Notice2022-16499
Policy Regarding N-acetyl-L-cysteine; 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
August 2, 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 final guidance for industry entitled "Policy Regarding N-acetyl-L-cysteine." The guidance explains 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 applies 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 147 (Tuesday, August 2, 2022)</title>
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[Federal Register Volume 87, Number 147 (Tuesday, August 2, 2022)]
[Notices]
[Pages 47220-47221]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-16499]
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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; Guidance for Industry;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of a final guidance for industry entitled ``Policy
Regarding N-acetyl-L-cysteine.'' The guidance explains 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 applies 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: The announcement of the guidance is published in the Federal
Register on August 2, 2022.
ADDRESSES: You may submit either electronic or written comments on FDA
guidances 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-0490 for ``Policy Regarding N-acetyl-L-cysteine: 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.'' The Agency 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 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 guidance.
FOR FURTHER INFORMATION CONTACT: Lisa Bieniek, Center for Food Safety
and Applied Nutrition, Office of Dietary Supplements and Programs (HFS-
810), Food and Drug Administration, 5001 Campus Dr., College Park, MD
20740, 240-402-4528; or Lauren 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 guidance for industry
entitled ``Policy Regarding N-acetyl-L-cysteine: Guidance for
Industry.'' We are issuing this guidance consistent with our good
guidance practices regulation (21 CFR 10.115). The guidance represents
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 alternative approach if it satisfies the requirements of the
applicable statutes and regulations.
In the Federal Register of April 22, 2022 (87 FR 24170), we made
available a draft guidance for industry entitled ``Policy Regarding N-
acetyl-L-cysteine: Draft Guidance for Industry,'' which explained our
intent to exercise enforcement discretion with respect to the sale and
distribution of certain products that contain NAC and are labeled as
dietary supplements. In the draft guidance, we explained FDA determined
that, under section
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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. We described that FDA denied 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.
In addition, we described that one citizen petition asked FDA to
issue a regulation that would determine NAC to be lawful under the FD&C
Act. We described that we have not yet reached a final decision on this
request, but 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). If, among other
considerations, we do 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.
We gave interested parties an opportunity to submit comments by May
23, 2022, to ensure their comments would be considered before we began
work on the final version of the guidance. We received comments on the
draft guidance that misinterpreted the guidance as converting NAC into
a ``drug'' under the FD&C Act. Our guidance does not convert NAC into a
``drug'' under the FD&C Act. Rather, our guidance states our intent to
exercise enforcement discretion with respect to the sale and
distribution of certain products that contain NAC and are labeled as
dietary supplements. We also received comments that supported our
intent to exercise enforcement discretion with respect to the sale and
distribution of certain products that contain NAC and are labeled as
dietary supplements, as well as comments that supported possible
notice-and-comment rulemaking to allow the use of NAC in or as a
dietary supplement. After careful review and consideration of the
comments to the draft guidance, we are finalizing the guidance without
substantive change.
As discussed in the guidance, the enforcement discretion policy
applies 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 intends
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 withdraw or revise this guidance in
accordance with 21 CFR 10.115.
The guidance announced in this notice finalizes the draft guidance,
dated April 2022.
II. Paperwork Reduction Act of 1995
FDA concludes that this 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 guidance at
either <a href="https://www.fda.gov/FoodGuidances">https://www.fda.gov/FoodGuidances</a>, <a href="https://www.fda.gov/CosmeticGuidances">https://www.fda.gov/CosmeticGuidances</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: July 27, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-16499 Filed 8-1-22; 8:45 am]
BILLING CODE 4164-01-P
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