FDA delays deeming rule deadlines; focuses on regulating nicotine

Food and Drug Administration (FDA) Commissioner Dr. Scott Gottlieb has unveiled changes in tobacco regulatory policy in addition to a new plan to reduce the addictive potential of combustible cigarettes.

In 2016, the “deeming rule” extended the regulatory authority of the FDA to all previously unregulated tobacco products. These products included e-cigarettes, cigars, hookah and pipe tobacco. The deeming rule brought newly regulated products under the provisions of the Tobacco Control Act of 2009, such as placing health warnings on packages and advertisements; prohibited the sale of newly regulated tobacco products to consumers under the age of 18; and required products on the market after February 15, 2007 to receive marketing authorization from FDA, among other regulations.

With the Commissioner’s new announcement, the deadline for submission of approval applications is extended until August 8, 2021 for combustible products and until August 8, 2022 for noncombustible products such as e-cigarettes. However, this new announcement does not affect other provisions such as the age restriction or the requirement for warning labels.

Commissioner Gottlieb also announced the Comprehensive Approach to Nicotine and Tobacco, which is a plan to reduce the concentration of nicotine in cigarettes to a “non-addictive level”. The goal is to reduce the addictive potential of cigarettes to enable current cigarette smokers to quit, reduce the likelihood that youth who experiment with cigarettes will become addicted, and shift cigarette smokers who still crave nicotine to less toxic products. This plan is only directed at reducing the nicotine concentration in cigarettes.

Going forward, the FDA will seek public comment on the risks, benefits and unintended consequences of lowering the level of nicotine in cigarettes. The FDA will also seek public comment about how flavors attract youth to tobacco products and how flavors may influence how adults switch from cigarettes to less harmful “forms of nicotine delivery”.

In the Commissioner’s public statement, he also said that during this initiative, the FDA will consider whether to exempt premium cigars from regulation.

How you can help

AADR will alert members when the FDA publishes requests public for comment on these issues. In the meantime, please send Science Policy Analyst Seun Ajiboye (sajiboye@iadr.org) information regarding the following as well as any other relevant information:

  • Previous research or public health experience with nicotine reduction in cigarettes
  • “Non-addictive” levels of nicotine in cigarettes
  • Unintended consequences of this initiative, especially regarding youth, vulnerable populations and health disparities.

FDA Comprehensive Approach to Nicotine and Tobacco Resources

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