# FDA WARNING_LETTER - Prime Nutrition - Unknown Date

Source: https://www.globalkeysolutions.net/records/warning_letter/prime-nutrition/01fded9c-7910-4003-981f-ebc9ca2a8595

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

---

## Details

- Record Type: WARNING_LETTER
- Company Name: Prime Nutrition
- Product Type: Food
- Office Name: Center for Food Safety and Applied Nutrition
- Summary: On April 24, 2015, the FDA issued a Warning Letter to Prime Nutrition regarding their product PWO/STIM, labeled as a dietary supplement. The product's Supplement Facts panel declares AMP Citrate, also known as DMBA, as a dietary ingredient.

The FDA determined that DMBA is a "new dietary ingredient" under section 413(a)(2) of the Act (21 U.S.C. 350b(a)(2)) and 21 CFR 190.6, requiring a notification. No such notification was submitted, rendering the product adulterated under sections 402(f)(1)(B) and 413(a) of the Act. Furthermore, the FDA stated there is no evidence establishing DMBA's safety for use as a dietary ingredient, making the product adulterated due to inadequate safety assurance.

The letter also highlights that synthetically produced DMBA is not a "dietary ingredient" as defined in section 201(ff)(1) of the Act (21 U.S.C. 321(ff)(1)), as it is not a vitamin, mineral, amino acid, herb, botanical, or a derivative thereof, nor is it commonly used as human food.

Prime Nutrition was requested to promptly correct these violations for PWO/STIM and any other products containing DMBA. Failure to

## Related Documents

- [WARNING_LETTER - 2025-11-30](https://www.globalkeysolutions.net/records/warning_letter/prime-nutrition/5fb89cdf-9281-44b1-b550-65a7645324d3)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/prime-nutrition/106b7f0c-da70-48d1-ba69-1fbc1d265ef6

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