The FDA announced today that to get youth to stop smoking, it will revisit significant parts of two policies that restrict access to newly regulated non-combustible tobacco products, electronic nicotine delivery systems, and e-cigarettes.
“The changes I seek would protect kids by having all flavored [electronic nicotine delivery systems] products (other than tobacco, mint and menthol flavors or nonflavored products) sold in age-restricted, in-person locations, and, if sold online, under heightened practices for age verification,” FDA commissioner Scott Gottlieb, MD, said in a press release.
The federal agency said it is taking another look at policies that extend the premarket application compliance date for newly regulated non-combustible tobacco products, electronic nicotine delivery systems (ENDS), and e-cigarettes to August 2022, and oversee most flavored ENDS that are sold online without additional, heightened age verification and other restrictions in place.
“These changes will not include mint- and menthol-flavored ENDS. This reflects a careful balancing of public health considerations,” Gottlieb said in the release. “Among all ENDS users, data suggests that mint- and menthol-flavored ENDS are more popular with adults than with kids. Any approach to mint- and menthol-flavored ENDS must acknowledge the possibility that the availability of these flavors in ENDS may be important to adult smokers seeking to transition away from cigarettes.”
“Moreover, I recognize that combustible cigarettes are still sold in menthol flavor, including in convenience stores. I don’t want to create a situation where the combustible products have features that make them more attractive than the non-combustible products. Or a situation where those who currently use menthol-flavored cigarettes might find it less attractive to switch completely to an e-cigarette,” he added.
Gottlieb also said in today's announcement that he proposes prohibiting flavors in cigars, and that the FDA intends to look into banning menthol in combustible tobacco products, including cigars and cigarettes.
The AAP said Gottlieb's newest proposals regarding e-cigarettes do not go far enough.
“Even with new sales restrictions announced today by FDA preventing flavored e-cigarettes from being sold at certain brick and mortar storefronts, teens will still find ways to access them. E-cigarette products that appeal to children have no business in the marketplace, period. FDA must take stronger action to protect young people,” Colleen A. Kraft, MD, MBA, FAAP, and president, AAP, said in a statement.
Conversely, the American College of Cardiology was encouraged by the FDA’s latest announcement.
The FDA announced today that to get youth to stop smoking, it will revisit significant parts of two policies that restrict access to newly regulated non-combustible tobacco products, electronic nicotine delivery systems, and e-cigarettes
“The FDA’s announcement restricting the sale of flavored e-cigarettes and other tobacco products shows they are ready to do their part in making tobacco products less available to our children. Let’s do our part to make sure they don’t become our future patients,” C. Michael Valentine, MD, FACC, president of the American College of Cardiology, said in a statement.
The latest FDA announcement comes on the heels of a new CDC report that found current e-cigarette use increased 78% among high school students and 48% among middle school students from 2017 to 2018. The data also showed 1.5 million more students are using e-cigarettes this year vs. last year.
In addition, NBC News reported that e-cigarette maker Juul took a preemptive step this week by removing most of its flavored products from retail stores and is scaling back its social media presence.
Juul has been under significant FDA scrutiny this year, most recently when the FDA took control of more than 1,000 pages of documents in a surprise inspection of Juul Labs earlier this fall. An FDA spokesperson told Healio Family Medicine the paperwork was connected to Juul’s marketing and sales practices.
The FDA under the Trump administration has made curtailing youth tobacco use one of its top priorities. Earlier this year, it conducted undercover blitzes targeting retailers who sell to minors and it previously announced plans to expand the “The Real Cost” campaign, which includes educational information on the dangers of ENDS and e-cigarettes for teenagers. – by Janel Miller
Disclosure: Gottlieb is FDA commissioner, Kraft is president of AAP, Valentine is president of the American College of Cardiology.