On shaky legal grounds, the FDA has targeted N-acetylcysteine (NAC), an important antioxidant supplement. Action Alert!
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. We must ensure the FDA doesn’t remove these supplements from the market.
In a slew of warning letters sent last year, the FDA targeted a number of supplement companies marketing “unapproved” cures for hangovers—which the agency absurdly considers to be a “disease.” 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; according to federal law, any substance approved as a drug before it was sold as a supplement cannot be sold as a supplement. All of this means that the status of NAC as a supplement is currently in dispute.
There are a number of problems with the FDA’s position. 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. In legal terms, this is referred to as “serious reliance interests”: the supplement industry took certain steps in reliance on the FDA’s decades-long treatment of NAC, and then the agency does a complete about-face without explaining why. 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.
Additionally, there are serious questions that must be answered about the FDA’s assertion that NAC was approved as a drug in 1963. As stakeholders have pointed out, the available documentation, obtained through Freedom of Information Act requests, allegedly proving that NAC was approved as a drug in 1963 is a handwritten note. The fact that the date is handwritten throws doubt on the reliability of the FDA’s assertions. Are consumers really to be denied access to such a beneficial product on the authority of a handwritten note (allegedly) from 1963?
Further, the alleged 1963 approval, and subsequent NAC drug approvals, were for inhaled drugs. For the FDA’s logic to apply here, the supplement would have to be the same “article” as the approved drug. Because NAC supplements are taken orally, at different dosages, there are significant differences between NAC drugs and NAC supplements. These important differences should be enough to keep NAC supplements on the market.
Threatening to ban NAC supplements negatively affects the health of many patients and would 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. Note that acetaminophen depletes glutathione, so those who regularly take it should consider, in consultation with an integrative doctor, supplementing with NAC to replenish glutathione levels. In fact, NAC is routinely used in hospitals to counteract acetaminophen toxicity.
There are already repercussions: Amazon has announced plans to remove NAC supplements from its site. NAC is far too important to be threatened by the FDA under any circumstances, much less on the authority of a handwritten note they think might be from 1963.
Action Alert! Write to the FDA and tell them not to threaten NAC supplements. Please send your message immediately.