Health, medical groups sue FDA over e-cigarette rule delay

[March 28, 2018] By Nate Raymond and Jilian Mincer

(Reuters) - Seven public health and medical groups on Tuesday filed a lawsuit challenging a U.S. Food and Drug Administration decision that they said would allow e-cigarettes to remain on the market for years without regulatory review.

The lawsuit, filed in federal court in Greenbelt, Maryland, argued the FDA in August improperly delayed a provision of a rule enacted in 2016 that allowed the agency to treat e-cigarettes and similar devices like cigarettes.

"This was the only remedy we thought we could take," said Erika Sward, assistant vice president of national advocacy at the American Lung Association, one of the groups that filed the lawsuit.

She said that amid the delay in implementing the rule, teen use of nicotine products including cigars and e-cigarettes has climbed to 20.2 percent while cigarette use has declined to 8 percent.

The FDA declined to comment.

The 2016 rule, adopted during Democratic President Barack Obama's administration, required companies to submit e-cigarettes for government approval. It has drawn industry opposition and lawsuits challenging its implementation as well.

Following the election of Republican President Donald Trump, the FDA issued guidance that the lawsuit said "fundamentally altered the statutory duties and responsibilities of manufacturers of newly deemed tobacco products."

In particular, the FDA delayed for up to six years beyond when the 2016 rule went into effect when manufacturers had to provide information about products on the market and undergo a review of their impact on public health, the lawsuit said.

Tuesday's lawsuit contended the FDA's guidance exceeded the agency's statutory authority under the Family Smoking Prevention and Tobacco Control Act, a 2009 law Congress passed that allowed the agency to extend its oversight to all tobacco products.

It also contended the FDA did not go through proper administrative procedures as the agency did not give the public an opportunity to comment on the change and did not articulate an adequate factual basis for it.

The other plaintiffs include the American Academy of Pediatrics and its Maryland chapter; American Cancer Society Cancer Action Network; American Heart Association; Campaign for Tobacco-Free Kids; Truth Initiative; and five pediatricians.

The case is American Academy of Pediatrics v. Food and Drug Administration, U.S. District Court, District of Maryland, No. 18-cv-00883.

(Reporting by Nate Raymond in Boston and Jilian Mincer in New York; Editing by David Gregorio)

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