FDA bans NAC as a supplement. Does the math do itself?
FDA quietly reverses its longstanding position on NAC, postulating that is is a "medicine" and thus should be removed from public sale
NAC, or N-acetyl cysteine, is derived from the amino acid L-cysteine. It has been available as a supplement, or as part of other supplements formulations, for decades. NAC was first introduced in the early 1960s, and saw its first medical uses in the late 1960s.
NAC has several notable benefits, mostly centered around the lungs, liver, psychiatric uses in compulsive/behavioral disorders, and its role in producing the body’s “master antioxidant,” glutathione.
Lung - loosens mucus in individuals suffering from bronchopulmonary disorders.
Liver - helps in liver detoxification, especially in instances of acetaminophen (Tylenol/Paracetamol) abuse/overdose.
Psychiatric - tentative efficacy evidence for Alzheimer's disease, autism, bipolar disorder, drug-induced neuropathy, major depressive disorder, obsessive-compulsive disorder, and schizophrenia. Also there is preliminary evidence showing efficacy in treating anxiety disorder, ADHD and even nicotine and gambling addictions.
Glutathione manufacture - NAC is converted to glutathione once ingested (either intravenously or orally)
In July 2020, the FDA sent a warning letter prohibiting the sale of NAC as a supplement. This has led to Amazon pulling every brand of NAC from its storefronts, leading to a race online to snatch up whatever remaining NAC is left from various online retailers. A supplement store near me, when asked if they had any NAC in stock, said they are entirely sold out and don’t know if, or when, any restocks will occur.
The Council for Responsible Nutrition (CRN) penned an entire letter to Steven Tave, the FDA’s Director of Dietary Supplement Programs Center for Food Safety and Applied Nutrition. The entire letter is here, but for the sake of summarizing the situation, this is a key excerpt:
For decades, manufacturers have safely marketed products containing NAC as dietary supplements in the United States. There are currently hundreds of dietary supplements containing NAC on the market, and thousands of consumers have come to rely on these products as a crucial source of nutrients. And, until recently, FDA has consistently and affirmatively permitted manufacturers to market these products. In fact, FDA has considered over 100 structure-function claim notifications regarding NAC and at least one qualified health claim petition for a dietary supplement containing NAC, and has not objected to the presence of NAC in any of these products.
But, in July 2020, FDA enacted a sudden policy change by issuing multiple warning letters asserting that products containing NAC cannot be marketed as dietary supplements under section 201(ff)(3)(B)(i) of the FDCA. Section 201(ff)(3)(B)(i) prohibits manufacturers from marketing products as dietary supplements if they contain an article that FDA has approved as a new drug under section 505 of the Act, unless that article was marketed in dietary supplements or food before it was approved as a drug (often called the “drug preclusion clause”). FDA’s warning letters assert that NAC was approved as a new drug in 1963 and, to FDA’s knowledge, was not marketed as a dietary supplement prior to that date. As such, FDA claims that products containing NAC cannot be marketed as dietary supplements. FDA has failed to provide any rationale for this policy change other than the basic assertions made in these warning letters.
FDA’s sudden policy change is legally invalid on multiple grounds. First, it is not even clear, from FDA records, whether section 201(ff)(3)(B)(i) applies to NAC as a dietary supplement. The decades-old records for NAC drug approval contain unreliable information, such as handwritten dates, and unverifiable information. Second, NAC drugs approved prior to 2016 appear to be comprised of different forms of NAC from that which is found in a dietary supplement. Third, interpreting FDCA section 201(ff)(3)(B)(i) to prohibit the marketing of dietary supplements containing NAC violates the well-established presumption against statutory retroactivity. CRN’s review of the drug approval records for NAC, and subsequent discovery of unreliable and conflicting information, demonstrates one of the significant dangers of statutory retroactivity. FDA’s policy change also is an arbitrary and capricious agency action that is invalid under the Administrative Procedure Act (APA). And finally, the equitable defense of laches prevents FDA from enforcing its new policy. For these reasons, we urge FDA to reverse this policy change and revert to its longstanding policy of allowing manufacturers to market dietary supplements containing NAC.
NAC has always been cheap and widely available. I am the furthest thing from a conspiracy theorist, but this quiet, sudden ban strikes me as curious, as many of the benefits of NAC could, in theory, be used to help combat COVID-19 as well as a host of other maladies. In fact, there are several clinical trials studying NAC as a treatment for COVID-19. Bear in mind treatment does not mean cure, as there is no known “cure” for COVID-19. Vaccination far and away remains your best protection against the disease.
If one wants to do a little dot connecting, this ban could easily be interpreted as a precursor to moving NAC to full-on drug status, which would mean it could be patented, marketed and sold as a prescription compound. It hasn’t yet, but if you’re into reading tea leaves, this move certainly suggests that this once affordable and widely-available supplement will see its next act as a prescription medication.
Will that happen? Who knows. The dust is yet to settle on this. But in the meantime, you have a small window in which you can act if you so choose.
My suggestion? If you can find any NAC, buy it.
Even in COVID-19 weren’t a thing, NAC is a smart compound to take due to its role in glutathione production. I’ve been taking NAC for about two years now, as well as liposomal glutathione from Designs for Health. As we age, glutathione plays a major role, and I wouldn’t ignore it.
I am not a doctor and you should not construe this as medical advice in any way, but for all my Pathfinding subscribers, I wanted to pass this information along. The situation with NAC right now strikes me as very curious, and I am not naive when it comes how money, lobbyists and the machinations of the real world operate.
Is this a cure for COVID-19? No. Can it replace vaccinations? Obviously not. But for those who want to keep their natural immune function working at its highest level, NAC is worthy addition to your supplement toolbox.
As always, if you have any questions if NAC is right for you, consult with your physician first.
Finally, here is Marc Lobliner of Tiger Fitness summarizing the situation that’s going on. He’s a bit bombastic yes, but that’s his personality, and he’s a strong voice in the fitness world, especially when encouraging people to be advocates in their own health outcomes.
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NAC vs Glutathione if you could only pick one, and why?
Excellent article!