WASHINGTON -- The FDA announced a crackdown on sales of the electronic cigarette JUUL to minors, acknowledging that the brand has become "wildly popular" with underage users who are able to buy the e-cigarette at brick-and-mortar retailers and on the internet.
Last week, FDA Commissioner Scott Gottlieb, MD, vowed to take steps to address the explosive growth of JUUL use among youth, in response to a plea by health groups and lawmakers.
Speaking at a Congressional budget hearing, Gottlieb said the agency would be "stepping into this fight in a vigorous way in the coming weeks" to prevent a new generation of kids and teens from becoming addicted to nicotine.
On Tuesday, the FDA outlined the steps it has taken and will take to keep JUUL and other e-cigarette brands from being sold to minors.
"The troubling reality is that electronic nicotine delivery systems such as e-cigarettes have become wildly popular with kids," Gottlieb said in a written statement. "We understand, by all accounts, many of them may be using products that (like the JUUL brand) closely resemble a USB flash drive, have high levels of nicotine and emissions that are hard to see. These characteristics may facilitate youth use by making the products more attractive to children and teens."
JUUL sales increased by more than 600% in 2017 alone, and the brand now commands over 50% of the market among e-cigarettes sold in convenience stores and other large retailers, according to the market research organization Nielsen.
The anecdotal evidence that JUUL is widely used by teens is overwhelming. But JUUL Labs, which markets the product, has not responded to requests from media, including ѻý, for specific information on sales to underage users.
On Tuesday, Gottlieb announced that the FDA sent , directing the company "to submit important documents to better understand the reportedly high rates of youth use and the particular youth appeal of these products."
The agency will require product marketing documents, research on the health and "toxicological, behavioral or physiological effects of the products, including youth initiation and use," and analyses of consumer complaints, youth-related adverse events associated with the e-cigarettes, and the appeal of certain design features or ingredients among different age groups.
"We don't yet fully understand why these products are so popular among youth," said Gottlieb's statement. "But it's imperative that we figure it out, and fast. These documents may help us get there."
Gottlieb also announced that earlier this month, the FDA launched a large-scale, undercover, nationwide blitz designed to curtail the sale of e-cigarettes -- and especially JUUL -- to minors at both brick-and-mortar retailers and online.
Since the beginning of March, FDA compliance checks have identified 40 violations for illegal sales of JUUL products to youth; the agency sent warning letters to all 40 retailers.
The FDA has also contacted the online retailer eBay, alerting company officials about listings for JUUL products on the website.
"We're thankful for eBay's swift action to remove the listings and voluntarily implement new measures to prevent new listings from being posted to the web retailer's site," Gottlieb noted.
Last summer, the FDA announced a major shift in tobacco policy, vowing to explore slashing nicotine levels in combustible cigarettes to non-addictive levels.
The move was widely praised by anti-tobacco and health groups. But the groups were highly critical of another provision of the policy shift -- delaying key regulatory action on e-cigarettes until the summer of 2022.
Gottlieb did not address the regulatory delay in Tuesday's letter, but he did reiterate the FDA's commitment to explore the potential of e-cigarettes and other electronic nicotine delivery systems (ENDS) to help longtime cigarette smokers kick the habit, while acknowledging that the agency needs to "step in" to protect children.
"As the FDA considers regulating nicotine levels in cigarettes to render combustible cigarettes minimally or non-addictive, products such as e-cigarettes may offer a potentially lower risk alternative for individual adults smokers," he noted. "These ENDS products will still need to be put through an appropriate series of regulatory gates by the FDA. But the viability of these products is severely undermined if those products entice youth to start using tobacco and nicotine."