Our team has previously written about the Food and Drug Administration’s (FDA) response to the Reagan-Udall Foundation report on the Center for Tobacco Product’s operations. If you missed our prior posts, check them out at the links below:
- Reagan-Udall Foundation Recommends Improvements to the FDA’s Center for Tobacco Products
- FDA Responds to Reagan-Udall Foundation Report
- Inside FDA’s Response to Reagan-Udall Foundation Report: Spotlight on the Science and Application Review Task Force
- Inside FDA’s Response to Reagan-Udall Foundation Report: Spotlight on the Cross-Cutting and Regulation and Guidance Task Forces
- Inside FDA’s Response to Reagan-Udall Foundation Report: Spotlight on the Public Education Campaigns and Resources Task Forces
On June 29, Dr. Brian King, director of the Center for Tobacco Products (CTP) at the FDA, issued an update on CTP’s efforts to address the 15 recommendations outlined in a report by an independent expert panel facilitated by the Reagan-Udall Foundation. Although he acknowledged that “implementation is no small task,” Dr. King said CTP has “already made significant strides” in implementing its plans to respond to the Reagan-Udall report.
Dr. King’s progress update lacked blockbuster news, but he did highlight several notable developments and upcoming opportunities for public engagement. In our view, the most significant updates concerned CTP’s new strategic plan, upcoming opportunities for engagement, new webpages, and news of user fees for all deemed tobacco products.
Five-Year Strategic Plan
Dr. King said he expects CTP to issue a finalized five-year strategic plan by December. To that end, on July 21, CTP published a list of the agency’s five proposed strategic goals, which include:
- Developing, advancing, and communicating comprehensive and impactful tobacco regulations and guidance;
- Ensuring timely, clear, and consistent product application review to protect public health;
- Ensuring compliance of regulated industry and tobacco products utilizing all available tools, including robust enforcement actions;
- Improving public health by enhancing knowledge and understanding of CTP tobacco product regulation and the risks associated with tobacco product use; and
- Advancing operational excellence.
Notably absent from this list of goals is any overarching public health goal, purpose, or endgame — for example, encouraging development of less harmful alternatives. FDA’s press release for its 2017 plan, by contrast, emphasized “striking an appropriate balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes.” Stakeholders can provide feedback on this and other aspects of CTP’s proposed goals in a virtual listening session on August 22. Note that requests to provide public comment on the strategic plan are due by August 14.
Upcoming Opportunities for Engagement
In his update, Dr. King noted that there will be several opportunities to engage with CTP this fall, including:
- Meeting Regarding Application Review – CTP is planning to hold a public meeting in fall 2023 to discuss the application review process for new tobacco products.
- Conference Presentations – CTP will present at the Tobacco Science Research Conference in Norfolk, VA (September 24-27) and the Cooperation Centre for Scientific Research Relative to Tobacco Smoke-Techno Conference in Cancun, Mexico (October 8-12).
- Meetings and Potential Invitation for Comments on Policy Agenda – CTP expects to publish a policy agenda by December and plans to seek stakeholder input during public meetings and through a Federal Register
Dr. King highlighted several new webpages rolled out by CTP in recent months, with more to come. New and updated sites include:
- Citizen Petition Webpage – CTP created a webpage that allows the public to easily access and view tobacco product-related citizen petitions.
- Requesting a CTP Speaker – CTP updated the Requesting a CTP Speaker webpage to provide a list of Dr. King’s presentations and information on how to request a copy of his slide decks.
- Compliance and Enforcement – CTP created a new webpage to allow the public to track its compliance and enforcement efforts. We note that the webpage shows that CTP continues to rely primarily on the issuance of warning letters, although it has issued 16 civil money complaints and, through the Department of Justice, secured six injunctions.
- Marketing Order Database – Building upon its Tobacco Product Marketing Orders webpage, CTP is developing a searchable public database of all tobacco products with a marketing order from FDA. It is unclear when this database will be published.
- Public Education Webpages – CTP anticipates updating its public education campaigns webpage by fall 2023 and publishing opportunities for providing public feedback. An area that has been sorely lacking in recent public health campaigns includes information regarding the relative risk of tobacco products and tobacco harm reduction. CTP’s update signals that the agency is continuing to research potential messaging approaches along these lines, but more definitive information is not yet available.
User Fees for All Tobacco Products
FDA is also trying to impose user fees on all deemed tobacco products, including electronic nicotine delivery systems, or e-cigarettes. Currently, FDA assesses and collects tobacco user fees from domestic manufacturers and importers of cigarettes, snuff, chewing tobacco, roll-your-own tobacco, cigars, and pipe tobacco. Dr. King noted that President Biden’s fiscal year 2024 budget sought an additional $100 million in user fees, indexed for inflation, as well as authority to include all deemed products among the tobacco classes for which FDA assesses and collects tobacco user fees.
Be sure to subscribe to our Tobacco Law Blog to stay up to date on new developments at CTP, including its continuing efforts to respond to the Reagan-Udall report.