On February 24, 2023, the Food and Drug Administration (“FDA”) issued a response to the report prepared by the Reagan-Udall Foundation in December 2022. The Foundation’s report was originally commissioned by FDA Commissioner Robert Califf, highlighted a number of issues with the operations of the agency’s Center for Tobacco Products, which has been tasked with regulating tobacco and nicotine products in the U.S., and proposed 15 recommendations for consideration by the agency. You can read our summary of the report’s findings here.

In its response, CTP notes that it is committed to addressing all 15 of the Reagan-Udall report’s recommendations as quickly as possible. To organize its efforts, CTP convened six task forces, each to focus on specific recommendations originally outlined in the report. The task forces and their areas of focus are as follows:

  • Cross-Cutting: create an implement a strategic plan; obtain public input about strategic plan, objectives and metrics; and improve transparency.
  • Science and Application Review: increase use of the Tobacco Products Scientific Advisory Committee; develop a clear and predictable framework for application review; and clarify the substantive review process.
  • Regulation and Guidance: create a more effective approach to achieve regulatory review and enforcement goals.
  • Compliance and Enforcement: establish an interagency task force to make enforcement a priority; consider statutory changes to streamline the tobacco enforcement process; explore alternative approaches to compliance; enhance communication to provide greater transparency on compliance and enforcement; ensure the Center’s workplan and goals reflect new priorities.
  • Public Education Campaigns: solicit broad input on public education campaigns.
  • Resources: improve abilities to recruit, hire, and retain personnel to meet public health mandates and pursue securing user fees from each sector.

Also of note is that CTP will immediately initiate the hiring process to create a new policy unit within the Office of the Center Director. This policy unit “will be responsible for providing overall policy coordination across CTP.”

Both CTP Director Brian King and FDA Commissioner Robert Califf issued statements announcing FDA’s response. Director King emphasized the CTP’s commitment to transparency regarding the implementation of the report’s recommendations and promised quarterly updates online, statements from leadership, and topic-specific announcements. Director King also noted that implementation of the recommendations will not sidetrack CTP’s current activities, which include continuing review of hundreds of premarket tobacco applications for new tobacco products. Commissioner Califf acknowledged that FDA must keep up with the rapid innovation in the e-cigarette industry but accused tobacco companies of hampering the agency’s work through various legal challenges.

Over the coming weeks the Tobacco Law Blog will dive deeper into each task force and the changes ahead at the Center for Tobacco Products. Stay tuned!

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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.

Photo of Christina Sava Christina Sava

Christina is an attorney in the firm’s Regulatory Investigations, Strategy + Enforcement (RISE) Practice Group. She helps clients navigate local, state, and federal regulations affecting the tobacco, hemp, and cannabis industries – including ancillary service providers. She brings extensive experience in the cannabis…

Christina is an attorney in the firm’s Regulatory Investigations, Strategy + Enforcement (RISE) Practice Group. She helps clients navigate local, state, and federal regulations affecting the tobacco, hemp, and cannabis industries – including ancillary service providers. She brings extensive experience in the cannabis industry to her work in the tobacco, nicotine, and vapor space, giving her a deep understanding of the challenges and opportunities of launching new products and marketing campaigns in a shifting regulatory landscape.