The Food and Drug Administration’s Center for Tobacco Products on Monday released its new five-year strategic plan. The plan outlines goals for the agency, including ensuring timely, clear and consistent product application review and strengthening the compliance of regulated industry using all available tools and robust enforcement actions.
CTP Director Brian King announced in February the department was working on the plan, following the recommendation from the Reagan-Udall Foundation. In December 2022, the foundation released a report with 15 recommendations for the CTP to follow, including developing a clearer framework for premarket tobacco product application (PMTA) reviews, providing greater transparency about its approach to compliance and enforcement, creating the new strategic plan and more.
The CTP’s strategic plan includes a new vision statement for the organization: “To make tobacco-related death and disease part of our nation’s past by ensuring a healthier future and advancing health equity for those living in the United States.”
It also states its mission is to “protect the public health of the U.S. population from tobacco-related death and disease by comprehensively regulating the manufacture, distribution and marketing of tobacco products; educating the public, especially youth, about the dangers of using tobacco products; and promoting and supporting strategies that ensure an equitable chance at living a healthier life for everyone.”
The plan outlines five goals, each of which include outcomes and objectives. Those 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.
- Advance operational excellence.
“Woven throughout this programmatic work is an unwavering commitment to advance four key overarching themes that are common to all the goals of the strategic plan: science, health equity, stakeholder engagement, and transparency,” King said in a statement announcing the plan.
As part of the first goal, the CTP said it will develop a cohesive regulation and guidance agenda that will be updated annually, and will continue to craft regulations and guidance that maximize public health benefits and promote industry compliance.
The CTP also committed to leveraging experience gained from reviewing PMTAs for millions of products, most of which were electronic nicotine delivery systems (ENDS), to make enhancements to the review processes that will foster greater accountability and transparency, it said. This includes advancing its tobacco regulatory science program to further support evidence-based decision making.
Another item of note to tobacco manufacturers and convenience-store retailers, the CTP aims to continue to identify manufacturers, distributors, retailers and importers who fail to comply with the law. Protecting the public from violative products is fundamental to CTP’s mission and requires vigilant surveillance and rigorous enforcement, the plan said. The FDA has been cracking down on flavored disposable vape products that are being sold illegally in the United States.
CTP will strive to ensure transparency regarding enforcement policies, it said. This includes developing a digital strategy for publicizing certain tobacco enforcement information and helping to facilitate public presentation of those tobacco products that are legal to sell through the development of a searchable public database of all tobacco products that have an FDA marketing order. Organizations, including the National Association of Convenience Stores (NACS) have previously asked the FDA for this list.
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