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Posted May 2, 2015

Maker of Garcinia, Joint Supplements and More Warned for Manufacturing Violations, Drug Claims

On March 25, 2015, the FDA issued a warning letter to JW Nutritional LLC, following a facility inspection which found the company's products, including  Vanish V2 Domestic, Mr. Hyde Fruit Punch, and Garcinia Cambogia to be adulterated because they prepared, packed, or held under conditions that violate Current Good Manufacturing Practices for dietary supplements.

These violations include failure to prepare and follow a master manufacturing record (MMR) identifies specifications for the points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the MMR, as required by federal regulations. 

In addition, statements made on product labels for Forged Methyl EAA, Forged Joint Repair and Forged Liver Support were found to be drug claims. For example, Forge Methyl EAA was promoted with statements such as "[S]arcosine [an ingredient in the product]...has been shown in studies to improve the symptoms of neurologic diseases such as schizophrenia and depression" and Forged Joint Repair was promoted with statements such as "Forged Joint Repair is enhanced with herbs and extracts that ...heal bones ...and provide ....anti-inflammatory support." 

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

See Related Warnings:

Seller of "Natural" Cough Syrup Warned for Manufacturing Violations, Drug Claims

Seller of Aloe, Sexual Enhancement Supplements and More Warned for Manufacturing Violations, Drug Claims

Maker of Aloe, Weight Loss Supplements and More Warned for Manufacturing Violations, Drug Claims

Seller of Omega-3 "Syrup" Warned for Manufacturing Violations and Drug Claims

Seller of Diabetes, Prostate Supplements and More Warned for Manufacturing Violations, Drug Claims

Seller of "Cleanse," Allergy Supplements and More Warned for Manufacturing Violations, Drug Claims

Maker of Herbal Supplements Warned for Manufacturing Violations and Drug Claims

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 letter, use the link below.