A trio who sold products marketed as dietary supplements but spiked with undeclared drugs from China have pleaded guilty to engaging in a mail fraud conspiracy, according to federal prosecutors in Puerto Rico.
Michelle Andujar-González, the president of BAJA PESO YA INC., Sahen L. Maldonado-López, the secretary, and María de Lourdes Irizarry-Rodríguez, an associate of the company, each face a maximum sentence of 20 years in prison, a fine of up to $250,000 and a supervised release term of up to three years, the U.S. Department of Justice (DOJ) announced Tuesday in a news release.
The defendants also agreed to forfeit $400,000 in proceeds traceable to the mail fraud conspiracy, according to the news release.
As part of a scheme from 2018 through May 2021, the defendants sold products containing undeclared drugs—sibutramine, phenolphthalein, and tadalafil—purchased from suppliers in China, DOJ said. The products were advertised on Facebook and the BAJA PESO YA INC. website and delivered through the mail to customers across the U.S., the agency added.
Sibutramine is a Schedule IV controlled substance banned by FDA in October 2010 due to risk of heart problems and strokes, and tadalafil is the active pharmaceutical ingredient in an FDA-approved drug (Cialis) to treat erectile dysfunction. Phenolphthalein was used in some laxative products until 1999, but studies have suggested the drug presents a cancer-causing risk, and FDA no longer recognizes it as “safe and effective,” according to DOJ’s news release.
The products’ labeling featured such claims as “Help contain appetite and hunger cravings,” “Lose weight starting in one week,” “Made of Natural Herbs,” and “Safe and Free of Side Effects," according to DOJ. From April 2015 through July 2019, FDA published notifications for drug-tainted products sold by the defendants, DOJ said.
“Products that claim to be dietary supplements but contain unapproved drug ingredients pose a serious risk to public health,” Special Agent in Charge Justin C. Fielder, FDA Office of Criminal Investigations Miami Field Office, said in the news release. “We will continue to investigate and bring to justice those who put profits above the health and safety of U.S. consumers.”
Attorneys representing the defendants did not immediately respond to requests for comment.
Last month, a Pennsylvania man pleaded guilty to a charge of conspiracy in connection with an alleged scheme to smuggle mislabeled drugs and sell them as dietary supplements. That case involved a years-long conspiracy to import from China and resell to consumers substances falsely labeled as “all natural” dietary supplements that contained undeclared sibutramine, according an Oct. 19 DOJ news release.