FDA Cracks Down on Underage Use of E-Cigarettes
FDA’s largest enforcement action to date gave warnings and fines to 1,300 retailers and requested plans to prevent teen vaping from five manufacturers
Earlier today, the Food and Drug Administration announced the launch of its largest coordinated enforcement effort in history, sending warning letters and fines to more than 1,300 retailers to combat the “epidemic” of e-cigarettes sales to minors.
“I use the word epidemic with great care,” FDA commissioner Scott Gottlieb said in a statement. “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.”
Since 2014, e-cigarettes have been “the most commonly used tobacco product among both middle school and high school students,” according to the 2017 National Youth Tobacco Survey, which is published by the FDA and the Centers for Disease Control and Prevention.
But the number of teens using e-cigarettes is believed to have jumped significantly since that last survey. While 2017 numbers listed more than 2 million middle school and high school students as e-cigarette users, Laurie McGinley at The Washington Post interviewed people familiar with preliminary data from the most recent survey, which is not yet published, who say the latest data reflects a 75 percent jump in high school students using e-cigarettes in 2018, an indicator of just how widespread “vaping” has become.
In the agency’s statement, the FDA rolled out significant new steps to face the problem. Today’s action included sending warning letters to retailers that were caught selling the products to underage customers during an undercover enforcement blitz that took place over the summer. Fines ranging from $279 to $11,182 were issued to retailers for repeated offenses. Twelve online companies were also delivered warning letters for selling teen-friendly vaping products.
Most significantly, the agency called on the five leading e-cigarette manufacturers, Vuse, blu, Juul, MarkTen XL, and Logic, which collectively represent 97 percent of the industry, to file plans to limit sales to underage consumers within 60 days. If the plans don’t significantly reduce the number of underage smokers, the agency says it will take steps to pull flavored e-cigarette products that appeal to teens off the market.
The debate over e-cigarettes is complex. The product is a small electronic device that converts a “juice,” typically propylene glycol mixed with nicotine and flavors, into an inhalable vapor. The flavors include almost any taste imaginable, including cheesecake, bourbon, gummy bears and Fruit Loops. The nicotine-spiked juice is often marketed as a way for smokers to wean themselves off the real thing since they can control the levels of nicotine in their vape juice. But vaping is not healthy for those who don’t already smoke. A recent study indicates that, besides leading to a nicotine addiction, vaping may be exposing teens to chemicals linked to cancer. Another study from National Academies of Sciences, Engineering, and Medicine earlier this year found that nicotine levels in e-cigs can be higher than in traditional tobacco products and can make users more likely to use the real thing.
Sheila Kaplan and Jan Hoffman at The New York Times report that in the past, Gottlieb has supported e-cigarettes for their potential to help adult smokers quit and considered them a critical piece of an ambitious plan to reduce traditional smoking revealed last year. But he now says the alarming rise in underage vaping caught public health officials by surprise and preventing teen smoking outweighs its benefit to adult smokers. “[T]he youth risk is paramount,” he said in his staff comments. “In closing the on-ramp to kids, we’re going to have to narrow the off-ramp for adults who want to migrate off combustible tobacco and onto e-cigs.”
One company in particular, Juul, has been singled out for its popularity among teens. In just three years, reports McGinley at the Post, the brand has captured 70 percent of the vaping market with its streamlined appearance and social media presence particularly appealing to adolescents. Juul has been under scrutiny by the FDA since April for its marketing practices. The company tells the Times' Kaplan and Hoffman that it has stepped up its monitoring of its retailers and polices the way its products are presented on social media and elsewhere. In a statement, the company says it will comply with the FDA request and is “committed to preventing underage use of [its] product.”
In an interview with the Post, Matthew Myers, president of the leading advocacy organization Campaign for Tobacco-Free Kids, calls the FDA’s action a “fundamental turning point.”
“This is potentially the most important step FDA has taken to curtail youth use of e-cigarettes,” he continues. However, Myers warns that it will only be effective if the agency requires manufacturers to immediately undergo a premarket review, assessing the risks of the products. That step was initially scheduled to take place this August, but the timeline was pushed back to 2022 in order to give the FDA and the industry more time to prepare.