FDA WARNING_LETTER - Mannatech Incorporated - January 13, 2017

The FDA inspected Mannatech Incorporated's Coppell, Texas facility from December 28, 2016, to January 13, 2017, and reviewed product labeling in May 2017. The inspection revealed violations of Current Good Manufacturing Practice (CGMP) for dietary supplements (21 CFR Part 111), causing products to be adulterated under section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act).

Specifically, the "BounceBack" product was deemed an unapproved new drug under section 201(g)(1)(B) and 201(p) of the Act due to therapeutic claims on its label and websites (e.g., "reduce soreness," "reduce muscle pain," "anti-inflammatory effects"). Introducing this product into interstate commerce without FDA approval violates sections 301(d) and 505(a) of the Act.

Dietary supplement CGMP violations included: 1. Failure to establish complete finished product specifications for identity, purity, strength, and composition for "Catalyst" and "Ambrotose Complex Powder" (21 CFR 111.70(e)). 2. Failure of quality control personnel to review and approve product complaint investigations, findings, and follow-up actions (21 CFR 111.560(b)).