FDA Releases Draft NAC Supplement Guidelines
The FDA on Thursday announced the availability of draft guidelines that, if finalized, would indicate “the agency’s intention to exercise its enforcement discretion” regarding the distribution and sale of products. labeled as dietary supplements and containing NAC (N-acetyl-L-cysteine).
The draft guidelines, to be published April 22 in the Federal Register, were released three weeks after the FDA reaffirmed its position in response to two citizen petitions that NAC is excluded from the definition of a supplement. food because the ingredient was first approved as a drug in 1963.
The FDA, however, is still considering initiating regulations to allow the use of NAC in supplements. To date, the agency has not identified any safety issues related to the ingredient.
“The discretionary enforcement policy would apply to products that would be legally marketed dietary supplements if NAC were not excluded from the definition of “dietary supplement” and are not otherwise in violation of the FD&C [Federal Food, Drug & Cosmetic] Act,” the FDA said in the draft guidance, which was announced via a constituents update.
Unless the FDA identifies “safety concerns” during its ongoing review, the agency said it intends to “exercise enforcement discretion” until that it has completed the development of notice and comment rules to permit the use of NAC in supplements or that it denies the regulatory application.
“Although our full safety review of NAC is ongoing, our initial review did not reveal any safety concerns regarding the use of this ingredient in or as a dietary supplement,” the FDA said in the statement. draft guidelines. “Additionally, NAC-containing products marketed as dietary supplements have been sold in the United States for over 30 years, and consumers continue to seek access to these products.”
The FDA said it would notify stakeholders by withdrawing or revising the guidance if it determines the enforcement discretion policy is no longer appropriate.
To ensure that FDA considers comments on the draft guidance before beginning work on a final document, the agency requested electronic or written comments within 30 days of posting the draft guidance in the Federal Register.
Although the draft guidelines, when finalized, will represent the FDA’s current thinking on NAC products labeled as dietary supplements, the guidelines do not create any rights for anyone and are not binding on the FDA or the public, the statement said. ‘agency.