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The Center for Tobacco Products (CTP) is a division of the U.S. Food and Drug Administration (FDA) responsible for regulating the tobacco industry. In 2022, a panel from the Reagan-Udall Foundation began a review of CTP's regulatory processes and agency operations and offered fifteen recommendations to improve its regulatory efforts across areas such as cross-cutting, science and application review, regulation and guidance, compliance and enforcement, public education campaigns, and resources.
We’ve already covered cross-cutting and science and application review in Part 1 of this article, click here to read it if you haven’t already. In this article we will cover regulation and guidance and compliance and enforcement.
Regulation and Guidance
The regulation and guidance related recommendations for CTP include actions to create a more effective approach to achieving regulatory review and enforcement goals. To achieve this, CTP will evaluate and redesign its current policy development program. Effective immediately, CTP will initiate the FDA hiring process to create a policy unit within the Office of the Center Director that will be responsible for providing overall policy coordination and issues management across CTP.
By the end of 2023, CTP will develop, publish, and maintain a comprehensive policy agenda of rules and guidances that are in development or planned for development. CTP will also solicit stakeholder feedback on potential rules and guidances related to the application review process, compliance and enforcement matters, and ways to increase efficiency during the application review process.
CTP will explore alternative approaches to increasing transparency and opportunities for stakeholder feedback, such as utilizing public meetings and advance notices of proposed rule-making. These actions are aimed at creating a more efficient and effective policy development program that aligns with CTP’s strategic plan.
Compliance and Enforcement
The Compliance and Enforcement related recommendations aim to enhance the enforcement of tobacco laws and ensure compliance with the regulations set by FDA.
The panel recommends the establishment of an interagency task force to prioritize enforcement of tobacco laws and address the marketing of illegal products and youth use. To achieve this, FDA plans to convene a summit with senior officials from various departments, including the U.S. Department of Health and Human Services (HHS) Office of General Counsel, FDA Office of the Commissioner, CTP, and the Department of Justice (DOJ).
The second compliance and enforcement related recommendation suggests considering statutory changes to streamline tobacco enforcement processes and increase consequences for violations. CTP will coordinate with relevant FDA and HHS offices and the administration to seek such changes from Congress.
CTP is also recommended to seek alternative approaches to achieving compliance outside of judicial enforcement actions through DOJ. CTP will explore approaches related to enforcement priorities and developing website content to encourage voluntary compliance with FDA's premarket requirements.
The fourth recommendation suggests enhancing communication to provide greater transparency on compliance and enforcement, including creating a searchable public database of all tobacco products that have an FDA marketing order.
Finally, the panel recommends ensuring that the work plan and goals for the Office of Compliance reflect any new priorities that the center adopts. The development of a new strategic plan for the Office of Compliance and Enforcement in alignment with CTP's new 5-year strategic plan has been initiated.
Want to learn more about the panel’s recommendations for CTP? Click here to check out Part 1 of this article and keep an eye out for Part 3 which will be posted soon!
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