
--products of acid-base reactions, such as removal of a proton from
protonated nicotine to generate the basic form of nicotine (``free''
nicotine). 86 FR 55300 at 55313 (Oct. 5, 2021).
<bullet> Label. We propose to define ``label'' as a display of
written, printed, or graphic matter upon the immediate container of any
article. For finished tobacco products, the term label means a display
of written, printed, or graphic matter upon the immediate container of
any finished tobacco product. Likewise, for a bulk tobacco product, the
term label means a display of written, printed, or graphic matter upon
the immediate container of any bulk tobacco product.
<bullet> Labeling. We propose to define ``labeling'' as all labels
and other
[[Page 15189]]
written, printed, or graphic matter: (1) upon any article or any of its
containers or wrappers or (2) accompanying such article.
<bullet> Management with executive responsibility. We propose to
define ``management with executive responsibility'' as one or more
designated personnel who have the authority and responsibility to
ensure compliance with TPMP requirements, including allocating
resources and making changes to the organizational structure,
buildings, facilities, equipment or the manufacture, preproduction
design validation, packing, and storage of a tobacco product. These
employees are typically senior employees with the authority to
establish or make changes to tobacco product manufacturing policies.
Such person(s) also would be responsible for ensuring that TPMP
requirements are communicated, understood, implemented, and followed at
all levels of the organization.
<bullet> Manual method, process, or procedure. We propose to define
``manual method, process, or procedure'' as any nonautomated method,
process, or procedure, including processes performed by hand with or
without the use of equipment.
<bullet> Manufacturing. We propose to define ``manufacturing'' as
the manufacturing, fabricating, assembling, processing, or labeling,
including the repackaging or relabeling, of a tobacco product. The term
``manufacturing'' includes establishing the specifications of a
finished or bulk tobacco product. Examples of manufacturing activities
include expanding (a process used with the tobacco leaf, typically dry
ice expanded tobacco), homogenizing, mixing, and formulating a tobacco
product.
<bullet> Manufacturing code. We propose to define ``manufacturing
code'' as any distinctive sequence or combination of letters, numbers,
or symbols that begins with the manufacturing date followed by the
batch number. The purpose of the manufacturing code is to allow
manufacturers and FDA to identify the production batch of a particular
finished or bulk product that has been released for distribution. This
information is intended to help determine the product's history (e.g.,
batch production records) and assist manufacturers and FDA in the event
of a nonconforming product investigation and any corrective actions to
be taken as a result of the investigation.
<bullet> Manufacturing date. We propose to define ``manufacturing
date'' as the month, day, and year in 2-digit numerical values in the
format (MMDDYY) that a finished or bulk tobacco product is packaged for
distribution. The manufacturing date is included in the manufacturing
code.
<bullet> Manufacturing material. We propose to define
``manufacturing material'' as material used in or used to facilitate
the manufacturing process that is not equipment and is not intended to
be part of the product. Such material would have to contact the tobacco
product or tobacco product-contact surface. An example of manufacturing
material would be a mold release agent used to facilitate the release
of a tobacco product from a mold.
<bullet> Master manufacturing record (MMR). We propose to define
``master manufacturing record'' as a document or designated compilation
of documents containing the established specifications for a tobacco
product including acceptance criteria for those specifications, all
relevant manufacturing methods and production process procedures for
the tobacco product, and all approved packaging, labeling, and labels
for the tobacco product. Tobacco product specifications, as used in
this definition, may be established by the manufacturer or required by
FDA. The MMR may be prepared either as a single document (or single
file of documents) or as a product-specific index system that
references and includes the location of all the required information.
<bullet> Nonconforming tobacco product. We propose to define
``nonconforming tobacco product'' as any tobacco product that does not
meet a product specification in the MMR (see proposed Sec.
1120.44(a)(1)); has packaging, labeling, or labels other than those
included in the MMR (see proposed Sec. 1120.44(a)(3)); or is a
contaminated tobacco product.
<bullet> Not normally associated. We propose to define ``not
normally associated'' as not an inherent risk of using the tobacco
product. In this context, the inherent risk would be associated with
using the specific category of tobacco product. For example, inherent
risks of using cigarettes include cancers of the mouth, throat, larynx,
esophagus, trachea, lung, stomach, liver, pancreas, kidney, bladder,
cervix, and colon/rectum, as well as one form of leukemia (Ref. 14).
Other examples of inherent risks of using cigarettes include stroke,
heart disease, peripheral vascular disease, COPD, tuberculosis, asthma,
pneumonia and other respiratory diseases (id.). Examples of inherent
risks of cigars include oral, laryngeal, pharyngeal, and esophageal
cancers, as well as lung cancer and heart disease (Ref. 15). Examples
of inherent risks of smokeless tobacco include oral and pancreatic
cancers (Ref. 16).
Examples of risks not normally associated with tobacco products
include lacerations of the gums or lips due to metal fragments found in
chewing tobacco; broken teeth caused by rocks found in chewing tobacco;
bodily injury caused by an exploding battery of an ENDS product;
vomiting, nausea, allergic reactions, dizziness, numbness, or headaches
caused by toxic chemical compounds found in nonconforming products; a
serious illness caused by a tobacco product contaminated by aflatoxin
from a fungus; and acute breathing difficulties associated with an
allergic reaction to a contaminated tobacco product (e.g., Ref. 17).
<bullet> Package or packaging. We propose to define ``package'' or
``packaging'' as a pack, box, carton, or container of any kind or, if
no other container, any wrapping (including cellophane), in which a
finished tobacco product is offered for sale, sold, or otherwise
distributed to consumers (this is also referred to as final package or
final packaging), or in which a bulk tobacco product is offered for
sale, sold, or otherwise distributed (including commercial distribution
and interplant transfers). For example, under the proposed definition,
a carton offered for sale to consumers, which holds individual
cigarette packages, would be considered a ``package'' or ``packaging.''
However, a shipping crate that holds multiple cartons of cigarettes, or
other multiple quantities of finished tobacco products, for
distribution to retailers would not be considered ``packages'' or
``packaging,'' because such shipping crates for distribution to
retailers are not containers or wrapping in which a finished tobacco
product is offered for sale, sold, or otherwise distributed to
consumers. We use the terms ``package'' and ``packaging''
interchangeably throughout this proposed rule.
<bullet> Personnel. We propose to define ``personnel'' as all
persons, including managers, staff, consultants, contractors, and
third-party entities, performing services for the manufacturer subject
to proposed part 1120. The term ``personnel'' includes independent
contractors performing services for the manufacturer.
<bullet> Relabeling. We propose to define ``relabeling'' as
operations in which the labeling of a finished tobacco product is
subsequently changed or replaced. This may be performed by the same
person who originally labeled the product. For example, if a finished
tobacco product fails an acceptance activity because it bears the wrong
label, the manufacturer
[[Page 15190]]
may relabel the product with the correct label.
<bullet> Repackaging. We propose to define ``repackaging'' as
operations in which the packaging of a finished tobacco product is
subsequently changed or replaced. This may be performed by the same
person who originally packaged the product. For example, if the package
of a finished tobacco product is damaged during storage, the
manufacturer may repackage the finished product in a new package.
<bullet> Representative sample. We propose to define
``representative sample'' as a sample that consists of a number of
units that are drawn based on a valid scientific rationale (such as
random sampling) and intended to ensure that the sample accurately
reflects the material being sampled.
<bullet> Reprocessing. We propose to define ``reprocessing'' as
using tobacco product that has been previously recovered from
manufacturing in the subsequent manufacture of a finished or bulk
tobacco product. FDA has observed that reprocessing is a routine
manufacturing process. An example of reprocessing would be using
tobacco recovered through a ripper short process for cigarettes (where
tobacco is removed from rejected cigarettes using equipment such as
feeders, shakers, and separators) to make other cigarettes. Similar
reprocessing occurs for smokeless tobacco, where the tobacco is
recovered from rejected finished or bulk tobacco products, for example,
due to incorrect weight or defective packaging/labels, and then used to
make other smokeless tobacco products.
<bullet> Returned tobacco product. We propose to define ``returned
tobacco product'' as commercially distributed finished or bulk tobacco
product returned to the tobacco product manufacturer by any person not
under the control of the tobacco product manufacturer, including a
wholesaler/distributor, retailer, consumer, or member of the public.
Individuals may return tobacco products to the manufacturer for a
number of reasons, including improper weight or taste.
<bullet> Rework. We propose to define ``rework'' as action taken on
a nonconforming or returned tobacco product to ensure that the product
meets the specifications and other requirements in the MMR of a
subsequently manufactured tobacco product before it is released for
further manufacturing or distribution. For example, a smokeless tobacco
product that fails an acceptance activity for pH level can be reworked
by further fermentation.
<bullet> Small tobacco product manufacturer. We propose to define
``small tobacco product manufacturer'' as a tobacco product
manufacturer that employs fewer than 350 employees. For purposes of
this definition, the number of employees of a manufacturer includes
those employees and personnel of each entity that controls, is
controlled by, or is under common control with such manufacturer.
<bullet> Specification. We propose to define ``specification'' as
any requirement with which a product, process, service, or other
activity must conform. A tobacco product specification is a requirement
established by the manufacturer (including specification developer,
contract manufacturer, or repackager/relabeler), including a
requirement established to ensure that the tobacco product meets any
applicable product standard under section 907 of the FD&C Act. Tobacco
product specifications can include physical, chemical, and biological
specifications. Examples of physical specifications include length,
circumference, and pressure drop for cigarettes, and cut size and
weight for smokeless tobacco products. An example of a chemical
specification is a pH level for smokeless tobacco products, and an
example of a biological specification is a specification related to the
use of a biological fermentation agent used during the manufacturing
process for smokeless tobacco products. Examples of a production
process specification are the upper and lower temperature and humidity
limits for specified durations, as part of the fermentation process for
a smokeless tobacco product. An example of a service specification is a
requirement with which a pest control service must conform.
This proposed rule would require that the tobacco product
specifications and acceptance criteria for those specifications be
included in the MMR for each finished and bulk tobacco product. For
example, if an ENDS manufacturer establishes a voltage specification
for an adjustable, variable voltage product with a range of 3-6V, the
MMR would have to indicate the voltage acceptance criteria that reflect
the tolerance that is established around the upper and lower
specifications.
<bullet> Tobacco product. The term ``tobacco product'' means any
product made or derived from tobacco, or containing nicotine from any
source, that is intended for human consumption, including any
component, part, or accessory of a tobacco product (except for raw
materials other than tobacco used in manufacturing a component, part,
or accessory of a tobacco product). The term ``tobacco product'' does
not mean an article that is a drug under section 201(g)(1) (21 U.S.C.
321(g)(1)), a device under section 201(h) (21 U.S.C. 321(h)), or a
combination product described in section 503(g) of the FD&C Act (21
U.S.C. 353(g)). The term ``tobacco product'' does not mean an article
that is a food under section 201(f) (21 U.S.C. 321(f)), if such article
contains no nicotine, or no more than trace amounts of naturally
occurring nicotine.
<bullet> Tobacco product-contact surface. We propose to define
``tobacco product-contact surface'' to mean a surface that comes into
contact with a tobacco product or a surface from which drainage (or
other transfer) ordinarily occurs onto the tobacco product or onto
surfaces that come into contact with the tobacco product during the
normal course of operations. This definition would include surfaces of
equipment that come into contact with the tobacco product.
<bullet> Tobacco product manufacturer. We propose to define the
term ``tobacco product manufacturer'' as any person(s), including any
repacker or relabeler, who: manufactures, fabricates, assembles,
processes, or labels a tobacco product; or imports a finished tobacco
product for sale or distribution in the United States. Tobacco product
manufacturer includes any person(s) who establishes the specifications
for a tobacco product.
FDA does not propose to define ``tobacco product manufacturer'' to
include third-party laboratories. A finished or bulk tobacco product
manufacturer who uses a third-party laboratory is responsible for
ensuring that the laboratory is qualified to provide services under
proposed Sec. 1120.62 and is competent to perform laboratory
activities associated with the manufacture of a finished or bulk
tobacco product under proposed Sec. 1120.68. A finished or bulk
tobacco product manufacturer who uses a third-party laboratory is also
responsible for ensuring that it receives from the third-party
laboratory all the documents and records (including all metadata)
needed to comply with the proposed TPMP requirements, including, for
example, proposed Sec. Sec. 1120.68(c) and 1120.122. It is the
finished or bulk tobacco product manufacturer, not the laboratory, that
is required to comply with the laboratory control requirements in
proposed Sec. 1120.68.
<bullet> Unique identifier. We propose to define ``unique
identifier'' as information, such as a code or number, that is
maintained for each accepted incoming product that would enable the
[[Page 15191]]
tobacco product manufacturer and FDA to identify the supplier and
unique shipment of the incoming product.
<bullet> Validation. We propose to define ``validation'' as
confirmation by examination and objective evidence that the particular
requirements can be consistently fulfilled. An example of a validation
activity would be the validation of the smokeless tobacco fermentation
process, which would demonstrate that when key parameters (e.g.,
temperature, pH, oven volatiles, and number of turns) are met,
conforming product will be produced in that batch. The relevant
parameters would be monitored to confirm that the batch was produced
within the validated ranges for the fermentation process.
<bullet> Verification. We propose to define ``verification'' as
confirmation by examination and objective evidence that specified
requirements have been fulfilled. Examples of verification activities
would include measuring a dimension such as the length or circumference
of a cigarette or cigar to confirm it meets a specified requirement,
conducting a laboratory analysis of a pH level to confirm it is within
a specified range, and performing a visual comparison of a hand-rolled
cigar against a standard or approved model to confirm the proper shape
and dimensions of that finished cigar.
B. Management System Requirements
1. Organization and Personnel
Proposed Sec. 1120.12 describes the proposed requirements for
finished and bulk tobacco product manufacturers' organization and
personnel. This section forms the foundation for manufacturers to
adequately perform and comply with the proposed requirements under
proposed part 1120. These proposed requirements are generally similar
to the organization and personnel requirements in the industry
recommendations, and similar practices that FDA has observed during
establishment inspections.
Specifically, proposed Sec. 1120.12(a) would require finished and
bulk tobacco product manufacturers to establish and maintain an
organizational structure that will ensure that their manufacturing
operations meet the requirements of part 1120. The organizational
structure should clearly delineate the parts of the organization and
personnel responsible for complying with the proposed requirements. FDA
has observed that it is standard industry practice to maintain an
organizational structure, position descriptions, and employee training
programs.
Proposed Sec. 1120.12(b) would require finished and bulk tobacco
product manufacturers to employ sufficient personnel to carry out the
requirements of proposed part 1120. Personnel must have the background,
education, training, and experience, or any combination thereof, needed
to carry out the requirements of proposed part 1120. Each manufacturer
should determine the appropriate background and necessary education for
personnel to carry out these requirements. A manufacturer may determine
that appropriate certifications and job-related trainings are necessary
for a particular job function. For example, employees responsible for
quality assurance could take classes or coursework relevant to their
role auditing the production process and evaluating the final product
for conformance to tobacco product specifications and other
requirements established in the MMR. FDA recommends that such training
be updated on a regular basis so that responsible employees are aware
of current procedures and controls to ensure that they can consistently
meet the requirements of proposed part 1120. Proposed Sec. 1120.12(b)
would also require manufacturers to maintain appropriate written
records of the background, education, training, and experience of its
personnel in the format described in proposed Sec. 1120.12(f) and
discussed in more detail below.
Proposed Sec. 1120.12(c) would require each finished and bulk
tobacco product manufacturer to designate, in writing (on paper or
electronically), the appropriate responsibility and authority for all
personnel who perform an activity subject to proposed part 1120.
Therefore, while proposed Sec. 1120.12(a) would require manufacturers
to establish an organizational structure, this provision would require
manufacturers to specifically designate the responsibilities and
authority for those personnel who would be responsible for performing
the activities required under proposed part 1120. This provision would
help manufacturers to ensure that their tobacco products conform to
their established specifications and reduce the likelihood that
nonconforming products would be distributed to consumers.
Proposed Sec. 1120.12(d) would require finished and bulk tobacco
product manufacturers to designate, in writing (on paper or
electronically), management with executive responsibility that has the
duty, power, and responsibility to implement the proposed requirements
under proposed part 1120. Management with executive responsibility
refers to those individual(s) who are ultimately responsible for
ensuring compliance with proposed part 1120. This responsibility would
include the allocation of resources, including facilities, equipment,
materials, controls, and personnel used for the manufacture,
preproduction design validation, packing, and storage of a tobacco
product. These employees are typically senior employees with the
authority to establish or make changes to tobacco product manufacturing
policies and ensure that they are effectively communicated throughout
the organization. Management with executive responsibility would be
required to establish and maintain required processes and procedures to
ensure compliance with requirements under proposed part 1120. Such
person(s) also would be required to ensure that TPMP requirements are
communicated, understood, implemented, and followed at all levels of
the organization. FDA believes that this proposed requirement is
generally similar to existing industry practice.
Proposed Sec. 1120.12(e) would require finished and bulk tobacco
product manufacturers to establish and maintain training procedures.
This provision would require that training procedures identify training
needs and establish training frequency for personnel based on the work
the employee performs. Under this provision, manufacturers should
assess whether employees need periodic or refresher training. FDA is
not proposing to prescribe the extent and frequency of training or type
of training, but rather the Agency believes that manufacturers should
have the flexibility to determine how to adequately train their
personnel to perform their assigned responsibilities in accordance with
proposed part 1120. For example, some tobacco manufacturing facilities
are only open for portions of the year and staffed with seasonal
personnel. In this case, a manufacturer may opt to train its personnel
at the start of each new manufacturing season.
Proposed Sec. 1120.12(e) would also require finished and bulk
tobacco product manufacturers to train personnel on their assigned
responsibility and on the TPMP requirements relevant to their
responsibility. Under this provision, manufacturers would not be
required to train personnel on all the requirements of the proposed
regulation, but rather on the provisions of the regulation that are
relevant to their assigned responsibility,
[[Page 15192]]
including their understanding of the relevant procedures and how to
maintain applicable records. Training should also cover the
consequences of improper performance so that personnel will be apprised
of nonconformities that can result if they do not adequately perform
their assigned responsibility and implement the tobacco product
manufacturing requirements relevant to their responsibility.
Proposed Sec. 1120.12(f) establishes the format for training
records required by Sec. 1120.12(b). These training records would be
required to include the type and description of the training, the
training date, the names of the parties performing and taking the
training, and documentation supporting completion. Training records
should demonstrate which personnel were trained, identify the training
completed, and illustrate whether that personnel received the proper
training for their job functions. Documentation supporting completion
may include the results of an assessment or examination given to
personnel upon completion of the training.
The Agency believes that the proposed organization and personnel
requirements would assure that the public health is protected by
requiring that the responsible individuals at all levels of the
organization have the knowledge, experience, and training to ensure
that the establishment manufactures and distributes tobacco products
that conform to established specifications and are not contaminated
during the manufacturing process. Deficiencies in personnel
qualification and training could increase the likelihood that a company
manufactures and distributes nonconforming tobacco products. For
example, one company found that spotting and staining of nonconforming
finished cigarettes was due to improper training, when personnel used
plasticizer instead of casing in the manufacturing process (Ref. 18).
In addition, if an employee responsible for analyzing samples in the
lab is not properly trained on the techniques for sample preparation
and extraction to measure for pH in smokeless tobacco, the results may
be unreliable and could lead to products that do not conform to the
established specifications for distribution. The pH can influence the
availability of nicotine and increase the risk to consumers beyond
those normally associated with the product (Ref. 19).
In addition, the Agency believes that the proposed personnel
requirements would help assure that tobacco products are in compliance
with the requirements of chapter IX of the FD&C Act. In particular, the
proposed requirements would help ensure that personnel with proper
background and expertise are participating in and monitoring the
production process, thus ensuring that the tobacco product does not
become adulterated or misbranded under section 902 or section 903 of
the FD&C Act. The proposed requirements also would help ensure that new
and modified risk tobacco products (MRTPs) are manufactured consistent
with the specifications provided in their applications (i.e., SE
Report, request for SE exemption, PMTA, MRTPA) and that pre-existing
products are manufactured consistent with their original
characteristics. For example, for an SE product, qualified personnel
are needed to ensure that tobacco products are manufactured to the
specifications described in the SE report. Similarly, these proposed
personnel requirements would help ensure that tobacco products that
were commercially marketed in the United States as of February 15, 2007
(pre-existing products), continue to be manufactured consistently with
their original characteristics.
Qualified and trained personnel are vital to a controlled
production process. Requiring manufacturers to have qualified personnel
with designated roles and who are appropriately trained would help
ensure that personnel are competent in their assigned roles. This, in
turn, would help ensure that manufacturing operations are performed
correctly and would reduce the chances of adulteration during the
manufacturing process. For example, qualified personnel with specific
responsibilities to clean tobacco product-contact surfaces would help
decrease the likelihood that products contain filthy, putrid, or
decomposed substances, or are otherwise contaminated by added poisonous
or deleterious substances that may render the product injurious to
health. This would also help ensure that products are not prepared or
held under insanitary conditions.
2. Tobacco Product Complaints
Proposed Sec. 1120.14 sets forth the requirements for the receipt,
evaluation, investigation, and documentation of all complaints. FDA
considers a ``complaint,'' in this context, to be any communication
(including written, electronic, and oral communication) that the
tobacco product does not meet expectations, is unsatisfactory or
unacceptable, or appears to be a nonconforming product. Tobacco product
complaints may come from any source, including healthcare
professionals, consumers, the public, and businesses (e.g., retailers,
other tobacco product manufacturers).
The proposed requirements are generally similar to complaint
handling processes that FDA has observed during establishment
inspections. For example, FDA is aware that tobacco product
manufacturers generally maintain complaint records containing
information about nonconforming tobacco products, such as incorrectly
packaged tobacco products, filters that fall off the filter rod of a
cigarette, broken or torn cigarettes, filter plug problems, and
irregular and improper burning of cigarettes. FDA is also aware of
complaint records containing information about contaminants and hazards
in finished tobacco products such as NTRMs (e.g., metal, glass, nails,
pins, wood, dirt, sand, stones, rocks, fabric, cloth, plastics),
biological materials (e.g., mold, mildew, hair, fingernails), oil or
greasy spots on cigarettes, chemicals (e.g., ammonia, cleaning agents,
kerosene), and the presence or infestation of tobacco beetles or
insects. Further, FDA is aware that manufacturers maintain reports of
complaints such as exploding e-cigarettes, excessive heating during use
and charging of ENDS, as well as cuts and lacerations, broken teeth,
vomiting, nausea, burns, allergic reactions, dizziness, numbness,
headaches, and other personal or property damage reported to tobacco
product manufacturers. These experiences and records have informed the
proposed complaint requirements.
Given the clear importance of tobacco product complaints in
alerting manufacturers and FDA to product problems, proposed Sec.
1120.14(a) would require finished and bulk tobacco product
manufacturers to establish and maintain procedures for the receipt,
evaluation, investigation, and documentation of all tobacco product
complaints. FDA believes it is necessary for manufacturers to establish
and maintain procedures to address all activities related to complaints
(i.e., receipt and processing; evaluation, investigation, and
documentation) in order to ensure that manufacturers properly handle
complaints.
Proposed Sec. 1120.14(a)(1) through (3) would require that the
tobacco product complaint procedures ensure that each complaint is: (1)
processed upon receipt in a uniform and timely manner; (2) evaluated
and, if necessary, investigated, in accordance with Sec. 1120.14(b)
and (c); and (3) documented in accordance with Sec. 1120.14(e). All
complaints would need to be processed upon receipt by the
[[Page 15193]]
manufacturer. Even complaints that may not appear to be directly
related to illness or injury (such as failure to meet a specification,
defective packaging, mixup of products, product bearing wrong labeling/
warning, or incorrect quantity of product) may be important in
identifying a nonconforming product or other manufacturing issue. Such
complaints may indicate that the product is adulterated or misbranded
and that a corrective action, such as a recall, is needed. Moreover,
even a complaint regarding a side effect that appears to be normally
associated with tobacco use may indicate a nonconforming product or a
product design issue and, therefore, would be required to be
investigated. For example, a complaint about respiratory distress could
be determined to be attributed to a nonconforming product due to
defective solder joints from an ENDS cartomizer that results in
metallic particles in the aerosol (Ref. 2). Similarly, a complaint
about dizziness or nausea could be due to the addition of too many
ammonia compounds and other substances to reconstituted tobacco in a
cigarette, which can affect free nicotine levels.
FDA is aware that some manufacturers have a corporate complaint
department that handles complaints for all establishments and others
have different complaint handling units for different product types and
different establishments, which could result in multiple processes for
handling complaints. Therefore, under proposed Sec. 1120.14,
manufacturers should designate in their procedures which individual(s)
are responsible for coordinating and performing all complaint handling
functions to ensure consistent handling, categorization, and
evaluation/investigation of complaints across the corporation and
establishments.
Proposed Sec. 1120.14(b) elaborates on the evaluation requirement
found in proposed Sec. 1120.14(a)(2). Proposed Sec. 1120.14(b) would
require that personnel evaluate each complaint to determine whether it
could be related to: (1) a nonconforming tobacco product; (2) a product
design issue; or (3) any adverse experience that is required to be
reported under a regulation issued under section 909(a) of the FD&C Act
or implementing regulations.\3\
---------------------------------------------------------------------------
\3\ We note that, currently, there are no adverse events
required to be reported under section 909(a) of the FD&C Act;
however, this provision would trigger automatically should FDA issue
a regulation based on section 909(a).
---------------------------------------------------------------------------
Complaint information may need to be incorporated into the risk
management process in proposed Sec. 1120.42 to inform the
manufacturer's risk assessment and risk treatment. For example, a
manufacturer that previously determined in its risk assessment that a
dissolvable tobacco product is unlikely to cause a safety hazard to
users would be required to reassess its risks, pursuant to proposed
Sec. 1120.42(a)(1)(iii), if it receives complaints alleging choking
adverse experiences that could change the previous risk assessment.
Proposed Sec. 1120.14(c)(1) states that if the evaluation
determines that the complaint could be related to the circumstances
identified in proposed Sec. 1120.14(b)(1) through (3), an
investigation must be performed (unless it is subject to the exception
as provided in proposed Sec. 1120.14(d). For example, if a complaint
evaluation indicates that an ENDS product explosion could be related to
an issue with the product's design, the tobacco product manufacturer
would be required to perform an investigation under Sec. 1120.14(c).
Records of previously received complaints may be relevant to this
evaluation. The evaluation phase would not be required to include an
analysis regarding the veracity of the complaint.
Accordingly, this proposed section would require that all
complaints be processed and evaluated. However, only certain complaints
would need to be investigated (i.e., complaints that could be related
to a nonconforming product, a product design issue, or reportable
adverse experience). For example, a complaint regarding the price of
the product or the size offerings distributed by the manufacturer (for
example, customer complaints that the manufacturer should offer a
larger package size) would need to be processed and evaluated but would
not need to be investigated under the proposed rule. However,
complaints regarding an exploding battery, metal or rocks found in the
tobacco, or nicotine poisoning of the user (or nonuser) would need to
be investigated.
As stated in proposed Sec. 1120.14(c)(2), the complaint
investigation would be required to identify the scope and cause of the
issue and the risk of illness or injury it poses. If a manufacturer's
investigation shows that the scope and cause of the issue cannot be
determined without the involvement of another entity, such as a
specification developer, contract manufacturer, or other entity or
establishment that performs a manufacturing operation for the product,
then the manufacturer should work together with the other entity to
determine the scope and cause of the issue. This would include the
timely reporting to other entities of all relevant information related
to the complaint.
For example, if complaints are reported to a contract manufacturer
and, after investigation, are determined to pertain to a possible
product design issue, the contract manufacturer should report these
complaints to the specification developer for further investigation.
The specification developer has the specific knowledge of the design
and development information of the finished tobacco product and would
be required to conduct an investigation of the product complaints and
implement CAPA, as needed pursuant to proposed Sec. 1120.16, including
potential redesign of the product. The contract manufacturer, in turn,
should continue to work with the specification developer to ensure that
the complaint is resolved in accordance with the proposed requirements
in this section. Similarly, if a finished tobacco product manufacturer
that only packages or labels bulk tobacco products receives complaints
of nonconforming products that may be related to the design or
manufacture of the incoming bulk tobacco product, it should report
these complaints to the bulk manufacturer who must then also conduct an
investigation into the scope and cause of the issue, the risk of
illness or injury posed by the issue, and whether any followup action
is necessary, and implement CAPA, as needed pursuant to proposed Sec.
1120.16. The finished tobacco product manufacturer should follow up
with the bulk manufacturer as needed to ensure that the product
complaints have been resolved in accordance with these proposed
requirements. This would include the finished tobacco product
manufacturer documenting the evaluation, investigation, and any
associated followup action regarding the complaint, including any
information provided by the bulk manufacturer.
A complaint investigation also must determine whether any followup
action is necessary, including whether a CAPA is necessary under
proposed Sec. 1120.16. Followup action could include, for example,
updating a procedure, requiring refresher training, making a
manufacturing process change, or other action to correct and prevent a
nonconforming product or design problem; initiating a recall; reporting
an adverse experience under a section 909(a) regulation; or beginning
to monitor the issue to see if there is a trend that might require
further action. This proposed requirement is necessary to ensure that
finished and bulk tobacco product manufacturers adequately
[[Page 15194]]
investigate complaints that could relate to nonconforming tobacco
products, issues related to product design, and reportable adverse
experiences to protect consumers, correct the issue, and prevent the
same or similar problems from occurring in the future.
A complaint investigation may lead the tobacco product manufacturer
to initiate a corrective action, such as a recall or a change to the
manufacturing process. For example, in one case, FDA received a
consumer complaint that an ENDS product created thick and searing smoke
that caused an unexpected health problem, specifically, sore, raw, and
swollen throat that persisted for several days (Ref. 20). If, during
the investigation, the manufacturer determined that the user's health
problem was due to excess voltage causing the atomizer coil to burn,
these proposed requirements would ensure that manufacturers investigate
the scope of such an issue, the risk of illness or injury it poses, and
whether any followup action, such as a CAPA, is necessary. A tobacco
product manufacturer may initiate a CAPA under proposed Sec. 1120.16,
to implement a design change to control the maximum voltage output to
prevent coil overheating. While some tobacco product manufacturers may
initiate such actions on their own, FDA believes that these
requirements are needed to ensure that all manufacturers take these
steps to assure the public health is protected.
Complaints could also identify a reasonably foreseeable risk not
previously known to the manufacturer, including risks that may occur
with normal use and reasonably foreseeable misuse of the tobacco
product, which could relate to a design issue. FDA acknowledges that a
manufacturer cannot possibly foresee every single potential misuse
during the design of a tobacco product, but should the manufacturer
become aware through a complaint of information about risks posed by
the product due to misuse, the corrective and preventive action
requirements under proposed Sec. 1120.16 and the risk management
requirements under proposed Sec. 1120.42 would be triggered, which
would include reassessing and treating the risk pursuant to proposed
Sec. 1120.42(a)(1)(iii). For example, an ENDS manufacturer may receive
complaints of respiratory distress for an ENDS product and determine in
its investigation that users are modifying the heating element to
increase voltage in order to produce greater clouds of vapor, resulting
in higher aerosol temperatures than designed that generate harmful
constituents such as formaldehyde, acetaldehyde, and acrolein (Ref.
21). Knowing that information, the manufacturer would reassess and
treat the risk and initiate appropriate corrective action, which may
include implementing design changes to prevent a user from
disassembling and modifying the heating element.
When conducting investigations, tobacco product manufacturers
should also review available records related to the complaint (e.g.,
acceptance records, nonconforming product records, or CAPA records).
For example, a tobacco product manufacturer may receive complaints
about an ENDS overheating. Even if the product is not returned, the
manufacturer may review other complaint files and determine that
complaints related to other ENDS models have been received. An
investigation and review of acceptance records (see proposed Sec.
1120.64) may reveal an increase in the number of heating element
components being rejected from a particular supplier. As a result of
the investigation, the tobacco product manufacturer may initiate a CAPA
to increase monitoring of the supplier and require additional testing
to ensure that received components meet established specifications.
Proposed Sec. 1120.14(d) provides an exception to the requirement
to conduct an investigation under Sec. 1120.14(c). This paragraph
would provide that a tobacco product manufacturer is not required to
complete an investigation if it has already conducted an investigation
of a similar complaint and the tobacco product manufacturer determines
and documents that the previous investigation results apply and another
investigation is not necessary. FDA interprets a similar complaint to
be one related to the same type of nonconformity or issue and likely to
have the same cause or source. Therefore, a tobacco product
manufacturer would not need to conduct an investigation if its
documentation includes a reference to a previous investigation and a
statement explaining why the complaints were sufficiently similar such
that the previous investigation results apply and another investigation
is not necessary. This analysis would be based on the particular facts
and circumstances at issue. For example, a tobacco product manufacturer
may determine and document that it need not investigate a complaint of
an ENDS overheating, because it had previously investigated a complaint
and found that a particular component caused the overheating and the
production record shows that the product at issue used the same
component from the same supplier, before the problem was corrected.
Proposed Sec. 1120.14(e) would require a manufacturer of finished
or bulk tobacco products to maintain complaint records containing the
information required by Sec. 1120.14(e)(1) through (14). Complaints
requiring investigation that may result in a risk of illness, injury,
or death not normally associated with tobacco product use must be
clearly identified or separated. Additional discussion of the meaning
of ``not normally associated'' can be found in section II.A.2. This
proposed requirement would enable tobacco product manufacturers to
recognize these types of complaints and prioritize appropriate followup
action.
Proposed Sec. 1120.14(e)(1) through (14) states that the complaint
record must include the following information, if available: the name
of the product, including brand and sub-brand; a description of the
product; manufacturing code; date the complaint was received; format of
complaint (i.e., oral or written); name, address, and phone number of
complainant; nature and details of the complaint, including how the
product was used; identification of individual(s) receiving complaint;
record of evaluation by the manufacturer, including the name of the
individual(s) performing the evaluation; if no investigation is
undertaken, the name of the individual(s) responsible for that decision
and the rationale for the decision; investigation date(s); record of
investigational activities performed and personnel who performed the
activities; results of investigation; and any follow up action taken,
including any reply to the complainant or any corrective and preventive
action taken. Some of this information would be obtained during the
evaluation stage while other information would be obtained during the
investigation stage, if an investigation is required. The complaint
record would also include activities performed by other entities that
assist in the investigation. For example, if a manufacturer reports a
complaint to another entity, such as a specification developer, or
contract manufacturer, because the manufacturer's investigation shows
that the scope and cause of the issue cannot be determined without the
involvement the other entity, then the manufacturer should include in
the complaint record information regarding the investigation performed
by the other entity, if available.
The information in proposed Sec. 1120.14(e) is basic information
that is
[[Page 15195]]
essential to any complaint investigation and necessary to ensure a
thorough complaint investigation and facilitate an appropriate
followup. The manufacturer should make a reasonable effort to obtain
the information listed in proposed Sec. 1120.14(e)(1) through (14).
For example, should some of the basic information in proposed Sec.
1120.14(e)(1) through (14) be missing with respect to a particular
complaint, a single unsuccessful attempt to reach the complainant would
not be considered by FDA to be a reasonable effort to obtain
information related to the complaint. If the information described in
proposed Sec. 1120.14(e)(1) through (14) cannot be obtained, this
provision would require the manufacturer to document the attempts to
obtain this information and explain why the information was not
included, as described in proposed Sec. 1120.14(f).
FDA believes that these proposed requirements would assure that the
public health is protected by requiring tobacco product manufacturers
to systematically handle the receipt, evaluation, investigation, and
documentation of all complaints to determine if there is a problem with
the tobacco product, a related tobacco product, or the manufacturing
process, and take appropriate action. If a tobacco product manufacturer
does not have a written complaint procedure, the manufacturer may not
properly evaluate and if necessary, investigate the received complaint
and may fail to identify a nonconforming tobacco product, a product
design issue, or a reportable adverse experience. For example, if a
customer reports to a manufacturer that there are metal objects in a
can of smokeless tobacco (e.g., Ref. 3), and the complaint procedures
do not describe how to perform an investigation, the manufacturer may
not conduct an adequate investigation and take an appropriate followup
action, including a corrective and preventive action that would prevent
consumer illness or injury from such contaminants.
Complaints from users and nonusers are an invaluable source of
information for tobacco product manufacturers. The evaluation and
investigation of complaints can help a tobacco product manufacturer
identify problems with a tobacco product's design, established
specifications, or production process. For example, if a manufacturer
is receiving complaints alleging explosions of ENDS, this proposed rule
would require the manufacturer to investigate the scope and cause of
the issue to determine if, for example, it is due to a design problem
or manufacturing problem. The investigation may determine that the
problem is due to use of a non-Original Equipment Manufacturer battery
charger that does not meet the manufacturer's established
specification. The U.S. Fire Administration has found that nearly 25
percent of e-cigarette fires occurred when the battery was being
charged (Ref. 22). Many e-cigarettes are charged using an ordinary
universal serial bus (USB) port charging connection that allows users
to connect the e-cigarette to power adapters that are not provided by
the original manufacturer of the device. Because the voltage and
current provided by USB ports can vary significantly between
manufacturers, use of a USB port or power adapter not supplied by the
original manufacturer may subject the battery to a higher current than
is safe, leading to thermal runaway that results in an explosion and/or
fire. As a result of this complaint information, the manufacturer may
initiate a CAPA pursuant to proposed Sec. 1120.16 (and further
discussed in section IV.B.3) to redesign the battery to have a
proprietary connection that could only be connected to a charging unit
designed to be compatible or redesign the battery management system to
detect an incompatible power adapter and prevent the battery from
charging. New information on increased likelihood of occurrence or
severity of harm obtained from tobacco product complaints should be
incorporated into the manufacturer's ongoing risk management activities
(i.e., review of new information that could change the original risk
assessment and risk treatment) under proposed Sec. 1120.42.
In addition, FDA believes that the proposed tobacco product
complaint requirements would help assure that tobacco products are in
compliance with the requirements of chapter IX of the FD&C Act.
Consumer complaints about adverse experiences or product problems may
indicate nonconforming tobacco products that are not being manufactured
to established specifications. Therefore, these proposed complaint
requirements would help tobacco product manufacturers to ensure that
new tobacco products and MRTPs are manufactured consistent with the
specifications provided in their applications (i.e., SE Report, request
for SE exemption, PMTA, MRTPA) and that pre-existing products are
manufactured consistent with their original characteristics. For
example, if numerous complaints are received about a product, the
manufacturer may investigate and learn that the product does not have
the same characteristics it had as of the pre-existing date.
Complaints can also indicate that distributed tobacco products are
adulterated or misbranded under section 902 or 903 of the FD&C Act. For
example, complaints could indicate that products have been ``prepared,
packed, or held under insanitary conditions'' (section 902(2) of the
FD&C Act). In addition, as noted previously, complaints can uncover
cross-contamination in a production process that resulted in an adverse
experience to the user, necessitating a change in the manufacturing
process to prevent the further production of cross-contaminated
products. The proposed requirements in this rule that would require
manufacturers to process, evaluate, investigate, and document
complaints would help them to address and prevent recurrence of such
adulteration.
These proposed complaint requirements also may help ensure that the
packaging, labeling, or labels of finished and bulk tobacco products
comply with applicable statutory and regulatory requirements. For
example, a complaint may note that tobacco products are missing labels
with required warning statements causing the products to be misbranded
under section 903 of the FD&C Act. The investigation may determine that
adequate acceptance activities are not being performed during the
packaging and labeling operations. This provision would enable the
manufacturer to ensure that required warning statements are applied to
prevent misbranded products from being commercially marketed.
3. Corrective and Preventive Actions
Proposed Sec. 1120.16 sets forth the requirements for CAPA. CAPA,
for purposes of proposed Sec. 1120.16, is a systematic assessment of
nonconforming tobacco products and design problems to determine the
cause and implement appropriate changes to the product specifications,
relevant manufacturing methods and production process procedures, and/
or packaging, labeling, and labels to correct and prevent the cause of
the nonconformity or design problem. CAPA also helps prevent the
distribution of identified nonconforming product and helps identify
design problems. These proposed requirements are generally similar to
the industry recommendations and to practices of tobacco product
manufacturing establishments that follow ISO 9001-2015 (Ref. 11).
Tobacco product manufacturers have utilized CAPA in
[[Page 15196]]
the past to take appropriate actions to correct and prevent identified
causes of nonconformities and design problems (e.g., Refs. 23-27). FDA
believes that all tobacco product manufacturers should implement CAPA
procedures.
Proposed Sec. 1120.16(a) would require finished and bulk tobacco
product manufacturers to establish and maintain procedures for
implementing CAPAs. Specifically, proposed Sec. 1120.16(a)(1) would
require such manufacturers to review and analyze processes, process
control records, complaints, production records, returned products,
reprocessed products, reworked products, and other sources of data to
identify existing and potential causes of nonconforming tobacco product
and design problems. These sources would help manufacturers identify
possible causes of nonconformities and design problems and may also
help manufacturers identify previously undetected problems.
Under the proposed rule, FDA expects that manufacturers would
periodically examine manufacturing processes to look for causes of
nonconforming tobacco products or design problems, and take steps to
prevent their occurrence. For example, under proposed Sec.
1120.16(a)(1) (and the proposed production processes and controls
provision discussed further below (see Sec. 1120.66)), a finished or
bulk e-liquid manufacturer would periodically review the mixing process
for an e-liquid to determine if it has been trending towards the upper
control limit for the nicotine concentration. Such an issue would
require a corrective action to maintain the mixing operation within the
control limits so as not to produce nonconforming product. Further,
records associated with other tobacco products manufactured using the
same equipment or production process, including records of tobacco
complaints, acceptance activities, nonconforming product, and returned
products could help determine if a repeated nonconformity is associated
with a manufacturing method or procedure.
Appropriate statistical methodology must be employed where
necessary to detect recurring problems. Statistical techniques (e.g.,
Ref. 28) are useful to identify trends of nonconforming product or
processes and records that indicate systemic problems that contribute
to nonconformities. Appropriate statistical tools, such as trend
analysis, can be used to review tobacco product complaints, process
controls, nonconforming product, acceptance activities, and production
records. It may be necessary to employ statistical techniques such as
trend analysis to identify recurring problems across multiple batches
and identify potential causes of nonconforming product or design
problems, which is an important part of preventive action.
Proposed Sec. 1120.16(a)(2) would require finished and bulk
tobacco product manufacturers to investigate the cause of design
problems or nonconformities relating to the tobacco product or the
manufacturing process. For example, if a validated cigarette-making
process has a normal 2 percent rejection rate and that rate rises to 10
percent, this provision (along with proposed Sec. 1120.74(b)) would
require the manufacturer to perform an investigation into the
nonconformance of the process. In this example, we would expect the
investigation to include an assessment of production batches
manufactured before and after the suspect batch, including records of
monitoring of the process control parameters required by proposed Sec.
1120.66(a)(2) and continued process verification results required by
proposed Sec. 1120.66(b)(3) to determine if other batches have been
affected and whether there are process deviations that require
revalidation of the manufacturing process pursuant to proposed Sec.
1120.66(a)(3).
If a manufacturer's investigation shows that the cause of the
design problem or nonconformity cannot be determined without the
involvement of another entity, such as a specification developer,
contract manufacturer, or other entity that performs a manufacturing
operation for the product, then the manufacturer should work together
with the other entity to determine the cause of the design problem or
nonconformity. This would include the timely reporting to other
entities of all relevant information related to the design problem or
nonconformity. For example, if a contract manufacturer investigates the
cause of a nonconformity in accordance with proposed Sec. Sec.
1120.16(a)(2) and 1120.74(b) and determines that it does not pertain to
its contract manufacturing process, the contract manufacturer should
report the information to the specification developer for
investigation. The specification developer has knowledge of, and
controls the design and development information of, the finished
tobacco product and may be in the best position to investigate whether
the nonconformity relates to a design problem, and to implement CAPA
for issues related to product design. Similarly, if a finished tobacco
product manufacturer who repackages or relabels tobacco products
performs a CAPA investigation and determines that the cause of a
nonconformity does not relate to its repackaging or relabeling process,
it should report the nonconformity to the other manufacturer(s), who
then can conduct an adequate investigation, determine the cause of the
nonconformity, and implement appropriate CAPA, for example changes to
process controls.
Proposed Sec. 1120.16(a)(3) would require finished and bulk
tobacco product manufacturers to identify and take actions needed to
correct and prevent the recurrence of design problems and
nonconformities and other related problems found in the investigation.
Correction and prevention of inadequate procedures and practices should
result in fewer tobacco product nonconformities. To comply with this
provision, for example, a manufacturer could decide to revise and
update inadequate procedures, identify and correct improper personnel
training, or require refresher training on a procedure to address
employees' failure to follow such procedure. When identifying such
actions, manufacturers should take into account the risk of illness or
injury posed by the design problem or nonconformance. The degree of
corrective and preventive action taken to eliminate or minimize design
problems or nonconformities should be appropriate to the magnitude of
the problem and commensurate with the associated risks. For example, to
address a more serious problem such as a design problem resulting in a
fire or explosion, the manufacturer may need to take a more significant
corrective and preventive action, such as a product redesign. When
performing the CAPA in such a scenario, the manufacturer may need to
incorporate its risk management process (see proposed Sec.
1120.42(a)(1)) to assess and treat the risk.
Proposed Sec. 1120.16(a)(4) would require finished and bulk
tobacco product manufacturers to verify or validate CAPAs to ensure
that the actions are effective and do not adversely affect the product.
Verification, as defined in proposed Sec. 1120.3, would refer to
confirmation by examination and objective evidence that specified
requirements have been fulfilled. Examples of verification activities
would include measuring a dimension such as the length or circumference
of a cigarette or cigar to confirm it meets a specified requirement,
conducting a laboratory analysis of a pH level to confirm it is within
a specified range, and performing a visual comparison of a hand-rolled
cigar against a standard or
[[Page 15197]]
approved model to confirm the proper shape and dimensions of that
finished cigar. Validation, as defined in proposed Sec. 1120.3, would
refer to confirmation by examination and objective evidence that the
particular requirements can be consistently fulfilled. An example of a
validation activity would be the validation of the smokeless tobacco
fermentation process, which would be used to demonstrate that when key
parameters (e.g., temperature, pH, oven volatiles, and number of turns)
are met, conforming product will be produced in that batch. The
relevant parameters would be monitored to confirm that the batch was
produced within the validated ranges for the fermentation process.
Verification and validation could also include the collection and
analysis of data, such as from acceptance activities and nonconforming
products, to confirm that a CAPA has effectively addressed the problem.
Moreover, if a tobacco product manufacturer determines that a process
change is required because the existing process cannot be maintained,
proposed Sec. 1120.16(a)(4) would require the manufacturer to verify
or validate that this CAPA does not adversely affect the tobacco
product by, for example, modifying an established specification.
Verification and validation activities provide an opportunity to
demonstrate through examination and objective evidence that the
proposed corrective and preventive action is effective and does not
introduce new or increased risks associated with the product,
production process, packing, and storage. For example, if a
manufacturer receives complaints about the presence of mold in finished
tobacco product, it may decide to initiate a CAPA to address this issue
by changing the packaging to control the moisture content of the
tobacco product. The manufacturer must verify or validate the newly
redesigned packaging, for example, by confirming that the new packaging
material's moisture barrier meets specified requirements or conducting
shelf life testing, respectively.
Proposed Sec. 1120.16(a)(5) would require finished and bulk
tobacco product manufacturers to implement and document changes to
tobacco product specifications, manufacturing methods and production
process procedures, and packaging, labeling, and labels needed to
correct and prevent identified causes of the design problem or the
nonconformity. A tobacco product manufacturer could comply with this
provision in many different ways. For example, a tobacco product
manufacturer that receives consumer complaints regarding respiratory
distress, may redesign an ENDS cartomizer to minimize metal and
silicate particles in the aerosol (Ref. 2). Similarly, a cigarette
manufacturer may determine that calibration procedures need to be
revised to correct the improper application of casings applied to cut
filler and prevent the recurrence of nonconforming product (Ref. 29).
Another example is a manufacturer that may change solvents used on
packaging (e.g., benzene, toluene, methyl ethyl ketone, methyl
cellosolve, cellosolve) that are found to contaminate cigarettes (Ref.
30).
Proposed Sec. 1120.16(a)(6) would require that information related
to the design problem or nonconformity and the CAPA taken be
disseminated to management with executive responsibility, those
responsible for acceptance activities of a tobacco product, and
personnel responsible for identifying training needs in accordance with
proposed Sec. 1120.12(e). This requirement would help ensure that
designated individuals who are responsible for implementing TPMP
requirements are notified about design problems, nonconformities, and
CAPAs and can adjust procedures accordingly.
Proposed Sec. 1120.16(b) would require that finished and bulk
tobacco product manufacturers maintain records of all activities
conducted under this section and that these records include the date
and time, the individual performing the activity, any information that
demonstrates the requirement was met, and any data or calculations
necessary to reconstruct the results. For purposes of this proposed
part 1120, FDA interprets ``reconstruct,'' in this context, to mean the
ability to re-create the results by analyzing all data, including
source and metadata data, and records, including calculations. Although
FDA is not proposing to prescribe a particular format to document CAPA
activities, this provision would require tobacco product manufacturers
to document all of the actions taken to address the requirements under
this section (e.g., Refs. 24-26).
The proposed Sec. 1120.16 requirements would help assure that the
public health is protected by requiring tobacco product manufacturers
to perform a systematic assessment of nonconforming products and design
problems to determine and address the cause. For example, nonconforming
product can result from inadequate or nonexistent tobacco product or
process specifications; failures of or problems with purchasing
controls; inadequate process controls; improper facilities or
equipment; inadequate training; and inadequate manufacturing methods
and procedures.
The proposed requirements would help ensure that nonconformities
and design problems are thoroughly investigated and effective CAPA are
taken to eliminate or minimize them and potential harms to the
consumer. For example, under this proposed section, an ENDS
manufacturer that receives complaints about respiratory distress and
metallic aftertaste from use of an ENDS product may initiate a CAPA
investigation. The manufacturer may determine that the cartomizer
aerosol contains traces of tin, copper, nickel, and silver metals
attributed to poor solder joints from the cartomizer supplier (Ref. 2),
and take a CAPA to change suppliers, use different cartomizer
materials, and implement solder joint reliability testing as an
acceptance activity (see Sec. 1120.64). While individual tobacco
product manufacturers may have used CAPA in the past, these proposed
requirements would ensure that all finished and bulk manufacturers take
these actions to prevent harms that could occur as a result of design
problems and nonconforming products.
CAPA can also help minimize or prevent contamination of finished or
bulk tobacco product. For example, due to increased consumer complaints
of plastic or Styrofoam material in finished tobacco products, a
manufacturer may initiate a CAPA to implement an optical sorter to
prevent the introduction of non-ferrous NTRMs into finished and bulk
tobacco products.
The proposed CAPA requirements would also help assure that tobacco
products are in compliance with the requirements of chapter IX of the
FD&C Act by establishing procedures for the manufacturer to follow in
taking appropriate action on nonconforming and contaminated tobacco
products both prior to, and after the manufacturer starts, marketing
the products. For example, a CAPA to prevent the introduction of non-
ferrous NTRMs into finished or bulk tobacco products, as discussed
above, would help ensure that the product is not adulterated under
section 902(a)(1) of the FD&C Act. Moreover, these provisions would
help ensure that appropriate measures are taken to address new or MRTPs
that do not conform to the specifications provided by the manufacturer
to FDA in the relevant tobacco product applications (i.e., SE Report,
SE exemption request, PMTA, MRTPA) and that pre-existing tobacco
products are manufactured consistent with their original
characteristics.
[[Page 15198]]
C. Buildings, Facilities, and Equipment
1. Personnel Practices
Proposed Sec. 1120.32 would require finished and bulk tobacco
product manufacturers to establish and maintain procedures for the
cleanliness, personal practices, and apparel of personnel. Under this
proposed requirement, the procedures must include requirements to
ensure that contact between the personnel and the tobacco product
manufacturer or the environment would not result in contamination of
the tobacco product. These proposed requirements are generally similar
to personnel practices that FDA has observed during establishment
inspections. Personnel can contaminate tobacco products by
unintentionally transferring bacteria, viruses, or disease through the
handling of tobacco products, and contamination (e.g., physical or
microbial) may occur at any time during the manufacturing process.
Therefore, this proposed rule would require each tobacco product
manufacturer to set up appropriate, consistent, and effective measures
to prevent personnel from contaminating tobacco products. Examples of
such measures for ``cleanliness, personal practices, and apparel'' can
include outer garment requirements, personal cleanliness, restrictions
on jewelry and other loose items, adequate hand washing before handling
a tobacco product, use of gloves, head coverings, or other protective
equipment, and daily checks on these practices.
This proposed requirement would help ensure that the public health
is protected by helping to prevent tobacco products from becoming
contaminated, which can adversely affect public health over and above
the risk normally associated with the use of the product. The proposed
requirements also would help assure that tobacco products are in
compliance with the requirements of chapter IX of the FD&C Act. These
measures would prevent a likely source of contamination and
nonconformity and help ensure that products are not manufactured under
insanitary conditions. Therefore, the requirements would help ensure
that products are not adulterated under section 902 of the FD&C Act.
2. Buildings, Facilities, and Grounds
Proposed Sec. 1120.34(a) would require finished and bulk tobacco
product manufacturers to ensure that any buildings and facilities used
in or for the manufacture, packaging, or storage of a tobacco product
are of suitable construction, design, and location to facilitate
cleaning and sanitation, maintenance, and proper operations. These
proposed requirements are generally similar to the controls for
buildings, facilities, and grounds in the industry recommendations, and
to practices that FDA has observed during establishment inspections.
The construction, design, and location of the physical plant
provide the infrastructure that enables a tobacco product manufacturer
to conduct its manufacturing operations. Therefore, this proposed rule
would require that each building and facility be maintained in an
appropriate condition to prevent tobacco product contamination. The
term ``suitable,'' as used in this provision, would mean that the
construction, design, and location of facilities would enable proper
cleaning and sanitizing, maintenance, and operation. Examples of
buildings and facilities that are inadequately constructed, designed or
located would include facilities that are constructed of particle board
that have exposed wood chips or flakes that could become a physical
hazard, facilities that are constructed of porous material and cannot
be adequately cleaned and sanitized, and buildings and facilities whose
equipment is so tightly placed that it prevents adequate cleaning and
maintenance of the building or facility. For the buildings and
facilities to facilitate ``proper operations'', they should be
constructed, designed, and located in a manner to facilitate the
logical flow of manufacturing activities from receipt and storage of
incoming materials, processing, packaging, and warehousing. FDA is not
proposing to require specific activities to satisfy this requirement;
rather the proposed rule is intended to provide flexibility for
manufacturers to determine what is appropriate based on the specific
manufacturing activities performed at the establishment.
Proposed Sec. 1120.34(a)(1) would require that buildings and
facilities have adequate lighting. FDA would consider this requirement
satisfied if lighting conditions enable the tobacco product
manufacturer to perform necessary manufacturing operations, including
cleaning, sanitation, and maintenance. Among other things, this
requirement is necessary to identify insanitary conditions that may not
be visible with inadequate lighting. For example, tobacco product
manufacturers may utilize visual inspection to remove NTRMs from the
production area and inadequate lighting may make it difficult for
personnel to identify and remove these materials. Manufacturers should
also take measures to make sure that lighting is not a source of
contamination. For example, lighting should not attract pests that can
contaminate or otherwise render the tobacco products adulterated or
misbranded under section 902 or 903 of the FD&C Act. Manufacturers
should cover lighting fixtures or use shatter-proof bulbs to prevent
tobacco products from becoming contaminated with glass shards if the
light bulbs shatter.
Proposed Sec. 1120.34(a)(2) would require that buildings and
facilities have adequate heating, ventilation, and cooling (HVAC). HVAC
equipment and systems are used to maintain the environmental conditions
of buildings and facilities. For example, a manufacturer may establish
temperature, relative humidity, and air flow conditions necessary for
storage, handling, or processing (such as mixing, cutting, or blending)
of tobacco product. Use of fans and other air-blowing equipment can
maintain air ventilation to minimize odors and vapors (including steam
and noxious fumes) in areas where they may contaminate product or
otherwise render product adulterated. This requirement would help
ensure that the HVAC equipment is designed and maintained to prevent
contamination of tobacco products. For example, manufacturers should
prevent conditions such as damaged or exposed HVAC duct insulation
hanging over processing equipment or leakage of hydraulic fluid from an
HVAC system on tobacco products that may contaminate tobacco products
(e.g., Ref. 31). While some tobacco product manufacturers may already
take such actions to control environmental conditions, these proposed
requirements would ensure that all manufacturers take these actions to
prevent contamination that could occur due to an inadequate HVAC
system.
Proposed Sec. 1120.34(a)(3) would require finished and bulk
tobacco product manufacturers to utilize adequate plumbing (including
control of drainage, backflow, sewage, and waste) to avoid being a
source of contamination or creating insanitary conditions. For example,
water pipes should be designed so condensation does not fall on the
tobacco product or tobacco product-contact surfaces, which can cause
contamination. In addition, floors cleaned with water (or water-soluble
products) should be designed with floor drains to facilitate adequate
drainage. Water by-products, sewage, and waste can be a source of
contamination if they touch a tobacco product-contact surface or become
a part of the tobacco product. Improper control of drainage, sewage,
and waste also can result in pooling and create insanitary conditions
or attract
[[Page 15199]]
pests that may contaminate tobacco products with filth. Filthy
conditions from improper control of drainage, sewage, and waste can be
transferred throughout the facility on shoes and equipment.
Proposed Sec. 1120.34(a)(4) would require that buildings and
facilities have adequate waste collection, storage, and disposal.
Adequate waste collection, storage, and disposal includes not creating
malodors that contaminate tobacco products or result in an attraction,
harborage, or breeding places for animals and pests. Trash bins should
have lids and be periodically emptied to help reduce the potential for
insanitary conditions from microbial contamination and pests.
Proposed Sec. 1120.34(a)(5) would require finished and bulk
tobacco product manufacturers to provide adequate readily accessible
handwashing and toilet facilities. The facilities must provide for
water at suitable temperatures and appropriate cleaning and sanitation
materials. FDA considers adequate hand-washing and toilet facilities to
have hand-cleaning and sanitizing preparation areas, towel service or
suitable drying stations, water control valves, appropriate signs,
shelving or hooks on which to rest garments while using the toilet, and
trash bins that are properly constructed and maintained. Handwashing
and sanitizing, when used with water at suitable temperatures and with
appropriate cleaning and sanitation materials, are an important means
of preventing tobacco product contamination by personnel.
Proposed Sec. 1120.34(b) would require finished and bulk tobacco
product manufacturers to maintain the facility grounds in a condition
to prevent contamination. The grounds consist of the actual physical
property where the buildings and facilities are located. Inadequately
maintained grounds can, for example, present a pest harborage area that
can be a source of contamination.
Proposed Sec. 1120.34(c) would require finished and bulk tobacco
product manufacturers to ensure that water used in the manufacturing
process, including water that is or may become part of the tobacco
product (e.g., water used as an ingredient or water used on a tobacco
product-contact surface) is potable, will not contaminate the tobacco
product, is maintained under positive pressure (e.g., to prevent back
siphonage that can draw water from a contaminated source into the water
supply system due to leaks or gaps in the mains, cross-connections, or
valves), and is supplied from sources that comply with all applicable
Federal, State, and local requirements. Water is commonly used in the
manufacture of tobacco products, and water that is untreated may be
contaminated with Escherichia coli (E. coli) and coliform bacteria. All
piping systems, hydrants, taps, faucets, hoses, buckets, and other
equipment used for the delivery of water that is used as an ingredient
or for use on tobacco product-contact surfaces, should be designed,
constructed, maintained, and operated in such a manner as to prevent
contamination of the water.
Under this proposal, the manufacturer's water supply should come
from a source for which adequate controls exist for testing, treatment,
and removal of contaminants (e.g., microbes and heavy metals).
Therefore, proposed Sec. 1120.34(c) would require that the water
be supplied from sources that comply with all applicable Federal,
State, and local requirements. For example, state governments have
water departments that administer the public water system and have
specific requirements to ensure that the water is safe for consumption
and use.
Proposed Sec. 1120.34(d) would require finished and bulk tobacco
product manufacturers to establish and maintain procedures for the
cleaning and sanitation of buildings, facilities, and grounds,
including procedures for the use of any cleaning compounds, sanitizing
agents, pesticide chemicals, rodenticides, insecticides, fungicides,
fumigating agents, and other toxic materials. An establishment's poor
cleaning and sanitation practices can increase the likelihood of
tobacco product contamination. A tobacco product manufacturer should
take into account the construction, design, and location of the
buildings and facilities as well as the manufacturing operations, when
establishing cleaning and sanitation procedures.
Specifically, proposed Sec. 1120.34(d)(1) would require that
manufacturers' cleaning and sanitation procedures detail the cleaning
schedules, equipment, and materials to be used in the cleaning and
sanitization, as appropriate, of the buildings, facilities, and
grounds.
Proposed Sec. 1120.34(d)(2) would require that these procedures
include measures to ensure that materials used for cleaning and
sanitation are identified, held, used, and stored in a manner to
protect against contamination of tobacco products and tobacco product-
contact surfaces. For example, FDA has observed on inspections that
cleaning and sanitation materials are sometimes stored in unmarked
containers in the manufacturing area (e.g., Ref. 32) and, consequently,
may be inadvertently used or mixed with tobacco product ingredients,
additives, or materials. This proposed provision would help prevent
this potential source of contamination. To help ensure that the use of
cleaning and sanitation materials are used in a manner that protects
against contamination, manufacturers should ensure that such materials
are appropriate for their intended purpose and nontoxic where possible.
Proposed Sec. 1120.34(d)(3) also would require that the use of
cleaning and sanitation materials comply with all applicable Federal,
State, and local requirements related to their application, use, or
storage. For example, hazardous cleaning and sanitation chemicals must
be handled, used, and stored in a manner consistent with the
information contained in their safety data sheets in accordance with
the hazard communication standard at 29 CFR 1910.1200(g).
Proposed Sec. 1120.34(e) would require finished and bulk tobacco
product manufacturers to establish and maintain procedures for
monitoring, controlling, and minimizing the presence of animals and
pests in the buildings, facilities, and grounds to protect against
contamination of tobacco products. This proposed requirement would be
limited to manufacturing activities and not extend to agricultural
activities including growing, cultivation, or curing of raw tobacco (21
U.S.C. 387). FDA acknowledges that tobacco is an agricultural crop and,
therefore, there is the likelihood that there will be a certain level
of animals and pests (such as tobacco beetles) in the tobacco. However,
it is important that manufacturers take appropriate action to control
these animals and pests, which can cause contamination (e.g., Refs. 33-
35). FDA is proposing that these procedures include requirements for
establishing threshold criteria for animals and pests. This provision
is intended to provide manufacturers with flexibility to quantitatively
establish acceptable levels of animals or pests, such as insects, that
may be present and the levels that would necessitate action to control
and minimize infestation in order to avoid contamination. Manufacturers
may employ pest control or fumigation to minimize the presence of
animals or pests (e.g., Ref. 36). This approach is recognized in the
Cooperation Centre for Scientific Research Relative to Tobacco's
(CORESTA's) Good Agricultural Practices Guidelines (Ref. 37).
[[Page 15200]]
This paragraph also would require that the procedures include a
requirement that any pesticide, including rodenticides, insecticides,
or fungicides used in the buildings, facilities, and grounds be
registered in accordance with the Federal Insecticide, Fungicide, and
Rodenticide Act (7 U.S.C. 136 et seq.) and used in accordance with its
label, as applicable and used in a manner that protects against
contamination. Pesticides, such as rodenticides, insecticides, or
fungicides are useful to manufacturers to monitor, control, and
minimize animals and pests effectively. The tobacco product
manufacturer should follow all applicable pesticide labels, identify
proper compounds to be used, use the correct concentration, and apply
it as directed to avoid contamination (e.g., Refs. 38-40). Use of
inappropriate pest control chemicals or use in an inappropriate manner
can contaminate tobacco products (e.g., Refs. 39-41).
Proposed Sec. 1120.34(f) would require finished and bulk tobacco
product manufacturers to maintain records of cleaning and sanitation
and animal and pest control activities required under this section.
These records would be required to include the date and time, the
individual performing the activity, the type of activity performed, any
information demonstrating the requirement was met, and any data or
calculations necessary to reconstruct the results. We believe these
records are necessary for tobacco product manufacturers to ensure that
the required activities have been conducted and for FDA to verify that
the activities have been adequately performed.
The proposed requirements for buildings, facilities, and grounds
would help assure that the public health is protected by helping to
prevent tobacco product contamination by, among other things, toxic
cleaning compounds, inadequate maintenance, or cross-contamination from
inadequate cleaning (e.g., Refs. 42-44). Insanitary conditions can
create the potential for growth of microorganisms that may render
tobacco products injurious to health beyond what is normally associated
with tobacco products (e.g., Refs. 45 and 46).
These proposed requirements also would help assure that tobacco
products are in compliance with the requirements of chapter IX of the
FD&C Act by helping to ensure that tobacco products are not ``prepared,
packed, or held under insanitary conditions'' that may contaminate
tobacco products and render them adulterated under section 902 of the
FD&C Act. As discussed above, inadequate or inappropriate maintenance,
cleaning and sanitizing procedures, or animal and pest control may
result in conditions that can adulterate tobacco products.
3. Equipment
Proposed Sec. 1120.36(a) would require finished and bulk tobacco
product manufacturers to ensure all equipment is appropriately designed
and constructed, and is suitable for its intended purpose. These
proposed requirements are generally similar to the equipment controls
in the industry recommendations and to controls that FDA has observed
during establishment inspections. The term ``equipment'' means any
machinery, tool, instrument, utensil, or other similar or related
article, used in the manufacture, preproduction design validation,
packing, or storage of a tobacco product. Equipment that is
appropriately designed, constructed, and suitable for its intended
purpose is designed and constructed in a manner that facilitates its
function, use, maintenance, and cleaning. For example, under this
proposal, a tobacco cutter would be required to be designed and
constructed to enable use, cleaning, and maintenance (e.g., inspection
and replacement of its cutting blade). It would also be required to be
suitable for its intended purpose to cut tobacco to particular
specifications (e.g., different cut sizes).
Proposed Sec. 1120.36(b) would require finished and bulk tobacco
product manufacturers to establish an
[…truncated; see source link]Indexed from Federal Register on March 10, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.