FDA WARNING_LETTER - Down to Earth Solutions, LLC - April 16, 2019

On April 10, 2019, the FDA issued a Warning Letter to Down To Earth Solutions, LLC, regarding their product Simply Skinny Pollen, labeled as a dietary supplement. The product's website declares 2-aminoisoheptane (DMHA) as a dietary ingredient.

The FDA states that DMHA is a "new dietary ingredient" under section 413(d) of the Act, as there is no information demonstrating it was lawfully marketed in the U.S. before October 15, 1994, or present in the food supply as an unchemically altered food. Therefore, a new dietary ingredient notification was required per section 413(a)(2) and 21 CFR 190.6, which was not submitted. This renders the product adulterated under sections 402(f) and 413(a) of the Act.

Furthermore, the FDA has no evidence establishing DMHA's safety as a dietary ingredient. Without a history of use or other safety evidence, dietary supplements containing DMHA are adulterated under sections 402(f) and 413(a) due to inadequate safety assurance.

The FDA also questions if DMHA is a dietary ingredient. If not, it would be an unsafe food additive, making the product adulterated under section 402(a)(2)(C)(i)