A federal judge on May 15 ruled the FDA acted illegally more than a year and a half ago when it allowed e-cigarette products geared toward kids and teens to remain on the market prior to and during the agency’s approval process.
U.S. District Judge Paul W. Grimm, of the U.S. District Court for the District of Maryland, ruled in favor of six American medical societies and five individual pediatricians Wednesday a year after the groups filed a lawsuit challenging the FDA’s decision to allow electronic cigarettes and cigars to remain on the commercial market until 2022 without obtaining FDA approval.
“In August 2017, without inviting public or stakeholder comment as required by the Administrative Procedure Act or building a new administrative record to guide its decision, FDA issued what it labeled a 'guidance' that fundamentally altered the statutory duties and responsibilities of manufacturers of newly deemed tobacco products,” the group wrote in the suit, filed March 27 of last year.
“Perhaps most significantly, FDA purported to exempt, on a categorical basis, manufacturers of newly deemed products from the Tobacco Control Act’s premarket review regime for up to six years beyond the effective date of the deeming rule (and, in practice, indefinitely beyond that time).”
The plaintiffs—which include the Campaign for Tobacco-Free Kids, American Academy of Pediatrics, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association and Truth Initiative—argued Congress mandates premarket review before new products can be marketed or distributed to consumers, making the FDA’s actions illegal. They said a delayed approval process meant more kids were exposed to and got hooked on e-cigarettes, especially since companies like Juul were manufacturing flavors specific to a younger palette, like candy and sweet fruits.
In his 54-page ruling, Grimm said the FDA’s five-year “compliance safe-harbor” likely allowed companies enough time to attract young users and get them addicted to nicotine before any of their products or flavors were pulled from the market, noting the delay gave manufacturers responsible for public harm “a holiday from meeting the obligations of the law.”
“Just as email and text messages replaced ‘snail mail,’ social media made face-to-face communications passé and the internet rendered libraries all but obsolete, it was only a matter of time before ‘electronic cigarettes’ replaced combustible tobacco products as a desirable means of nicotine delivery,” Grimm wrote. “As it turns out, even addiction has become electronic...especially, as manufacturers of e-cigarette products have learned, if they are fruit or dessert flavored and marketed as cool and alluring.”
The plaintiffs in the 2018 lawsuit issued a statement May 16 applauding Grimm’s decision.
“Judge Grimm has rightly recognized that the FDA’s years-long delay in reviewing e-cigarettes and cigars is causing great harm to kids and public health and cannot be allowed to stand,” they wrote.
Grimm has given the plaintiffs 14 days to tell him what remedial action they’d like to see and the FDA 14 days to respond.