Juul E-Cigarettes Face FDA Probe
Agency requests information on marketing and ingredients from company selling ‘Fruit Medley’ flavored e-cigs
Juul’s e-cigarette flavors include “Creme Brulee” and “Fruit Medley,” which critics have said make it more attractive to youngsters.
PHOTO:RICHARD B. LEVINE/NEWSCOM/ZUMA PRESS
Saabira Chaudhuri and Anne Marie Chaker
Updated April 24, 2018 9:36 p.m. ET
The Food and Drug Administration on Tuesday said it is moving against the sale of e-cigarettes to minors by targeting Juul Labs Inc., the maker of one of the most popular such products in the U.S.
The FDA said it has requested information from the San Francisco startup that could help explain why its products appeal to youngsters. It is seeking documents on its marketing, as well as on its research on health effects, and whether design features and ingredients appeal to specific age groups.
The Juul device, which resembles a USB flash drive, delivers a powerful dose of nicotine, derived from tobacco, in a patented salt solution that smokers say closely mimics the feeling of inhaling cigarettes. The Juul liquid’s 5% nicotine concentration is significantly higher than that of most other commercially available e-cigarettes. Juul flavors include “Creme Brulee” and “Fruit Medley,” which critics have said make it more attractive to minors.
Juul has become a teen status symbol and a growing problem in U.S. schools. In recent months, Juul Labs has captured close to half the estimated $2 billion e-cigarette category, according to a Wells Fargo analysis of Nielsen sales data.
FDA Commissioner Scott Gottlieb said e-cigarettes “have become wildly popular with kids.” Their resemblance to flash drives, high levels of nicotine and nearly invisible emissions could be making the products more attractive to children and teenagers, he added.
In addition to Juul, the agency mentioned e-cigarette brands myblu and KandyPens, saying they have similar characteristics that could facilitate youth use. An FDA spokesman declined to say whether the companies behind them had been contacted.
“Juul Labs agrees with the FDA that illegal sales of our product to minors is unacceptable,” said a company spokeswoman. “We already have in place programs to identify and act upon these violations at retail and online marketplaces, and we will have more aggressive plans to announce in the coming days.”
KandyPens Inc. is a Santa Barbara, Calif., company that sells vaporizers that resemble pens and flash drives, and highlights hip-hop videos that feature its products.
KandyPens says its products aren’t intended to be used only with nicotine. “All of our products are sold empty,” said Graham Gibson, chief executive of KandyPens. “We can’t control what people put in our products.”
The myblu device is sold by a subsidiary of tobacco company Imperial Brands PLC. It introduced myblu in February with flavors including blueberry and mango apricot. The company said Thursday the products are for adult smokers and it supports efforts to crack down on retailers selling to minors.
The agency said it had also contacted eBay Inc., which has removed listings for Juul products on its site.
Medical and advocacy groups, including the American Academy of Pediatrics and the Campaign for Tobacco-Free Kids, last month sued the FDA, challenging its decision last summer to extend certain deadlines for e-cigarette makers even as it moved to cut back on nicotine levels in traditional cigarettes.
The FDA currently allows e-cigarettes that were on the market as of Aug. 8, 2016, to stay on the market until at least 2022 without undergoing review. But companies can’t introduce new e-cigarette products or change existing products without first going through a review by the agency.
The Campaign for Tobacco-Free Kids said Tuesday the FDA’s measures hadn’t gone far enough.
“The FDA must do more by taking off the market Juul flavors like mango and cool cucumber that clearly appeal to kids, preventing the introduction of look-alike products and subjecting e-cigarettes to FDA review of their public health impact, as required by law,” said its president, Matthew Myers.
Already on the market are products that piggyback on Juul’s popularity. Eonsmoke LLC, sells nicotine pods with a 6% nicotine solution. Chief Executive Michael Tolmach said he expects sales of his Juul-compatible e-cigarettes to reach $30 million this year.
Soter Technologies LLC in Hauppauge, N.Y., says it gets about 100 orders a month from schools for its Fly Sense vaping detector, which can be installed in bathrooms. Some parents even look to install them at home. “We get 10 calls a week from parents saying, ‘can you help me?,’” said Chief Executive Derek Peterson.
While the FDA has accepted that e-cigarettes and other cigarette alternatives have a role to play in helping smokers quit, the agency on Tuesday said it would take new measures to prevent children from accessing e-cigarettes. It didn’t provide details.
While cigarette use has declined among teens for years, vaping is rising fast despite federal regulations prohibiting anyone under 18 from purchasing e-cigarettes. Some states have higher minimum ages of up to 21.
A survey of close to 3,000 high school students in Connecticut showed that 22% of those who reported having used an e-cigarette had used a Juul, according to findings presented earlier this year at a meeting of the Society for Research on Nicotine and Tobacco.
The FDA last month called for public comment on the role that flavors play in the initiation, use and cessation of tobacco products. For e-cigarettes the agency’s stance so far has been that flavors can be harmful if they lure minors but good if they encourage addicted adult smokers to switch to them.
As underage use became a growing problem, Juul in August raised the minimum age requirement for buying products on its website to 21 from 18. Juul Labs executives have denied the product was designed to appeal to children and say the flavors can be important for adults who are trying to quit smoking.
Traditional cigarette companies are also pursuing e-cigarettes and other gadgets that promise to deliver nicotine without the more harmful effects that come with tobacco combustion.
Imperial Brands, which sells Kool and other cigarettes, has blu e-cigarettes. British American Tobacco PLC sells an e-cigarette brand called Vuse in the U.S. while Altria GroupInc. sells Green Smoke and MarkTen.