A former Texas resident and his sport supplement company pleaded guilty today to a felony charge relating to the introduction of unapproved new drugs into interstate commerce, the Department of Justice announced.
Brett David Becker, 32, currently of Concord, Michigan, and Accelerated Genetix LLC, a sport supplement company based in Argyle, Texas, pleaded guilty in the U.S. District Court for the Western District of Virginia to one count of distributing unapproved new drugs with the intent to mislead and defraud the FDA and consumers. Becker admitted that, from approximately Janaury 2016 to March 2019, he and his company unlawfully distributed Selective Androgen Receptor Modulators (SARMs) and other substances that the FDA has not approved, including Ostarine and Ligandrol. SARMs are synthetic chemicals designed to mimic the effects of testosterone and other anabolic steroids. The FDA has long warned against the use of SARMs like those found in Accelerated Genetix products, including stating in a 2017 warning letter to another firm that SARMs have been linked to life-threatening reactions including liver toxicity, and have the potential to increase the risk of heart attack and stroke.
“Drugs masquerading as dietary supplements sidestep the FDA approval process and put consumers at risk,” said Acting Assistant Attorney General Jeffrey Bossert Clark of the Justice Department’s Civil Division. “The Department of Justice will continue to work with FDA to ensure a safe and effective drug supply.”
In connection with his plea, Becker agreed to forfeit approximately $3.5 million, which reflects the proceeds related to Accelerated Genetix products sold across the United States through retail outlets and over the internet.
“Becker and his company put their customers’ health at risk by unlawfully distributing drugs without FDA approval,” said Acting U.S. Attorney Bubar of the Western District of Virginia. “This case is particularly troubling, given the FDA’s explicit and repeated warnings about the dangers of SARMs. FDA regulations are integral to safeguarding consumers, and I am proud of our federal team that took on this investigation to ensure the processes and the public are protected.”
“The FDA’s laws are designed to protect the public health by ensuring, among other things, that drugs are safe and effective for their intended uses,” said FDA Assistant Commissioner for Criminal Investigations Catherine A. Hermsen. “Those who manufacture drugs disguised as supplements outside the FDA’s oversight endanger consumers. We remain committed to bringing to justice companies and individuals who attempt to subvert the regulatory functions of the FDA by distributing unapproved, and potentially dangerous, drugs.”
In pleading guilty, Becker also admitted that he intended to mislead and defraud the FDA and consumers by importing these ingredients even after learning they were mislabeled by the distributor when they were shipped from China to the United States; misrepresenting Accelerated Genetix products as “dietary supplements” to create the impression that they were safe and legal to use; and manufacturing a custom order of a SARMs product despite knowing it was illegal to introduce the unapproved new drug into interstate commerce.
U.S. District Judge Jones took the defendants’ guilty pleas in federal court in Abingdon, Virginia, and set sentencing for March 15, 2021.
Assistant U.S. Attorney Randy Ramseyer of the U.S. Attorney’s Office for the Western District of Virginia and Trial Attorney Speare Hodges of the Department of Justice Civil Division’s Consumer Protection Branch are prosecuting the case. This matter was investigated by the Food and Drug Administration’s Office of Criminal Investigations.