# FDA WARNING_LETTER - DBM Nutrition - Unknown Date

Source: https://www.keypedia.com/records/warning_letter/dbm-nutrition/3d0054bb-8112-442c-823f-a6876e1a16eb

> FDA WARNING_LETTER for DBM Nutrition on Unknown Date. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: DBM Nutrition
- Product Type: Food
- Office Name: Center for Food Safety and Applied Nutrition
- Summary: The FDA issued a Warning Letter to DBM Nutrition regarding its product, DBM Endurance World Championship Countess, marketed as a dietary supplement. The letter identifies a violation concerning the inclusion of Picamilon (also known as pikatropin, nicotinyl-gamma-aminobutyric acid, or nicotinoyl-GABA) as a dietary ingredient on the product's labeling.

The FDA asserts that Picamilon does not meet the definition of a dietary ingredient under section 201(ff)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(ff)(1)]. It is not a vitamin, mineral, herb, botanical, amino acid, or a dietary substance for supplementing the diet, nor is it a concentrate, metabolite, constituent, extract, or combination of these. The FDA states Picamilon is a unique chemical entity synthesized from niacin and gamma-aminobutyric acid.

This misdeclaration causes the product to be misbranded under section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] because its labeling is false or misleading. Furthermore, Picamilon is not approved as a food additive or prior sanctioned for use in dietary supplements, and the FDA has not found a basis to conclude it is Generally Recognized As Safe (GRAS) for food use.

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

Company: https://www.keypedia.com/companies/dbm-nutrition/c1885367-dbd5-461c-8cf5-4db4c1ea02a4

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