FDA WARNING_LETTER - Hi Tech Pharmaceuticals - April 16, 2019

The FDA issued a Warning Letter to Hi-Tech Pharmaceuticals, Inc. on April 10, 2019, regarding their dietary supplement products Ultimate Orange, HydroxyElite, Lipodrene Elite, and Synadrene. The letter states that these products are adulterated because they contain 2-Aminoisoheptane HCl (DMHA), which is declared as a dietary ingredient.

The FDA asserts that DMHA is a "new dietary ingredient" as it was not marketed in the U.S. before October 15, 1994, and there is no evidence of its prior presence in the food supply as an unchemically altered food article. Therefore, a new dietary ingredient notification (NDIN) was required under section 413(a)(2) of the Act and 21 CFR 190.6, which was not submitted. Even if an NDIN had been submitted, the FDA knows of no evidence establishing DMHA's safety for use as a dietary ingredient, making products containing it adulterated under sections 402(f) and 413(a) of the Act due to inadequate safety assurance.

Furthermore, the FDA questions whether DMHA is, in fact, a dietary ingredient. If not, it would be considered an unsafe food additive, rendering the products adulterated under section 402(a)(2)(C)(i) of the Act, as it