Always on the lookout for unapproved drugs and supplements being sold, the U.S. Food and Drug Administration (FDA) has ramped up its enforcement actions against selective androgen receptor modulators (SARMs), which are banned under the Controlled Substances Act. While the agency has the public interest at heart, any aggressive law enforcement actions like this carry the risk of implicating innocent healthcare providers and subjecting them to an intrusive investigation that consumes their time and resources and harms their reputation.

SARMs: A New Non-Steroid Muscle Growth Compound

The drugs at issue are SARMs, or selective androgen receptor modulator. These are new compounds produced in a laboratory to mimic the muscle producing aspects of steroids without elevating a patient’s testosterone levels.

The goal of SARM development is to help patients who suffer from medical conditions that deteriorate or weaken their bones or muscles, like cancer, osteoporosis, or multiple sclerosis. Many of these patients need the muscle or bone supplementation that traditional steroids provide, but cannot handle the side effects that steroids have on their testosterone levels.

A couple of examples of SARM compounds include:

• Ibutamoren
• Testolone
• Cardarine
• Andarine
• LGD-4033 (Ligandrol)
• Ostarine (Enobosarm)

Importantly, though, all of these compounds are still in the research and development stage. While there are several clinical trials studying SARMs, none of the compounds have been approved by the FDA for any medical purpose.

Muscle Growth Makes SARMs Popular in Bodybuilding Community

Despite the lack of FDA approval, SARMs have become popular among professional and amateur athletes, particularly those in the bodybuilding community. Drawn to the muscle growth that the compounds can provide without elevating their testosterone in ways that betray traditional steroid use, these athletes have increasingly turned to SARMs as an alternative to steroids.

Noting its potential for abuse and performance enhancement, numerous sports governing bodies have included SARMs in their lists of forbidden substances and anti-doping protocols. These measures have already led to the suspensions of several professional athletes, including former basketball all-star Joakim Noah back in 2017.

SARMs have become especially prevalent in amateur bodybuilding communities, where athletes want the enhanced muscle growth and are unconcerned about anti-doping consequences or drug testing.

SARMs Linked to Significant Health Issues

However, research has linked SARM compounds to some serious safety concerns, including significant short-term health issues, including increased risks of life threatening reactions such as heart attacks, strokes, and liver toxicity. Additionally, the compounds are new enough that long-term health effects are still unknown.

Because of these risks, the FDA has not approved SARMs for medical or therapeutic use in the United States.

Nevertheless, the drug continues to have a market, including with the dietary supplement industry. Individuals and companies continue to fill it with unapproved SARM compounds in products, often with misleading labels that either do not disclose the presence of the SARMs or with packaging that call the product a “dietary supplement” or a “sports supplement” to make it seem as if FDA approval is not necessary.

FDA’s Escalating War Against SARMs

In an attempt to rein in the manufacture and sale of unapproved SARM compounds, the FDA started by issuing warning letters to alleged violators. These warning letters inform the recipient that the FDA is aware of the manufacture or sale of unapproved drugs or that the product has been misbranded or mislabeled. The letter points to specific statutes or regulations that are being violated by the alleged conduct and tells the recipient to take corrective action or risk facing additional FDA investigations and potentially even a criminal referral to the U.S. Department of Justice (DOJ). The letters generally give recipients 15 days to address the alleged violations or to challenge the allegations laid out in the letter.

Importantly, these warning letters are publicly accessible. People and companies that receive one, even a baseless one, can suffer significant reputational harm.

On October 31, 2017, the FDA also issued a press release, stating that the agency had become concerned by how widespread SARM usage had become, particularly in the bodybuilding community. That press release pointed to no fewer than four warning letters that had already been issued.

In the years since, though, the FDA has shifted away from issuing warning letters and instead jumping straight into intensive, invasive, and thorough FDA investigations and criminal referrals.

One of the first cases to get filed ended with a plea deal on November 25, 2020.

That case involved the owner of a North Carolina sporting supplement company. He pled guilty to a felony offense of distributing unapproved new drugs with the intent of defrauding and misleading consumers and the FDA. As a part of his plea deal, he also admitted to:

• Mislabeling products
• Omitting unapproved drugs from the labels
• Falsely claiming that his company was registered and licensed to sell the compounds
• Unlawfully importing drug ingredients from abroad to evade FDA scrutiny
• Wrongly labeling the products as “dietary” or “sports supplements” in order to make it appear that they did not require FDA approval

He forfeited $1.2 million in profits and was fined an additional $350,000. He was sentenced to a year and a day in federal prison.

Soon thereafter, a chiropractor in New Jersey pled guilty to similar charges. His unlawful SARM distribution business was smaller, though, so he forfeited only $150,000 in profits, paid a $10,000 fine, and spent eight months in prison.

The most recent SARM conviction, however, involved manufacturing the compound in addition to selling it. In that case, the owner of a South Carolina supplement company admitted to creating and distributing what he labeled as “dietary supplements” with unapproved SARM compounds in them. He also allegedly used multiple addresses and fake business names to import anabolic steroids from China. He forfeited $200,000 in profits and was sentenced to a year and a day in federal prison.

Dr. Nick Oberheiden, an FDA investigation attorney at the national healthcare defense law firm Oberheiden P.C., notes, “The transition from issuing warning letters to issuing criminal charges is a significant escalation in enforcement tactics. It shows that the FDA is worried that the situation is getting out of hand and they need to start making examples of some people in order to deter others from getting into the industry. Unfortunately, when this happens we often see innocent parties facing scrutiny for things that they did not do and suffering serious consequences that they do not deserve.”