The Food and Drug Administration’s Center for Tobacco Products (“CTP”) has released a strategic plan intended to guide the Center’s activity for the next five years. While the strategic plan highlights the laudable goals of regulatory clarity, stronger enforcement against non-compliant actors and more timely and transparent application review, the plan is problematic in that it promotes an agenda of burdensome new regulations and does not provide a clear emphasis on the promotion of less harmful alternatives in the tobacco and nicotine marketplace.  

The creation of a strategic plan is part of CTP’s efforts to improve its effectiveness. In 2022 and 2023, at the request of FDA commissioner Robert Califf, an independent, FDA-focused organization known as the Reagan-Udall Foundation undertook an investigation of CTP with the goal of issuing recommendations to enhance its operations. The Foundation’s final report included a recommendation that FDA create a strategic plan that “identifies the Center’s strategic objectives and plots an operational roadmap of the steps CTP will take over the next five years to achieve those objectives.” In furtherance of the creation of the strategic plan, FDA solicited public comments and held a listening session regarding the plan in the summer of 2023.

The final plan is aimed at reducing the “negative health effects caused by tobacco use by ensuring a well-regulated marketplace, preventing people from starting to use tobacco products, encouraging people who use tobacco products to quit, and reducing the harm caused by tobacco product use.” The strategic plan’s five overarching goals are as follows:

  1. Develop, Advance, and Communicate Comprehensive and Impactful Tobacco Regulations and Guidance
  • As part of this commitment, CTP seeks to fully implement existing regulations and guidance documents but also to develop a cohesive regulation and guidance agenda that will be updated annually.
  • Going forward, CTP will continue to develop and issue additional guidance documents and regulations that address premarket requirements, registration and listing, tobacco product testing, and compliance.
  • In conjunction with this goal, CTP has published a policy agenda of rules and guidance documents that are in development or planned for development.  We will provide a separate analysis of these regulatory priorities, but our take is that the primary objective of the agenda appears to be the introduction of a plethora of extremely burdensome new regulations, including caps on nicotine levels and flavor bans, that will have a devastating impact on industry.

2. Ensure Timely, Clear, and Consistent Product Application Review

  • CTP indicates that this goal includes developing “further information for the public and regulated industry about how the ‘appropriate for the protection of public health’ standard is evaluated.”
  • CTP here also identifies that it intends to ensure that “the most robust and reliable science informs regulatory and product review decision-making,” by ensuring that the Center is funding and conducting research to fill any knowledge gaps. Interestingly, the report does not mention efforts to evaluate and consider existing research or research that might be funded and/or conducted by industry or other parties.
  • All stakeholders agree that CTP must more efficiently and transparently review premarket applications using the best available science.  As they say, “the devil is in the details,” and our take is that CTP has significant room for improvement in this area given the extremely slow place of application review (in many cases, more than three years) and CTP’s unpredictable and shifting review standards over the last few years.

3. Strengthen Compliance of Regulated Industry Utilizing All Available Tools, Including Robust Enforcement Actions

  • As part of this goal, CTP says it will “help to facilitate public presentation of those tobacco products that are legal to sell through the development of a searchable product database of all tobacco products that have an FDA marketing order.”

  • CTP notes that while it focuses on obtaining voluntary compliance from the industry, it remains “firmly committed to aggressive enforcement of the law and pursuing enforcement actions against manufacturers, distributors, importers, and retailers for violating the law.” CTP notes that it will continue to seek civil money penalties and injunctions when manufacturers continue to violate the law after receiving a warning letter. Last year saw an increase in such actions for FDA, and it appears industry can continue to see similar enforcement efforts across the country in 2024.

  • CTP also notes that it will continue to coordinate and work with U.S. Customs and Border Protection and the U.S. Postal Service to enhance import screening, surveillance, and enforcement “to better prevent violative tobacco products from entering the United States.”

  • Our take is that, while CTP has made progress in enforcement against noncompliant actors, there remains room for significant improvement.  CTP should more timely follow up on warning letters; currently CTP typically takes a year or more to follow up on warning letters.  We agree that FDA should bolster enforcement at the U.S. border, including through broader use of FDA Import Alerts, under which specific products or entire companies’ products, are automatically detained at the border.

4. Enhance Knowledge and Understanding of the Risks Associated with Tobacco Product Use

  • While we hoped this goal referred to CTP enhancing its own knowledge about the risks associated with novel tobacco products, the goal is instead focused on public education campaigns, particularly directed towards young people.
  • CTP does, however, note that it will educate adults who use tobacco products about the relative risks of different products using a “data-driven approach.” These educational efforts will apparently be driven by research seeking to understand “the continuum of risk, relative risk perceptions, and modified risk products among adults who use tobacco and other population groups.”
  • As CTP operationalizes this goal, we hope that it results in the promotion of less harmful alternatives, including through the authorization of more reduced-risk products.

5. Advance Operational Excellence 

  • This goal focuses on attracting and retaining a highly qualified, inclusive, and high-performing workforce within CTP. CTP states that it will place greater emphasis on “workload management, career development, succession planning, and employee compensation and recognition programs.”
  • CTP also commits to accountability and responsibility of its financial resources, and other improvements to its internal operations.

Notably, the five overarching goals are the same ones announced by the Center when it opened the public comment period on the strategic plan. We previously remarked that no overarching public health goal is identified, especially not a goal to promote development of less harmful alternatives. This was a departure from FDA’s 2017 roadmap which sought to “strik[e] an appropriate balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes.” At that time, FDA placed emphasis on “envisioning a world where… adults who still need or want nicotine could get it from alternative and less harmful sources.” This latest strategic plan places more emphasis on public communication of existing policy rather than tailoring the Center’s activity to the reality of the harm reduction continuum. The strategic plan is also missing recommendations from the Reagan-Udall Foundation report, including:

  • Characterizing the critical scientific questions that must be answered for effective operation of the tobacco program and define the specific research needed to resolve them, including who is best positioned to conduct the necessary research.
  • Acknowledging where gaps in the data exist in making policy judgments (such as the Center’s harm reduction posture).

Our take on this is that CTP’s strategic plan leaves little in its goals to distinguish it from the Centers for Disease Control or any other health agency, calling into question its strategic relevance under the framework originally set up by the Tobacco Control Act.  The lack of any focus on promoting reduced harm tobacco and nicotine products is a huge lost opportunity.  Nonetheless, compliant industry actors are sure to appreciate the Center’s focus on enforcement against noncompliant actors and efforts to clarify the “appropriate for the public health” standard. Also noteworthy is the mention of a public database of lawful new tobacco products. As the year progresses, our team will be monitoring the Center’s progress towards these goals.

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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.