Seven public health groups and several pediatricians are suing the Food and Drug Administration for delaying regulation of e-cigarettes and some tobacco products.
The FDA brought e-cigarettes, cigars and hookah within its oversight in 2016 when it expanded the definition of tobacco products. It planned to require such products that were on the market as of Aug. 8, 2016, when the so-called deeming rule was enacted, to undergo review starting this year.
Last summer, the agency extended the deadline as part of a sweeping plan to overhaul tobacco regulation. Under the revised timeline, manufacturers won't need to file until 2021 for combustible products like cigars and until 2022, for noncombustible products like e-cigarettes.
At the time, the FDA said the decision would give it time to explore better measures to make tobacco products less toxic, appealing and addictive. It also said it would give manufacturers more time to put together thorough and accurate applications.
The lawsuit filed Tuesday in a Maryland federal court calls the FDA's guidance "arbitrary and capricious and not the product of reasoned decisionmaking." The plaintiffs claim the agency abdicated and rewrote its responsibilities granted under the Tobacco Control Act. They also maintain the agency issued the rule without required public input.
"Our concern is that we can't leave our kids vulnerable while FDA waits for e-cig manufacturers to apply," said Campaign for Tobacco-Free Kids President Matthew Myers.
An FDA spokesman said the agency does not comment on possible, pending or ongoing legislation.
This is the second time the Campaign for Tobacco-Free Kids has sued the FDA. The first was in 2016 when it joined other organizations to try and force the agency to require graphic health warnings on cigarette packs and advertising.
The group filed the new suit with the American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, Truth Initiative, American Academy of Pediatrics, Democracy Forward and several individual pediatricians.
They hoped the FDA would reverse its decision, but after multiple conversations and inaction in the months since, they realized their only option was litigation, Myers said. Adding to the sense of urgency was the flow of media reports that teenagers and adolescents are using e-cigarettes, particularly the popular JUUL brand.
Allowing such products to stay on the market unregulated for years will only exacerbate the problem, Myers said.
"From our perspective, the use of e-cigs by kids is such a serious problem, we think urgent action is needed to curtail it," he said.
A number of rules to regulate e-cigarettes and other tobacco products have still gone or are slated to go into effect, such as age requirements and identification checks. The newly regulated products must also include warning statements, list ingredients and remove modified-risk claims, among other requirements.
Manufacturers are also still required to request and receive approval in order to sell products that weren't on the market before Aug. 6, 2018.
Under Commissioner Scott Gottlieb, the FDA has welcomed the idea that nicotine products exist on this spectrum, with conventional cigarettes being the most risky and e-cigarettes being potentially less risky. It's a balancing act that includes trying to convince adult smokers to ditch conventional cigarettes without enticing kids.
Part of the FDA's tobacco overhaul includes seeking to lower the amount of nicotine in cigarettes to minimally or nonaddictive levels. The agency's also seeking information on the role flavors play in attracting people to nicotine products. It's also reconsidering how it should regulate premium cigars.