Takeaways from Listening Session on the Development of FDA’s Center for Tobacco Products Strategic Plan

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On August 22, 2023, the Troutman Pepper Tobacco + Nicotine Team attended the Food and Drug Administration’s Center for Tobacco Products (“CTP”) virtual listening session on the development of CTP’s strategic plan.  We previously blogged about CTP’s intent to issue a finalized five-year strategic plan by December 2023, including the agency’s five proposed strategic goals. 

Almost 60 stakeholders from the tobacco industry, trade associations, medical and scientific communities, law enforcement and others had the opportunity to comment on the proposed goal areas.

The comments covered a wide range of topics including:

  • Supporting development of less harmful alternatives to combustible products and encouraging CTP to do more to counter the widespread belief that vaping is more harmful than combustible products;
  • Requesting clarification on the appropriate for the protection of public health (APPH) standard and prioritizing regulatory action for products posing the highest risk to public health;
  • Advocating for and against FDA’s proposed menthol cigarette and cigar characterizing flavor bans, with most comments against both bans citing issues enforcement, including in minority communities, and warning that any ban encourages illicit trade;
  • Requesting more transparency from CTP on standards, guidance, submission processes and forms;
  • Seeking more robust enforcement against the proliferation of unlawfully marketed products (i.e., those new products without a marketing order and without a pending premarket submission); and
  • Requesting CTP to publish lists of authorized products and products with pending premarket submissions.

Many of the commenters indicated they would also be submitting written comments, which are due by August 29, 2023

Stay tuned to see how CTP incorporates these comments in its forthcoming strategic plan. 

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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