# FDA WARNING_LETTER - Formulife, Inc. - September 11, 2012

Source: https://www.globalkeysolutions.net/records/warning_letter/formulife-inc/72a6472d-9b2d-45e7-88e0-ca9718310ca9

> FDA WARNING_LETTER for Formulife, Inc. on September 11, 2012. Product: Drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: WARNING_LETTER
- Company Name: Formulife, Inc.
- Inspection Date: 2012-09-11
- Product Type: Drugs
- Office Name: Dallas District Office
- Summary: On August 1-September 11, 2012, the FDA inspected Formulife, Inc./Purus Labs, Inc. in Dallas, TX. The inspection revealed several violations.

The company distributes dietary supplements, including "Fat Smack – XR Thermolipolytic," "Muscle Marinade Fresh Fruit," and "Muscle Marinade Cherry Limeade," that declare 2-amino-4-methylhexane (dimethylamylamine or DMAA) as a dietary ingredient. The FDA determined DMAA is not a dietary ingredient but an unsafe food additive, rendering these products adulterated under 21 U.S.C. § 342(a)(2)(C). Furthermore, these products violate 21 U.S.C. § 331(ll) because DMAA was approved as a drug in 1948 and was not marketed in food prior to approval. The FDA requires immediate cessation of distribution for all DMAA-containing products.

The "D-Pol" product is promoted on www.puruslabs.net with therapeutic claims (e.g., lowering blood pressure, preventing endothelial dysfunction), classifying it as an unapproved new drug under 21 U.S.C. § 321(g)(1) and § 321(p). It is also misbranded under 21 U.S.C. § 352(f)(1) due to

## Related Officers

- [District Director](https://www.globalkeysolutions.net/people/reynaldo-rodriguez/6e765ccb-f28d-433b-85cb-eafb8b8c35df)

Company: https://www.globalkeysolutions.net/companies/formulife-inc/0e943eb5-26ca-41fd-94e2-20dff1d07aa8

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9