FDA Warns Companies on Adulterated Dietary Supplements

Some of the supplements contain new dietary ingredients for which the agency has not received the required premarket NDI notifications.

Male hand holding craft envelope with text WARNING on blue background, concept

Update (May 10, 2022, 3:20 pm ET): FDA’s original announcement on May 9, 2022, as reported in an earlier version of this article, listed Glanbia Performance Nutrition (Manufacturing) Inc. among the companies that received warning letters. In an updated announcement posted on May 10, 2022, Glanbia was removed from FDA’s announcement, and is no longer listed among the companies receiving warning letters. 

Silver Spring, MD—The Food and Drug Administration (FDA) has issued warning letters to 11 companies for selling adulterated dietary supplements. FDA reported that letters are being sent for various reasons, including:

  • Some of the supplements contain new dietary ingredients (NDIs) for which the agency has not received the required premarket NDI notifications.
  • Some of the supplements also are drugs, despite lacking approval, because they are intended for use in the cure, mitigation, treatment, or prevention of disease. 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.
  • Some of the supplements are being flagged for unsafe food additives.

Warning letters were sent to:

FDA reported that supplements sold by the companies listed above contain one or more of the following:

  • 5-alpha-hydroxy-laxogenin
  • higenamine
  • higenamine HCl
  • hordenine
  • hordenine HCl
  • octopamine.

FDA noted that it has raised concerns about several of these ingredients, and pointed to potential adverse effects of higenamine on the cardiovascular system.

The agency added that is as not evaluated whether the unapproved products subject to this latest round of warning letters 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.

Warned companies have 15 working days to tell FDA how these issues will be addressed, or to provide reasoning and supporting information detailing why 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.

This latest round of warnings, which were sent on May 9, come just days after FDA sent warning letters to five companies for selling products labeled as containing delta-8 tetrahydrocannabinol (delta-8 THC) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). Those letters mark the first time warnings have been issued for products containing delta-8 THC, which FDA said has psychoactive and intoxicating effects and may be dangerous to consumers.

Related: FDA Sends Warning Letters to CBD, Delta-8 THC Companies
Dietary Supplement Listing Act of 2022 Introduced; Industry Divided
FDA Issuing Enforcement Discretion Guidance on NAC