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Posted December 20, 2017

Seller of Supplements for Pain and Allergies Warned for Manufacturing Violations, Drug Claims

On December 13, 2017, the FDA issued a warning letter to GnuPharma Corporation, following a facility inspection which found a number of the company's products, including Relief capsules, Foundation capsules, Aller-geez capsules, Fit capsules, Aller-Geez Tea, Foundation herbal tea and Relief Tea 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 specifications for each dietary supplement manufactured for the identity, purity, strength, and composition of the finished batch of the dietary supplement, and failure to establish for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement, as required for federal regulations.

In addition, statements made about some products on the company's website or product labels were found to be drug claims. For example, the label for Relief capsules states "... assists with daily pain." The label for Foundation capsules states "assists with inflammation."

See ConsumerLab.com's Turmeric and Curcumin Supplements Review for tests of related products.

Aller-geez capsules were promoted with statements such as "decongestant," and "natural way to provide relief from occasional itchy nose, watery, eyes, and occasional sneezing."

For related information, see ConsumerLab.com's answer to the question Which supplements are best for seasonal allergies? >>

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.