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Posted November 12, 2017

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

On November 2, 2017, the FDA issued a warning letter to Create-A-Pack Foods, Inc. following a facility inspection which found the company's products, including its Herbal Cleanse 5 Day Cleansing Program Dietary Supplement boxed kit which contains Herbal Cleanse Intensive Cleansing Blend and Herbal Cleanse Precleansing Blend, to be adulterated because they were prepared, packed, or held under conditions that violate Current Good Manufacturing Practices for dietary supplements. 

These violations include using product ingredients which did not meet manufacturing specifications. For example, the products contained burdock root which exceeded microbial specifications (contained unacceptable amounts of microbes) and stinging nettle leaf extract which did not meet identity specifications. The company also failed to confirm the identity of other components, such as green tea flavoring.

The products were also found to be misbranded because their labels include incorrect information, such as wrong ingredients and fail to provide other, required information. For example, Herbal Cleanse Precleansing Blend lists magnesium chelate as an ingredient when it is not used in the product, and fails to list magnesium lactate as an ingredient, which is used in the product. Some of the product labels fail to list the plant part for certain ingredients, as required by federal regulations.

See's Review of Weight Loss Supplements for tests of related products.

See related warnings:

Seller of 5-HTP, Chromium, Curcumin and More Warned for Drug Claims

Seller of Muscle Supplements and More Warned for Manufacturing Violations

Creatine Powder Containing DMAA Recalled

FDA Warns Seller of Acai, Garcinia & More for Drug Claims

FDA Warns Dr. Carolyn Dean of Drug Claims Made for Magnesium, Calcium & Other Mineral Supplements

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