The Council for Responsible Nutrition has responded to FDA regarding recent warning letters from the Agency alleging that N-acetyl-L-cysteine (NAC) is not a dietary supplement, and therefore prohibited from being marketed as such under the Federal Food, Drug, and Cosmetic Act.
Photo © iStockphoto.com/ Kuzma
The Council for Responsible Nutrition (CRN; Washington, D.C.) has responded to FDA regarding recent warning letters from the Agency alleging that N-acetyl-L-cysteine (NAC) is not a dietary supplement, and therefore prohibited from being marketed as such under the Federal Food, Drug, and Cosmetic Act (FDCA). It is CRN’s opinion that the policy is legally invalid and represents a drastic departure from its previous policy that has allowed manufacturers to safely market products with NAC as supplements.
FDA asserted in multiple warning letters that NAC was approved as a new drug in 1963, and was not to the Agency’s knowledge marketed as a dietary supplement before that time. This would mean that NAC does not qualify for a drug preclusion clause, and is therefore unlawful as a dietary supplement under Section 201(ff)(3)(B)(i) of the FDCA. In its letter to FDA, CRN argues that the sudden policy change is invalid because it unclear whether FDCA section 201(ff)(3)(B)(i) applies to NAC because the records of NAC’s drug approval contains unreliable and conflicting information. For example, the warning letters cite a 1963 date for drug approval, while a different document CRN found states that NAC was approved as a drug in 1985.
CRN also argues that NAC drugs approved prior to 2016 appear to be comprised of different forms of NAC compared to those found in dietary supplements. According to CRN, NAC drug approval records indicate that no NAC drugs were approved for oral use until 2016, well after supplement companies began marketing NAC in supplements. Additionally, CRN argues that interpreting FDCA section 201(ff)(3)(B)(i) to prohibit the marketing of supplements containing NAC, “violates the well-established presumption against statutory retroactivity.”
CRN’s full letter can be viewed here.
What's next for NPA and CRN in their complaints against New York state?
May 2nd 2024The latest updates in the efforts of the Natural Products Association and the Council for Responsible Nutrition to sue New York state for its law banning the sale of weight management and muscle building supplements to minors.
Judge denies CRN’s motion for preliminary injunction but its lawsuit against NY state will proceed
April 23rd 2024The judge in CRN's lawsuit against NY state's law banning the sale of weight management and muscle building supplements to minors has denied its motion for a preliminary injunction, but determined that CRN has standing to sue on behalf of its members.
CRN NY State lawsuit update: Dispatch from SupplySide East 2024
April 18th 2024CRN's Steve Mister updates Nutritional Outlook about its ongoing litigation against NY State. The organization sued the state to prevent the enforcement of law that bans sale of weight management supplements to minors.
U.S. Hemp Authority announces Adult Use Hemp Product Certification Program
April 15th 2024The U.S. Hemp Authority (USHA) has announced the launch of its Adult Use Hemp Product Certification Program in an effort to “reshape public policy around hemp, and to build confidence among retailers and consumers alike.”