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Posted February 20, 2013

FDA Warns USPLabs For Adulteration and Drug Claims

On December 4, 2012 the FDA issued a warning letter to USPLabs, LLC following facility inspections which found the company's products, including dietary supplements Jacked3d, OxyElite Pro, Prime, and Super Cissus, to be adulterated because they were prepared, packed, or held under conditions that violate Current Good Manufacturing Practices. This is the second FDA warning letter the company received in 2012.

USPLabs' violations include failure to establish product specifications for the identity and purity of finished batches of dietary supplements and failure to conduct at least one appropriate test or examination to verify the identity of a component that is a dietary ingredient.

The FDA also found statements made on the Super Cissus label, such as "Cissus quadrangularis, has been found to reduce LDL .... In an eight-week randomized, double blind, placebo-controlled study ... obese subjects taking Cissus experienced reductions in ... LDL .... were found to be drug claims. Super Cissus is an extract of Cissus quadrangularis which is promoted for joint, tendon and ligamament health.

(See's Review of Joint Health Supplements for tests of related products.)

OxyELITEPRO contains Bauhinia purpurea, Bacopa monniera, Cirsium oligophyllum, and Rauwolscine canescens and is promoted for weight loss. Jacked3d contains arginine, creatine, beta-alanine, caffeine and Schisandra chinensis. Both supplements were previously found to contain DMAA, a substance not permitted in dietary supplements, prompting a warning letter from the FDA in April of 2012. USPlabs has since released a reformulated version of Jacked3d that does not contain DMAA, called Jacked3d Micro.

Prime contains extracts of Tribulus aquaticus and Terminalia chebula and is promoted for muscle building.

(See's Reviews of Weight Loss Supplements, Muscle Enhancer Supplements and Energy Drinks for tests of related products.)

See Related Warnings:

USPLabs Settles Class Action Lawsuit Over Controversial DMAA Ingredient

FDA Says DMAA Can't Be Sold as a Supplement -- Warns Sellers

For more information about the FDA's warning letter, use the link below.