FDA Releases Draft Guidance on Enforcement Discretion for Certain NAC Products

FDA Releases Draft Guidance on Enforcement Discretion for Certain NAC Products

NAC Products Dietary Supplements

Navigating the FDA and NAC regulations can be intimidating, but with the right information and guidance, you’ll be able to understand and comply with all applicable rules. In this article, we’ll provide a comprehensive overview of the FDA and NAC regulations so you can ensure your product meets all necessary requirements.

What is the NAC?

The NAC, or the Dietary Supplement Health and Education Act of 1994, is legislation that establishes guidelines for dietary supplements within the United States. This legislation sets standards to ensure a product’s safety and requires labels to accurately reflect the desired uses of an herbal supplement. It also requires manufacturers to provide appropriate information regarding the manufacturing process and ingredients used in a supplement.

What’s New?

On April 22, 2022, the U.S. Food and Drug Administration (FDA) announced the release of a draft guidance on the policy regarding products labeled as dietary supplements that contain N-acetyl-L-cysteine (NAC).

The draft guidance, when finalized, will outline how the FDA will exercise enforcement discretion with respect to the sale and distribution of certain NAC-containing dietary supplements. The enforcement policy would apply to products that would be lawfully marketed as dietary supplements if NAC were not excluded from the definition of “dietary supplement” and are not otherwise in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Background

Historically, the FDA has determined that NAC is excluded from the dietary supplement definition under the FD&C Act because NAC was approved as a new drug before it was marketed as a dietary supplement or as a food. With regards to the drug classification, N-acetyl-L-cysteine (NAC) has been approved by the FDA to treat liver side effects from an overdose of Tylenol (acetaminophen), and to loosen the thick mucus in the lungs of people with cystic fibrosis or chronic obstructive pulmonary disease.

The FDA received two citizen petitions asking the agency to reconsider its position on the use of NAC as a dietary supplement and has since been conducting a review of the ingredient and any potential safety concerns. If the FDA does not identify safety-related concerns following a review of the available data and information on NAC, a rule may be proposed providing that NAC is not excluded from the definition of dietary supplement.

NAC-containing products represented as dietary supplements have been sold in the United States for over 30 years and consumers continue to seek access to such products. In the interim, the FDA issued this draft guidance to explain the policy regarding products labeled as dietary supplements that contain NAC.

Tips for Compliance with NAC and FDA Regulations:

Following a strict set of NAC and FDA regulations is crucial for ensuring the safety of dietary supplements on the market. Manufacturers should have familiarization with each regulation, maintain accurate records and verify the product’s claims. Additionally, ensure proper packaging and labeling to meet regulatory standards while also adding clarity and transparency to product information.

It’s also important to be aware of special requirements for products marketed across state lines, as well as regulations applicable to combinations of products or marketing techniques.

Preparing Documents to Satisfy NAC and FDA Requirements:

Manufacturers should keep detailed documents to meet NAC and FDA requirements. This includes a record of each step in the manufacturing process, which must be maintained to demonstrate the company’s safety standards and production processes comply with the regulations.

Copies of invoices, labels, certificates of analysis, and other relevant documents should be kept for audit purposes. Furthermore, proper inspection and testing records should be created and kept on file to prove that products conform to established standards before being released into markets.

Conclusion

Unless the FDA identifies safety-related concerns on the use of NAC in dietary supplements, the FDA would intend to exercise enforcement discretion (as described in the draft guidance) until either of the following occurs: completion of notice-and-comment rulemaking to allow the use of NAC in or as a dietary supplement or denying the citizen petition’s request for rulemaking. If the FDA determines that this enforcement discretion policy is no longer appropriate, stakeholders will be notified by withdrawing or revising the guidance.

How we can help

The experts at Quality Smart Solutions offer regulatory compliance support for dietary supplements label compliance, foods, cosmetics, OTC drugs, and medical devices in North America.

Contact us today to learn more about how we can support your compliance needs during and after licensing!

Need compliance help regulating your dietary supplements including the New Dietary Ingredient Notification (NDIN)? Contact Quality Smart Solutions today! We can help.  Email us at info@qualitysmartsolutions.com, or call us at 1-800-396-5144.  We would be happy to serve your compliance needs.

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