November 16, 2018

Permanent Injunction Issued Against Dietary Supplements Containing Undisclosed Drugs

The 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. This injunction requires the defendants to cease the distribution of their products until they take remedial measures and comply with the Federal Food, Drug, and Cosmetic Act.

Order of Permanent Injunction

The notice states that the defendants violated the Act by selling unapproved drugs and misbranded drugs to consumer on more than 100 different websites. The complaint states that the label on these products claimed, without FDA approval or any clinical studies demonstrating safety and effectiveness, that they could treat or provident serious conditions. Some of those conditions included impotence and prostatitis.

Testing at the FDA laboratory found that some of the4se products contained undisclosed sildenafil, which is the active pharmaceutical ingredient in the drug, which is only available by prescription, in Viagra. The use of this drug can pose serious health risks to patients who have underlying medical conditions such as high blood pressure and heart disease. Sildenafil is a phosphodiesterase type-5 (PDE-5) inhibitor. The products are drugs as defined by the FD&C Act because they are “intended to prevent, treat, or cure disease conditions and/or affect the structure or function of the body.”

Donald D. Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research said in a statement, “Despite our warning, the defendants refused to comply with the law, and they put consumers at serious risk. Particularly egregious is the undisclosed presence of sildenafil, a potentially dangerous active pharmaceutical ingredient that requires a doctor’s prescription. We will continue to take aggressive action when we learn of unsafe products and dishonest marketing.”

A warning letter was issued to the companies after the lab analysis found the presence of an undeclared pharmaceutical ingredient in several products. When that method did not achieve the desired results, the order of permanent injunction was filed.

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