New York Nutrition Company – FDA Warning Letter, May 9, 2022

The FDA issued a Warning Letter to Mr. Lovatt concerning his dietary supplement products, Lean Muscle For Her and Lean Muscle. The letter states that these products are adulterated under the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they contain an unsafe food additive.

The core violation is the inclusion of 5-alpha-hydroxy-laxogenin, declared as a dietary ingredient on the labels. However, the FDA asserts that 5-alpha-hydroxy-laxogenin does not meet the definition of a dietary ingredient under section 201(ff)(1) of the FD&C Act. Since it is not a dietary ingredient, it is considered a non-dietary ingredient. Non-dietary ingredients in dietary supplements must either be generally recognized as safe (GRAS) for their intended use or be approved as a food additive. The FDA states that 5-alpha-hydroxy-laxogenin is not GRAS and is not otherwise exempt from the food additive definition.

Consequently, its presence renders the products adulterated under section 402(a)(2)(C)(i) of the FD&C Act, as they contain an unsafe food additive. Introducing or delivering adulterated food into interstate commerce is a prohibited act under section 301(a) of the FD&C Act.

The letter requires a written response within fifteen working days detailing specific corrective actions taken to address the violations and prevent recurrence,