FDA SARM Warning

On October 31st, 2017, the US Food and Drugs Administration (FDA) issued a press release on the dangers of selective androgen receptor modulators (SARMs) being used in muscle building supplements. This is coming in the wake of SARMs being promoted as an FDA approved bodybuilding ingredient, when it is not.

According to Donald D. Ashley, J.D, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, “We are extremely concerned about unscrupulous companies marketing body-building products with potentially dangerous ingredients.

Body-building products that contain selective androgen receptor modulators, or SARMs, have not been approved by the FDA and are associated with serious safety concerns, including potential to increase the risk of heart attack or stroke and life threatening reactions like liver damage. “We will continue to take action against companies marketing these products to protect the public health.”

In pursuance of this, the FDA sent warning letters to some of the companies selling SARMs based supplements and requires them to reply the letters in 15 days or less, with a concrete plan about how to resolve the problem or face injunctions, possible prosecution and/or asset forfeiture.

The companies, which are Panther Sports Nutrition, IronMagLabs, and Infantry Labs, have been reported to consistently sell supplements containing SARMs and misinforming the public of their benefits.

These supplements have not undergone any testing with the FDA and aren’t approved dietary supplements. Unfortunately, consumers don’t know how to identify SARMs and may not even be aware of their ingestion until it’s too late. The FDA’s list of SARMs that are usually found in dietary supplements include Andarine, Ostarine, Enobosarm, Ligandrol, Testolone, S-22, and YK11.

The use of SARMs has been linked to a few very dangerous side effects. Some of these include liver toxicity, and the increased risk of stroke and heart attacks. There’s also the possible risk of unidentified side effects due to long term usage.

The FDA therefore warns current and intending users to immediately cease all usage of these supplements and speak to their doctors about possible or observed side effects of the drug.

The FDA also encourages users who have experienced significant side effects, including but not limited to the adverse effects earlier mentioned to report these side effects to both their healthcare practitioners and the board.

Consumers can do this through the FDA’s MedWatch Adverse Event Reporting program. Reporting the side effects is easy. Just go to the MedWatch Online Voluntary Reporting Form, and download the form. Once filled and completed, the report can be submitted online or faxed to 1-800-FDA-0178.

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