By Brian King, Director of FDA’s Center for Tobacco Products
February 24, 2023
 
In September 2022, an independent expert panel facilitated by the Reagan-Udall Foundation began an operational evaluation of the Center for Tobacco Products (CTP) at the request of Food and Drug Administration Commissioner, Dr. Robert Califf. The final report was issued on Dec. 19, 2022, and included 15 recommendations across a number of areas. CTP welcomed the opportunity for the independent external review, and we are committed to addressing all the recommendations outlined in the report as expeditiously as possible. Importantly, implementation of some recommendations will take time, and others will require collaboration with several entities beyond CTP, including some groups outside FDA.

The following summarizes our approach to reviewing the recommendations, as well as the center’s responses and next steps. A more detailed description of CTP’s plan for addressing the recommendations, including our planned efforts to be proactive, may be accessed on our new webpage, Actions to Address Recommendations from the Reagan-Udall Evaluation of CTP. As the following illustrates, today’s announcement is just the first step of several we are taking to strengthen FDA’s tobacco program.

An All-Center Approach

Before receiving the report, a facilitated planning session was held with leadership from across CTP’s offices to develop a comprehensive, center-wide process for reviewing and assessing the recommendations. The process included the establishment of six task forces that would assess and develop responses to the report’s recommendations, including activities to address them and timing for implementation. The task forces were comprised of staff with subject matter expertise in each respective area, both from within CTP and across FDA. The task forces were organized into the following topic areas: cross-cutting, science and application review, regulation and guidance, compliance and enforcement, public education campaigns, and resources.

All CTP staff were given the opportunity to provide feedback on the center’s approach to addressing the recommendations. Specifically, in addition to convening task forces, we also held CTP-wide meetings and conducted a CTP-wide survey that asked staff about their thoughts on the report’s recommendations and any suggested activities in response to them. We received many valuable responses from staff across the center. The task forces reviewed the survey responses relevant to their topic area and considered this input while developing the response to the report recommendations.

An advisory council composed of senior FDA leadership was also created to provide consultation to the task forces.

Response to Recommendations

Cross-Cutting

Effective immediately, CTP will initiate the development of a comprehensive 5-year strategic plan, building upon the foundation of the center’s previous strategic plans. Given the profound impact of tobacco-related disparities across CTP’s programmatic portfolio, the plan will include advancing health equity as a central tenet and focus on being proactive in its activities.

Collecting internal and external feedback will be critical to inform the plan’s development. As noted in the report, being transparent about our key activities will ensure external stakeholders have a clear view of our plans going forward. Toward that end, we will be appointing internal transparency liaisons within each CTP Office, who will be responsible for objectively identifying areas for transparency enhancement, working with necessary personnel in their office to implement changes, and monitoring progress over time. We will also take immediate actions toward transparency; for example, a new webpage will feature the center’s responses to citizen petitions and we will resume posting scientific policy memos and reviewer guides when appropriate.

Additionally, we will share routine updates on the status of the strategic plan development process, and we intend to issue interim strategic goals by summer 2023. We anticipate soliciting stakeholder input on the plan by summer and intend to release the strategic plan to the public no later than December 2023.

Science and Application Review

CTP has made enormous progress in Premarket Tobacco Application (PMTA) reviews, although there is much work still to do; to date, the agency has made important progress in the review of e-cigarette products, authorizing several tobacco-flavored e-cigarette products and devices and rejecting marketing applications for millions of products that did not meet the requirements in the law. While CTP has always worked to ensure our reviews are based on science and supported by our regulations, there are opportunities to enhance efficiency of the PMTA review process.

The center has started developing a more efficient framework for high-quality tobacco product application reviews. Our goals are to work internally and through engagement with external stakeholders to better communicate on scientific issues and practices to support efficiency, effectiveness, and transparency; hire additional staff to enhance program management and implementation, including for application review; and increase internal communication to improve scientific engagement and deliberation. These efforts also include activities such as resuming posting of scientific policy memos and reviewer guides, when appropriate, so that applicants have greater insight into the regulatory review process, and communication through public events, such as workshops and listening sessions. We look forward to engaging more with our stakeholders to improve the application review process.

Going forward, CTP will hold more frequent meetings of the Tobacco Products Scientific Advisory Committee (TPSAC) to obtain input on scientific issues related to our regulatory authorities – with the next to be held by fall 2023 and the goal of holding one or more TPSAC meetings per year. CTP will also reassess and update our criteria for holding a TPSAC meeting and will also reassess and update criteria for other types of convenings to discuss scientific issues. The topics brought before TPSAC may include broader scientific matters central to premarket evaluation, as well as discussions of individual product applications. CTP will also ensure that the necessary internal infrastructure is in place to support increased use of TPSAC.

In tandem with these changes, as of late March, we will be happy to welcome a new Office of Science Director, Dr. Matthew Farrelly, who will lead the office into its next chapter. Together, we will strive toward improving the efficiency, effectiveness, and transparency of the application review process, as well as regularly engaging with stakeholders in the months ahead.

Regulations and Guidance

Since CTP’s inception in 2009, the center has published 16 final rules – an average of over one per year. We are also in the process of finalizing rules related to menthol cigarettes and flavored cigars. To support the public health goals of the Tobacco Control Act, CTP provides guidance to help industry understand and comply with legal requirements. To date, CTP has published 35 draft guidances and 50 final Level 1 guidances. Level 1 guidances set forth new, or more than minor changes to, interpretations or policies on regulatory issues.

As recommended in the report, effective immediately, CTP will initiate the FDA hiring process to create a new policy unit within the Office of the Center Director that would be responsible for providing overall policy coordination across CTP. To provide additional transparency, we will also develop, publish, and maintain a comprehensive policy agenda of rules and guidances that are in development or planned for development at the center. The center anticipates publishing the policy agenda by the end of the year, after evaluating our policy development program to ensure a more efficient approach to issuing regulation and guidance that meets our strategic priorities. Following the initial publication, CTP will update the policy agenda annually.

Compliance and Enforcement

Compliance and enforcement are an essential component of CTP’s programmatic portfolio, and we continue to look for opportunities to enhance these efforts. Since 2009, CTP has issued over 1,500 warning letters resulting from inspections and investigations of tobacco manufacturers, including vape shops, and online surveillance of websites operated by tobacco manufacturers and/or retailers for violating the law. Further, CTP has issued over 120,000 warning letters to brick-and-mortar tobacco retailers, and for repeated violations, issued over 27,000 civil money penalties and 220 no-tobacco-sale orders. For the first time, the Department of Justice (DOJ), on behalf of FDA, filed complaints for permanent injunctions against six e-cigarette manufacturers in October 2022; the complaints were filed for failing to submit premarket applications for their products and continuing to illegally manufacture their products, despite receiving a previous warning letter from FDA that they were in violation of the law. Earlier this week, CTP announced the center’s first civil money penalty complaints against manufacturers, which were issued to four manufacturers for manufacturing and selling e-liquids without marketing authorization after receiving a previous warning from FDA.

Recognizing opportunities to enhance our compliance and enforcement work, FDA will convene a summit related to enforcement with senior officials from the Department of Health and Human Services (HHS), FDA, and DOJ. FDA does not have independent litigation authority, and we therefore work with DOJ to inform our enforcement actions.

CTP will consider whether statutory changes are needed to assist the center in enforcing the law. If statutory changes are needed, CTP in coordination with relevant FDA and HHS offices and the administration, will seek such changes from Congress.

CTP will also explore alternative approaches to achieve compliance outside of judicial enforcement actions through DOJ. Approaches will include those related to enforcement priorities and developing additional website content to effectively educate industry and encourage voluntary compliance with FDA’s premarket requirements for new tobacco products. We also plan to continue activities with other government agencies and organizations in addition to DOJ to maximize enforcement and compliance activities.

CTP plans to be more transparent about its compliance and enforcement activities and its development of any new enforcement priorities. The center plans to create a comprehensive webpage for all enforcement activities for products that are illegally marketed without FDA authorization, routinely reach out to industry trade groups and other industry stakeholders to keep them apprised of the development of new enforcement priorities and updates, and enhance FDA’s Tobacco Product Marketing Order webpage. Planning has already begun for development of a searchable public database of all tobacco products that have an FDA marketing order.

Public Education Campaigns

Rooted in science, CTP’s tobacco public education campaigns are critical to our public health mission. Our award-winning public education campaign, “The Real Cost,” continues to prevent youth from tobacco initiation and use, including e-cigarettes; earlier this year, we released two new ads, including one that focuses on the negative mental health effects of cigarette smoking and withdrawal. Additionally, in 2022, we released a new youth e-cigarette prevention campaign, “Next Legends,” to educate American Indian and Alaska Native youth about the harms of e-cigarettes.

CTP has several longstanding ways in which we have sought engagement on our public education campaigns. However, we recognize there are always opportunities for continued improvement. With that goal in mind, CTP will develop, publish, and promote resources that describe the mechanisms we currently use to solicit and consider public input on our campaigns to ensure relevant stakeholders are aware of the many ways they may share their feedback with us.

We will also explore new ways for soliciting and considering public input on our campaign program. This includes input on formative research into messaging for adult smokers that nicotine – while highly addictive – is delivered through products that represent a continuum of risk.

Resources

CTP has a dedicated staff of more than 1,100 individuals who work tirelessly to achieve our center’s mission to reduce tobacco-related disease and death. CTP staff are the lifeblood of our successes, and it is essential that we have the resources and personnel necessary to achieve our mission.

Consistent with the report recommendation, we are also engaging with relevant entities within FDA, HHS, and the Office of Personnel Management to identify solutions to facilitate more timely and efficient hiring of qualified and diverse professionals that match CTP’s needs.

Additional user fees for all product types regulated by CTP, including for e-cigarettes, would help the center best achieve our mission, including allowing us to hire more staff to conduct product review and compliance and enforcement actions, among other activities. Since fiscal year 2020, CTP has pursued an additional $100 million in user fees for tobacco regulation in our annual budget that is adjusted annually for inflation, and authority to assess and collect user fees for e-cigarettes and all other regulated products.

Next Steps

The actions outlined in CTP’s response to the evaluation are a blueprint for action, and there is still much work to be done. While some of the report recommendations can be acted upon immediately, others will take time to fully plan and implement, but we are committed to incorporating the activities into CTP’s everyday workflow as expeditiously as possible. Toward that end, we are hard at work planning the timing and prioritization of each activity.

As we move ahead, we remain unwavering in our commitment to transparency regarding our plans and progress – which was an overriding point made across the evaluation report. We are committed to providing routine updates in numerous ways, including quarterly updates to the new website, additional statements from CTP leadership, and other topic-specific announcements. An integral part of this transparency will be stakeholder engagement. I encourage you to check the newly developed webpage for our latest updates and opportunities for engagement.

In closing, I want to unequivocally reinforce that while CTP is committed to implementing these activities as expeditiously as possible, it will not be at the expense of continued progress on our standard portfolio of activities, as implementation of the recommendations will ultimately strengthen these activities. As always, we will be driven by strong science, health equity, stakeholder engagement, and transparency. I am proud to be at the helm of CTP during this critical juncture in its history and look forward to optimizing our efforts to best meet the center’s mission of protecting Americans from tobacco-related disease and death.