Steel Supplements Inc – FDA Warning Letter, May 9, 2022

The FDA issued a Warning Letter on May 4, 2022, concerning several dietary supplement products: Shredded-AF, Charged-AF, Alpha-AF, 3-EPI-Andro, Focused-AF, and Amped-AF. The letter states that introducing or delivering these products into interstate commerce violates the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they are adulterated dietary supplements.

The first category of adulteration involves unsafe food additives. Shredded-AF, Charged-AF, Alpha-AF, and 3-EPI-Andro contain hordenine HCl, higenamine HCl, and 5-alpha-hydroxy-laxogenin, respectively. The FDA determined these are not "dietary ingredients" as defined by section 201(ff)(1) of the FD&C Act. Since they are not generally recognized as safe (GRAS) for their intended use and do not qualify for other exemptions, they are considered unapproved food additives, rendering the products adulterated under section 402(a)(2)(C)(i).

The second category of adulteration pertains to new dietary ingredients. Focused-AF contains higenamine, and Amped-AF contains hordenine. While these are considered "dietary ingredients" as constituents of botanicals, the FDA states they are "new dietary ingredients" (not marketed before October 15, 1