The U.S. Food and Drug Administration (FDA) is requiring companies that produce e-cigarettes to come up with a plan within the next two months on how to prevent e-cigarettes from getting into the hands of minors.
FDA Commissioner Scott Gottlieb said in a speech on Sept. 12 that while he’s excited about the possibility of e-cigarettes being used to transition adults off of the more toxic traditional cigarettes, he’s alarmed by the uptick in their use by kids, mainly teenagers.
“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,” he said.
Between 2011 and 2015, e-cigarette use among high schoolers grew 900 percent, according to the U.S. surgeon general. Last year, an annual survey by National Institute on Drug Abuse (NIDA) found e-cigarette use among teens declined, but showed that vaping, which includes e-cigarettes, increased slightly from a year earlier in most age groups.
The plans that e-cigarette manufacturers must submit have to demonstrate how companies will “convincingly” address the widespread use of their products by minors, Gottlieb said, or the FDA will “revisit” what enforcement actions it can take for products already on the market.
“I’ve been warning the e-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,” he said.
On Sept. 12, the FDA sent out warning letters to the makers of five e-cigarette brands that collectively make up more than 97 percent of the market: JUUL, Vuse, MarkTen, blu e-cigs, and Logic.
“Let me be clear,” Gottlieb said, “this may require these brands to revise their sales and marketing practices, including online sales; to stop distributing their products to retailers who sell to kids.”
The FDA, in conjunction with the Federal Trade Commission, has already gone after companies marketing flavored e-cigarette liquids in packaging that resembles kid-friendly products such as juice boxes, candy, and cookies. And it’s looking into significantly curbing all flavored liquids. Gottlieb says the agency is now considering how it might implement such a policy.
JUUL, which has received special attention from the FDA in its enforcement blitz, sent out a statement shortly after Gottlieb’s speech saying that it wanted to “be part of the solution” and that it planned to comply with the FDA’s new request. It also seems to want to be part of the decision-making process, if the FDA does limit the types of flavors that it can put on the market.
“Appropriate flavors play an important role in helping adult smokers switch. By working together, we believe we can help adult smokers while preventing access to minors, and we will continue to engage with the FDA to fulfill our mission,” Kevin Burns, JUUL Labs CEO, said in a statement.
Altria, which is the maker of MarkTen, posted on Twitter a link on Sept. 12 that directs to a page on its website that talks about the ways the company is working to prevent addiction in minors.
“Manufacturers and retailers cannot address this issue alone,” the page indicates. “With federal regulation in place, the FDA has the opportunity to do more to address social source access and we encourage them to do so.”
The FDA is also ramping up enforcement of sales to minors by sellers.
Since June, the FDA has sent 1,100 warning letters to stores for the illegal sale of e-cigarettes to minors after a nationwide, undercover blitz of brick-and-mortar stores. In the same timeframe, it also fined 131 stores that continued to sell to minors after being warned.
Gottlieb also put manufacturers on notice that they need to get serious about selling online to straw buyers who resell to kids.
“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,” he said. “If the companies don’t know, or if they don’t want to know, that straw purchases are occurring, we’ll now be helping to identify it for them.”
If the FDA finds that sites are selling to straw buyers, Gottlieb said FDA has both civil and criminal penalties at its disposal.