Posted March 29, 2016

Maker of Bone Health, Prostate, Cholesterol Supplements and More Warned for Drug Claims

On March 17, 2016, the FDA issued a warning letter to Rx Vitamins, Inc., following a facility inspection which found the company's products, includingTestost-Rx, DB-7, The Bone Density Formula, NaturLo Cholesterol, ThyRx-7 and Arth-9 to be misbranded. The labels for some of these products did not provide a domestic address or phone number which consumers can use to report an adverse event, did not identify the products as dietary supplements, or did not include the plant part used. In addition, the label for ThyRx-7 provided an incorrect serving size.

In addition, statements made on the company's website about other products, including Acid Block, Activated Enzyme Formula, ARTH-9, Chewable Licorice, NaturLo Cholesterol, ResveraCaps and Advanced Prostate Formula, were found to be drug claims. For example, ARTH-9 was promoted with statements such as "[F]ortified with Vitamin C, calcium and zinc l-monomethionine to aid in tissue repair."  NaturLo Cholesterol was promoted with statements such as "[S]hown in clinical studies to significantly lower LDL cholesterol." Advanced Prostate Formula was promoted with statements such as "[P]rostate gland tends to enlarge naturally, impeding bladder function ...Advanced Prostate Formula... designed to address this concern."  

See ConsumerLab.com's Reviews of Joint Health Supplements , Digestive Enzyme Supplements, Cholesterol-lowering Supplements, and Prostate Supplements for tests of related products.

See Related Warnings:

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