Document ID: FDA-2022-D-0490-0373
Agency: fda
Document Type: Notice
Title: Policy Regarding N-acetyl-L-cysteine; Guidance for Industry; Availability
Posted Date: 2022-08-02T04:00Z

[Federal Register Volume 87, Number 147 (Tuesday, August 2, 2022)]
[Notices]
[Pages 47220-47221]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
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 https://www.regulations.gov.
     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:
     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.
     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 https://www.regulations.gov or at the Dockets Management 
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
     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 https://www.regulations.gov. 
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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov 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

[[Page 47221]]

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 https://www.fda.gov/FoodGuidances, https://www.fda.gov/CosmeticGuidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov. 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