The head of the US Food and Drug Administration took aim Wednesday at Juul and other e-cigarette manufacturers, warning that they must show in the next two months how they’ll keep the devices out of the hands of young people.
Noting an “epidemic” surge in teen use of e-cigarettes, Gottlieb warned the FDA might require companies to change their sales and marketing practices; stop distributing products to retailers who sell to kids; and remove flavored e-cigarette products from the market.
“I use the word epidemic with great care,” Gottlieb said. “E-cigs have become an almost ubiquitous — and dangerous — trend among teens. The disturbing and accelerating trajectory of use we’re seeing in youth, and the resulting path to addiction, must end. It’s simply not tolerable.”
Juul, MarkTen, Vuse, Blu and Logic control 97% of the e-cigarette market, the FDA said. In the next 60 days, the FDA plans to investigate the five e-cigarette companies’ marketing and sales practices, with possible “boots on the ground inspections,” Gottlieb said.
The agency will also be increasing federal enforcement actions on e-cig sales to minors in convenience stores and other retail sites, Gottlieb said. On Wednesday, it announced “historic action” against more than 1,300 retailers who illegally sold Juul and other e-cigarettes to minors during a crack down on retailers this summer. Gottlieb called the action the largest coordinated enforcement effort in the agency’s history.
The FDA will also look closely at “straw purchases,” in which adults visit web-based stores and buy in bulk to resell to minors. Federal law prohibits the sale of e-cigarettes to people younger than 18.
“If young adults go online and buy 100 units of a product to sell to teens, that activity ought to be easy for a product manufacturer to identify,” said Gottlieb. If manufacturers aren’t willing to do the research, he said, the FDA will do it for them, with appropriate consequences.
“Let me be clear: Everything is on the table,” said Gottlieb. “This includes the resources of our civil and criminal enforcement tools.”
A generation addicted?
E-cigarette makers argue the devices help adult smokers give up cigarettes — potentially saving them from related illnesses — by giving a nicotine fix without the smoke and smell of combustible cigarettes. The scientific consensus, however, is still out on the long-term health effects of vaping.
The FDA recognized the impact its actions might have on adults trying to stop smoking, Gottlieb said, but emerging research on how flavored products encourage excessive use by young people shows action must be taken.
More than 2 million middle and high school students were current users of e-cigarettes in 2017, the FDA said, and e-cigarettes were the most commonly used tobacco product by youth. Youths are more likely than adults to vape, according to the US Centers for Disease Control and Prevention.
“I’ll be clear. The FDA won’t tolerate a whole generation of young people becoming addicted to nicotine as a tradeoff for enabling adults to have unfettered access to these same products,” Gottlieb said Wednesday.
“We’re especially focused on the flavored e-cigarettes. And we’re seriously considering a policy change that would lead to the immediate removal of these flavored products from the market.”
Juul Labs, which controls about 70% of the market, said in its statement that “appropriate flavors” play a role in adults changing their smoking habits, but added that they “are committed to preventing underage use of our product, and we want to be part of the solution in keeping e-cigarettes out of the hands of young people.”
Several other manufacturers targeted by the FDA — MarkTen, Vuse, Blu and Logic — also issued statements agreeing with the need to limit access to minors and announcing their willingness to work with the FDA to reach a solution.
The Vapor Technology Association, which says it represents over 600 vaping manufacturers and distributors, also supports limiting teen access, but added that the new actions by the FDA ventured “into dangerous territory” by not being in the best interest of public health.
In a statement, VTA Executive Director Tony Abboud asked: “Does FDA really want millions of Americans to return to smoking cigarettes?”
A change of plan
Last year, the FDA announced that it would delay regulations that could have halted the sales of many e-cigarettes. Instead, the agency gave extensions till August 2022 to new and existing vaping products. The agency said it allowed the extra time to strike an appropriate balance between regulation and encouraging the development of innovative tobacco products that may help older smokers quit.
At that time of the extension, Gottlieb said Wednesday, the agency didn’t foresee the “epidemic'”of adolescent use that has become one of the plan’s biggest challenges.
“Today we can see that this epidemic of addiction was emerging when we first announced our plan last summer,” said Gottlieb. “Hindsight, and the data now available to us, reveal these trends.”
Since Wednesday’s action did not change the current 2022 timeline for regulatory review, some said the agency’s action fell short.
“We need to go further,” said Michael Bloomberg, the billionaire philanthropist who has worked for years to reduce tobacco use.
“The FDA should immediately move to regulate flavored e-cigarettes, instead of waiting until 2022, as it is currently planning to do,” Bloomberg said in a statement.
The Campaign for Tobacco-Free Kids also called for stronger action.
In a statement, Matthew Myers, the campaign’s president, said the FDA’s action would only represent a turning point if it “reverses its policy and requires that all of these products undergo agency review now, not four years from now.”
The American Medical Association’s Dr. Barbara McAneny also said the FDA could do much more, pledging that the association would “continue to advocate for more stringent policies.”
U.S. Senate Democratic Whip Dick Durbin and Republican Sen. Lisa Murkowski also asked the FDA to end delays. In a statement, they called for support for their bipartisan legislation, introduced in July, which would ban flavored cigars and place stringent controls on e-juice flavorings.
FDA actions so far
In April the agency launched a Youth Tobacco Prevention Plan, designed to address some of the known public health risks, such as flavors, that contribute to adolescent use of e-cigarettes.
Shortly after the launch, the FDA cracked down on e-liquids marketed to resemble kid-friendly foods like juice boxes, candy and cookies. As part of today’s action, the agency sent an additional 12 warning letters to another 12 companies that continue to sell the products.
The FDA also targeted Juul retailers this spring, issuing 56 warning letters and six civil monetary penalties. Today’s effort notches up that action, becoming, said Gottlieb, the “largest ever coordinated initiative against violative sales in the history of the FDA.”
The agency said it plans to unveil a new e-cigarette public education campaign targeted to youth next week, and will soon announce wider access to new nicotine replacement therapies to help more adult smokers quit cigarettes.’