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Posted September 4, 2018

Federal Court Shuts Down Maker of Sexual Enhancement Products

On August 30, 2018, the FDA announced that U.S. District Court for the District of New Jersey has 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 for selling sexual enhancement products containing an undeclared prescription drug. The FDA considers these products to be unapproved and misbranded drugs. The injunction requires company to stop directly or indirectly manufacturing or distributing the products.

According to the FDA's announcement, the products were sold to U.S. consumers using more than 100 websites, and were promoted with claims they could treat or prevent a variety of serious conditions, including erectile dysfunction, impotence and prostatitis. FDA laboratory testing found some of the products contained undisclosed sildenafil. 

Sildenafil, the active ingredient in the prescription drugs Viagra is prescribed for erectile dysfunction. It can cause symptoms like headache and flushing, and can interact with medications containing nitrates such as nitroglycerine, resulting in dangerously low blood pressure that may be life threatening.

In 2015, R Thomas Marketing, LLC received a warning letter from the FDA that detailed violations of its products, including Black Ant, Herb Viagra, Real Skill, and Stree Overlord. The products were recalled in 2016.

(See's Review of Sexual Enhancer Supplements for tests of related products.)

In the FDA's news release about the injunction, the FDA's director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research Donald D. Ashley said, "Despite our warning, the defendants refused to comply with the law, and they put consumers at serious risk... We will continue to take aggressive action when we learn of unsafe products and dishonest marketing." 

See Related Warnings:

Sexual Enhancement Supplements Containing Undeclared Drugs Recalled

Sexual Enhancement Supplement Recalled

Men's Sexual Enhancement Supplement Recalled

Seller of Male Enhancement, Prostate Supplements & More Warned for Drug Claims

AMPT "Sexual Enhancement" Coffee Recalled

To read the FDA's press release, use the link below.