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FDA vows to strengthen compliance for electronic nicotine products, calls for banning menthol in cigarettes, cigars

November 15, 2018

By Jennifer Garvin

Silver Spring, Md. — In an effort to curtail youth tobacco use, the Food and Drug Administration announced Nov. 15 plans to strengthen the agency's compliance policy for electronic nicotine delivery systems products that are flavored by requiring they be sold in age-restricted locations in person and improving age verification processes for online.

The announcement comes on the heels of the FDA and Centers for Disease Control and Prevention's release of the 2018 National Youth Tobacco Survey results, which shows more than 3.6 million middle and high school students are considered current (past 30 days) e-cigarette users — an increase of more than 1.5 million students in 2017.

"The data show that kids using e-cigarettes are going to be more likely to try combustible cigarettes later. This is a large pool of future risk," said Scott Gottlieb, M.D., FDA commissioner, in a press statement. "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. The data make unmistakably clear that, if we're to break the cycle of addiction to nicotine, preventing youth initiation on nicotine is a paramount imperative."

"[This] confirms the need for FDA's ongoing policy proposals and enforcement actions," said Alex Azar, secretary, U.S. Department of Health and Human Services. "HHS's work will continue to balance the need to prevent youth use of e-cigarettes with ensuring they are available as an off-ramp for adults who are trying to quit combustible cigarettes."

ADA President Jeffrey M. Cole called the FDA's Nov. 15 statement a "positive step to help protect our youth."

"We are concerned about the many health risks associated with the increased use of nontraditional tobacco products like e-cigarettes, especially among youth and young adults," Dr. Cole said. "We are hopeful the FDA will begin enforcing its tobacco product 'deeming rule,' which would impose similar requirements on all 'next generation' tobacco products."

Commissioner Gottlieb said the changes to electronic nicotine delivery systems products — known as ENDS products — will not include mint- and menthol-flavored electronic tobacco since current data suggests those flavors are "more popular with adults than with kids" and those products could be needed by adult smokers "seeking to transition away from cigarettes." He added that should evidence show that "kids' use of mint or menthol e-cigarettes isn't declining" he would revisit this aspect of the compliance policy.

Dr. Gottlieb also said the FDA is seeking to ban menthol in all combustible tobacco products such as cigarettes and cigars, and called for the agency to re-evaluate its regulatory approach to flavored cigars.

"The bottom line is that these efforts to address flavors and protect youth would dramatically impact the ability of American kids to access tobacco products that we know are both appealing and addicting," Dr. Gottlieb said. "This policy framework reflects a re-doubling of the FDA's efforts to protect kids from all nicotine-containing products."

The Association has long advocated for tighter federal regulations on all forms of tobacco and has urged the FDA to expand its regulation of products it deemed to be covered by the Family Smoking Prevention and Tobacco Control Act. In 2016, the FDA issued a final rule on tobacco products, expanding the agency's authority to regulate all tobacco but later postponed enforcement of the rule until 2021 for combustible products such as cigars, pipe tobacco and hookah tobacco, and 2022 for noncombustible products such as e-cigarettes. In 2017 the ADA asked the FDA to reconsider its decision to delay enforcement of the tobacco product deeming rule but the agency did not do so.

For more information on the ADA's advocacy efforts on tobacco visit