Original Post
Constituent Update
May 9, 2022
Today, the U.S. Food and Drug Administration (FDA) posted warning letters to 11 companies for selling adulterated dietary supplements that contain, in some cases, new dietary ingredients (NDIs) for which the FDA has not received the required premarket NDI notifications and, in others, unsafe food additives. Some of the identified dietary supplements also are drugs, despite lacking approval, because they are intended for use in the cure, mitigation, treatment, or prevention of disease. These products could potentially harm consumers.
Warning letters were sent to the following 11 companies:
- Advanced Nutritional Supplements, LLC
- Exclusive Nutrition Products, LLC (Black Dragon Labs)
- Assault Labs
- Glanbia Performance Nutrition (Manufacturing) Inc.
- 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 dietary supplements sold by the companies listed above contain one or more of the following ingredients: 5-alpha-hydroxy-laxogenin, higenamine, higenamine HCl, hordenine, hordenine HCl, and octopamine. The agency has previously expressed concern about several of these ingredients for reasons including, for example, the potential adverse effects of higenamine on the cardiovascular system.
Some of the products cited in the warning letters are also unapproved new drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease and they lack FDA approval. Under the Federal Food, Drug, and Cosmetic Act, products intended to diagnose, cure, treat, mitigate, or prevent disease are drugs and are subject to the requirements that apply to drugs, even if they are labeled as dietary supplements, and generally require preapproval from the FDA. The agency has not evaluated whether the unapproved products subject to the warning letters announced today are effective for their intended use, what the proper dosage might be, how they could interact with FDA-approved drugs or other substances, or whether they have dangerous side effects or other safety concerns.
The FDA has requested responses from the companies within 15 working days stating how they will address these issues, or providing their reasoning and supporting information as to why they think the products are not in violation of the law. Failure to adequately address this matter may result in legal action, including product seizure and/or injunction.
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