Posted April 23, 2018

FDA Warns Seller of Joint Health Supplements & More for Manufacturing Violations

On March 29, 2018, the FDA issued a warning letter to South Texas Botanicals following a facility inspection which found a number of the company's products, including Joint Support, to be adulterated because they were prepared, packed, or held under conditions that violate Current Good Manufacturing Practices for dietary supplements.  

These violations include failure to establish specifications for the identity of components that are used to manufacture a dietary supplement, failure to establish product specifications for the identity, purity, strength, and composition of the finished batch of dietary supplements to ensure the quality of the dietary supplement, as required by federal regulations, and failure to ensure quality control measures.

In addition, certain statements made about the products on the company's website and on product labels were found to be drug claims. For example, Joint Support was promoted with statements such as "[R]elieves...arthritis pains... Support regrowth of joint tissue and cartilage reducing the need for artificial joint replacement..." 

(See ConsumerLab.com's Review of Glucosamine, Chondroitin, MSM and Boswellia Supplements for Joint Health for tests of related products.)

Several of the company's products were also found to be misbranded because their labels included drug claims, incorrect information, or were missing information required by federal regulations.

See related recalls and warnings:

FDA Warns Seller of Milk Thistle, Chromium, Joint Supplements & More for Manufacturing Violations

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 Joint Supplement Warned for Manufacturing Violations, Drug Claims

Seller of Joint Health, Omega-3 Supplements & More Warned for Manufacturing Violations, Drug Claims

To read the complete recall, use the link below.