The FDA issued a warning letter to an online retailer selling multiple selective androgen receptor modulators (SARMs) earlier this month, in an ongoing effort to curb their use in consumers, the agency said.
This recent letter advised a California-based company, known as Warrior Labz SARMS, and its owner, Jeremy Brown, to stop actively marketing SARMs products for human use.
“Despite statements on your product labeling marketing your products for ‘research purpose only’ and ‘not for human consumption,’ evidence obtained from your website establishes that your products are intended to be drugs for human use,” the letter stated.
According to an FDA consumer warning released in April, SARMs are “chemical substances that mimic the effects of testosterone and anabolic steroids” and they are not approved by the FDA.
The agency noted that several studies have shown that SARMs are associated with serious and life-threatening health problems, including:
- Increased risk of heart attack or stroke
- Psychosis or hallucinations
- Sleep disturbances
- Sexual dysfunction
- Liver injury and acute liver failure
- Infertility
- Pregnancy miscarriage
- Testicular shrinkage
The letter said that the Warrior Labz SARMS website was marketing several drugs they claimed could address issues such as weight loss or muscle growth. Among the products marketed on the website as SARMs included RAD-140 Testolone, MK-677 Ibutamoren, MK-2866 Ostarine, and LGD-4033 Ligandrol.
The agency also expressed concerns about the company’s sale of unapproved new drugs that are intended for injection or intranasal administration.
The agency has sent warning letters to several companies for advertising and selling these drugs, and it has even pursued criminal action against some of these companies. SARMs and their use to promote muscle growth or weight loss, especially among those focused on bodybuilding, have long been a concern among the medical community.
The FDA said it continues to receive adverse event reports associated with the use of SARMs. It also stated that “the real number of consumers experiencing adverse events is likely higher due to underreporting,” since the drugs are not approved. The nature of these drugs could mean that consumers are afraid to report adverse events or unaware of the opportunity to file a report at all, the agency noted. It also pointed out that some consumers might be unaware that their symptoms are related to the SARMs products.
The agency emphasized that online vendors, like Warrior Labz SARMS, and social media influencers are pushing inaccurate information about the safety and efficacy of SARMs. These companies and influencers tend to market the drugs as dietary supplements or experimental drugs. Still, these products tend to be marketed without warning labels, which may mislead consumers to believe they are safe. SARMs cannot be legally marketed in the U.S., the FDA noted.
In the letter, the FDA claimed that Brown is “responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.”
Furthermore, Brown is responsible for ensuring his company complies with “all requirements of federal law, including FDA regulations,” the letter noted. “Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.”
Brown did not respond to requests for comment.
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