Health Groups File Suit to Expedite FDA Review of E-Cigarettes, Cigars

WASHINGTON, March 27, 2018 /PRNewswire-USNewswire/ — Seven public health and medical groups, including Campaign for Tobacco-Free Kids, and several individual pediatricians, filed suit today in federal court in Maryland challenging a U.S. Food and Drug Administration (FDA) decision that allows electronic cigarettes and cigars – including candy-flavored products that appeal to kids – to stay on the market for years without being reviewed by the agency.

The lawsuit was filed by the American Academy of Pediatrics and its Maryland chapter, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids, Truth Initiative and five individual pediatricians.

Although the groups strongly support the FDA’s new efforts to reduce nicotine levels in cigarettes to minimally or non-addictive levels, they also believe that the FDA’s August 2017 decision to exempt e-cigarettes and cigars from agency review for years to come is unlawful and harms public health.

The lawsuit contends that the FDA’s decision leaves on the market tobacco products that appeal to kids, deprives the FDA and the public of critical information about the health impact of products already on the market, and relieves manufacturers of the burden to produce scientific evidence that their products have a public health benefit.

The FDA’s decision to delay product reviews leaves young people more vulnerable to kid-friendly e-cigarettes and cigars that may lead to a lifetime of tobacco addiction. FDA review “should remove from the commercial marketplace those tobacco products that pose the greatest health risks, particularly those targeted at children and teenagers,” according to the lawsuit. In addition, the FDA’s decision “will hinder the development of the science needed to understand, and to educate the public about, which products actually do promote smoking cessation and how they can be marketed without exposing young people to unnecessary risk.”

The need for the FDA to review e-cigarettes now on the market has been underscored by the recent surge in popularity of JUUL, which has become the best-selling e-cigarette brand and is reported to be widely used by teens. JUUL e-cigarettes look like USB flash drives; they are sold in flavors including mango, crème brulee and fruit medley; and the manufacturer claims that each JUUL cartridge contains as much nicotine as a pack of cigarettes. According to widespread news stories, reports from educators and documented social media posts, JUUL e-cigarettes have become very popular among high school and college students (see reports by The Boston Globe, Pittsburgh Post-Gazette, NPR and