The FDA Continues to Crack Down on SARM Manufacturing and Distribution

Following several years of issuing warning letters, the U.S. Food and Drug Administration (FDA) has recently started to investigate and prosecute the people and companies that manufacture and distribute SARMs, or selective androgen receptor modulators. Already, there have been several felony convictions that have put people behind bars for years and imposed considerable monetary penalties.

The FDA investigation attorneys at the national law firm Oberheiden P.C. are closely monitoring the situation.

What are SARMs?

Selective androgen receptor modulators are compounds that stimulate tissue growth without some of the collateral effects that come with taking an anabolic steroid. They could potentially be used as a therapeutic drug for people who are suffering from medical conditions that harm bones, muscles, and muscle growth, like cancer and osteoporosis. A couple of examples of SARMs include:

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

However, their tissue growth capabilities make SARMs very popular among athletes and bodybuilders, as the drugs can help them build muscle without elevating their testosterone. It is also why SARMs have been prohibited by competitive sports bodies and agencies, and have been included in anti-doping lists of forbidden substances.

The FDA Has Not Approved Any SARMs for Medical Use

The problem with using, manufacturing, or selling SARMs is that the FDA has not approved any of these compounds yet. They are still a recent development and the subject of lots of research. Additionally, SARMs have been linked to significant health issues in people who do manage to take them, whether through clinical trials or the black market. Just a couple of the adverse health effects include increased risks of:

• Liver toxicity
• Stroke
• Heart attacks and cardiac arrests

Additionally, the long-term health effects from taking a SARM compound are unknown.

The FDA Has Warned Companies to Stop Making, Selling, or Mislabeling SARMs

In the last few years, the FDA has escalated its deterrence and enforcement measures against companies that make and sell SARM compounds for bodybuilding purposes by sending warning letters to potential violators. The agency’s press release on October 31, 2017, alone mentioned four such warning letters to companies purportedly selling the compounds as a steroid alternative.

These warning letters, such as this more recent one, inform the recipient that the FDA has learned that the substances that are being sold are unapproved SARMs or include the compound. The letters then explain why SARMs have not been approved by the FDA for use in the U.S., point to specific statutes and regulations that prohibit the manufacture and sale of unapproved drugs, and inform the recipient of the dangers of taking SARMs.

In many cases, the warning letters also inform recipients that labeling SARMs as “dietary supplements” in order to get around the FDA approval process is illegal. These mislabeled “supplements” often fail to disclose the presence of the SARM compounds, putting the consumer at risk.

Warnings Have Escalated to Investigations and Convictions

Recently, though, the FDA has moved away from merely sending warning letters and has instead conducted intrusive investigations and made several criminal referrals to the U.S. Department of Justice (DOJ) for prosecution.

Some of those cases have already wound their way through the federal court system, ending with plea deals and criminal convictions and the penalties that come with them.

One of the first cases culminated in a plea deal on November 25, 2020.

In that case, the owner of a sport supplement company in North Carolina pleaded guilty to the felony offense of distributing unapproved new drugs with the intent to defraud and mislead the FDA and consumers. He also admitted to mislabeling the products he sold, leaving unapproved ingredients off the labels, falsely claiming that his company was licensed to sell the drugs, unlawfully importing drug ingredients to bypass FDA scrutiny, and calling the products “dietary supplements” or “sports supplements” to make it seem as if they were legal and did not require FDA approval.

As a part of that guilty plea, the company owner agreed to forfeit $1.2 million in profit obtained from selling SARMs over the internet. He was later sentenced to one year and one day in federal prison and fined an additional $350,000.

A New Jersey chiropractor subsequently pleaded guilty to a similar collection of charges. He was sentenced to eight months in prison, paid a $10,000 fine, and forfeited $150,000 in profits from his much smaller venture.

The owner of a South Carolina supplement company pleaded guilty to charges related to manufacturing the drugs, in addition to selling them to the bodybuilding community. He allegedly used multiple businesses and addresses and worked with Chinese importers to hide the nature of the anabolic steroids that he imported. He also admitted to creating and selling unapproved SARM compounds in the guise of “dietary supplements.” He was sentenced to one year and one day in prison and forfeited $200,000 in profits.

Most of these cases are moving forward in the Western District Court of Virginia.

Protect Your Rights and Interests During an FDA Investigation With the Attorneys at Oberheiden P.C.

The FDA’s aggressive enforcement of the law with regard to unlawful SARM manufacture and distribution is a significant risk to healthcare providers who are complying with the law. The agency’s eagerness to make examples out of bad actors runs the risk of implicating reputable healthcare companies.

Getting effective legal representation to ensure that you and your company are not caught up in criminal charges that you did not commit, or even avoiding the inconvenience of an intrusive and embarrassing FDA investigation, is critical. The FDA defense lawyers at Oberheiden P.C. have helped numerous healthcare companies and their executives prepare for FDA audits and investigations, monitored those investigations to ensure that they complied with the scope of the inspection and did not violate your rights, and implemented strict FDA compliance mechanisms that have helped to avoid scrutiny entirely.

Contact Oberheiden P.C. online today or call our national healthcare defense firm at (888) 680-1745 to get started on your case. Regardless of your situation – whether you suspect that you are under FDA scrutiny, have received an FDA warning letter about allegedly unlawful SARM manufacture or distribution, or have been charged with a federal offense – our attorneys can help you through it.