The U.S. District Court for the District of New Jersey entered an order of permanent injunction against S Hackett Marketing LLC doing business as Just Enhance; R Thomas Marketing LLC; Shawn Hackett, president and owner of Just Enhance; and Roger Thomas, president and founder of R Thomas Marketing LLC. The permanent injunction requires the defendants to cease the distribution of drugs until they take specific remedial measures and comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act).
The defendants violated the FD&C Act by selling unapproved and misbranded drugs to U.S. consumers using more than 100 websites. According to the complaint, the label on the defendants’ products claimed—without FDA approval or clinical studies demonstrating safety and effectiveness—that the products could treat or prevent a variety of serious conditions, including erectile dysfunction, impotence and prostatitis. The complaint also stated the products were misbranded because they did not include adequate directions for use and their labels omitted material information.
The FDA issued a warning letter to the companies after the agency conducted laboratory analysis that revealed the presence of an undeclared pharmaceutical ingredient in several products. Laboratory testing found some of the products contained undisclosed sildenafil.
Source: FDA.gov, August 30, 2018