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March 21, 2018

FDA takes aim at flavored tobacco products

Daily Briefing

    FDA on Tuesday took its first steps toward regulating flavors in tobacco, issuing an advance notice of proposed rulemaking that seeks data, research, and public comments on how flavors such as menthol contribute to tobacco addiction.

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    The move comes after FDA last week issued an advance notice of proposed rulemaking in its effort to lower nicotine levels in cigarettes. Both moves are part of a comprehensive plan FDA announced in July 2017 to reduce tobacco-related disease and death.

    FDA seeks public's input on tobacco flavors

    FDA in its latest notice provided an overview of current research on how flavors, such as menthol, lead to the initiation, use, and cessation of tobacco products, particularly among younger U.S. residents. FDA Commissioner Scott Gottlieb said, "For years we have recognized that flavors in these products appeal to kids and promote youth initiation," which is why "Congress prohibited the use of most characterizing flavors in cigarettes."

    However, flavors remain present in other tobacco products, including small cigars and electronic cigarettes (e-cigarettes), MedPage Today reports. Gottlieb cited research that found more than 65% of youth who have tried a cigar said their first cigar was flavored. Gottlieb added that "e-cigarettes are the most commonly used tobacco product among middle and high school students, and flavors are identified as one of the top three reasons for use."

    FDA in the notice seeks public feedback on how the agency should regulate flavors in tobacco products to promote public health. FDA in the notice asked for comments, data, and research on:

    • Consumers' perceptions of health risks associated with flavored tobacco products, including how such products contribute to addiction;
    • The effects of local, state, and international efforts to restrict the sale or marketing of flavored tobacco products;
    • The role flavors play in the initiation of tobacco use, particularly among youth and young adults;
    • The role flavors might play in helping adults who smoke cigarettes reduce their cigarette use and/or switch to potentially less harmful tobacco products;
    • The role flavors in non-combusted tobacco products might play in helping individuals quit using combusted or all tobacco products, as well as how the flavors might cause individuals to begin using more than one type of tobacco product; and
    • Whether certain flavors in tobacco products present potential adverse health effects.

    FDA is accepting public comments on the notice for 90 days.


    Chris Hansen, president of the American Cancer Society Cancer Action Network, in a statement said the organization "welcomes … Gottlieb's actions to assess the role tobacco flavoring plays in tobacco use … and urge[s] the FDA to move forward swiftly with a proposed rule to protect the public health by prohibiting all flavoring—including menthol—in all tobacco products."

    American Heart Association CEO Nancy Brown said, "We encourage the FDA to quickly move beyond information gathering and develop a strong flavoring product standard." Brown added, "There is already clear evidence that flavored tobacco products, including menthol, harm the public health."

    Robin Koval, president of Truth Initiative, applauded FDA's latest move, saying, "More than any other flavoring menthol is impeding progress on driving down smoking rates."

    Matthew Myers, president of Tobacco Free Kids, said "FDA has been down the menthol road many times, and the evidence is overwhelming that menthol is associated with increased use among youth and African Americans." Myers added that there is little evidence showing flavors help individuals who smoke cigarettes quit (G, Reuters, 3/20; Roubein, The Hill, 3/20; Boyles, MedPage Today, 3/20; Gottlieb statement, 3/20; American Cancer Society Cancer Action Network statement, 3/20).

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