DOJ Press Release –
A New Jersey chiropractor pleaded guilty today to a felony charge relating to the distribution of steroid-like drugs in purported dietary supplements.
According to court documents, Nicholas Andrew Puccio, 41, currently of Columbus, New Jersey, pleaded 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. The United States alleged that from 2016 to 2020, Puccio marketed drugs as “dietary supplements” to the bodybuilding and fitness community. The supplements included a product labeled as containing ostarine, a type of synthetic steroid known as a Selective Androgen Receptor Modulator (SARM). The FDA has long warned against the use of SARMs, including stating in a 2017 warning letter to another firm that SARMs had been linked to life-threatening reactions such as liver toxicity, and have the potential to increase the risk of heart attack and stroke.
“Undermining the FDA drug approval process puts consumers at risk, especially when those drugs contain ingredients that can cause harm,” said Acting Assistant Attorney General Brian M. Boynton of the Justice Department’s Civil Division. “The Department of Justice will continue to work closely with the FDA to prosecute those who put profit before the public health.”
“When Mr. Puccio marketed unapproved drugs as dietary supplements, he sidestepped important safeguards to protect the public, and must be held accountable,” said Acting U.S. Attorney Daniel P. Bubar of the Western District of Virginia. “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.”
“Marketing misbranded dietary supplements that contain unapproved drugs is illegal and is a threat to public health,” said Assistant Commissioner for Criminal Investigations Catherine A. Hermsen of the FDA’s Office of Criminal Investigations. “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.”
Puccio pleaded guilty before Judge James P. Jones in U.S. District Court for the Western District of Virginia. He is scheduled to be sentenced on Sept. 23, and faces a maximum penalty of three years in prison. A federal district court judge will determine any sentence after considering the U.S. Sentencing Guidelines and other statutory factors.
The FDA’s Office of Criminal Investigations is investigating the case.
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 Civil Division’s Consumer Protection Branch are prosecuting the case.Arrests Dietary Supplements Misbranded Ostarine Provider Arrest Steroids