May 20, 2022

FDA Warns Companies Allegedly Selling Adulterated Dietary Supplements

The FDA has sent warning letters to companies that are allegedly selling adulterated dietary supplements. The supplements contain new dietary ingredients for which the FDA has not received the required premarket NDI notifications. Others contain unsafe food additives. And others are drugs that have not been approved, because they are intended for use in the care, mitigation treatment, or prevention of disease.

Edit: The FDA has removed Glanbia from this list

FDA Warns Companies Alleged.y Selling Adulterated Dietary Supplements

“On May 9, 2022, the FDA issued a Constituent Update (below) stating that Glanbia Performance Nutrition (Manufacturing), Inc. (Glanbia), along with 10 other companies, was illegally selling adulterated dietary supplements. However, the FDA has since determined that Glanbia was incorrectly identified and does not sell the products Uplift Max and Shred Her Max, which were cited in the FDA Warning Letter sent to the company on May 4, 2022.

The error occurred because the website on which the products Uplift Max and Shred Her Max are sold incorrectly stated that the site was the property of one of Glanbia’s subsidiaries, Optimum Nutrition.

Glanbia discovered this error and immediately notified the FDA. As a result, the Warning Letter the FDA issued to Glanbia has been retracted and the FDA is continuing its investigation to determine the responsible firm and reissue the warning letter.

The FDA regrets the confusion this error has caused.”

The companies are:

Advanced Nutritional Supplements, LLC

Exclusive Nutrition Products, LLC (Black Dragon Labs)

Assault Labs

IronMag Labs

Killer Labz (Performax Labs Inc)

Complete Nutrition LLC

Max Muscle

New York Nutrition Company (American Metabolix)

Nutritional Sales and Customer Service LLC

Steel Supplements, Inc.

The supplements sold by these companies contain one or more of the following ingredients: 5-alpha-hydroxy-laxogenin, higenamine, higenamine HCl, hordenine, hordenine HCl, and octopamine. The FDA has expressed concern about several of these ingredients for possible adverse effects. For instance, higenamine can affect the cardiovascular system.

Some of these products are unapproved new drugs because they lack FDA approval and are intended to cure, mitigate, treat, or prevent disease. Under the Federal Food, Drug, and Cosmetic Act, these products are subject to the same requirements that apply to drugs, even if they are labeled as dietary supplements.

The agency has not evaluated whether the unapproved products are effective for their intended use, what the proper dosage is, how the supplements could interact with FDA-approved drugs or other substance, or whether they may have dangerous side effects or other safety concerns.

You can follow the links on the FDA web site for more information about the potentially adulterated dietary supplements made by each of those companies. The FDA has requested responses from the companies within 15 working days, stating how they will address these issues.

 

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