A coalition of public health groups sued the Food and Drug Administration on Tuesday, seeking to block a new policy that could allow a wave of new flavored e-cigarettes and nicotine pouches to enter the market without completing the required scientific review.
The lawsuit asks for a judge to set aside a policy that was announced in May and finalized just days after executives of companies pushing for it dined with President Trump at his golf club in Florida. Two days before the lunch, Reynolds American, which sent top staff members to the meeting, donated $5 million to a super PAC backed by the president, campaign finance records show.
The new policy says that the F.D.A. will not use its enforcement authority against makers of products that have made significant progress toward an agency approval decision. In practice, the policy is expected to allow major tobacco companies to begin selling an array of new flavored tobacco pouches and e-cigarettes within a matter of months.
Until May, the F.D.A. had authorized companies to sell vapes only in menthol or plain tobacco flavors, which are thought to be less appealing to young people. But unauthorized products with high levels of nicotine in flavors like strawberry slushie have poured in from China and are being sold illegally throughout the United States.
Led by the Campaign for Tobacco-Free Kids, the plaintiffs in the lawsuit include the American Lung Association, American Heart Association, American Cancer Society Cancer Action Network and the American Academy of Pediatrics.
The groups said that the new policy violates the Tobacco Control Act, enacted during the Obama administration, which required each individual e-cigarette and tobacco pouch to undergo an extensive F.D.A. review before obtaining a “marketing granted order,” which is similar to an approval. The oversight is focused on whether each product is “appropriate for the protection of public health,” often measured by a company’s studies of its effect in helping adults quit smoking cigarettes without attracting young tobacco users.
“By illegally allowing the sale of unauthorized e-cigarettes and nicotine pouches, including products with proven youth appeal, this guidance helps the tobacco industry target kids and threatens the hard-won progress our nation has made in reducing youth tobacco use,” a statement from the plaintiff groups said.
A spokeswoman for the F.D.A. declined to comment on the litigation.
The lawsuit against the F.D.A. and its parent agency, the Department of Health and Human Services, was filed in the U.S. District Court for the District of Maryland by legal teams from the Campaign for Tobacco-Free Kids and Democracy Forward, a left-leaning group that has challenged a number of Trump administration policies.
The groups are asking the judge to declare that the policy is invalid and to block its implementation, including a provision for the F.D.A. to create a list of new products that can be sold.
The new policy also states that the F.D.A. will escalate its efforts to crack down on the flow of unauthorized vapes coming into the United States, a bipartisan goal shared by public health groups and tobacco executives.
Tadeu Marroco, chief executive of British American Tobacco, which owns Reynolds American, said during a call with investors last month that the illicit products comprise nearly 70 percent of the roughly $9 billion dollar vape market in the United States. He said the company was talking to the F.D.A. and preparing new tobacco pouch and e-cigarette products.
“We have long advocated for increased enforcement and a return to a regulated marketplace that is not overrun with illicit products,” Mr. Marroco said during the call, adding: “So these are all very positive and the size of the prize, like I said, is very high.”
David Sutton, a spokesman for Altria, which makes Marlboro cigarettes and was represented at the lunch with Mr. Trump, called the new policy “an important step toward addressing the illicit market by pairing enforcement with expansion of a legal, regulated marketplace for smoke-free products.”
The company said it was working on its product strategy and “will continue to advocate for predictable and permanent regulatory reform.”
