# FDA WARNING_LETTER - Better Body Sports, LLC - June 27, 2018

Source: https://www.keypedia.com/records/warning_letter/better-body-sports-llc/d22b1356-c497-4400-bf84-41c0ee756d9d

> FDA WARNING_LETTER for Better Body Sports, LLC on June 27, 2018. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Better Body Sports, LLC
- Inspection Date: 2018-06-27
- Product Type: Food
- Office Name: Center for Food Safety and Applied Nutrition
- Summary: On April 22, 2015, the FDA issued a Warning Letter to Better Body Sports, LLC, regarding its product, Phoenix Extreme, marketed as a dietary supplement. The letter identifies a violation under section 403(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343(a)(1)], stating that the product is misbranded because its labeling is false or misleading.

The core issue is the inclusion of R-beta-methylphenethylamine (also known as Beta-methylphenethylamine, MePEA, or BMPEA) in the "Phoenix Extreme Blend" and its declaration as a dietary ingredient. The FDA asserts that BMPEA does not meet the definition of a dietary ingredient as defined in section 201(ff)(1) of the Act [21 U.S.C. § 321(ff)(1)]. Specifically, BMPEA is not a vitamin, mineral, herb or other botanical, amino acid, dietary substance for human use to supplement the diet, nor a concentrate, metabolite, constituent, extract, or combination of these substances.

The FDA also notes that BMPEA is not approved as a food additive, prior sanctioned for use in dietary supplements, nor is there a basis to conclude it is Generally Recognized As Safe (GRAS) for use in food.

Better Body Sports,

## Related Officers

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

Company: https://www.keypedia.com/companies/better-body-sports-llc/06564ca8-fa06-458e-844f-16baa61588f1

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