FDA WARNING_LETTER - Total Body Nutrition - April 16, 2019

On April 11, 2019, the FDA issued a Warning Letter to Mohammad Islam, President of TBN Labs LLC, regarding their dietary supplement products: 1,3D NOX, Shredder, and Tummy Tuck. The Supplement Facts panels on these products declare 2-aminoisoheptane (DMHA) as a dietary ingredient.

The FDA states that DMHA is a "new dietary ingredient" under section 413(d) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 350b(d)]. Dietary supplements containing new dietary ingredients are deemed adulterated under section 402(f) of the Act [21 U.S.C. § 342(f)] unless specific requirements are met: either the ingredient was present in the food supply before October 15, 1994, or a safety notification was submitted to the FDA at least 75 days prior to introduction into interstate commerce.

The FDA asserts there is no information demonstrating DMHA was lawfully marketed as a dietary ingredient before October 15, 1994, nor evidence of its presence in the food supply as an unchemically altered food. Therefore, assuming DMHA is a dietary ingredient, the products are adulterated under sections 402(f) and 413(a) of the Act