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Posted October 3, 2014

Seller of Green Tea, Prostate, Pain Supplements and More Warned for Manufacturing Violations and Drug Claims

On July 25, 2014, the FDA issued a warning letter to AMS Health Sciences, LLC following a facility inspection which found the company's products, including saba ACE, UROPOWER, UROSure, Digest-Eze, Shark Cartilage, Colloidal Silver, and Mobilite 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 established finished product specifications for the finished batches of saba ACE and saba X-treme 5000 and failure to implement quality control operations in manufacturing, packaging, labeling, and holding operations for producing dietary supplement to ensure quality and that the dietary supplement is packaged and labeled as specified in the master manufacturing record.

Statements made about saba ACE, UROPOWER, UROSure, Digest-Eze, Shark Cartilage, Colloidal Silver, and Mobilite on the company's website and product labels were also found to be drug claims. 

For example, saba ACE was promoted with statements such as "Green Tea also helps prevent tooth decay, lowers cholesterol and blood pressure, fights cancer, prevents inflammation and liver disease, fights infection," and "Semonostachya Menglaensis & Lotus Leaf Extract... stop bleeding or to treat blood diseases... can even treat skin disorders." 

(See ConsumerLab.com's Reviews of Green Tea Supplements and Drinks and Cholesterol-Lowerers for tests of related products.)

UROPOWER was promoted with statements such as "UROPOWER has been proven statistically and clinically beneficial to those who have used it as demonstrated by improving voiding symptoms, PSA, EPS and prostate related ... pain," and "Lowers your EPS (white blood cells in the prostate secretion." 

(See ConsumerLab.com's Review of Prostate Supplements for tests of related products.)

Shark Cartilage was promoted with statements such as "This non-steroidal anti-inflammatory product acts as [a] pain reliever." 

Colloidal Silver was promoted with statements such as "Colloidal Silver is effective against infections, colds ... Destructive bacteria, virus and fungus organisms are killed within minutes of contact.

(See ConsumerLab's answer to the question, Is ingesting colloidal silver helpful for any condition and is it safe to use? for more information.)

See Related Warnings:

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.