A US Food and Drug Administration (FDA) initiative to stem tobacco use and nicotine addiction in children will focus on the role that flavor, including menthol, plays in the “initiation, use, and cessation of tobacco products,” according to a press release.1

FDA Commissioner Scott Gottlieb, MD, announced the issue of an advance notice of proposed rulemaking (ANPRM)2 that calls upon stakeholders “share data, research, and information” ahead of the development of regulatory guidance.

“For years we have recognized that flavors in [tobacco] products appeal to kids and promote youth initiation,” said Dr Gottlieb in the press release.1 “The data backs this up, and as a result, Congress prohibited the use of most characterizing flavors in cigarettes.”

Despite this prohibition, more than 65% of children and adolescents who report having tried a cigar indicated that their first cigar was flavored. This group are also more likely to smoke menthol vs nonmenthol cigarettes. Additionally, flavors are among the most commonly cited reasons why children and adolescents turn to electronic cigarettes or other nicotine delivery systems.

The agency also indicated that this flavor-based research may benefit adult smokers. Data examination will include an assessment of how flavored nicotine products may help current smokers switch to non-combusted tobacco products.

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“With all this in mind…we believe it’s important that we re-examine the issue of flavors as we work to best protect public health and significantly reduce tobacco-related disease and death,” said Dr Gottlieb. “Ultimately, we’re working to ensure our policies achieve the greatest public health benefit.”

The FDA is seeking comments, data, and research results on the following topics:

  • The role of flavors in initiation of tobacco use among children and adolescents;
  • The role of flavors in aiding adult smokers in reducing cigarette use or transitioning to less harmful products;
  • The role of flavors in transitioning from combusted to non-combusted tobacco products;
  • Consumer perceptions of the risks and addictiveness associated with flavored tobacco products;
  • Harms and adverse effects associated with the use of certain flavors of tobacco products; and
  • The impact of local-, state-, and international-level efforts to restrict the marketing and sale of flavored tobacco products.

The federal register will be open for public comment for 90 days, beginning on March 21, 2018. To add your comment, please visit the website.

References

  1. Statement from FDA commissioner Scott Gottlieb, MD, on efforts to reduce tobacco use, especially among youth, by exploring options to address the role of flavors — including menthol — in tobacco products [news release]. Silver Springs, MD: US Food and Drug Administration. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm601690.htm. Published March 20, 2018. Accessed March 20, 2018.
  2. Federal Register. US Food and Drug Administration. Regulation of flavors in tobacco products. https://www.federalregister.gov/documents/2018/03/21/2018-05655/regulation-of-flavors-in-tobacco-products. Published March 20, 2018.