An e-cigarette. Photo Credit: Credit: joseluisserranoariza/Shutterstock.com

Several anti-smoking groups and doctors have filed a lawsuit challenging the U.S. Food and Drug Administration's decision to delay its review of e-cigarettes.

The suit, filed Tuesday in a federal court in Maryland, accuses the agency of exceeding its authority and not following proper procedure last year when it pushed back to 2022 the deadline by which e-cigarette makers must submit their products for review. Plaintiffs in the suit argue that the delay harms public health, particularly for young people because it leaves them vulnerable to kid-friendly e-cigarettes and cigars that may lead to a lifetime of tobacco addiction.

Those plaintiffs include seven advocacy groups, including the American Academy of Pediatrics and the American Heart Association, as well as five physicians.

“Were the FDA to perform its statutory responsibilities, its premarket review should remove from the commercial marketplace those tobacco products that pose the greatest public health risks, particularly those targeted at children and teenagers,” the complaint stated. “Postponing premarket review prolongs the period during which regulators, consumers and public health professionals are all denied the basic facts needed to make informed judgments.”

A spokesperson for the FDA declined to comment, citing pending litigation. He pointed out, however, that the agency since early last year has been engaged in a comprehensive, long-term campaign to reduce tobacco-related diseases and death, including a reduction in the amount of nicotine in cigarettes.

In a tweet posted Tuesday, FDA Commissioner Scott Gottlieb said: “FDA shares the belief that tobacco products, including e-cigs, should never be marketed to, sold to, or used by kids and the agency will be taking new steps soon to help keep kids from using tobacco products.” Neither that tweet nor later ones elaborated on these “new steps.”

E-cigarettes are devices that typically deliver nicotine, flavorings and other additives to users through an inhaled aerosol and are often referred to as “vaping” because of the smoke-like substance emitted during exhalation, according to the Centers for Disease Control and Prevention.

According to the complaint in this suit, the FDA was authorized to regulate the products in 2016. Although scientists still are not fully informed about e-cigarettes' effect on health, enough is known to justify efforts to prevent e-cigarette use by young people, according to the CDC.

A 2016 U.S. Surgeon General's report found that e-cigarettes are now the form of tobacco most commonly used by youth in the United States. Anti-smoking advocates argue that this is the case because manufacturers specifically market them to kids by selling them in a wide array of candy and other flavors, including chocolate, gummy bear and cotton candy. The taste of e-cigarettes is one of the most widely reported reasons why young people use them, according to the CDC.

The public health groups' lawsuit is brought under the federal Tobacco Control Act, the 2009 law that established FDA oversight of tobacco products, and the Administrative Procedure Act. It asks the court to prevent the agency from pushing back the review deadline.

The FDA “offered no meaningful justification for ripping a hole in the statutory framework by exempting, for more than half a decade, newly deemed products from premarket review—review FDA previously described as 'central' to the regulatory scheme Congress enacted for tobacco products,” the complaint stated.

The plaintiffs are represented, on a pro bono basis, by partner Kelly Dunbar and senior associates Lynn Eisenberg, Kevin Lamb and Beth Neitzel, all in the Washington, D.C., office of Wilmer Cutler Pickering Hale and Dorr, as well as by lawyers at Democracy Forward Foundation and the legal staff of the Campaign for Tobacco-Free Kids. The defendants have until next month to respond to the allegations.