Chiropractor who sold ostarine in 'supplements' pleads guilty

Josh Long, Associate editorial director, SupplySide Supplement Journal

June 10, 2021

2 Min Read
Plea Agreement 2021.jpg

A New Jersey chiropractor charged with marketing drugs as “dietary supplements” has pleaded guilty to a felony charge, the U.S. Department of Justice (DOJ) announced Thursday.

Nicholas Andrew Puccio, 41, of Columbus, New Jersey, pleaded guilty to introducing an unapproved new drug into interstate commerce with the intent to defraud and mislead FDA and consumers, according to a DOJ news release.

From 2016 to 2020, the U.S. government alleged, Puccio marketed drugs as dietary supplements to the bodybuilding and fitness community, including a product labeled as containing ostarine. Ostarine is a type of synthetic steroid known as a selective androgen receptor modulator (SARM).

FDA in 2017 raised concerns about the safety of SARMs and issued warning letters to several companies selling them. That was the same year FDA seized products from the facilities of a company that openly sold SARMs and was associated with a former bankruptcy lawyer with a colorful nickname and online personality: Charles Anthony Hughes, aka “Dr. Tony Huge."

In its 2017 warning letters, FDA stated SARMs had been linked to such life-threatening reactions as liver toxicity and have the potential to increase the risk of heart attack and stroke.

“When Mr. Puccio marketed unapproved drugs as dietary supplements, he sidestepped important safeguards to protect the public, and must be held accountable,” Acting U.S. Attorney Daniel P. Bubar of the Western District of Virginia said in a statement. “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.”

Puccio’s plea follows one in December when the owner of a North Carolina-based company admitted to selling SARMs and other drug compounds as undeclared ingredients in products marketed as sports supplements and research chemicals.

Puccio, who pleaded guilty before Judge James P. Jones in U.S. District Court for the Western District of Virginia, is scheduled to be sentenced on Sept. 23. He faces a maximum penalty of three years in prison, according to the government.

DOJ said his sentence will be determined based on a judge’s consideration of U.S. sentencing guidelines and other statutory factors.

According to Puccio’s plea agreement, he agreed to forfeit $150,000 to the U.S. government, including remitting $65,000 before the entry of his guilty plea and $85,000 on or before Sept. 15. Among other conditions, Puccio also agreed he will not play a “role in the manufacture, sale or distribution of any product (a) containing any ingredient listed on the FDA’s Dietary Supplement Ingredient Advisory List or (b) that is represented to be a dietary supplement when, in fact, it is not.”

David Barger, an attorney representing Puccio, did not immediately respond to a request for comment.

 

 

 

About the Author

Josh Long

Associate editorial director, SupplySide Supplement Journal , Informa Markets Health and Nutrition

Josh Long directs the online news, feature and op-ed coverage at SupplySide Supplement Journal (formerly known as Natural Products Insider), which targets the health and wellness industry. He has been reporting on developments in the dietary supplement industry for over a decade, with a focus on regulatory issues, including at the Food and Drug Administration.

He has moderated and/or presented at industry trade shows, including SupplySide East, SupplySide West, Natural Products Expo West, NBJ Summit and the annual Dietary Supplement Regulatory Summit.

Connect with Josh on LinkedIn and ping him with story ideas at [email protected]

Education and previous experience

Josh majored in journalism and graduated from Arizona State University the same year "Jake the Snake" Plummer led the Sun Devils to the Rose Bowl against the Ohio State Buckeyes. He also holds a J.D. from the University of Wyoming College of Law, was admitted in 2008 to practice law in the state of Colorado and spent a year clerking for a state district court judge.

Over more than a quarter century, he’s written on various topics for newspapers and business-to-business publications – from the Yavapai in Arizona and a controversial plan for a nuclear-waste incinerator in Idaho to nuanced issues, including FDA enforcement of the Dietary Supplement Health and Education Act of 1994 (DSHEA).

Since the late 1990s, his articles have been published in a variety of media, including but not limited to, the Cape Cod Times (in Massachusetts), Sedona Red Rock News (in Arizona), Denver Post (in Colorado), Casper Star-Tribune (in Wyoming), now-defunct Jackson Hole Guide (in Wyoming), Colorado Lawyer (published by the Colorado Bar Association) and Nutrition Business Journal.

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