Amid mounting reports of e-cigarette dangers, Food and Drug Administration (FDA) Commissioner Scott Gottlieb has declared youth vaping an epidemic.
In a statement released Wednesday, Gottlieb addressed the 5 major manufacturers (makers of popular devices Juul, Vuse, MarkTen XL, Blu, and Logic) that make up more than 97 percent of the U.S. e-cigarette market. If the brands can’t submit “robust” enough plans to prevent e-cigarette use among minors, the agency will halt their sales.
The Risk to Teens
E-cigarettes are by far the most popular tobacco product among teens. Of the 3.6 million young tobacco users in 2017, 2.1 million used e-cigarettes, according to CDC data. The research showed that about 12 percent of high school students and 3 percent of middle school students used e-cigarettes in the last 30 days.
Psychologists worry that these numbers indicate widespread “self-medicating” in teens who are anxious or depressed. Meanwhile, surveys show that many teens are unaware of the risks, which include exposure to toxins and explosions.
“No one can look at the data and say there’s no problem,” Gottlieb said. “Teenagers are becoming regular users, and the proportion of regular users is increasing. We’re going to have to take action.”
Last week’s announcement followed the FDA’s advance notice of proposed rulemaking (ANPRM) last March, in which the agency announced plans to examine “the role that flavors – including menthol – play in initiation, use, and cessation of tobacco products.” The effort was criticized as too little, too late by parents and public advocates. The American Lung Association (ALA) and other health groups sued the FDA to expedite delayed e-cigarette review.
And up until now, because they were already on the market, the 5 major brands were largely immune from the FDA’s 2016 decision to regulate e-cigarettes like other tobacco products.
Under the FDA’s new approach, that immunity is lifted. The agency will also more closely evaluate the “net public health impact” of new products before authorizing companies to market them.
The FDA also announced the results of its largest-to-date enforcement effort against 1,100 retailers – 131 of which have been issued penalties for selling to minors. And for the first time, Gottlieb announced citing companies for illegal sales. The agency has yet to name names.
The Implications for Adults
The point of Gottlieb’s crackdown over the last several months has been to weigh the supposed benefits of e-cigarettes to adults who want to quit smoking – which haven’t yet been proven – against the risk to underage e-cigarette users who are now hooked on nicotine.
He is also exploring possible reasons for the epidemic. Adding to concerns over mental health, critics have said the device’s attractively flavored e-liquid – given names like “cotton candy” and “gummi bear” – target children attracted to “cool” or “forbidden” substances. Acknowledging that flavors “play an important role in driving the youth appeal,” Gottlieb says he is prepared to protect children by making vaping less attractive to adults.
Vapers United, a group that promotes vaping as a way to quit smoking, argues this could send ex-smokers back to cigarettes.
“The FDA needs to be very cautious about the adverse effects that flavoring bans or excess regulation could have on this trend – smokers using vapor as a way to stop consuming cigarettes and move towards a healthier lifestyle,” said spokeswoman Liz Mair.
Similarly, Juul CEO Kevin Burns has in the past warned that restricting flavors “will negatively impact current adult smokers.” To Gottlieb’s Wednesday announcement, Burns responded by saying Juul “will work proactively with FDA in response to its request.”
“We are committed to preventing underage use of our product, and we want to be part of the solution in keeping e-cigarettes out of the hands of young people,” he said in a statement.
Other manufacturers echoed Burns’s enthusiasm to cooperate, insisting they have only targeted adults. But 1 tobacco control organization, while more encouraged by the FDA’s latest action than previous, said giving companies the chance to help prevent teen vaping is like “asking the proverbial fox to guard the henhouse.”
“What we’re living through now are the unintended consequences” of Gottlieb’s delayed action, said Truth Initiative CEO and president, Robin Koval. “Congress gave FDA all the authority and FDA has all the tools they need to regulate this market, and they need to do this quickly.”
The 5 major manufacturers have 60 days to submit their plans.