Originally posted on The Wall Street Journal by Jennifer Maloney on September 12, 2018.

Calling a surge in teen use of e-cigarettes an epidemic, the head of the Food and Drug Administration said he is considering pulling all flavored e-cigarettes from the U.S. market.

After years of declining U.S. smoking rates, sales of e-cigarettes have jumped in the past year, fueled in part by online startups selling vaporizers and nicotine-laced liquids. The most popular brand, Juul, sells refills with mango, cucumber and creme flavors. Each $4 pod contains as much nicotine as a pack of cigarettes.

“The number of teenagers we believe are now using these products…has reached an epidemic proportion,” said FDA Commissioner Scott Gottlieb, who outlined new measures Wednesday to curb underage use.

For decades, the U.S. has been combating cigarette smoking by slapping taxes on products, limiting advertising and raising age limits. Smoking rates have fallen to about 16% of U.S. adults from about 25% in 1997, though more than 480,000 people annually die from smoking-related diseases.

Last year, the FDA said it wanted to reduce nicotine levels in cigarettes and urge smokers to switch to less harmful products, like e-cigarettes. The agency encouraged companies to introduce such alternatives, but those products have become popular among children. In 2017, 2.1 million middle- and high-school students had used e-cigarettes in the past 30 days, according to a federal study. Dr. Gottlieb said 2018 data showed much higher usage, but declined to disclose the figures.

Dr. Gottlieb said he believes that certain flavors make the products appealing to teens. “The availability of e-cigarettes cannot come at the expense of addicting a new generation of youth onto nicotine, and it won’t,” he said in an interview.

The announcement marks an about-face for the agency, which in 2016 granted a grace period for e-cigarettes already on the market until the manufacturers submitted products for FDA review. Last year, Dr. Gottlieb extended that grace period to 2022, allowing Juul Labs Inc. and others to continue to sell their existing products.

The FDA said it was sending letters Wednesday to Juul and four other top e-cigarette manufacturers, asking them to respond within 60 days with convincing plans for reducing teen use or risk having their products yanked.

“Juul Labs will work proactively with FDA in response to its request,” a spokeswoman said. “We are committed to preventing underage use of our product.”

The warning stopped short of what some antismoking groups have requested. The Campaign for Tobacco-Free Kids has called for a total ban on flavored e-cigarettes and wants immediate removal of products that have been launched without FDA approval since 2016.

Juul has captured 72% of the estimated $2.3 billion annual U.S. e-cigarette market, according to a Wells Fargo analysis of Nielsen sales data. That figure doesn’t include internet sales. The startup recently raised $650 million in a financing round that valued the company at about $15 billion.

Traditional tobacco and menthol flavors represent less than 10% of Juul’s retail sales, according to Piper Jaffray analyst Michael Lavery. The FDA in 2009 banned all flavored cigarettes except for menthols.

Juul’s vaporizers, introduced in 2015, have become a teen status symbol and a growing problem in U.S. schools. British American Tobacco PLC’s Vuse represents 10% of the market and Altria Group Inc.’s MarkTen and Green Smoke represent 8%, according to Wells Fargo. Imperial Tobacco Group PLC’s Blu and Japan Tobacco Inc.’s Logic hold the fourth and fifth spots in the U.S. market, respectively.

Shares of tobacco companies advanced on the news, which fanned investor hopes that the U.S. regulator might crack down on a startup that has been taking market share. Marlboro maker Altria and Camel maker BAT gained more than 6% apiece Wednesday.

BAT’s R.J. Reynolds Vapor Co. on Wednesday applauded Dr. Gottlieb’s approach and said it looked forward to addressing “this important public health issue.” An Altria spokesman said the company welcomed the FDA’s action on “an issue we have focused on for decades.” The maker of Blu said it would work with the FDA to further strengthen its youth access prevention policies. A Logic spokesman said it would work with the FDA “to show that Logic markets its products only to adults.”

The FDA is attempting to thread “a public-health needle, which is trying to sustain the market” for products that adults could use as smoking-cessation tools while protecting children from becoming addicted to nicotine, Dr. Gottlieb said. He said that if he hadn’t extended the grace period, manufacturers would still have been able to keep their products on store shelves until next year.

“I think we’re going to have to step into this market,” Dr. Gottlieb said. “I am willing to narrow the off-ramp for adults to close the on-ramp for kids.”

Juul said its products are intended for adult cigarette smokers looking to quit. Facing increased pressure to curb widespread use of its devices by teens, Juul over the past year has changed its marketing practices and no longer uses images of models or people under 35 in its marketing.

Last summer it raised to 21 the minimum age to buy from its website and since then it said it has strengthened the tools it uses to block purchase attempts by those under 21 on its own site. The company also conducts random compliance checks of independent retail stores, the company has said.

The FDA said Wednesday it conducted an enforcement blitz this summer and found that products from Juul and other top manufacturers were illegally sold to minors at more than 1,100 stores and websites. It imposed 131 fines for repeat offenders.


If you have used, or know someone who has used a Juul, we are here to help. The Hannon Law Firm is actively investigating this matter and would welcome the opportunity to talk to you about your concerns and experience. Contact us by calling 303-861-8800, or by filling out the contact form below.