E-cigarette: US government seeks court injunctions against six manufacturers as FDA steps up enforcement



CNN

The US Department of Justice filed a lawsuit against six e-cigarette makers on Tuesday, seeking permanent injunctions against the makers on behalf of the US Food and Drug Administration. The flurry of complaints marked the first time the FDA has taken such action against e-cigarette makers to enforce its premarket review requirements for new tobacco products.

The six makers failed to submit the necessary premarket applications for their e-cigarette products “and continued to illegally manufacture, sell, and distribute their products, despite the FDA’s previous warning that they were in violation of the law,” it said. said the FDA. in a statement.

“Today’s enforcement actions represent an important step for the FDA in preventing tobacco product manufacturers from breaking the law,” said Brian King, director of the FDA’s Center for Tobacco Products. “We will not sit idly by as manufacturers repeatedly break the law, especially after they have had multiple opportunities to comply.”

The Federal Food, Drug, and Cosmetic Act requires companies to submit applications to the FDA and have them approved before manufacturing, selling, or distributing new tobacco products. Companies that had products on the market before this provision came into effect still had to submit applications.

The FDA says it issued nearly 300 warning letters between January 2021 and September 9, 2022, for non-submission of applications, and most of those companies pulled their products from the market. This month, the agency sent a warning letter to the maker of Puff Bar products, which are particularly popular with young people, for operating without a marketing authorization order. In June, the agency ordered e-cigarette giant Juul Labs to pull its products from the market, but a court blocked that ban, so those products are still available.

Lawyers have criticized the FDA for being too slow to act on the majority of premarket applications. In May, the agency announced that it would not complete its review of all premarket applications from e-cigarette companies until June 2023, nearly two years past the court’s deadline for making a decision on these products.

Erika Sward, assistant vice president for national advocacy for the American Lung Association, said Tuesday’s actions send “a very important message to manufacturers that they need to obey the law.”

“This is a monumental first step for the FDA and the DOJ, and we are truly encouraged by this action,” she said. “I am really happy that this is the kind of step forward. That’s what the FDA had to do all along, and we’re very happy to see that.

Sward credited King, who was named director of the Center for Tobacco Products in July, with providing the impetus for the stock rise.

“We’re hopeful this indicates that the FDA and DOJ will take more action against other recalcitrant manufacturers,” she said. “And we also very much hope that manufacturers will understand that under Dr. King’s leadership, this is a different Center for Tobacco Products.”

The complaints were filed against manufacturers who, according to the FDA, continued to manufacture and distribute nicotine products even after being warned that they were breaking the law. According to court documents, all six manufacturers received warning letters from the FDA informing them that they were manufacturing tobacco products that did not have the required approval.

Several of the defendants also participated in teleconferences with the FDA after receiving the warning letters, the government said. Some of the manufacturers reportedly told the agency they would stop making and distributing the nicotine products in question, but follow-up inspections showed the products were still being made and sold, according to the complaints.

“These cases are an important step in stopping the illegal sale of unauthorized electronic nicotine delivery system products,” said Senior Assistant Deputy Attorney General Brian M. Boynton, who leads the DOJ’s Civil Division, in a press release. “The Department of Justice will continue to work closely with the FDA to stop the distribution of illegal and unauthorized tobacco products.”

The six companies named in court filings Tuesday are Morin Enterprises Inc., doing business as E-Cig Crib, Minnesota; Soul Vapor LLC in West Virginia; Super Vape’z LLC in Washington; Vapor Craft LLC in Georgia; Lucky’s Convenience & Tobacco LLC, doing business as Lucky’s Vape & Smoke Shop, Kansas; and Seditious Vapors LLC, doing business as Butt Out, Arizona. The companies have not yet responded to CNN’s requests for comment.

“Mr. King seems happy to kick down the doors of small businesses but turns a blind eye to the millions of Americans who rely on vaping nicotine to quit smoking,” said Amanda Wheeler, president of the American Vapor Manufacturers Association. , in a statement. “The ongoing result is that countless people are repelled to smoking.”

About Jefferey G. Cannon

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