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. 

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Photo of Melissa Aikman Melissa Aikman

Melissa is an experienced paralegal in the firm’s Regulatory Investigations, Strategy + Enforcement (RISE) Practice Group and supports lawyers within the tobacco practice. Her substantial paralegal experience in the tobacco industry ranges from implementing plans for meeting FDA requirements, which regulate the manufacture,

Melissa is an experienced paralegal in the firm’s Regulatory Investigations, Strategy + Enforcement (RISE) Practice Group and supports lawyers within the tobacco practice. Her substantial paralegal experience in the tobacco industry ranges from implementing plans for meeting FDA requirements, which regulate the manufacture, packaging, and sale of tobacco products in the U.S., to supporting clients to ensure compliance with various state regulations governing licenses, permits, and escrow payments. Melissa also works closely with the firm’s Enforcement Actions and Investigations group. In this capacity, she assists in representing businesses in regulatory compliance matters initiated by governmental agencies and commercial litigation.

Photo of Bryan Haynes Bryan Haynes

Bryan Haynes serves clients by developing and implementing creative solutions for complex issues. Specializing in tobacco industry regulatory compliance and enforcement matters, Bryan efficiently assists clients in complying with regulatory obligations and managing risk, consistent with clients’ business objectives.

Photo of Agustin Rodriguez Agustin Rodriguez

Agustin is sought after by clients for his strategic counsel on their most challenging competitive and regulatory compliance issues, including tobacco Master Settlement Agreement issues, federal and state enforcement investigations, licensing and excise tax issues, developing compliance programs, and evaluating advertising and marketing…

Agustin is sought after by clients for his strategic counsel on their most challenging competitive and regulatory compliance issues, including tobacco Master Settlement Agreement issues, federal and state enforcement investigations, licensing and excise tax issues, developing compliance programs, and evaluating advertising and marketing practices. A partner in the firm’s Regulatory Investigations, Strategy + Enforcement (RISE) Practice Group as well as its Tobacco and Cannabis law practices, he represents manufacturers, distributors, retailers, and suppliers in all aspects of their businesses, including regulatory compliance, FDA requirements, administrative disputes involving federal or state governmental entities, mergers and acquisitions, commercial agreements, and taxation matters.