87 FR 147 pgs. 47220-47221 - Policy Regarding N-acetyl-L-cysteine; Guidance for Industry; Availability
Type: NOTICEVolume: 87Number: 147Pages: 47220 - 47221
Pages: 47220, 47221Docket number: [Docket No. FDA-2022-D-0490]
FR document: [FR Doc. 2022-16499 Filed 8-1-22; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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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.
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.
[top] 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
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]
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