FDA WARNING_LETTER - Nutritional Sales and Customer Service, LLC - May 09, 2022

The FDA issued a Warning Letter to Mr. Cohen regarding the product Synedrex, labeled as a dietary supplement. The product is deemed an adulterated dietary supplement due to the presence of "new dietary ingredients" (NDIs): octopamine, hordenine, and higenamine.

These ingredients are considered NDIs under section 413(d) of the FD&C Act because there is no information demonstrating they were lawfully marketed as dietary ingredients in the U.S. before October 15, 1994, or present in the food supply in an unchemically altered form. Consequently, a premarket NDI notification is required under section 413(a)(2) of the FD&C Act and 21 CFR 190.6, which FDA has not received.

Furthermore, based on FDA's safety evaluation, there is no history of use or other evidence establishing that hordenine or higenamine are reasonably expected to be safe as dietary ingredients. Therefore, even with NDI notifications, dietary supplements containing hordenine or higenamine would still be adulterated under sections 402(f) and 413(a) of the FD&C Act, and under section 402(f)(1)(B) due to lack of reasonable assurance of safety.

Introducing or delivering adulterated dietary supplements into interstate commerce is prohibited under sections 301(