Indictment Alleges Sale of Purported ‘Supplements’ Tainted With Sildenafil

It’s a common scam, as a 28-count indictment alleged against four individuals: the marketing of products as “dietary supplements” that contain unapproved drugs—including substances for sexual performance and weight loss.

According to an indictment recently announced by Rosa Emilia Rodríguez-Vélez, U.S. Attorney for the District of Puerto Rico, the accused marketed to American consumers purported “dietary supplements” for male enhancement or weight loss. But, the indictment alleged, the products were drugs under the Federal Food, Drug and Cosmetic Act (FDCA).

Touting such names as Hard Ten Days, La Pepa Negra and Natural Max Slimming Advanced – Fat Burner, the products were marketed and sold through “online stores” on platforms such as eBay.com and Bonanzo.com, the U.S. Department of Justice (DOJ) said in a March 8 news release.

Many of the male-enhancement pills contained sildenafil, the active pharmaceutical ingredient found in such drugs as “Cialis” and “Viagra,” according to the government, which noted the products didn’t advertise sildenafil.

“The object of the conspiracy was for defendants to unlawfully enrich themselves by purchasing from overseas suppliers, illegally importing into the United States, and subsequently selling to American consumers FDA-regulated products that were counterfeit and/or misbranded,” the DOJ news release asserted. “From at least on or about October 3, 2013, defendants purchased from overseas suppliers located in China, and imported into the United States ‘dietary supplements,’ latex condoms, and make-up that were counterfeit and/or misbranded under the FDCA. In an effort to evade detection by law enforcement, when ordering the illegal products from China, defendants had the packages shipped to a trans-shipper located in Miami, Florida, who would then re-package and/or re-label the parcels and send them to defendants in Puerto Rico.”

The defendants also allegedly hawked counterfeit condoms and counterfeit lipstick kits.

Those indicted include Carlos Enrique Velázquez-Gines, Mayra Evelise Gines-Otero, Noriam Ivette Flores-Deleon and Vanessa Marrero-Hernández. They were charged with mail and wire fraud conspiracy, mail fraud, trafficking in counterfeit goods, introducing misbranded articles into interstate commerce, distribution of a controlled substance, international money laundering and smuggling.

Financially at stake: a forfeiture allegation of roughly $3.7 million, six properties or homes, two bank accounts, one Pay Pal account and three certificates of deposit.

If convicted, the defendants face a maximum possible sentence of 30 years for the conspiracy charges, 10 years for trafficking counterfeit goods and three years for introducing and receiving misbranded products in interstate commerce, DOJ divulged. Velázquez-Gines also faces up to 20 years in prison for international money laundering and 20 years for smuggling, according to the news release.

Leading the investigation was FDA’s Office of Criminal Investigations (OCI), Immigration and Customs Enforcement-Homeland Security Investigation, and US Postal Inspectors, with the collaboration of Customs and Border Protection and the Puerto Rico Department of Treasury (Departamento de Hacienda).

“These defendants sold counterfeit and misbranded medical devices, as well as counterfeit and misbranded male-enhancement pills,” Rodríguez-Vélez said in a statement. “Some of these medications contained drugs that the consumers were not aware of and could cause danger to their health, including heart attacks or strokes. The U.S. Attorney’s Office will continue to work with the FDA to protect the public from adulterated and misbranded products, and to ensure that dietary supplement sellers provide accurate information about their products.”

The defendants could not be immediately reached for comment.