Notice2024-10055
Modified Risk Tobacco Product Application: Renewal Application for IQOS 3.0 System Holder and Charger, Heated Tobacco Product, Submitted by Philip Morris Products S.A.
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
May 10, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing an opportunity to provide public comment on a modified risk tobacco product application (MRTPA). The application is for renewal of an existing modified risk tobacco product (MRTP) order for the IQOS 3.0 System Holder and Charger, a Heated Tobacco Product (HTP), submitted by Philip Morris Products S.A.
Full Text
<html>
<head>
<title>Federal Register, Volume 89 Issue 92 (Friday, May 10, 2024)</title>
</head>
<body><pre>
[Federal Register Volume 89, Number 92 (Friday, May 10, 2024)]
[Notices]
[Pages 40487-40488]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-10055]
[[Page 40487]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0408]
Modified Risk Tobacco Product Application: Renewal Application
for IQOS 3.0 System Holder and Charger, Heated Tobacco Product,
Submitted by Philip Morris Products S.A.
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity to provide public comment on a modified risk tobacco
product application (MRTPA). The application is for renewal of an
existing modified risk tobacco product (MRTP) order for the IQOS 3.0
System Holder and Charger, a Heated Tobacco Product (HTP), submitted by
Philip Morris Products S.A.
DATES: Electronic or written comments on the application may be
submitted beginning May 10, 2024. FDA will establish a closing date for
the comment period as described in section I.
ADDRESSES: You may submit comments as follows:
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-2021-N-0408 for ``Modified Risk Tobacco Product Application:
Renewal application for the IQOS 3.0 System Holder and Charger, Heated
Tobacco Product (HTP), Submitted by Philip Morris Products S.A.''
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="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read 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.
FOR FURTHER INFORMATION CONTACT: Adrian Mixon or Dhanya John, Office of
Regulations, Center for Tobacco Products, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993-
0002, 1-877-287-1373, email: <a href="/cdn-cgi/l/email-protection#296a7d797b4c4e5c45485d4046475a694f4d480741415a074e465f"><span class="__cf_email__" data-cfemail="0e4d5a5e5c6b697b626f7a6761607d4e686a6f2066667d20696178">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Section 911 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
(21 U.S.C. 387k) addresses the marketing and distribution of MRTPs.
MRTPs are tobacco products that are sold or distributed for use to
reduce harm or the risk of tobacco-related disease associated with
commercially marketed tobacco products. Section 911(a) of the FD&C Act
prohibits the introduction or delivery for introduction into interstate
commerce of any MRTP unless an order issued by FDA pursuant to section
911(g) of the FD&C Act is effective with respect to such product.
Section 911(d) of the FD&C Act describes the information that must
be included in a MRTPA, which must be filed and evaluated by FDA before
an applicant can receive an order from FDA. FDA is required by section
911(e) of the FD&C Act to make a MRTPA available to the public (except
for matters in the application that are trade secrets or otherwise
confidential commercial information) and to request comments by
interested persons on the information contained in the application and
on the label, labeling, and advertising accompanying the application.
The determination of whether an order is appropriate under section 911
of the FD&C Act is based on the scientific information submitted by the
applicant as well as the scientific evidence and other information that
is made available to the Agency, including through public comments.
Section 911(g) of the FD&C Act describes the demonstrations
applicants must make to obtain an order from FDA under either section
911(g)(1) or (2). The applicant, Philip Morris Products S.A., is
seeking a renewal under section 911(g)(2) of an order previously issued
under section 911(g)(2) of the FD&C Act.
FDA may issue an order under section 911(g)(2) of the FD&C Act with
respect to a tobacco product that does not
[[Page 40488]]
satisfy the section 911(g)(1) standard. A person seeking an order under
section 911(g)(2) of the FD&C Act must show that:
<bullet> Such an order would be appropriate to promote the public
health;
<bullet> Any aspect of the label, labeling, and advertising for the
product that would cause the product to be an MRTP is limited to an
explicit or implicit representation that the tobacco product or its
smoke does not contain or is free of a substance or contains a reduced
level of a substance, or presents a reduced exposure to a substance in
tobacco smoke;
<bullet> Scientific evidence is not available and, using the best
available scientific methods, cannot be made available without
conducting long-term epidemiological studies for an application to meet
the standards for obtaining an order under section 911(g)(1) of the
FD&C Act;
<bullet> The scientific evidence that is available without
conducting long-term epidemiological studies demonstrates that a
measurable and substantial reduction in morbidity or mortality among
individual tobacco users is reasonably likely in subsequent studies;
<bullet> The magnitude of overall reductions in exposure to the
substance or substances which are the subject of the application is
substantial, such substance or substances are harmful, and the product
as actually used exposes consumers to the specified reduced level of
the substance or substances;
<bullet> The product as actually used by consumers will not expose
them to higher levels of other harmful substances compared to the
similar types of tobacco products then on the market unless such
increases are minimal and the reasonably likely overall impact of use
of the product remains a substantial and measurable reduction in
overall morbidity and mortality among individual tobacco users;
<bullet> Testing of actual consumer perception shows that, as the
applicant proposes to label and market the product, consumers will not
be misled into believing that the product is or has been demonstrated
to be less harmful or presents or has been demonstrated to present less
of a risk of disease than one or more other commercially marketed
tobacco products; and
<bullet> Issuance of the exposure modification order is expected to
benefit the health of the population as a whole taking into account
both users of tobacco products and persons who do not currently use
tobacco products.
Section 911(g)(4) of the FD&C Act describes factors that FDA must
take into account in evaluating whether a tobacco product benefits the
health of individuals and the population as a whole.
FDA is issuing this notice to inform the public that the MRTPA for
the following product submitted by Philip Morris Products S.A. has been
filed and is being made available for public comment:
<bullet> MR0000254.PD3: IQOS 3.0 System Holder and Charger
The applicant is seeking renewal of the authorization to market the
IQOS 3.0 System Holder and Charger, a product that previously received
authorization under section 911(g)(2) of the FD&C Act \1\ to be
marketed as a modified risk tobacco product with reduced exposure
claims. For purposes of premarket review, FDA has identified these
tobacco products as heated tobacco products (HTPs). HTPs meet the
definition of a cigarette, but the tobacco is heated and not combusted
(products that do not exceed 350[deg] C). The applicant is including
information from the previous MRTPA by cross-reference.
---------------------------------------------------------------------------
\1\ The notice of availability for the IQOS 3 System Holder and
Charger MRTPA that received a modified risk granted order appeared
in the Federal Register of May 14, 2021 (86 FR 26530), and the
docket containing notices and public comments, FDA-2021-N-0408, is
accessible at: <a href="https://www.regulations.gov/document/FDA-2021-N-0408-0001">https://www.regulations.gov/document/FDA-2021-N-0408-0001</a>.
---------------------------------------------------------------------------
FDA will post the application documents, including any amendments,
to its website for the MRTPAs (see section II) for public comment on a
rolling basis as they are redacted in accordance with applicable laws.
In this document, FDA is announcing the availability of the first batch
of application documents for public comment. FDA intends to establish a
closing date for the comment period that is both at least 180 days
after the date of this notice and at least 30 days after the final
documents from the application are made available for public comment.
FDA will announce the closing date at least 30 days in advance. FDA
believes that this comment period is appropriate given the volume and
complexity of information in the MRTPA that has not been available for
public comment as part of the previously authorized MRTPA for the IQOS
system.
FDA will notify the public about the availability of additional
application documents and comment period closing date via the Agency's
web page for the MRTPA (see section II) and by other means of public
communication, such as by email to individuals who have signed up to
receive email alerts. To receive email alerts, visit FDA's email
subscription service management website (<a href="https://www.fda.gov/about-fda/contact-fda/get-email-updates">https://www.fda.gov/about-fda/contact-fda/get-email-updates</a>), provide an email address, scroll down
to the ``Tobacco'' heading, select ``Modified Risk Tobacco Product
Application Update'', and click ``Submit.'' FDA does not intend to
issue additional notices in the Federal Register regarding the
availability of additional application documents, including amendments,
or the comment period for this MRTPA. To encourage public participation
consistent with section 911(e) of the FD&C Act, FDA is making the
redacted MRTPAs that are the subject of this notice available
electronically (see section II).
II. Electronic Access
Persons with access to the internet may obtain the document(s) at
<a href="https://www.fda.gov/tobacco-products/advertising-and-promotion/philip-morris-products-sa-modified-risk-tobacco-product-mrtp-applications">https://www.fda.gov/tobacco-products/advertising-and-promotion/philip-morris-products-sa-modified-risk-tobacco-product-mrtp-applications</a>.
Dated: May 3, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-10055 Filed 5-9-24; 8:45 am]
BILLING CODE 4164-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on May 10, 2024.
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.