November 19, 2018 03:55 pm News Staff – The AAFP has hailed a recent move by the FDA toward restricting the sale of most flavored e-cigarette products and banning menthol in combustible cigarettes -- a long-tolerated gateway to nicotine and tobacco addiction.
FDA Commissioner Scott Gottlieb, M.D., announced on Nov. 15 that his agency would seek to confine the sales of most flavored electronic nicotine delivery system (ENDS) products to age-restricted locations and require more robust age verification for online sales of these products. The agency also aims to ban menthol in combustible tobacco products, as well as all flavoring agents in cigars.
The proposed restriction on flavored ENDS products would exempt mint, menthol and tobacco flavors, and unflavored pods.
The moves "have the potential to impact generations to come and help ensure that the youngest members of society are safeguarded against what we know to be addictive and a deadly public health concern," said AAFP President John Cullen, M.D., of Valdez, Alaska, in a statement that applauded the FDA's announcement.
The agency's actions are the latest tactical maneuvers in its Comprehensive Plan for Tobacco and Nicotine Regulation. They follow a September crackdown on brick-and-mortar ENDS vendors, largely centered on market-leading JUUL e-cigarette products, and an April expansion of FDA efforts to curb youth tobacco and e-cigarette use.
Gottlieb's announcement -- which happened to come on the same day as this year's Great American Smokeout, the awareness campaign begun in 1976 by the American Cancer Society -- emphasized that underage smoking and nicotine addiction were again primary targets of the FDA. The director's unusually long and personal statement read as a kind of call for a Great American Vapeout.
"I will not allow a generation of children to become addicted to nicotine through e-cigarettes," Gotlieb said in the statement. "We won't let this pool of kids, a pool of future potential smokers, of future disease and death, to continue to build. We'll take whatever action is necessary to stop these trends from continuing."
A CDC Morbidity and Mortality Weekly Report issued on Nov. 16 quantifies those trends with alarming new statistics: Over the past year, it says, "overall tobacco product use increased by 38 percent among high school students … and by 29 percent among middle school students."
Gottlieb's announcement caps an eventful year for federal agencies charged with overseeing tobacco- and nicotine-related products.
In March, a group of public health organizations and physicians led by the American Academy of Pediatrics filed a lawsuit against the FDA, HHS and the individual heads of those agencies. The suit contended that an FDA decision to delay product reviews of e-cigarettes and cigars was unlawful and constituted a severe threat to public health. The case is ongoing.
In the days before Gottlieb's announcement, the company behind JUUL said it would suspend sales of most of its flavored e-cigarette pods in retail stores and halt U.S. social-media promotions. (The latter action follows a petition, signed this past summer by the AAFP and other medical and public health organizations, calling on the Federal Trade Commission to protect American consumers from possibly illegal marketing of combustible tobacco products.)
JUUL Labs commands more than 70 percent of the e-cigarette market in this country, making it the FDA's most visible adversary as it tries to stem what it sees as an epidemic of teen e-cigarette use.
The proposed ENDS policy could take effect as soon as early 2019, following a comment period that ends Jan. 2. That would be good news to the Academy, which will comment by that deadline.
The "increased regulation proposed today, including banning flavored cigars and halting the marketing of ENDS to children, protects them from predatory practices that lead to increased consumption," the AAFP said in its statement. "In addition, banning the sale of flavored ENDS products that are sold in locations open to all ages protects them from health harms associated with tobacco use.
"The FDA must continue to help regulate an industry that is in direct conflict with public health."
Combustible tobacco products, meanwhile, owe much of their longstanding sway over U.S. public health to the other target in Gottlieb's sights: menthol.
Studies have long indicated that mentholated tobacco products, which make up some 35 percent of U.S. cigarette sales, make it easier for people to start smoking and harder for them to quit, and are disproportionately favored by black smokers.
The FDA has long accepted the science behind menthol's impacts.
A 2011 report from an FDA advisory panel was unequivocal: "Menthol smokers show greater signs of nicotine dependence and are less likely to successfully quit smoking. These findings, combined with the evidence indicating that menthol's cooling and anesthetic properties can reduce the harshness of cigarette smoke and the evidence indicating that menthol cigarettes are marketed as a smoother alternative to nonmenthol cigarettes, make it likely that menthol cigarettes pose a public health risk above that seen with nonmenthol cigarettes."
Related AAFP News Coverage
Rise of 'JUULing' Among Youth Sparks Sharp Response
Academy Offers Members Physician/Patient Resources
(8/6/2018)
More From AAFP
Electronic nicotine delivery systems (ENDS) fact sheet(2 page PDF)
Additional Resource
CDC: Youth and Tobacco Use