FDA puts e-cig makers on notice: Fix 'epidemic' teen use or products may be pulled from market

Federal regulators are threatening to pull e-cigarettes from shelves if manufacturers do not control teen use, which officials say has reached epidemic levels.

The Food and Drug Administration was prepared to embrace e-cigarettes as a way to wean adult smokers from cigarettes, but the agency is rethinking its approach after seeing scores of teens vaping. The crackdown by the FDA includes historic action against more than 1,300 retailers and five major manufacturers for their roles in "perpetuating youth access," the agency said.

"E-cigs have become an almost ubiquitous — and dangerous — trend among teenagers," FDA Commissioner Scott Gottlieb said in a statement. "The disturbing and accelerating trajectory of use we're seeing in youth, and the resulting path to addiction, must end. The FDA cannot tolerate a whole generation of young people becoming addicted to nicotine as a trade off for enabling adults to access these products."

The e-cigarette craze has driven what's arguably the largest uptick of teen nicotine use in decades after years of driving cigarette smoking rates to record lows. Teens who would have never smoked cigarettes are happily inhaling fruity flavors, sometimes without realizing it is packed with nicotine, an addictive substance. Middle school and high school students sneak the devices into schools and flaunt pictures of their vapes or of themselves performing tricks on Instagram.

FDA order targets five brands

The FDA is specifically ordering five brands — Juul, British American Tobacco's Vuse, Altria's MarkTen. Imperial Brands' Blu E-cigs and Japan Tobacco's Logic — to submit plans within 60 days detailing how they will prevent teens from using their products. The agency may require the companies to revise their sales and marketing practices, to stop distributing products to retailers who sell to kids and to stop selling some or all of their flavored e-cigarette products until they clear the application process.

Between now and the 60-day mark, the FDA will investigate manufacturers' marketing and sales practices, including holding "boots on the ground inspections."

A Juul spokeswoman said the company will work proactively with the FDA in response to its request. "We welcome the FDA's actions today, and we look forward to sharing our thoughts about how to prevent and reduce youth usage, an issue we've focused on for decades," an Altria spokesman said.

Fontem Ventures, a subsidiary of Imperial Brands, said in a statement it's "evaluating today's request and statement from the FDA," but it welcomes "the opportunity to demonstrate and work with the FDA to further strengthen" its youth access prevention policies and procedures. A Logic spokesman said the company has received the agency's request and will "continue to work with the agency to demonstrate" that it "markets its products only to adults."

BAT will provide the agency with a comprehensive plan in 60 days, as requested, a spokesman for R.J. Reynolds Vapor, a unit of BAT, said in a statement.

Tobacco stocks surged on news of the FDA's action.

As part of the FDA's largest-ever coordinated action against illegal sales, the agency has sent warning letters to more than 1,100 retailers that are selling e-cigarettes to teens despite a federal ban on sales to minors. It has fined 131 retailers, with fines ranging from $279 to $11,182.

These actions come after the agency conducted a blitz of both brick-and-mortar and online retailers between June and the end of August. The FDA warned and fined more than 60 retailers in that first retail effort.

Across the entire e-cigarette category, the FDA is considering restricting manufacturers from selling flavored nicotine liquid or making the products undergo an agency review. Products that were on the market before Aug. 8, 2016, were supposed to start undergoing review this year until Gottlieb extended the deadline until Aug. 8, 2022, so manufacturers would have more time to file complete applications.

Anti-tobacco groups applauded the idea but said the FDA's actions didn't go far enough. They want to see the agency to stick to the original deadline of this year and restrict the use of flavors.

Looking for 'straw' purchases

Additionally, the agency is investigating whether manufacturers' online shops are being used for "straw" purchases, where buyers resell products to minors. If the FDA identifies problems, it can take both civil and criminal actions.

"Let me be clear: Everything is on the table, including all our civil and criminal enforcement tools," Gottlieb said. "If the companies don't know, or if they don't want to know, that these straw purchases are occurring, we'll now be helping to identify it for them."

Gabby Jones | Bloomberg | Getty Images
Juul Labs' e-cigarette flavored pods. Each pod delivers around 200 puffs, with a 5 percent nicotine weight, and is available to purchase in packs of four.  

E-cigarettes are a major component of the FDA's sweeping tobacco initiatives, which includes its quest to lower the amount of nicotine in conventional cigarettes to minimally or nonaddictive levels. These devices are billed as a less harmful way for adults who can't or don't want to quit smoking to continue receiving nicotine. However, any potential benefits to adults have been overshadowed by the surge in teen use.

Lawmakers gave the FDA authority to regulate tobacco products in 2009 when Congress passed the Tobacco Control Act. The agency extended its reach to e-cigarettes in 2016, the year it decided products that were already on the market would need to be reviewed and new products would need to apply first.

Juul, which is privately held, dominates the market, representing about 72 percent of sales, according to Nielsen data compiled by Wells Fargo analyst Bonnie Herzog. Most Juul pods contain 5 percent nicotine, as much as a pack of cigarettes. Its eight flavors include sweet options like creme (formerly known as creme brulee), which critics say appeal to kids, not former adult smokers trying to quit. The FDA has already started the process of examining the role flavors play in both cases.

Flavors may drive youth use

Gottlieb said Wednesday he believes certain flavors "are one of the principal drivers" of teen use.

"We know that the flavors play an important role in driving the youth appeal," Gottlieb said. "And in view of the trends underway, we may take steps to curtail the marketing and selling of flavored products. We are actively evaluating how we would implement such a policy."

E-cigarette manufacturers have touted initiatives they've taken to keep their products out of kids' hands. However, Gottlieb said in his view, they've treated these issues "like a public relations challenge rather than seriously considering their legal obligations, the public health mandate and the existential threat to these products."

Lawmakers, including Senate Minority Leader Chuck Schumer, D-N.Y., have pressed the FDA to do something to control youth use. Despite the criticism he faced, Gottlieb has remained largely supportive of e-cigarettes. But he repeatedly warned companies to seriously address teen use.

"This isn't our choice alone," Gottlieb said. "I've been warning the electronic cigarette industry for more than a year that they needed to do much more to stem the youth trends. In my view, they treated these issues like a public relations challenge rather than seriously considering their legal obligations, the public health mandate, and the existential threat to these products."

Under Gottlieb, the FDA has embraced e-cigarettes as a potentially less harmful alternative for adult smokers. As part of Gottlieb's sweeping plan to overhaul tobacco regulation, he wants to reduce the amount of nicotine in conventional cigarettes to minimally or nonaddictive levels. In doing that, Gottlieb recognizes he needs to give people who are already hooked another less harmful option.

"We're committed to the comprehensive approach to address addiction to nicotine that we announced last year," Gottlieb said. "But at the same time, we see clear signs that youth use of electronic cigarettes has reached an epidemic proportion, and we must adjust certain aspects of our comprehensive strategy to stem this clear and present danger."

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