The administration’s move comes as health officials across the country investigate more than 450 cases, including six deaths, of lung disease linked to vaping. Many patients have reported using cannabis-related products, but authorities have not ruled out any specific type of vaping. With the picture still murky, critics have seized the moment to press for tougher regulation of conventional e-cigarettes, which come in sweet and fruity flavors that have been favored by many young people.
Azar said Wednesday the administration intends to “clear the market” of flavored e-cigarettes to reverse a worsening youth vaping epidemic. He said preliminary data from the 2019 National Youth Tobacco Survey shows a continued, troubling rise in youth e-cigarette use. The data indicated more than a quarter of high school students have used e-cigarettes in the past 30 days — up from a little over a fifth in 2018. The overwhelming majority of students said they used fruity, menthol or mint flavors.
Azar said the FDA is finalizing a plan on flavored e-cigarettes in the next several weeks that probably would go into effect a month later. The policy, he said, would require most flavored e-cigarettes, including mint and menthol, to be removed from the market. The flavored products would not be allowed back on the market until — and if — they receive specific approval from the FDA.
The policy wouldn’t affect tobacco-flavored e-cigarettes, whose manufacturers would have until next May to file for approval.
In a statement late Wednesday, a spokesman for Juul Labs said, “We strongly agree with the need for aggressive category-wide action on flavored products. We will fully comply with the final FDA policy when effective.” People on both sides of the issue, however, said the FDA might face lawsuits from some industry interests as it moves forward with the tougher policy.
Matthew L. Myers, president of the anti-tobacco group Campaign for Tobacco-Free Kids, said the plan is a “long way from the finish line,” but added, “If, in fact, they pull flavored e-cigarettes from the market, it is an extraordinary step in the face of a real crisis.” He said that flavored e-cigarettes are fueling a rise of youth e-cigarette use, “which apparently has gotten dramatically worse over the last year.”
The Vapor Technology Association, an industry group, said it would be a “public health travesty” to ban flavored e-cigarettes. Such “government overreach,” the group said, will result in the closure of thousands of small vape shops and force many Americans “to switch back to deadly cigarettes.”
Gregory Conley, president of the American Vaping Association, a consumer group, warned, “In the history of the United States, prohibition has never worked.”
The administration move comes amid rising calls from states, communities and members of Congress for tougher e-cigarette regulation — and stepped-up FDA public efforts on the problem.
Last week, Michigan became the first state to ban almost all e-cigarettes. On Monday, New York Gov. Andrew M. Cuomo (D) said he would introduce a bill to ban flavored e-cigarettes. On the same day, the FDA blasted Juul Labs, the dominant player in the domestic e-cigarette market, for illegally marketing its products as less harmful than regular cigarettes, which it does not have FDA authorization to do. On Tuesday, billionaire Michael Bloomberg announced plans to spend $160 million over three years to try to end the youth vaping problem by targeting flavored e-cigarettes.
The regulation of e-cigarettes has a complicated history. The FDA got the authority to regulate tobacco products in 2009, when President Barack Obama signed the Family Smoking Prevention and Tobacco Control Act. The agency extended its authority to e-cigarettes in 2016, saying existing products could stay on the market while pursuing FDA approval — a policy called “enforcement discretion.”
Product applications for FDA approval were due in 2018. Azar said Wednesday that Obama administration delays in regulating e-cigarettes helped spawn the eventual youth epidemic.
But the Trump administration itself contributed to delays in some key areas. When Scott Gottlieb became FDA commissioner in 2017, he pushed the deadline for product applications back to 2022. He billed it as part of a strategy to move smokers to a less harmful alternative while moving to reduce nicotine in conventional cigarettes.
But a year ago, after Gottlieb received data showing a surge in youth vaping — caused primarily by Juul’s huge popularity — he changed course and proposed new sales restrictions for most flavored products. He also moved up the production application deadline to 2021. And he warned that some types of products might have to be banned if youth use kept increasing.
Gottlieb left the administration in April and was replaced in acting capacity by Sharpless. Subsequently, a federal judge in Maryland moved the product application deadline even earlier, to May 2020. If the administration moves forward with its flavor ban and prevails in potential lawsuits, that timetable would be upended, with most e-flavored products probably prohibited much earlier.
Tobacco-flavored e-cigarettes would be exempt from the new policy to ensure smokers an alternative to regular cigarettes, administration officials said. Those products tend to be less appealing to young people.
Myers, of the Campaign for Tobacco-Free Kids, said that studies show that tobacco-flavored e-cigarettes were the largest seller through 2015, but that changed when Juul began selling its popular flavors, including mango. In recent years, he said, sales of tobacco flavors have dropped precipitously. The market, he said in an email, changed from one that did not depend on flavors “to one that was all about flavors.”
Juul has vehemently denied allegations that it marketed its product to youths. The company has already stopped selling many flavored products — not including mint and menthol, however — in retail establishments, and has tightened its age-verification requirements online and in stores.
Sen. Richard J. Durbin (D-Ill.), who last week told Sharpless he should take action against e-cigarettes or resign, applauded the administration action, saying, “Finally the FDA is doing its job."
Conservative and libertarian groups were less enthusiastic. “The federal government should be embracing solutions that can address this public health problem, not blocking Americans from gaining access to those solutions,” said Daren Bakst, a senior research fellow at the Heritage Foundation.
John Wagner and Lena H. Sun contributed to this report.