On December 18, 2023, Dr. Brian King, the Director of FDA’s Center for Tobacco Products announced the Center’s new five-year strategic plan which outlines the Center’s programmatic and workforce initiatives and includes five goals, ten outcomes, and several corresponding objectives.
The new strategic plan incorporates recommendations from the Reagan-Udall Foundation report published in December 2022. The Reagan-Udall Foundation report provided fifteen recommendations for CTP which included improving transparency regarding the Center’s approach to Premarket Tobacco Product Application (PMTA) reviews and compliance and enforcement. The report highlighted industry concerns with the CTP’s framework for approaching PMTA reviews, particularly after FDA issued Refuse To Accept (RTA) letters, Refuse to File (RTF) Letters, or Marketing Denial Orders (MDOs) for millions of deemed tobacco products. The five-year plan seeks to address the issues of transparency, enforcement, and education.
The five goals are:
- Develop, advance, and communicate comprehensive and impactful tobacco regulations and guidance;
- Ensure timely, clear, and consistent product application review;
- Strengthen compliance of regulated industry utilizing all available tools, including robust enforcement actions;
- Enhance knowledge and understanding of the risks associated with tobacco product use; and
- Advance operational excellence.
To achieve these goals, CTP plans to develop and implement several guidance documents to ensure that regulations are clear and accessible. Furthermore, CTP will develop new processes to review PMTA efficiently and to communicate the review process and marketing decisions transparently. CTP also plans to pursue more robust enforcement actions by collaborating with other federal and state agencies.
CTP highlighted the importance of promoting education surrounding the risks of tobacco product use, particularly for preventing youth initiation, and educating adults on the benefits of cessation, including the relative risks of different tobacco products. The fifth and last goal regards CTP’s operational goals by supporting its workforce and operating efficiently.
In conjunction with this strategic plan, CTP also published the Center’s policy agenda of rules and guidance documents. The policy agenda provides guidance documents in development, including current and long-term priorities for the Center.
The Center’s current priorities include:
- Tobacco Product Standard for Menthol in Cigarettes;
- Tobacco Product Standard for Characterizing Flavors in Cigars;
- Tobacco Product Standard for Nicotine Level of Certain Tobacco Products;
- Prohibition of Sale of Tobacco Products to Persons Younger Than 21 Years of Age;
- Administrative Detention of Tobacco Products; and
- Requirements for Tobacco Product Manufacturing Practice.
The ultimate goal of the strategic plan is to reduce harm caused by tobacco product use and to work with regulated industries in a manner that demonstrates a commitment to science, health equity, stakeholder engagement, and transparency.
