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FDA, DOJ sue vape shops for ignoring warnings about illegal sales

FDA, DOJ sue vape shops for ignoring warnings about illegal sales

The Food and Drug Administration (FDA) on Tuesday said it is taking legal action against six e-cigarette manufacturers to stop them from selling and promoting their products.

The agency for the first time asked the Department of Justice (DOJ) to seek permanent injunctions against vaping companies, after the companies repeatedly ignored warnings that some of their products are illegal, FDA and DOJ said in a joint release.

The action represents an escalation for the Biden administration, which has been facing criticism from Democratic lawmakers and advocacy groups for not doing enough to enforce existing law. 

Over the past year, the FDA has been fielding applications from hundreds of e-cigarette manufacturers, authorizing some and rejecting many others. 

It is illegal to sell or distribute e-cigarettes that the FDA has not authorized, though many companies have been ignoring that requirement and their products have remained on the market. Until now, the FDA has only sent warning letters to companies it says are breaking the law.

“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. 

According to the agency, all six of the companies the FDA is suing — E-Cig Crib, Soul Vapor LLC, Super Vape’z LLC, Vapor Craft LLC, Lucky’s Vape & Smoke Shop and Butt Out — previously received formal warning letters stating they were in violation of the law because they had not submitted the legally required applications seeking permission to sell their products. 

An agency spokeswoman said the companies “repeatedly violated the FDA’s premarket review requirements for new tobacco products, even after the FDA warned them about such violations.”

The FDA’s prior warnings noted that further violations could lead to enforcement action, including injunction. 

The companies can enter consent decrees of a permanent injunction, which prevent them from directly or indirectly manufacturing, selling or distributing any new tobacco products unless they get marketing authorization and agree to an FDA inspection of their facilities.

For the companies that don’t agree to consent decrees, the government can request injunctions preventing those defendants from directly or indirectly manufacturing, selling or distributing any unauthorized tobacco products.

Advocacy groups cheered the action, though none of the companies are major players in the e-cigarette market. Puff Bar, which is one of the most popular brands among youth, only received a warning letter earlier this month.

The FDA wouldn’t comment if similar actions are planned against other companies that have received warning letters.