FDA: SARMs not worth the health risk ‘for a few extra likes’

28-Apr-2023 - Last updated on 12-May-2023 at 20:35 GMT

The U.S. Food and Drug Administration (FDA) issued an advisory this week warning of adverse event reports related to selective androgen receptor modulators (SARMs). In the letter, the agency also takes issue with online vendors and social media influencers who promote SARMs as safe and effective.

“Targeting teenagers and young adults, videos on social media platforms tout SARMs as a quick or easy way to improve physical appearance, gain muscle mass, or increase athletic performance,” the FDA warning reads. “The reality is SARMs are potentially dangerous.”

The concocted chemical substances, which mimic the effects of testosterone and anabolic steroids, are not FDA approved and are often marketed as dietary supplements or “sold for research purposes only” without warnings on the labels.

Potentially dangerous side effects

“SARMs cannot be legally marketed as dietary supplements or drugs for human use,” the FDA emphasized in a video accompanying the warning. “These products are not worth risking your health for a few extra likes.”

Among the potential side effects listed are increased risk of heart attack or stroke, psychosis and hallucinations, sleep disturbances, sexual dysfunction, liver injury and acute liver failure, infertility, pregnancy miscarriage, and not least testicular shrinkage.

“SARMS are not legitimate dietary supplements; they are unapproved drugs,” Steve Mister, president and CEO at the Council for Responsible Nutrition (CRN) told NutraIngredients-USA. “While some SARM-containing products masquerade as being supplements, these products are patently illegal.”

He added that in 2018, as the industry was seeing an increase in these products, CRN developed voluntary guidelines with its members against the distribution or marketing of dietary supplement products containing SARMs. This was accompanied by the launch of a #SARMsCanHarm campaign to raise awareness of the potential dangers among consumers.

Despite its clear stance, FDA said that it continues to receive adverse event reports associated with SARMs use and acknowledged that the real number of adverse events is likely higher due to underreporting by reluctant or uninformed consumers.

Past actions and action needed

In the past, the FDA has issued warning letters to companies selling unapproved products marketed as SARMs, in addition to pursuing select criminal actions against distributors of these products.

Just this month, an Idaho man pled guilty to a federal felony for selling over $4.4 million in product through his SARMTECH company website and faces a maximum penalty of three years in federal prison. A search of FDA records returns over a dozen additional convictions tied to the smuggling, misbranding and distribution of SARMs. In one of the biggest cases, a federal court sentenced the founder of Blackstone Labs to 4.5 years in prison and ordered him to forfeit $2.9 million for conspiring to sell SARMs and other products as dietary supplements. He was released just before Christmas last year after serving 11 months.

The latest consumer advisory follows a similar FDA letter issued in 2017 against SARMs use in body building products, raising questions as to whether much has changed in the last six year. It was accompanied by three warning letters to companies that “represented the best snapshot of the issue”, an FDA spokesperson said at the time.

“Surely, consumer warnings and advisories have their place but if the FDA is serious about eliminating the illicit SARMs market, it will need to be more consistent in its enforcement operations against the marketers,” Rick Collins, founding partner at Collins Gann McCloskey & Barr, told NutraIngredients-USA. “Perhaps enforcement administrators and field agents have bigger fish to fry.”

Although he noted that there must be more dangerous drug product markets out there and that government resources are limited, he added that “spotty and inconsistent enforcement actions tend to suggest to some in this market that the Government doesn’t really care so much, despite the advisories every few years”.

“Companies who continue to market these ingredients as dietary supplements should face swift and strong enforcement actions by the FDA,” CRN’s Mister said.

The SARMs Control Act that never was

In 2018, US Senators Orrin Hatch (R-UT) and Sheldon Whitehouse (D-RI) introduced a legislative solution called the "SARMs Control Act". Although never passed, the bill would have added SARMs to the federal list of controlled substances and shifted enforcement jurisdiction from FDA to the U.S. Drug Enforcement Agency (DEA).

“I’m poorly inclined toward any proposed law that expands the war on drugs into the fitness market and criminalizes not just marketers but otherwise law-abiding end users,” Collins commented. “For example, someone who walked into an independent health food store and bought a SARMs product for personal use could be arrested and prosecuted as a federal drug criminal for its possession immediately upon the law taking effect.”

When the act was presented, the American Herbal Products Association, Consumer Healthcare Products Association, Council for Responsible Nutrition, United Natural Products Alliance and the US Anti-Doping Agency expressed their joint support for the initiative.

“I think there are better ways to crack down on the market, one of which is simply to enforce the existing laws in a more consistent and expansive way,” Collins added.