AACR Applauds FDA’s Decision to Remove Juul E-Cigarettes From the Market
WASHINGTON, D.C. – The American Association for Cancer Research (AACR) strongly supports the actions taken by the Center for Tobacco Products at the U.S. Food and Drug Administration (FDA) under the leadership of Commissioner Robert Califf, MD, to order Juul Labs Inc. to take its e-cigarettes off the market. This decision from the FDA stemmed from its work of conducting a review of U.S. vaping products, weighing their popularity with young people against their potential benefits for adults who smoke. All U.S. e-cigarette manufacturers in 2020 were required to submit their products for FDA review to remain on the market.
“Juul e-cigarettes were key drivers of the dramatic growth in U.S. youth e-cigarette use in the past five years, which resulted in millions of high school students using e-cigarettes,” said Margaret Foti, PhD, MD (hc), chief executive officer of AACR. “The FDA’s important decision to remove these products from the market is a major step in addressing the youth e-cigarette epidemic that has threatened to reverse years of progress in the reduction of tobacco use.”
Juul e-cigarettes comprised nearly two-thirds of the e-cigarette market in 2019, aided in large part by the company’s predatory advertising toward youth and large variety of flavors that appealed to young people. Scientific studies have found e-cigarettes expose users to toxic chemicals that damage DNA and promote uncontrolled cell growth, key steps in cancer development. While the level of carcinogen exposure from e-cigarettes is significantly lower than from smoking tobacco, no tobacco product is safe for public health. Additionally, nicotine itself impairs the immune system, raises blood pressure, worsens memory, and harms the ability of youth to learn.
“E-cigarette companies have billed their products as a way to help adults quit smoking cigarettes, but after more than a decade on the market, the evidence has not proved those claims. Instead, there is plenty of evidence e-cigarettes addicted millions of American youth to nicotine and subsequently caused them to transition to smoking tobacco,” said Roy S. Herbst, MD, PhD, deputy director for clinical affairs at Yale Cancer Center, assistant dean for translational research at Yale School of Medicine, and chair of the AACR Science Policy and Government Affairs Committee. “The FDA made the right decision to call for the removal of Juul e-cigarettes from the market. The law states it was Juul’s responsibility to prove to the FDA that their products were appropriate for public health. However, after the FDA’s review of these products, it is clear that Juul failed to provide sufficient evidence to overcome its legacy of fueling the youth e-cigarette epidemic.”
Several forms of FDA-approved smoking cessation therapies are currently available, including nicotine replacement therapies, varenicline, and counseling. If an e-cigarette manufacturer wants to prove that its products help with smoking cessation, the AACR strongly supports such companies following the same regulatory steps as nicotine replacement therapies by conducting clinical trials.
“The AACR has been proud to help build the evidence base on new and emerging tobacco products and to shape policy that helps prevent cancer and protects public health,” said Lisa M. Coussens, PhD, associate director for basic research at Oregon Health and Science University Knight Cancer Institute and president of the AACR. “We look forward to continuing working with the Biden administration and Congress at this critical time to reduce the incidence of disease and mortality from tobacco product use.”