FDA Finds Drug Spiked “Supplement”
NAC products must be compliant
FDA purchased and tested “dietary supplement” products from an online retailer that was selling products in the US. FDA discovered some of the products to contain drug spiked ingredients such as SARMs (selective androgen receptor modulators) and the authorized Investigational New Drug (IND) ibutamoren. Taking these types of products can be dangerous.
Unethical companies spiking their “supplements” with drugs is nothing new and a few bad actors cast a shadow on the regulated and compliant supplement industry. What’s interesting about this warning letter is it included NAC.
A quick primer on NAC. In 2020 FDA sent several warning letters to companies marketing NAC supplements which included claims related to hangover prevention. FDA’s position at the time was that NAC was not a lawful dietary ingredient because it was investigated as a new drug (IND) before it was marketed as a supplement. Read more about this.
Industry fought back and in 2022 FDA announced this enforcement discretion policy “applies to products that would be lawfully marketed dietary supplements if NAC were not excluded from the definition of “dietary supplement” and that are not otherwise in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act)” which essentially means FDA would not scrutinize supplements unless companies broke other rules, such a making disease claims or adulterating the product with drugs.
Here’s FDA’s thoughts. The enforcement discretion does not apply since the product contained drug spiked ingredients.
From warning letter: 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. As described in FDA’s August 2022 Policy Regarding N-acetyl-L-cysteine: Guidance for Industry,2 we intend to exercise enforcement discretion with respect to the sale and distribution of NAC-containing products that are labeled as dietary supplements and would be lawfully marketed dietary supplements if NAC were not excluded from the definition of “dietary supplement” and are not otherwise in violation of the FD&C Act. However, as the guidance notes, the enforcement discretion policy does not apply to NAC-containing products that are adulterated or misbranded under the FD&C Act.”
A key takeaway here is not to purchase supplements from sketchy websites and if you use NAC in your supplements, which is okay, triple check to ensure there are no out of bounds medical claims in any marketing. Btw: Apex Compliance can quickly scan your website, YouTube, Instagram, Facebook, and pre-published content for issues, then we help you replace phrases before they lead to regulatory issues. Info and free demo here.
Read the full warning letter here.
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