The lawsuit is challenging an agency decision last summer to grant lengthy deadline extensions to manufacturers seeking FDA approval for their products. Originally, the companies were required to submit such product-review applications by this August for any item that went on the market after February 2007. The revised timeline changed that to August 2021 for cigars and August 2022 for e-cigarettes.
The extensions have been embraced by the e-cigarette industry, which feared that many of its products would be banned under the original schedule. In the suit filed Tuesday, health groups argue that the delay allows flavored tobacco products that target children and teenagers to remain on the market.
The organizations suing include the American Academy of Pediatrics, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids and Truth Initiative. Several individual pediatricians also joined the case, which was filed in federal court in Maryland.
The FDA declined to comment on the legal action.
The litigation comes as FDA Commissioner Scott Gottlieb oversees a major overhaul of tobacco regulations centered on nicotine and its addictive properties. Last summer, in announcing that new framework, Gottlieb pledged to take the unprecedented step of reducing nicotine in conventional cigarettes to minimally addictive or nonaddictive levels. His plan is strongly supported by the same groups that sued the FDA on Tuesday.
Gottlieb describes tobacco use as a “continuum of risk” involving products that deliver nicotine, with traditional cigarettes being the most dangerous and products like e-cigarettes being less harmful and providing a possible tool for smokers to quit regular cigarettes. “We need to envision a world where cigarettes lose their addictive potential through reduced nicotine levels,” he said last summer. “And a world where less harmful alternative forms, efficiently delivering satisfying levels of nicotine, are available for those adults who need or want them.”
In recent weeks, the agency has taken the first step to cutting nicotine levels in cigarettes. It also has said it will take another look at menthol — which it explored banning in 2013 — and other flavors in tobacco products. And it said it is reconsidering how to regulate premium cigars, an action anti-tobacco groups worry might result in weaker rules.
On Tuesday, the groups suing the FDA pointed to a best-selling e-cigarette brand called JUUL as evidence that the FDA shouldn't delay its review of e-cigarettes. JUUL looks like a USB flash drive and comes in such flavors as mango, creme brulee and fruit medley. It is wildly popular among teenagers.
The lawsuit contends that the FDA, in delaying product reviews of e-cigarettes and cigars, is exceeding its authority under the 2009 tobacco-control act and violating the Administrative Procedures Act because it did not give the public an opportunity to comment.