Posted November 25, 2017

Seller of "BounceBack" Joint Supplement and Others Products Warned for Drug Claims

On November 14, 2017, the FDA sent a warning letter to Mannatech Incorporated following a facility inspection that found the products BounceBack, MannaBears, ImmunoSTART, TruSHAPE, and Catalyst to be in violation of the Current Good Manufacturing Practices, including misbranded and adulterated drugs.

These violations include failure to establish specifications for each dietary supplement for the identity, purity, strength, and composition of the finished batch of the dietary supplements, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement, and failure to satisfy the requirements for the review and investigation of product complaints, as required by federal regulations.

Additionally BounceBack contains drug claims. For example, the product label states "clinically shown to reduce soreness," and the website www.mannatech.com states "reduce joint pain and inflammation."

(See ConsumerLab.com's Product Review on Joint Health Supplements.)

See related warnings:

FDA Warns Seller of Supplements for Allergies, Joint Pain, Bone Health, and More

Seller of Mineral, Joint Supplements and More Warned for Manufacturing Violations, Drug Claims

Seller of Aloe, Prostate and Joint Supplements Warned for Manufacturing Violations

Seller of Joint Supplement Warned for Manufacturing Violations, Drug Claims

Use the link below to read the full warning letter.