Posted August 21, 2014

Seller of Joint Supplement Warned for Manufacturing Violations and Drug Claims

On July 17, 2014, the FDA issued a warning letter to Klein Laboratories, Inc., following a facility inspection which found the company's joint pain supplement, Osteojuv, to be adulterated because it was prepared, packed, or held under conditions that violate Current Good Manufacturing Practices for dietary supplements.

The numerous violations listed in the warning include failure to conduct identity testing to verify the identity of a component that is a dietary ingredient prior to using the component in the manufacture of Osteojuv, failure to establish product specifications for the identity, purity, strength, and composition of the finished batch of the supplement, and failure to hold dietary supplement components under conditions that would prevent their mixup, contamination, or deterioration.

In addition, statements made about Osteojuv on the label were found to be drug claims, including "Aggressively Target: ...Pain" and "Aggressively Target: ...Inflammation."

Osteojuv contains glucosamine, chondroitin, hyaluronic acid, white willow bar, UCII collagen, calcium and other ingredients and is promoted to treat joint pain and inflammation.

See ConsumerLab.com's Reviews of Joint Health Supplements and Calcium Supplements for tests of related products.

See Related Warnings:

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

Vita Springs Health Warned for Manufacturing Violations and Drug Claims

Seller of Flaxseed, Ginkgo and More Warned for Manufacturing Violations and Drug Claims

Seller of Aloe, Thyroid and Other Supplements Warned for Manufacturing Violations and Drug Claims

Herbal Supplement Company Warned For Drug Claims, Manufacturing Violations

Maker of Digestive Health Supplement Warned For Manufacturing Violations, Drug Claims

To read the FDA's warning, use the link below.