CTP’s Progress Addressing Recommendations from the Reagan-Udall Evaluation

By Brian King, Director of FDA’s Center for Tobacco Products
October 27, 2023

The Center for Tobacco Products (CTP) continues to make progress to address the recommendations arising from last year’s independent operational evaluation conducted by an expert panel facilitated by the Reagan-Udall Foundation (RUF). Since I shared our plans to respond to the evaluation in February, CTP has made considerable progress in meaningfully addressing the recommendations. The center provided an initial update on our progress in June, and I’m pleased to provide our latest accomplishments below. A comprehensive list of status updates for each recommendation is also available at the updated Actions to Address Recommendations from the Reagan-Udall Evaluation of CTP webpage.

Cross-Cutting

The development of a new strategic plan is a key priority for the center, and we are on track to release the final plan by December 2023. Over the past several months, we have continued to work with our colleagues in the FDA Office of Operation’s Office of Planning, Evaluation, and Risk Management to develop the plan and solicit internal and external input.

As part of an iterative, center-wide process, CTP developed proposed goal areas for the strategic plan with four proposed cross-cutting themes: science, transparency, stakeholder engagement, and health equity. All CTP staff were given opportunities to provide feedback on the strategic plan, including the proposed goals and cross-cutting themes.

In July, CTP published a Federal Register notice to solicit comments on the development of the strategic plan and shared the five proposed strategic goals and cross-cutting themes. Over 2,400 comments were submitted to the Federal Register docket.

Additionally, a public listening session was held on Aug. 22. Over 550 people attended the listening session and 59 people provided a verbal public comment. For those that missed the session, we posted a video recording and transcript on FDA's Listening Session: Developing FDA’s Center for Tobacco Products’ Strategic Plan webpage.  

The center is currently reviewing and considering these comments as we finalize the strategic plan. I look forward to sharing the final strategic plan by the end of this year, which will outline the center’s programmatic and workforce initiatives for the next five years. 

Science and Application Review

To date, the center has received applications for more than 26 million deemed products and has made determinations on 99 percent of these applications. This includes completing acceptance review of 100 percent of the non-tobacco nicotine applications received by May 2022. CTP continues to make progress reviewing the considerable volume of applications that have been submitted in recent years. We are committed to making determinations on the remaining applications as expeditiously as possible, while ensuring the decisions are scientifically accurate, legally defensible, and aligned with the premarket authorization authorities granted by Congress.

CTP also continues to develop resources and engage with stakeholders to better communicate on scientific issues and practices to support efficiency, effectiveness, and transparency in premarket application review. Earlier this week, the center hosted a public meeting on the premarket tobacco product application process on the FDA White Oak Campus in Silver Spring, Maryland. There was also a virtual attendance option for those unable to join in person. CTP’s Office of Science staff shared information and answered questions on various topics related to premarket review. We look forward to further engaging with stakeholders related to tobacco product application processes.

In addition to public engagement, the center has continued to develop resources for those submitting premarket applications. In September, CTP launched the FDA Tobacco Product Application Tips webpage, which includes in-depth information on how to complete and submit the PMTA forms. We also launched a validator tool that enables applicants to verify the data they have included in Form FDA 4057b and make necessary corrections before submitting an application. CTP is hopeful this voluntary tool helps minimize the chances of application rejection and reduce potential delays in application processing.

The Office of Science has also hired dedicated coordinators, for both the premarket tobacco application (PMTA) and substantial equivalence (SE) pathways, who are focused on the continued development and refinement of program priorities, setting goals, and coordinating implementation across the office. Additional staffing resources have been focused on improving transparency, stakeholder engagement, and communications, including developing and implementing a plan to post scientific memos and reviewer guides, when appropriate.

Regulations and Guidance

CTP is in the process of finalizing the final rules regarding menthol as a characterizing flavor in cigarettes and characterizing flavors (other than tobacco) in cigars. Final regulations such as these go through an extensive rulemaking process that requires considerable time and effort. The final rules were submitted to the White House Office of Management and Budget (OMB) in October 2023. Finalizing these two product standards remains a top priority for the FDA. The center also continues work toward publishing a proposed rule that would establish a maximum nicotine level to reduce the addictiveness of cigarettes and certain other combusted tobacco products. As appropriate, CTP will continue to provide updates on the status of the rulemaking process. 

The center is also making progress toward the creation of a policy unit within CTP’s Office of the Center Director. The center recently advertised nationwide for the position of Associate Director for Policy and Partnerships. This position will be responsible for providing overall policy coordination and issues management across CTP and will lead the policy unit within the Office of the Center Director. This job opening closed in mid-September and we have initiated the application review process.

Compliance and Enforcement

As the center has made abundantly clear through our ongoing and escalating compliance and enforcement actions, we will continue to use the full scope of our authorities, as appropriate, to hold those who break the law accountable. CTP will take swift action to curb the sale of illegal tobacco products, especially those that appeal to youth.

Since my previous update in June, the center has taken multiple significant actions against those making, distributing, importing, or selling illegal e-cigarette products. This summer, CTP issued warning letters to three distributors, 15 online retailers, and three manufacturers and/or distributors for selling multiple illegal youth-appealing e-cigarette products. CTP also announced the issuance of 168 warning letters to brick-and-mortar retailers for illegally selling youth-appealing e-cigarettes. These warning letters were the result of a coordinated nationwide retailer inspection effort conducted throughout the month of August. In August, we also issued warning letters to 15 online retailers selling illegal e-cigarette products packaged to look like youth-appealing characters, school supplies, toys, and drinks. In September, CTP issued complaints for civil money penalties (CMPs) seeking the highest monetary penalty levied to date against 22 retailers for the illegal sale of youth appealing e-cigarettes.

In addition to the actions CTP has taken to curb the sale of illegal tobacco products, we are prioritizing continued collaboration with our federal partners. In July, senior officials from the U.S. Department of Health and Human Services (HHS) Office of General Counsel (including FDA’s Office of the Chief Counsel), FDA Office of the Commissioner, CTP, and the Department of Justice (DOJ) met to continue ongoing discussions and close collaboration on issues related to enforcement. Center staff have also established recurring meetings with the Bureau of Alcohol, Tobacco, Firearms and Explosives and are collaborating on a case-by-case basis with the Tobacco Tax and Trade Bureau.

Information about our latest actions is routinely updated on the Advisory and Enforcement Actions Against Industry for Unauthorized Tobacco Products webpage. We are working to finalize additional website content that will further outline and describe the compliance and enforcement process related to the manufacture, distribution, and sale of unauthorized tobacco products. The center is also continuing to work on a centralized searchable public database of all tobacco products with a marketing order, with the center awarding an information technology contract for this work in July. FDA also recently created a list of authorized e-cigarette products in a printable, 1-page flyer. Both the database and the flyer are compiled from existing information on FDA’s website, including the Tobacco Products Marketing Orders page, and aim to improve the presentation of this information.

Public Education Campaigns

Throughout the years, CTP’s award-winning public education campaigns have had a significant impact on preventing youth tobacco product use, including e-cigarettes. Our commitment to extensive message testing and research with various audiences remains critical to the development and success of these campaigns.

The center also continues to solicit input on our campaigns, including from the general public. We are currently finalizing updates to the public education webpages that will share information documenting the importance of, and opportunities to provide input into, CTP’s campaign program. When ready later this fall, we will share this information in a variety of ways, including through public presentations and on the center’s social media channels.

As I noted in a commentary published in the scientific journal Addiction, opportunities exist to educate adults who smoke about the relative risks of tobacco products, including e-cigarettes. In August, the National Institutes of Health (NIH), in coordination with CTP, published a funding opportunity for research on the continuum of risk for tobacco products. The funded project will use health communication research to better understand the impact that messaging about the continuum of risk for tobacco products may have on various segments of the population, including both intended and unintended audiences. However, as noted in the aforementioned commentary, research and message testing are critical. It’s also necessary to note that any adult education efforts should be accompanied by efforts to prevent youth tobacco product use, encourage first-line use of FDA-approved cessation therapies, and for adults who smoke and choose to use e-cigarettes, reinforce the importance of completely transitioning to e-cigarettes.

Resources

The critical work that CTP does each day would not be possible without our greatest resource: our staff. The center continues to support the development of our workforce by advancing operational enhancements that align with the RUF recommendations. CTP continues to use a new interagency agreement with the Office of Personnel Management (OPM) to evaluate position descriptions. Through this agreement, we are expeditiously reviewing position classifications to reduce hiring delays. The center is also working steadfastly to establish an additional interagency agreement with OPM to assist with hiring by posting job announcements and evaluating applicants. CTP expects to have this interagency agreement in place by the end of 2023. Since the last update, CTP has also been in discussions with OPM and HHS to secure direct hire authority for the center, which would allow CTP to hire qualified candidates more quickly for critical positions; this authority, which the center previously had from October 2019 to October 2021, was granted in October 2023.

We also continue to provide briefings to key stakeholders, including Congress, about a potential framework for securing user fees for all products CTP regulates; this would include e-cigarettes, for which the center does not currently have authority to collect user fees to support the regulation of this product category. Consistent with the president’s fiscal year (FY) 2024 budget, CTP is requesting an additional $100M in user fees, indexed for inflation, and authority to include all deemed products among the tobacco classes for which FDA assesses and collects tobacco user fees.

Next Steps

I am proud of CTP’s significant accomplishments in the eight months since sharing our “all-center” approach to responding to the RUF evaluation. Some of the planned actions require more time, and contributions outside of the center, than others, but we continue to make strides in all areas to put our blueprint into action. I am also optimistic about the initiatives anticipated over the next several months, including the release of a new strategic plan.

For more detailed information about all of our progress, including planned actions and status updates, I encourage you to visit our webpage, Actions to Address Recommendations from the Reagan-Udall Evaluation of CTP.