FDA Seeks Information on Role of Flavors in Initiation, Cessation of Tobacco Use

The FDA on March 21 issued a separate advance notice of proposed rulemaking to study the use of flavors in tobacco products, including e-cigarettes.

The agency “is seeking comments, data, research results, or other information about, among other things, how flavors attract youth to initiate tobacco product use and about whether and how certain flavors may help adult cigarette smokers reduce cigarette use and switch to potentially less harmful products,” according to the notice. The comment period ends June 19.

In 2009, the FDA banned the use of all characterizing flavors except for menthol and tobacco in cigarettes. Since then, the market for flavored non-cigarette tobacco products has exploded, particularly e-cigarettes, which deliver nicotine extracted from tobacco, and little cigars. There are more than 7,700 unique e-cigarette flavors clearly aimed at youth, such as cotton candy, sour apple, gummy bear, cherry dynamite, cookies n’ cream, pop rocks, slushie, and even 20 different “unicorn” flavors, according to a 2017 report by the Campaign for Tobacco-Free Kids, American Lung Association, American Academy of Pediatrics, and other related organizations.

While there has been a steep drop in use of traditional, combustible cigarettes by young people, overall youth tobacco use has remained steady, mostly due to the popularity of flavored e-cigarettes and flavored mini cigars, according to the report. Current use of e-cigarettes among high school students is now at 16 percent, a 10-fold increase from 2011.

“In the spirit of our commitment to preventing kids from using tobacco, we are taking a closer look at flavors in tobacco products to better understand their level of impact on youth initiation,” FDA Commissioner Scott Gottlieb, M.D., said in a press statement. “And as a public health agency, it’s important that we also explore how flavors, under a properly regulated framework that protects youth, may also be helping some currently addicted adult cigarette smokers switch to certain non-combustible forms of tobacco products.”

Douglas M. Ziedonis, M.D., M.P.H., the associate vice chancellor for health sciences and professor of psychiatry at the University of California, San Diego, told Psychiatric News that he isn’t buying that the flavors are helping adults to quit smoking. “I think that what attracts adults to e-cigarettes is that there seems to be less stigma associated with them than with regular cigarettes, which have been banned in more and more locations,” he said. “Patients feel they have to hide their usage of regular cigarettes.”

Other patients turn to e-cigarettes because of the known health risks of cigarettes, Ziedonis said. “But are these products really helpful for patients trying to quit—or do patients just end up doing both?” He called for more research on e-cigarettes, including on the long-term health consequences which he said are unknown. ■