Dominant Nutrition LLC formerly 8 Weeks Out Labs

Warning LetterOpen

Nancy Abbott Owner Dominant Nutrition LLC formerly 8 Weeks Out Labs 1523 E. Sonterra Blvd #1020 San Antonio , TX 78258 United StatesIssued Oct 21, 2021Office of Human and Animal Foods West

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations2

Issue DateOct 21, 2021

Product TypeDietary Supplements

StatusOpen

Letter Details

Firm: Dominant Nutrition LLC formerly 8 Weeks Out Labs
Location: Nancy Abbott Owner Dominant Nutrition LLC formerly 8 Weeks Out Labs 1523 E. Sonterra Blvd #1020 San Antonio , TX 78258 United States
FEI Number: N/A
Country: United States
Issue Date: October 21, 2021
Issuing Office: Office of Human and Animal Foods West
Product Type: Dietary Supplements
Status: Open

Summary

Dominant Nutrition LLC (formerly 8 Weeks Out Labs) was cited for marketing the dietary supplement LipogenX containing Hordenine, a new dietary ingredient not present in the U.S. food supply before October 15, 1994. The company failed to comply with section 413 of the FD&C Act by neither demonstrating that Hordenine had been chemically unaltered in the food supply nor submitting safety substantiation at least 75 days before marketing the product, rendering the supplement adulterated. The FDA identified these violations during a September 2021 review of the company's website, where four products (ADIPROPEN ULTRA, SUPERJOINTS, OPTIMUM-CLA, and LipogenX) were offered for sale.

Dominant Nutrition LLC formerly 8 Weeks Out Labs FDA Warning Letter, October 21, 2021