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Latest Posted May 11, 2022

FDA Warns 10 Companies for Selling Workout Supplements With Dangerous Ingredients

On May 4, 2022, the FDA issued warning letters to 10 companies for selling products promoted for muscle building, fat burning and other uses that contain potentially dangerous ingredients not permitted in dietary supplements, including hordenine, higenamine, 5-alpha-hydroxy-laxogenin, and CBD.

Hordenine, higenamine and 5-alpha-hydroxy-laxogenin are considered "possibly unsafe" by the FDA and are on the FDA's Dietary Supplement Ingredient Advisory List. Hordenine, also known as anhaline, eremursine, and peyocactine is added as an ingredient in some weight loss products to increase metabolism, and is also sometimes found in Huperzine A supplements, which are typically promoted to prevent or treat memory loss. However, hordenine may cause adverse effects such as rapid heart rate and high blood pressure.

Higenamine, also known as Norcoclaurine, DL-DEMETHYLCOCLAURINE, and more, is a naturally occurring stimulant which was, prior to 2018, permitted to be sold as a dietary supplement ingredient in the U.S. However, the substance is known to increase heart rate and have other serious cardiovascular effects when small doses (less than 5 mg) are taken intravenously, and there are no known studies on the effects of taking the large, oral doses found in many of the supplements that were tested.

5-alpha-hydroxy-laxogenin is often promoted as a “natural anabolic” and is advertised to increase muscle and enhance workout performance. It can cause potential side effects such as diarrhea, headaches, and kidney damage.

(See ConsumerLab’s reviews of Weight Loss Supplements and Muscle Enhancers for tests of related products).

Although there are many CBD products on the market, the FDA does not consider it to be a dietary supplement ingredient and is not permitted to labeled as a dietary supplement (see ConsumerLab’s Review of CBD Oils and Hemp Extracts for more information about safety and side effects and our tests of products).

Use the links below to for more details and to read the warning letters issued to each company:

Several of these companies have been warned by the FDA in previous years. For example, Ironmag Labs received an FDA warning in 2017 because its bodybuilding supplement, Super DMZ 4.0, contained a steroid-like substance.

The companies are required to respond in writing to the FDA within 15 days of receipt of the warning letter, outlining steps taken to address any violations. According to the FDA, “Failure to adequately address this matter may result in legal action, including product seizure and/or injunction.”

For more information, use the link below.

FDA Sends Warning Letters to Multiple Companies for Illegally Selling Adulterated Dietary Supplements

See related recalls and warnings:

Recalled Vitamin D Contains Potentially Dangerous Ingredient

FDA Warns Sellers of Bodybuilding Supplements Containing Steroid-Like Substances

Higenamine -- A Potentially Dangerous Stimulant -- Found in Some Supplements

Nine Banned Stimulants Found in Workout, Weight Loss Supplements

DMHA and Phenibut Are Not Permitted in Dietary Supplements, Warns FDA