Four individuals arrested, charged with trafficking counterfeit FDA-regulated goods

Four individuals were arrested recently and charged with the alleged sale of counterfeit male enhancement pills, weight loss pills, condoms, and cosmetics.

Carlos Enrique Velázquez-Gines, Mayra Evelise Gines-Otero, Noriam Ivette Flores-Deleon, and Vanessa Marrero-Hernández 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.

This investigation was conducted by U.S. Immigration and Customs Enforcement’s (ICE) Homeland Security Investigations (HSI) special agents in collaboration with the U.S. Food and Drug Administration’s (FDA) Office of Criminal Investigations (OCI), the U.S. Postal Inspection Service, U.S. Customs and Border Protection (CBP), and the Puerto Rico Department of Treasury.

The male-enhancement pills contained the active pharmaceutical ingredient sildenafil, found in popular and well-known products such as “Viagra” and “Cialis.” Defendants also sold counterfeit condoms. Male latex condoms are medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA). The defendants also sold counterfeit Kylie Cosmetics brand products, including lipstick kits. Lipstick is a cosmetic under the FDCA.

“These defendants sold counterfeit and misbranded medical devices, as well as counterfeit and misbranded male-enhancement pills,” Rosa Emilia Rodríguez-Vélez, U.S. attorney for the District of Puerto Rico, said. “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 face a forfeiture allegation of approximately $3.7 million, six properties or homes, two bank accounts, one PayPal 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. Velázquez-Gines faces up to 20 years in prison for international money laundering and 20 years for smuggling. The case is being prosecuted by Assistant U.S. Attorney Edward Veronda.

“The trafficking of counterfeit goods is simply illegal and in some cases, as this, it becomes a problem of public health and safety and at times threatens national security,” Orlando Baez, the acting special agent in charge who oversees HSI operations throughout Puerto Rico and the U.S. Virgin Islands, said. “This illegal activity represents a triple threat as it delivers substandard and often dangerous goods into the economy, rob citizens of good-paying jobs, and generate proceeds that are often funneled back into other criminal enterprises. HSI will continue to work with its enforcement partners to combat the distribution of counterfeit products especially those who that endanger public health.”