By Nicole Wetsman
The Food and Drug Administration just took its first legal action against companies it says are selling e-cigarettes illegally. After facing criticism for not doing enough to keep illegal vapes off the market, the agency asked the Department of Justice to file for injunctions against six manufacturers — which would bar them from selling the products.
“We will not stand by as manufacturers repeatedly break the law, especially after being afforded multiple opportunities to comply,” Brian King, director of the FDA’s Center for Tobacco Products, said in a statement.
Companies need clearance from the FDA before they’re able to sell tobacco products, which includes vapes and e-cigarettes. Over the past year, the agency has been fielding applications from hundreds of companies that make cigarettes, authorizing a handful and rejecting many others.
Still, many companies continued to produce and sell new products without going through the FDA’s process. Until now, the agency has only sent warning letters to companies it says are breaking the law — it has issued nearly 300 so far, according to the statement. But in many cases, those letters haven’t been effective. According to a Stat News investigation, more than half of products named in warning letters were still on the market this summer.
The FDA says the six companies facing injunctions had received warnings but continued to sell unauthorized e-cigarettes. The companies are in Minnesota, West Virginia, Washington, Georgia, Kansas, and Arizona.
The injunctions signal a shift in the FDA’s approach to overseeing vapes and e-cigarettes and could be a warning to other companies in similar positions. The agency has other enforcement tools at its disposal, including the authority to issue monetary penalties.
The six companies facing the injunctions can agree to a consent degree, which would “prevent them from directly or indirectly manufacturing, selling or distributing any new tobacco products unless and until certain prerequisites are met” — including a requirement that those products receive FDA authorization. If the companies don’t agree, the federal agencies can ask the courts to prevent them from manufacturing and selling products.
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By Nicole Wetsman