# FDA WARNING_LETTER - Mannatech Incorporated - January 13, 2017

Source: https://www.keypedia.com/records/warning_letter/mannatech-incorporated/0cb8f06b-79b7-4d21-b317-5c75cd624e9a

> FDA WARNING_LETTER for Mannatech Incorporated on January 13, 2017. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Mannatech Incorporated
- Inspection Date: 2017-01-13
- Product Type: Food
- Office Name: Dallas District Office
- Summary: 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)).

## Related Officers

- [Greg Wilburn](https://www.keypedia.com/people/greg-wilburn/4211d954-1127-433f-9d70-c1b17ee64fa0)
- [Program Director](https://www.keypedia.com/people/edmundo-garcia/d47fc6d7-1ed9-4a65-bcaf-b3860041ca55)

Company: https://www.keypedia.com/companies/mannatech-incorporated/73481531-a6ae-4b93-92ef-4f4dc5c5e25a

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