Key Takeaways

• An independent external evaluation conducted by the Reagan-Udall Foundation contained 15 recommendations aimed at strengthening the Tobacco Program’s regulatory processes and operations.
• The Center for Tobacco Products (CTP) has adopted an “All-Center Approach” that consists of six task forces, each designed to address specific recommendations from the evaluation.
• The response notes that implementation of all recommendations will not be immediate. Some will require collaboration with entities beyond CTP and the Food and Drug Administration (FDA), and others will be gradual and take time.

FDA Commissioner Robert M. Califf, MD, MACC, released a statement on Feb. 24, 2023, announcing next steps the FDA’s CTP plans to take in response to an external evaluation conducted by the Reagan-Udall Foundation. Califf commissioned the external evaluation in September 2022 to analyze the entirety of the Tobacco Program’s operations. The final report contained 15 recommendations stretching across all areas and aimed at strengthening the program by improving communication, transparency and efficiency. In response, CTP adopted an “All-Center Approach” consisting of six distinct task forces designed to address each recommendation and issued a summary of next steps. The response notes that implementation of all recommendations will not be immediate. Some will be gradual and take time, while others will require collaboration with entities beyond CTP and FDA.

Cross-Cutting

Effective immediately, CTP will begin development of a comprehensive five-year strategic plan to be released by the end of the year. CTP will source internal and external feedback to develop the plan, which will focus on advancing health equity, improving transparency and encouraging proactivity by the agency.

Science Application Review

The center announced plans to enhance efficiency and transparency of the application review process. In order to accomplish this, CTP will increase use of and collaboration with the Tobacco Products Scientific Advisory Committee to obtain input on scientific and policy issues. Additionally, CTP will develop a clear and predictable framework for application submission and reviews by improving communication with external stakeholders through community workshops, listening sessions and posting of scientific policy memos and reviewer guides, as well as by hiring additional personnel responsible for program management, implementation and application review.

Regulations and Guidance

As recommended in the evaluation, CTP will immediately initiate the hiring for a new policy unit within the Office of the Center Director that would be responsible for providing overall policy coordination across CTP. Furthermore, by the end of the year, CTP will develop and maintain a comprehensive policy agenda of rules and guidance that are in the process of development or planned for development and will be updated annually.

Compliance and Enforcement

The agency highlighted its renewed compliance and enforcement plans. CTP will continue to work with government agencies such as the Department of Justice; U.S. Customs and Border Protection; the U.S. Postal Service; Federal Trade Commission; and Bureau of Alcohol, Tobacco, Firearms and Explosives; as well as with other partners at the state/local/territorial/tribal levels to maximize compliance and enforcement activities where there are shared interests and jurisdictions. The FDA will also explore alternative approaches to achieve compliance outside of judicial enforcement actions and improve transparency regarding priorities and activities.

Public Education Campaigns

As suggested by the evaluation, CTP will explore new ways for soliciting and considering input on its public education campaigns, including research with target audiences, discussions with stakeholders and analysis of social media efforts.

Resources

Consistent with the report’s recommendations, CTP will seek to hire additional staff in a more timely and efficient manner to manage the vast workload. Additionally, the Center will continue to seek authority to collect user fees for all products it regulates. This would allow CTP to hire more staff to conduct product reviews and issue compliance and enforcement actions, among other activities.

CTP plans to enhance and increase its public communications to provide greater transparency about its approach to compliance and enforcement. By this spring, it plans to begin posting content to a new comprehensive webpage for all enforcement activities, which will include a searchable public database of all tobacco products that have an FDA marketing order, to discourage the sale of illegal products. Additionally, CTP plans to conduct more public meetings and workshops, as well as provide further information regarding the application review process.

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