Posted May 24, 2016

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

On May 13, 2016, the FDA issued a warning letter to Rocky Fork Formulas, Inc., following a facility inspection which found the company's products, including  Angio Fin, Arthritis Complex HS, EPA 1000, Gluco-Poise, Liver Complex, Niacin 500 Time-Released, Prostate Complex HS, Univase and Virex Complex 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 establish specifications that provide sufficient assurance that products received from a supplier for packaging or labeling as dietary supplements are adequately identified and are consistent with purchase orders, and failure to establish and follow written procedures for packaging and labeling operations, as required by federal regulations.

In addition, statements about these products on the company's website were found to be drug claims. For example, Arthritis Complex HS was promoted with statements such as "Arthritis Complex HS also contains anti-inflammatory herbs Boswellia serrata and Turmeric and even MSM... Arthritis Complex also contains a powerful fatty acid- CMO -Cetyl Myristoleate, used to help rebuild damaged cartilage in both Rheumatoid and osteo arthritis."

EPA 1000 was promoted with statements such as "These oils have been cited in numerous studies as being an important factor in preventing heart and coronary disease."

Niacin 500 Time-Released was promoted with statements such as, " Niacin lowers cholesterol... and has also been used to alleviate joint pain."  

(See ConsumerLab.com's Reviews of Joint Health Supplements, Fish Oil and Omega-3 Fatty Acid Supplements, and B Vitamin Supplements for tests of related products.)

See Related Warnings:

Seller of Turmeric, Milk Thistle and More Warned for Manufacturing Violations, Drug Claims

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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

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