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The Latest on NAC

The Latest on NAC

Two important updates on the future of NAC, a critical antioxidant supplement—and why we need to keep fighting for access. Action Alert!

FDA Denies NAC Citizens Petition

Last week, the FDA denied two Citizens Petitions from the supplement industry requesting the agency reach a determination that N-acetyl-L-cysteine (NAC) is included in the definition of a dietary supplement. 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. We think it has a lot to do with recent excitement about NAC in the drug industry: a drug company is investigating NAC as a treatment for a rare genetic disorder that damages the myelin sheath, which insulates nerve cells in the brain. The Phase 1 trial was completed in March 2020. There are 17 trials looking at NAC, in both drug and supplement form, in the treatment of COVID. Additionally, there are over 50 trials looking at NAC for a variety of other conditions. Given these facts, it seems reasonable to assume that the FDA is setting the stage for a new NAC drug to come to market by removing the competition from much cheaper NAC supplements. 

FDA Dangles the Axe over NAC

In the same Constituent Update denying the Citizens Petitions, the FDA said it is “considering exercising enforcement discretion” regarding NAC supplements as it decides whether to issue a rulemaking allowing NAC to be a legal supplement. Translation: NAC supplements may be safe from FDA enforcement…for now. But until the legality of NAC supplements is established, the FDA could act at any time to remove them from the market.

Despite this tentative determination, much damage has already been done. 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.

We cannot wait for the FDA to act. We must continue to push Congress to take action to protect NAC.

Action Alert! Tell Congress to protect NAC supplements. Please send your message immediately.

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One thought on “The Latest on NAC

  • Brik

    Why do I see no mention in these petitions to FDA that NAC cannot be banned because it is naturally occurring in food. “N-acetylcysteine (also known as N-acetyl-cysteine, NAC) is a precursor to the amino acid L-cysteine and consequently the antioxidant glutathione (GSH) [1]. It is most notably found in plants of the Allium species, especially in the onion (Allium cepa, 45 mg NAC/kg) [2,3].
    “https://www.mdpi.com/2076-3921/8/5/111/htm#:~:text=N%2Dacetylcysteine%20(NAC)%2C,as%20an%20antidote%20in%20poisonings.”

    FDA law states, “For substances used in food prior to January 1, 1958, a grandfather clause allows experience based on common use in food to be used in asserting an ingredient is safe under the conditions of their intended use.” Since NAC was found in food, it is therefore grandfathered in as a GRAS (Generally Recognized as Safe) ingredient.

    “”The GRAS List”
    1958 Food Additives Amendment: Congress recognized that many food substances would not require a formal premarket review by FDA to assure their safety, either because:
    Their safety had been established by a long history of use in food; or
    By virtue of the nature of the substances, their conditions of use, and the information generally available to scientists.
    Two-step definition of “food additive:”
    Broadly includes any substance that becomes a component of food or otherwise affects the characteristics of food.
    Excludes substances that are recognized, among qualified experts, as having been adequately shown through scientific procedures (or, in the case of a substance used in food prior to January 1, 1958, through experience based on common use in food) to be safe under the conditions of their intended use.”https://www.fda.gov/food/generally-recognized-safe-gras/fdas-approach-gras-provision-history-processes

    Just like resveratrol is found naturally occurring grapes, peanut skins, etc., and that could not be restricted either as a drug even though it had been researched as such in the 90’s, NAC should fall under the same guidelines. RSV was researched as an anticancer drug, which sounds pretty weighty, yet there are no plans by FDA to remove it from the market. Why is no one talking about NAC being found in onions or other Allium foods?

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