FDA Threatens to Remove e-Cigarettes From Market

In the face of skyrocketing e-cigarette use by adolescents, the US Food and Drug Administration (FDA) said it has not ruled out taking the products off the market, according to testimony at a January 18 public hearing. The FDA held the public hearing to discuss the role of drug therapies in the treatment of adolescent nicotine addiction.

"I’ll tell you this. If the youth use continues to rise, and we see significant increases in use in 2019, on top of what we found in 2018, I believe this entire category will face an existential threat," FDA Commissioner Scott Gottlieb, MD, said at the meeting.

"I find myself debating with tobacco makers and retailers the merits of selling fruity flavors in ways that remain easily accessible to kids, but if this epidemic continues to mount, I'm sure the debate will change to...questioning whether or not these products should continue to be marketed at all without authorized premarket tobacco applications," Gottlieb continued. "It really could be 'game over' for some of these products until they have successfully traversed the regulatory process in full."

Representatives from medical groups, consumer groups, the tobacco industry, and others were at the meeting. Some questioned why the FDA had not done more to regulate e-cigarettes before now.

"Unlike the nicotine replacement therapies, these products have been permitted to escape regulation. Why has the FDA not exercised its authority with respect to the marketing of these products, but it has insisted on [it] with respect to the approval and marketing of nicotine replacement therapies?" Daniel A. Hussar, PhD, pharmacist and dean emeritus, Philadelphia College of Pharmacy, University of the Sciences, Pennsylvania, asked at the meeting.

Flavors such as mint, menthol, and fruity flavors mask the strong taste of tobacco in the vaping pods and appeal to young people. Several speakers at the meeting called for the FDA to ban all flavors, including mint and menthol, from e-cigarettes.

A number of attendees said the focus should be on preventing adolescents from ever using e-cigarettes in the first place. Adolescents can order e-cigarettes easily online, and no age verification system is effective at preventing underage youth from obtaining them in that manner, Lauren Lempert, JD, the Center for Tobacco Control Research and Education, University of California, San Francisco, said at the meeting.

Treatment Options Limited

Gottlieb said there is an urgent need for effective ways to help adolescents quit using e-cigarettes.

"For these addicted young people, the reasons that they try e-cigarettes may not matter anymore. These young people are hooked on vaping, and their worried parents, physicians, and the public health community are searching for tools to help them quit," Gottlieb explained.

Tobacco cessation products approved for adults include nicotine replacement therapies, such as nicotine patches, gum, lozenges, nasal spray, and inhalers; and medications, such as bupropion (multiple brands) and varenicline (Chantix, Pfizer).

Gottlieb added that although there is ample research on tobacco cessation products in adults, there is little research on the effects of medications and behavioral approaches in adolescents. Behavioral approaches currently used in adults may not work for adolescents who have different needs.

Many Adolescents Think e-Cigarettes Are Safe

In December 2018, the Office of the US Surgeon General issued an e-cigarette advisory in which it declared e-cigarette use in young people an epidemic.

In addition, the percentage of high school–aged adolescents who reported using e-cigarettes during the past 30 days rose by 78% from 2017 to 2018, according to the 2018 National Youth Tobacco Survey. e-Cigarette use by middle school–aged children rose by 48% during the same period.

e-Cigarettes are attractive to adolescents because adolescents think they're safe, they like the flavors, and e-cigarette ads target adolescents, Lempert said at the FDA hearing.

In addition, because e-cigarettes are marketed as a tool to help adults break their dependency on traditional cigarettes, many adolescents do not fully understand they can become addicted to e-cigarettes.

And though they are perceived as safe, research suggests the chemicals in vaping juice are harmful to the lungs and mouth and have the potential to cause cancer and periodontal disease.

Gottlieb said he does not want to keep e-cigarettes from adults who are using them to quit smoking combustible tobacco products, but he also does not want e-cigarettes to cause nicotine addiction in adolescents who may have never used other tobacco products.

"The major marketers of these products don't seem to fully understand the scope of this challenge, or they don't seem to fully be committed to their own stated obligations and commitments they made publicly and privately to curtail this youth use to the FDA," Gottlieb explained.

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