Indications that our advocacy is working to protect access to n-acetylcysteine (NAC), a precursor to glutathione and an important antioxidant. Action Alert!
Recently, the FDA issued a final guidance describing how it will treat NAC supplements. It remains largely unchanged from the draft version of this guidance we reported on in May of this year in that it describes how the agency is considering a rulemaking to legalize the sale of NAC supplements. But an important update in the guidance signals we are another step closer to a huge win.
Recall that, in the FDA’s view, NAC is not a legal supplement because the agency argues it was first approved as a drug. After significant stakeholder backlash, the agency said it was “likely to consider” a rulemaking to legalize NAC supplements despite its approval as a drug pending a safety review.
Here’s the important update in the final version of the guidance:
While FDA’s full safety review of NAC remains ongoing, our initial review has not revealed safety concerns with respect to the use of this ingredient in or as a dietary supplement. In addition, NAC-containing products represented as dietary supplements have been sold in the U.S. for over 30 years, and consumers continue to seek access to such products [emphasis added].
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.
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.
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.