FDA's Latest Plan Will Fail at Addressing E-cigarette Epidemic

Statement of Harold Wimmer, President and CEO of the American Lung Association, in response to the U.S. Food and Drug Administration’s (FDA’s) release today of the draft guidance for the tobacco industry regarding “Modifications to Compliance Policy for Certain Deemed Tobacco Products”:

“FDA’s latest proposal to address the e-cigarette epidemic falls far short of what is needed to end the e-cigarette epidemic. With this guidance, FDA continues to take half measures that will not protect our nation’s children from the predatory marketing practices of the tobacco industry. Until FDA is willing to take meaningful action by removing all flavored tobacco products, including mint and menthol, from the marketplace, America’s youth remain at high risk for a lifetime of addiction to tobacco products. 

“In November, along with my counterparts at our major public health partners, I sent a letter to FDA Commissioner Scott Gottlieb, M.D., outlining key principles and actions that were needed to halt the e-cigarette epidemic. Unfortunately, today’s guidance fails to meet these principles – including FDA’s continued failure to enforce the Tobacco Control Act and require all e-cigarettes, cigars and hookah go through premarket review. FDA cannot rely on voluntary efforts by the tobacco industry, nor should FDA only act to restrict sales. 

“The youth e-cigarette epidemic is in large part due to FDA’s failure in July 2017 to enforce the Tobacco Control Act. Had FDA moved forward with the 2018 requirement that all e-cigarettes, cigars and other newly deemed products go through the premarket review process, youth e-cigarette use would be far lower than it is today. The American Lung Association warned then, as we do now: There is no question that the 2017 announcement undermined key public health protections designed to protect the health of Americans and our nation’s children. We noted that ‘of particular concern is the long and unreasonable delay for newly-regulated tobacco products to submit tobacco product applications for FDA review as required under the final deeming rule.’

“In our comments on the draft guidance, the American Lung Association will urge FDA to require all flavored cigars through premarket review immediately. FDA has the legal authority to remove all flavored cigars from the marketplace that are not appropriate for the protection of the public health. The question is whether they will now act quickly to use this authority to protect our kids.

“In 2017, the American Lung Association and partners filed a lawsuit against the FDA for its failure to enforce the Tobacco Control Act and the ‘deeming’ rule. The fundamental reasons for this lawsuit remain now as they did then: FDA’s delays of reviewing these products violates the law.”

Learn more about e-cigarettes and lung health at Lung.org/ecigs. For media interested in speaking with an expert about e-cigarettes, tobacco use and lung health, contact the American Lung Association at [email protected] or 312-801-7628.