An update from the FDA shows our advocacy to defend access to a critical antioxidant supplement is working. Action Alert!
The FDA recently released a guidance on the agency’s policy towards N-acetyl-L-cysteine (NAC), a critical antioxidant supplement. It reiterates some of the points we covered in an earlier update on NAC, with a key addition: barring any issues that arise during a safety review currently being conducted, the agency is “likely to propose a rule providing that NAC is not excluded from the definition of dietary supplement.” We may be on the cusp of a huge victory in protecting access to affordable NAC supplements.
We can’t emphasize enough how great a win this would be. Such a rulemaking for NAC would be momentous because it has never been done before. Not only would it be a victory for NAC, but it would set a precedent that could be used to protect access to other supplement ingredients in the future, like CBD for example.
Recall from our previous coverage that the agency has stated in warning letters to supplement makers that NAC does not meet the definition of a supplement because it was approved as a drug first in 1963.
We, and many others, believe there are many issues with the FDA’s legal arguments that NAC is not a supplement. It has a lot to do with recent excitement about NAC in the drug industry, with dozens of ongoing clinical trials looking at NAC to treat a variety of conditions and the FDA setting the stage for a new NAC drug to come to market by removing the competition from much cheaper NAC supplements.
Both the grassroots and industry have pushed back hard on the FDA’s position, forcing the agency to pivot and rethink its policy. Thank you to all ANH members who have helped us take a stand for NAC.
The guidance also explains that, during this review period, the agency will exercise enforcement discretion against legally marketed NAC supplements—meaning the agency won’t pull products from the market based on their determination that NAC is not a legal supplement. Despite this leniency, the FDA’s stance has made it more difficult to access NAC. Last year, Amazon announced its plans to remove NAC supplements from its website. We’ve also heard reports that PayPal will not process payments that contain NAC supplements.
It’s still possible the FDA could, in its review, find some bogus safety issues with NAC that would prevent the rulemaking solidifying its stance as a supplement. But the FDA’s words in the guidance are encouraging, and we should thank the agency for contemplating a rulemaking to protect access to a crucial supplement.
Action Alert! Thank the FDA for considering a rulemaking to protect access to affordable NAC supplements. Please send your message immediately.
