# FDA WARNING_LETTER - Total Body Nutrition - April 16, 2019

Source: https://www.globalkeysolutions.net/records/warning_letter/total-body-nutrition/d6b8e743-5793-41ea-bf0a-19efd9e8638f

> FDA WARNING_LETTER for Total Body Nutrition on April 16, 2019. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Total Body Nutrition
- Inspection Date: 2019-04-16
- Product Type: Food
- Office Name: Center for Food Safety and Applied Nutrition
- Summary: 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

## Related Documents

- [WARNING_LETTER - 2017-03-31](https://www.globalkeysolutions.net/records/warning_letter/total-body-nutrition/9141e005-6bb9-4742-8546-62a343b472f6)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/total-body-nutrition/ba733217-d5bd-4f24-a374-e5768eb07abc

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