Companies ordered to stop selling sexual enhancement products

A district court in New Jersey issued an order of permanent injunction against two companies — Just Enhance and R Thomas Marketing LLC — for selling unapproved and misbranded sexual enhancement drugs via 100 websites, according to an FDA press release.

According to the FDA, the companies had previously received a warning letter after an analysis showed the presence of an undeclared pharmaceutical ingredient in several products.

“Despite our warning, the defendants refused to comply with the law, and they put consumers at serious risk,” Donald D. Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, said in the release.

FDA’s allegations claim the defendants violated the Food, Drug, and Cosmetic Act by claiming their products could treat or prevent a variety of serious conditions, including prostatitis, impotence, and erectile dysfunction without FDA approval or clinical studies demonstrating safety and effectiveness. The products were also allegedly misbranded because they did not include sufficient directions for use and their labels did not include material information.

FDA further stated that laboratory tests showed some of the products contained undisclosed sildenafil, the active pharmaceutical ingredient in Viagra. Sildenafil can pose serious health risks to patients with underlying medical issues, such as high BP and heart disease, according to the release.

“We will continue to take aggressive action when we learn of unsafe products and dishonest marketing,” Ashely said.

The district court’s order remains in effect until the defendants take “specific remedial measures and comply” with the Food, Drug, and Cosmetic Act, the release stated.

Disclosure: Ashley works for the FDA.