TRENTON, NJ — On Aug. 31, a federal court in New Jersey entered an order of permanent injunction prohibiting two companies in the Bronx and Trenton and their executives from distributing unapproved and misbranded drugs, U.S. Attorney Craig Carpenito and acting Assistant Attorney Gen. Chad A. Readler of the Justice Department’s Civil Division announced.
The injunction, entered by U.S. District Judge Michael Shipp in Trenton federal court, permanently enjoins S Hackett Marketing LLC doing business as Just Enhance of Trenton; R Thomas Marketing LLC of the Bronx; Shawn Hackett, the president and owner of Just Enhance; and Roger Thomas, the president and founder of R Thomas Marketing LLC, from continuing to distribute unapproved and misbranded drugs in violation of the Federal Food, Drug and Cosmetic Act.
On July 5, 2017, the Justice Department filed a complaint at the request of the U.S. Food and Drug Administration alleging that Just Enhance and R Thomas Marketing use more than 100 websites to promote and distribute sexual enhancement products to U.S. consumers. It also alleges that many of the products are unapproved drugs containing the undisclosed ingredient sildenafil, which is the active pharmaceutical ingredient in the prescription drug Viagra.
According to the complaint, the labeling for defendants’ products claim — without FDA approval or clinical studies demonstrating safety and effectiveness — that the products can treat or prevent a variety of serious conditions, including erectile dysfunction, impotence and prostatitis. In addition, the labeling does not reveal the potentially adverse consequences that may result from using a product containing sildenafil.
After the defendants failed to respond to filings or even appear in the action, the government moved for a default judgment with a proposed order of permanent injunction. The permanent injunction entered Aug. 31 requires that the defendants cease distributing unapproved and misbranded drugs and directs R Thomas Marketing and Just Enhance to cease distribution of all drugs until the companies implement specified remedial measures to ensure compliance with the FDCA.