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

Source: https://www.keypedia.com/records/warning_letter/down-to-earth-solutions-llc/d071c7b3-7298-4685-8e3e-bd1a628324d2

> FDA WARNING_LETTER for Down to Earth Solutions, LLC on April 16, 2019. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Down to Earth Solutions, LLC
- Inspection Date: 2019-04-16
- Product Type: Food
- Office Name: Center for Food Safety and Applied Nutrition
- Summary: 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)

## Related Officers

- [Director](https://www.keypedia.com/people/william-a-correll/f9e634a2-8e56-4c9b-984c-304f0c7db122)

Company: https://www.keypedia.com/companies/down-to-earth-solutions-llc/4a633e08-25e8-45eb-adb2-97cd4b4b1f7f

Office: https://www.keypedia.com/offices/center-for-food-safety-and-applied-nutrition/e04dc4e5-ee4f-4b0d-be8c-1139531ddab2