FDA Examining Lowering Nicotine Levels in Cigarettes

HealthDay News — The US Food and Drug Administration plans to begin a public dialogue about reducing nicotine levels in combustible cigarettes to non-addictive levels through achievable product standards, agency officials said Friday.

In addition, the FDA is delaying implementation of last year’s rules on cigars and electronic cigarettes currently on the market until 2021 and 2022, respectively. That will allow time to ensure the regulatory standards are appropriate, FDA Commissioner Scott Gottlieb, MD, said at a morning media briefing. “We want to make sure those products, particularly the e-cigarettes, go through an appropriate set of regulatory dates to make sure they’re safe, make sure they are meeting standards,” he said.

Central to the FDA’s new approach to tobacco control is the belief that products such as e-cigarettes and cigars should not be used by children. Rules are needed to deal with “kid-appealing” flavors, Gottlieb said. Cigarette smoking is the leading cause of preventable disease and death in the United States, according to the US Centers for Disease Control and Prevention. Studies have shown that most cigarette smokers start as teens, and the FDA wants to prevent them from getting addicted in the first place, potentially stemming rates of lung disease.

“Here’s an opportunity to reframe the debate [about e-cigarettes],” Mitch Zeller, JD, the FDA’s director of the Center for Tobacco Products, said during Friday’s news conference. “We need to ask some tough questions about the benefits and potential risks about any new technology. But those questions should be asked through a reframing of what’s it going to take to address the leading cause of disease and death related to tobacco use, which is cigarettes,” he said. The agency will also review its position on premium cigars, reopening a discussion on special regulations for these cigars, Zeller added.

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FDA announces comprehensive regulatory plan to shift trajectory of tobacco-related disease, death [press release]. Silver Spring, MD: FDA. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm568923.htm. Published July 28,2017. Accessed Septmeber 1, 2017.