USPlabs, LLC – FDA Warning Letter, Feb 21, 2012

The FDA inspected USPlabs, LLC, from February 7-21, 2012, evaluating the manufacturing of dietary supplements like Jack3d, OxyElite Pro, and Super Cissus. A review of the website in October 2012 revealed serious violations.

Super Cissus is deemed an unapproved new drug under section 201(g)(1)(B) and 201(p) of the Act due to disease claims (e.g., "reduce LDL") on its labeling, making it intended for disease treatment. It is not generally recognized as safe and effective and lacks FDA approval. Furthermore, it is misbranded under section 502(f)(1) because it's not amenable to self-diagnosis and lacks adequate directions for lay use. Introducing this misbranded drug into interstate commerce violates section 301(a).

Even if not an unapproved drug, all USPlabs' products are adulterated dietary supplements under section 402(g)(1) for failing to comply with Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 111). As a distributor using contract manufacturers, USPlabs is responsible for compliance.

Specific CGMP violations include: 1. Failure to establish and follow written procedures for product complaint review and investigation, specifically lacking quality control personnel approval for investigation decisions and findings (21 CFR 111.5