Notice2022-08560
Policy Regarding N-acetyl-L-cysteine: Draft Guidance for Industry; Availability
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
April 22, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled "Policy Regarding N-acetyl-L-cysteine: Draft Guidance for Industry." The draft guidance, when finalized, will explain our intent to exercise enforcement discretion with respect to the sale and distribution of certain products that contain N-acetyl-L-cysteine (NAC) and are labeled as dietary supplements. This enforcement discretion policy would apply to products that would be lawfully marketed dietary supplements if NAC were not excluded from the definition of "dietary supplement" and that are not otherwise in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Full Text
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<title>Federal Register, Volume 87 Issue 78 (Friday, April 22, 2022)</title>
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[Federal Register Volume 87, Number 78 (Friday, April 22, 2022)]
[Notices]
[Pages 24170-24172]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-08560]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-D-0490]
Policy Regarding N-acetyl-L-cysteine: Draft Guidance for
Industry; Availability
AGENCY: Food and Drug Administration, Health and Human Services (HHS).
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of a draft guidance for industry entitled ``Policy
Regarding N-acetyl-L-cysteine: Draft Guidance for Industry.'' The draft
guidance, when finalized, will explain our intent to exercise
enforcement discretion with respect to the sale and distribution of
certain products that contain N-acetyl-L-cysteine (NAC) and are labeled
as dietary supplements. This enforcement discretion policy would apply
to products that would be lawfully marketed dietary supplements if NAC
were not excluded from the definition of ``dietary supplement'' and
that are not otherwise in violation of the Federal Food, Drug, and
Cosmetic Act (FD&C Act).
DATES: Submit either electronic or written comments on the draft
guidance
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by May 23, 2022 to ensure that we consider your comment on the draft
guidance before we begin work on the final version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time 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-2022-D-0490for ``Policy Regarding N-acetyl-L-cysteine: Draft
Guidance for Industry.'' 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.'' We will review
this copy, including the claimed confidential information, in our
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 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.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of the draft guidance to
the Office of Dietary Supplement Programs, Center for Food Safety and
Applied Nutrition, Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740. Send two self-addressed adhesive labels to
assist that office in processing your request. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance.
FOR FURTHER INFORMATION CONTACT: Gerie Voss, Center for Food Safety and
Applied Nutrition (HFS-810), Food and Drug Administration, 5001 Campus
Dr., College Park, MD 20740, 240-620-9744; or Lauren Ferguson Baham,
Center for Food Safety and Applied Nutrition, Office of Regulations and
Policy (HFS-024), Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740, 240-402-2378.
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of a draft guidance for industry
entitled ``Policy Regarding N-acetyl-L-cysteine: Draft Guidance for
Industry.'' We are issuing the draft guidance consistent with our good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on this topic. It
does not establish any rights for any person and is not binding on FDA
or the public. You can use an alternate approach if it satisfies the
requirements of the applicable statutes and regulations.
FDA has determined that, under section 201(ff)(3)(B)(i) of the FD&C
Act (21 U.S.C. 321(ff)(3)(B)(i)), NAC is excluded from the dietary
supplement definition because NAC was approved as a new drug before it
was marketed as a dietary supplement or as a food. FDA received two
citizen petitions requesting that we conclude that NAC is not excluded
from the definition of dietary supplement under section 201(ff)(3)(B)
of the FD&C Act. On March 31, 2022, we denied this request.
In addition, one of the citizen petitions asked FDA ``to recommend
and support to the Secretary of HHS'' that he issue a regulation that
would determine NAC to be lawful under the FD&C Act. As we stated in
our response to the citizen petitions, we have not yet reached a final
decision on this request, but we are considering initiating rulemaking
under section 201(ff)(3)(B) of the FD&C Act to permit the use of NAC in
or as a dietary supplement (i.e., to provide by regulation that NAC is
not excluded from the definition of dietary supplement), and, if, among
other considerations, FDA does not identify safety-related concerns as
we continue our review of the available data and information, we are
likely to propose a rule providing that NAC is not excluded from the
definition of dietary supplement. While our full safety review of NAC
remains ongoing, our initial review has not revealed safety concerns
with respect to the use of this ingredient in or as a dietary
supplement. In addition, NAC-containing products represented as dietary
supplements have been sold in the United States for more than 30 years,
and consumers continue to seek access to such products.
Accordingly, the draft guidance, if finalized, would state our
intent to exercise enforcement discretion with respect to the sale and
distribution of
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certain products that contain NAC and are labeled as dietary
supplements. The enforcement discretion policy would apply to products
that would be lawfully marketed dietary supplements if NAC were not
excluded from the definition of ``dietary supplement'' and that are not
otherwise in violation of the FD&C Act. Unless we identify safety-
related concerns during our ongoing review, FDA would intend to
exercise enforcement discretion until either of the following occurs:
we complete notice-and-comment rulemaking to allow the use of NAC in or
as a dietary supplement (if we move forward with such proceedings), or
we deny the citizen petition's request for rulemaking. Should we
determine that this enforcement discretion policy is no longer
appropriate, we will notify stakeholders by withdrawing or revising
this guidance in accordance with 21 CFR 10.115.
II. Paperwork Reduction Act of 1995
FDA tentatively concludes that this draft guidance contains no
collection of information. Therefore, clearance by the Office of
Management and Budget under the Paperwork Reduction Act of 1995 is not
required.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at <a href="https://www.fda.gov/FoodGuidances">https://www.fda.gov/FoodGuidances</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Use the FDA website listed in the previous
sentence to find the most current version of the guidance.
Dated: April 15, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-08560 Filed 4-21-22; 8:45 am]
BILLING CODE 4164-01-P
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