The FDA is to blame for the sharp rise in e-cigarette use among the nation’s youths – and its latest proposal to fix the problem won’t accomplish much.
That’s according to the American Lung Association (ALA), which is giving a thumbs-down to the FDA’s “Modifications to Compliance Policy for Certain Deemed Tobacco Products.”
ALA president and CEO says the agency’s plan “falls far short” of what is needed to keep e-cigarettes out of the hands of young people.
“With this guidance, the FDA continues to take half measures that will not protect our nation’s children from the predatory marketing practices of the tobacco industry,” said Wimmer.
At issue: the proposal’s exclusion of mint- and menthol-flavored tobacco products, which the FDA says predominantly appeal to adult users.
“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.”
Wimmer blaming the youth e-cigarette epidemic in large part on the 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 ALA 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.’”
Youth use of e-cigarettes – or, electronic delivery nicotine systems (ENDS) have skyrocketed in recent years, with a 78 percent increase among high school students from 2017 to 2018 alone.1
The ALA and other public health organizations sent a letter to FDA Commissioner Scott Gottlieb, M.D., outlining key principles and actions that were needed to halt the e-cigarette epidemic.
The FDA’s recent guidance does not include one of the suggested actions: that all e-cigarettes, cigars and hookah go through premarket review.
In 2017, the ALA 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.
Click here to read Modifications to Compliance Policy for Certain Deemed Tobacco Products.
1. Cullen, K.A., B.K. Ambrose, A.S. Gentzke, et al., “Notes from the Field: Increase in e-cigarette use and any tobacco product use among middle and high school students – United States, 2011-2018,” Morbidity and Mortality Weekly, 67(45);1276-1277 (2018).