The Food and Drug Administration (“FDA”) oversees the regulation of prescription drugs, over-the-counter drugs, medical devices, many food items, cosmetics and tobacco products. This includes e-cigarettes. It is illegal to manufacture, sell or distribute e-cigarettes without first obtaining the FDA’s approval.

Recently, the U.S. Department of Justice filed complaints in Federal Courts on behalf of the FDA. The complaints ask Federal Judges to stop six e-cigarette manufacturers from manufacturing, selling, and distributing their products This is the first time the FDA has filed complaints like this.

Why were the lawsuits filed?

Six e-cigarette manufacturers began manufacturing, selling and distributing their products without ever getting the FDA’s approval to do so. They never submitted the proper premarket applications to the FDA. Instead, they ignored the law and started placing harmful products on the market. The e-cigarettes may never have been approved by the FDA.

The FDA notified the companies several times that they are in violation of the law. But they still illegally manufacture, sell and distribute the e-cigarettes. Over the past year and a half, the FDA has sent approximately 300 warning letters to companies for failure to have their e-cigarettes properly approved. Most of the companies have complied, but the six companies listed below ignored the warnings.

Since they continue to ignore the FDA, the FDA is asking Federal Judges to enforce the law and make them stop manufacturing, selling, and distributing their products. The FDA is asking the companies to go through the proper process for the FDA to approve their e-cigarettes. There may be monetary penalties as well. The FDA may also be able to seize the illegal products.

Who are the defendants?

The FDA has filed suit against the following companies who manufacture e-cigarettes:

The purpose of the FDA is to keep the public safe and informed. Unauthorized sale of e-cigarettes may cause serious harm to consumers.

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