TRENTON, N.J. - A federal court in New Jersey today entered an order of permanent injunction prohibiting two companies in Bronx, New York, and Trenton, New Jersey, and their executives from distributing unapproved and misbranded drugs, U.S. Attorney Craig Carpenito and Acting Assistant Attorney General 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 d/b/a Just Enhance of Trenton, New Jersey; R Thomas Marketing LLC of Bronx, New York; 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 (FDCA).
On July 5, 2017, the Justice Department filed a complaint at the request of the U.S. Food and Drug Administration (FDA). The complaint alleges that Just Enhance and R Thomas Marketing LLC use over 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 today requires that the defendants cease distributing unapproved and misbranded drugs and directs R Thomas Marketing LLC and Just Enhance to cease distribution of all drugs until the companies implement specified remedial measures to ensure compliance with the FDCA.
The government is represented by Assistant U.S. Attorney Susan Pappy of the New Jersey U.S. Attorney’s Office and Trial Attorney Jocelyn Hines of the Civil Division’s Consumer Protection Branch, with the assistance of Associate Chief Counsel for Enforcement Michael Varrone of the FDA, Office of General Counsel, and Department of Health and Human Services.
Additional information about the Consumer Protection Branch and its enforcement efforts may be found at http://www.justice.gov/civil/consumer-protection-branch. For more information about the U.S. Attorney’s Office for the District of New Jersey, visit its website at https://www.justice.gov/usao-nj.
Source: U.S. Department of Justice, Office of the United States Attorneys
