Tell the FDA Not to Ban NAC Supplements

Over the last few months, we’ve been telling you about the FDA’s attack against N-acetylcysteine (NAC), an important antioxidant supplement. We believe the FDA is clearing the market of affordable NAC supplements in an effort to eliminate competition for NAC drugs that could be coming to market in the next few years. Now, Congress is stepping in. Senator Mike Lee (R-AZ) has submitted a letter to the FDA asking serious questions about their conduct towards NAC. He also released a video discussing this issue. We need to help Sen. Lee build momentum behind this important work to hold the FDA’s feet to the fire.

Write to Congress and urge them to support Sen. Lee's efforts.

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Please protect NAC supplements

Dear [Decision Maker],

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The FDA has declared that NAC, a vital antioxidant with a number of important health benefits, is not a legal dietary supplement. This is a direct threat to a supplement that many integrative doctors and patients rely on to address a variety of health conditions. Senator Mike Lee has written a letter to the FDA asking them to clarify their actions and to ask serious questions about their conduct on NAC. I urge you to support his efforts.

In a slew of warning letters sent last year, the FDA targeted a number of supplement companies marketing "unapproved" cures for hangovers. Some of these products contain NAC. In the letters to those companies, the FDA states that NAC does not meet the legal definition of a supplement because it was approved as a drug in 1963.

Banning NAC would negatively affect the health of many patients and remove an important tool from the arsenals of integrative doctors. NAC protects the body from toxins, is a selective immune system enhancer, and helps remove free radicals, which contribute to neurogenerative diseases and aging. In Europe, NAC is a prescription medicine used to reduce congestion.

NAC is also a precursor to glutathione, one of the body's most important antioxidants. Glutathione plays crucial roles in nutrient metabolism and the regulation of many cellular events (such as gene expression, protein synthesis, cell proliferation, and more); glutathione deficiency contributes to oxidative stress, which is implicated in the development of many diseases: Alzheimer's, Parkinson's, liver disease, HIV, heart attack, cancer, stroke, and diabetes.

There are a number of issues with the FDA's stated position on NAC. For one, the agency considered many health claims (both structure/function claims and qualified health claims) in relation to NAC supplements, and did not raise these objections about the legality of NAC supplements then. For years, the FDA treated NAC like a supplement, and companies invested considerable resources in developing NAC products and submitting health claims to the FDA. Doctors and patients have also come to rely on these products. Courts have found that when agency policies involve "serious reliance interests," it is arbitrary and capricious for those interests to be disregarded without adequate explanation.

Please help protect access to NAC supplements and support Sen. Lee's efforts to hold the FDA accountable.

Sincerely,
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[Your Email]