A New Jersey supplement company owner pleads guilty to introducing an unapproved new drug into interstate commerce “with the intent to defraud and mislead the U.S. Food and Drug Administration (FDA) and consumers,” according to a news release from the U.S. Department of Justice. The owner is Nicholas Andrew Puccio. The government alleges that from 2016 to 2020, Puccio marketed drugs as dietary supplements to the bodybuilding and fitness community.
The supplements allegedly included a product labeled as containing ostarine, a type of synthetic steroid known as a Selective Androgen Receptor Modulator (SARM). Dietary supplements cannot contain unapproved drugs or they are considered unapproved new drugs by the FDA.
The FDA has long warned against the use of SARMs, stating that they can be linked to life-threatening reactions such as liver toxicity. They also have the potential of increasing the risk of heart attack and stroke.
Acting U.S. Attorney Daniel P. Bubar of the Western District of Virginia said in a statement, “When Mr. Puccio marketed unapproved drugs as dietary supplements, he sidestepped important safeguards to protect the public, and must be held accountable. Our office will continue to closely partner with FDA to ensure safety and effectiveness in our drug supply and prosecute those who flout these rules.”
The supplement company owner pleaded guilty before Judge James P. Jone in the U.S. District Court for the Western District of Virginia. A federal court judge will determine Puccio’s sentence on September 23, 2021 after he considers the U.S. Sentencing Guidelines and other statutory factors.
