Improving Tobacco Regulations: Recommendations for FDA’s CTP – Part 1
Updated: Jul 17
The Center for Tobacco Products (CTP) is a division of the U.S. Food and Drug Administration (FDA) that regulates the manufacturing, marketing, and distribution of tobacco products in the country. In September 2022 a panel from the Reagan-Udall Foundation began a review of CTP as requested by the FDA Commissioner, Dr. Robert Califf. They reviewed CTP’s regulatory processes and agency operations relating to regulations and guidance, application review, compliance and enforcement, and communication with the public and other stakeholders.
The panel offered fifteen recommendations related to CTP’s regulatory efforts, including cross-cutting, science and application review, regulation and guidance, compliance and enforcement, public education campaigns, and resources. In this article we will cover cross-cutting and science and application review.
One of the areas the panel provided recommendations for was cross-cutting issues. Among these recommendations were three important actions. First, the panel suggested that CTP should create and implement a strategic plan to position itself for the future and address current challenges in a more proactive manner. CTP will initiate the development of a comprehensive 5-year strategic plan that will include robust internal and external engagement during its development.
Second, the panel advised that CTP should obtain public input about the strategic plan, objectives, and metrics. As part of the strategic planning process, CTP will implement a robust external engagement plan to obtain public input on the strategic plan.
Third, the panel recommended that CTP should improve the overall transparency of the tobacco program, particularly with respect to the regulatory process and its scientific underpinnings. To achieve this, CTP will develop an operational strategy that facilitates a culture of enhanced transparency and information sharing, both internally within CTP and externally with stakeholders and the public.
Science and Application Review
The science and application review related recommendations are aimed at improving the efficiency and effectiveness of CTP’s regulatory processes.
The first recommendation, to increase the use of the Tobacco Products Scientific Advisory Committee (TPSAC), calls for greater input from scientific experts on regulatory issues. To achieve this, CTP will work to hold more TPSAC meetings, reassess criteria for holding meetings, and ensure internal infrastructure supports TPSAC's use.
The second recommendation seeks to develop a clear and predictable framework for premarket tobacco product application (PMTA) and modified risk tobacco product (MRTP) application submission and reviews. CTP will undertake several actions, including hiring more staff and conducting a public meeting, to improve communication with stakeholders and make the review process more efficient.
The final recommendation encourages CTP to clarify its process for premarket reviews, including by providing additional information and exploring options for more flexible reviews. By implementing these recommendations, CTP aims to enhance its scientific review and regulatory processes, ultimately improving public health outcomes.
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