Last July, FDA sent out warning letters to supplement companies, informing them that N-acetyl cysteine (NAC) could no longer be marketed as an ingredient in food supplements, using the justification that it was also a licensed drug.
FDA has concluded that NAC products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(i) of the Act [21 U.S.C. § 321(ff)(3)(B)(i)]. Under this provision, if an article (such as NAC) has been approved as a new drug under section 505 of the Act [21 U.S.C. § 355], then products containing that article are outside the definition of a dietary supplement, unless before such approval that article was marketed as a dietary supplement or as a food. NAC was approved as a new drug under section 505 of the Act [21 U.S.C. § 355] on September 14, 1963. FDA is not aware of any evidence that NAC was marketed as a dietary supplement or as a food prior to that date.
But other drugs, such as Coenzyme Q10 and Vitamin D, are licensed as drugs but also permitted to be sold as supplements. And the federal government’s PubChem website lists many virtues of NAC.
In the case of NAC, it has been available as a licensed drug for 57 years in the US. It is widely used and very safe. Unlike many supplements, it has been extensively studied. Clinicaltrials.gov lists 541 studies for the search term ‘N-acetyl cysteine.’ Why did FDA suddenly decide its OTC use should be restricted?
This is especially troubling as a number of doctors have said it is useful in the treatment of Covid-19, especially during the late, cytokine storm stage, since it works as an antioxidant and a substrate for the production of glutathione. In fact, there is a growing body of literature on its benefits for Covid. Here is just one review.
Last week, Amazon stopped selling all products containing NAC. While no absolutely final decision has been made by FDA regarding NAC, it might be the third effective Covid treatment that the FDA has attempted to suppress, after the chloroquine drugs and ivermectin. Stay tuned.