[Federal Register Volume 87, Number 78 (Friday, April 22, 2022)]
[Notices]
[Pages 24170-24172]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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Policy Regarding N-acetyl-L-cysteine: Draft Guidance for 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availability of a draft guidance for industry entitled ``Policy 
Regarding N-acetyl-L-cysteine: Draft Guidance for Industry.'' The draft 
guidance, when finalized, will explain our intent to exercise 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DATES: Submit either electronic or written comments on the draft 
guidance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by May 23, 2022 to ensure that we consider your comment on the draft 
guidance before we begin work on the final version of the guidance.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:
     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-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 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.'' 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 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 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

[[Page 24172]]

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 https://www.fda.gov/FoodGuidances, 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: 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