NEWARK, N.J. – A federal court in New Jersey has issued a permanent injunction against 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, for distributing unapproved and misbranded drugs.
The injunction, entered by the U.S. District Court for the District of New Jersey, permanently enjoins the defendants from continuing to distribute unapproved new drugs and misbranded drugs in violation of the Federal Food, Drug, and Cosmetic Act (FDCA).
According to the complaint filed by the U.S. Food and Drug Administration (FDA), Just Enhance and R Thomas Marketing LLC use over 100 websites to promote and distribute sexual enhancement products to U.S. consumers. The products, which are unapproved drugs containing the undisclosed ingredient, sildenafil, claim to treat or prevent a variety of serious conditions, including erectile dysfunction, impotence, and prostatitis, without FDA approval or clinical studies demonstrating safety and effectiveness.
The defendants, who failed to respond or even appear in the action, will be required to cease the distribution of unapproved new drugs and misbranded drugs. The permanent injunction directs the defendants to cease distribution of all drugs until the companies implement specified remedial measures to ensure compliance with the FDCA.
The government is represented by Trial Attorney Jocelyn Hines of the Civil Division’s Consumer Protection Branch and Assistant U.S. Attorney Susan Pappy of the New Jersey U.S. Attorney’s Office Health Care and Government Fraud Unit, with the assistance of Associate Chief Counsel for Enforcement Laura Akowuah of the FDA, Office of General Counsel, Department of Health and Human Services.
“Compliance with the Food, Drug, and Cosmetic Act is necessary to ensure that consumers have complete confidence in the safety and effectiveness of the drugs they use,” said Acting Assistant Attorney General Chad A. Readler of the Civil Division. “The U.S. Food and Drug Administration and the U.S. Department of Justice will continue to work together to enforce labeling requirements and protect consumers from the dangers of undisclosed ingredients in drugs.”
The case is U.S. v. S Hackett Marketing LLC et al., No. 1:17-cv-01112 (D.N.J.).
Defendant/respondent: S Hackett Marketing LLC d/b/a Just Enhance, R Thomas Marketing LLC, Shawn Hackett, Roger Thomas
Exact criminal charges: Distributing unapproved and misbranded drugs in violation of the Federal Food, Drug, and Cosmetic Act (FDCA)
City and state: Trenton, New Jersey; Bronx, New York
Exact date: July 5, 2017
Sentence or outcome: Permanent injunction
Dollar amounts: None
Key Facts
- State: New Jersey
- Category: Drug Trafficking|Fraud & Financial Crimes
- Source: DOJ Press Release â†â€â€
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