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Posted June 19, 2018

FDA Warns Seller of Weight Control Patches

On June 6, 2018, the FDA issued a warning letter to Health Management Group, Inc., following a facility inspection which found a number of the company's products, including AM/PM FAT BURNING & APPETITE SUPPRESSING WEIGHT CONTROL PATCHES 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 establish and follow written procedures for the responsibilities of the quality control operations, as required by federal regulations. The FDA also advised the company that topical patch products are not dietary supplements because they are not intended for ingestion.

AM/PM FAT BURNING & APPETITE SUPPRESSING WEIGHT CONTROL PATCHES contain green tea extract, Forslean (Coleus forskohlii) as well as other ingredients promoted for weight loss. Statements made about this product were found to be drug claims. For example, AM/PM FAT BURNING & APPETITE SUPPRESSING WEIGHT CONTROL PATCHES  were promoted with claims such as "The AM Patch helps promote weight loss with ingredients that target fat burning, increased energy and enhanced metabolism," and "The PM Patch helps promote weight loss with ingredients that focus on evening appetite suppression."  

See ConsumerLab.com's Reviews of Weight Loss Supplements (which includes information about Forslean) and Green Tea Supplements and Drinks for more information about these ingredients and tests of related products.

Also see ConsumerLab.com's answer to the question: Do vitamin B12 patches, like those from PatchMD, really work? for more information about "patch" products. 

See Related Warnings:

Weight Loss and Cleanse Supplements Contain Adulterated and Improperly Labeled Ingredients, FDA Warns

Weight Loss Supplement Recalled

Weight Loss Supplements Containing Undeclared Drug Recalled

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