FDA WARNING_LETTER - Line One Nutrition, Inc - April 16, 2019

On April 10, 2019, the FDA issued a Warning Letter to Line One Nutrition regarding their dietary supplement product, Lean Pills®, which contains 2-amino-5-methylheptane (DMHA).

The FDA states that DMHA is a "new dietary ingredient" (NDI) as it was not marketed in the U.S. before October 15, 1994, and there is no information indicating its presence in the food supply as an unchemically altered food article. Therefore, Lean Pills® is deemed adulterated under sections 402(f) and 413(a) of the Federal Food, Drug, and Cosmetic Act (the Act) because Line One Nutrition failed to submit a required NDI notification at least 75 days before introducing the product into interstate commerce.

Furthermore, the FDA indicates there is no history of use or other evidence establishing DMHA's safety as a dietary ingredient, making products containing it adulterated under sections 402(f) and 413(a) due to inadequate safety assurance. The FDA also questions if DMHA is a dietary ingredient at all. If not, it would be an unapproved and unsafe food additive, rendering the product adulterated under section 402(a)(2)(C)(i) of the Act.

Line One Nutrition is required to take prompt action to correct these violations, including ceasing