FDA Takes Steps to Prevent Access to Flavored Tobacco Products, Ban Menthol Cigarettes

The FDA today announced new actions aimed at reversing the increasing trend of youth nicotine use and combating youth access to e-cigarettes. Though the agency stopped short of an expected ban on flavored e-cigarettes, it will move to outlaw menthol cigarettes and flavored cigars, 2 products that disproportionately harm African Americans.

The FDA’s proposals include plans to sequester flavored e-cigarettes in stores and ensure strong age-verification procedures for retail and online sellers. Legal experts said the FDA did not have the legal authority to impose a ban without going through a long and complex process that would have led to protracted court battles.

“We advance our efforts to combat youth access and appeal with a policy framework that firmly and directly addresses the core of the epidemic: flavors,” said FDA Commissioner Scott Gottlieb, MD. “The policies I’m outlining now strive to strike a careful public health balance between our imperative to enable the opportunities to transition to noncombustible products to be available for adults, and our solemn mandate to make nicotine products less accessible and less appealing to children.”

Gottlieb noted that new data from the 2018 National Youth Tobacco Survey (NYTS) show an astonishing increase in kids’ use of e-cigarettes and other electronic nicotine delivery systems (ENDS), reversing years of favorable trends in the country to prevent youth addiction to tobacco products. “These increases must stop,” Gottlieb stated. “I will not allow a generation of children to become addicted to nicotine through e-cigarettes.”

The Commissioner said he was directing the FDA’s Center for Tobacco Products (CTP) to revisit its 2017 compliance policy for ENDS products that are flavored (including all flavors other than tobacco, mint, and menthol) to be sold in age-restricted, in-person locations, and, if sold online, under heightened practices for age verification.

The changes will not include mint- and menthol-flavored ENDS, which reflects “a careful balancing of public health considerations,” because 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, Gottlieb explained, and because combustible cigarettes are still sold in menthol flavors, the agency must strike a difficult compromise because it does not want to create a situation where combustible products have features that make them more attractive than noncombustible products.

However, the Commissioner expressed deep concerns about the availability of menthol-flavored cigarettes because they represent a common and pernicious route by which kids initiate combustible cigarettes and because they disproportionately and adversely affect underserved communities.

Although he is not proposing revisions to the compliance policy for mint- and menthol-flavored e-cigarettes at this time, Gottlieb put manufacturers on notice saying that the FDA will advance a notice of proposed rulemaking that would seek to ban menthol in combustible tobacco products, including cigarettes and cigars, because of the heightened use of menthol cigarettes among youth. Additionally, the FDA will also be proposing a policy to ban flavors in cigars because research shows that a higher proportion of youth who smoke cigars use flavored cigars.

Today’s proposals come on top of earlier actions taken by the FDA to educate teens about the consequences of addiction to e-cigarettes and to address their use of e-cigarettes and ENDS, including escalating enforcement against retailers who illegally sell ENDS products to minors, partnering with the Federal Trade Commission to target e-liquid manufacturers whose products use misleading imagery that appeal to kids (eg, mimicking juice boxes, lollipops, and other foods), and calling on manufacturers to take voluntary actions to prevent youth access to these products. Recently, Juul Labs, the largest e-cigarette seller, announced it would suspend store sales of its flavored pods with the exception of mint, menthol, and tobacco; shut down its social media promotions, and toughen online verification of age requirements.

Gottlieb presented NYTS data showing that from 2017 to 2018 there was a 78% increase in current e-cigarette use among high-school students and a 48% increase among middle-school students. The total number of middle and high school students currently using e-cigarettes rose to 3.6 million—1.5 million more than the previous year. In addition, more than a quarter (27.7%) of current high school e-cigarette users are using the product regularly (on 20 or more days in the past month), and more than two-thirds (67.8%) are using flavored e-cigarettes. Both these numbers have risen significantly since 2017.