On this page:
- Background: Reagan-Udall Foundation (RUF) Evaluation
- CTP's Review of the Evaluation Report
- Recommendations, Actions, and Status Updates
In September 2022, per the request of the FDA Commissioner, Dr. Robert Califf, an independent expert panel facilitated by the Reagan-Udall Foundation began an operational evaluation of the agency’s Center for Tobacco Products (CTP). The evaluation’s goal was to help ensure that CTP has the tools to address today’s challenges as it works to prevent tobacco use among youth and to reduce tobacco-attributable death and disease.
The evaluation assessed processes and operations related to several topic areas within CTP’s portfolio, including:
- Regulations and guidance,
- Application review,
- Compliance and enforcement, with a focus on efforts to remove illegal products from the market, and
- Communication with the public and other external stakeholders.
The final report from the operational evaluation’s independent expert panel included 15 recommendations, which were released on December 19, 2022. Subsequently, CTP was charged by the Commissioner with leading the agency’s response to the recommendations, including developing a plan to meaningfully address the report’s findings and recommendations.
The approach used by CTP to review and respond to the evaluation recommendations was described in a statement released by the CTP Director. In brief, in January 2023, CTP convened six distinct task forces to address the recommendations, which were led by relevant center leadership for the topic area of focus. The task forces were comprised of agency staff with relevant subject matter expertise for each topic area, both across CTP and in other relevant FDA offices.
The task forces included:
- Science and Application Review
- Regulation and Guidance
- Compliance and Enforcement
- Public Education Campaigns
To ensure broad CTP staff engagement beyond just those serving on the task forces, a survey was sent to all CTP staff to seek their input on the report findings and actions to address the recommendations. The staff input was shared with the relevant task forces. The task forces convened throughout January 2023, during which they deliberated over actions to address the recommendations.
CTP welcomed the opportunity for the evaluation and appreciates the work of the independent expert evaluation panel. CTP is committed to addressing all 15 recommendations in the report as quickly as possible. Implementation of some recommendations will take time and others will require collaboration, including with federal partners outside FDA. Therefore, some activities will take longer to be initiated or completed. But regardless of whether these planned actions are immediate or long-term, CTP will continue to provide public updates on progress in achieving them.
Information on the status of CTP activities to address each recommendation are provided below, by topic area. The recommendation numbers correspond to those in the panel’s report. These activities will be updated routinely to reflect CTP’s latest progress.
The statements below by CTP Director Brian King summarize all actions and status updates that have been completed by a specific date.
To view current progress on each recommendation, please review the sections below.
To address today’s challenges and position itself for the future, CTP must pivot from a reactive mode to a proactive mode. CTP must invest the time, now, with staff and public input, to create and implement a strategic plan that identifies CTP’s strategic objectives and plots an operational roadmap of the steps CTP will take over the next five years to achieve those objectives.
- Effective immediately, CTP will initiate the development of a comprehensive 5-year strategic plan that will include robust internal and external engagement during its development, including the issuance of interim strategic goals by summer 2023. Development will begin by February 2023, with an anticipated release date of the comprehensive strategic plan no later than December 2023. The development of the strategic plan will include consideration of all the specific sub-components suggested by the evaluators, as well as elements to advance health equity.
- A new 5-year strategic plan is currently in development and is on track to be released by December 2023. The development of the strategic plan is being facilitated by a team from the FDA Office of Operation’s Office of Planning, Evaluation, and Risk Management.
- In July 2023, CTP shared five proposed goal areas for the strategic plan that were shaped by staff and leaders from across the center. These goal areas were accompanied by four proposed cross-cutting themes: health equity, science, transparency, and stakeholder engagement.
CTP should obtain public input during the development of the strategic plan and communicate with stakeholders and the public about CTP’s strategic objectives as well as key messages, and metrics for measuring plan effectiveness.
- By summer 2023, as part of the larger strategic planning process that includes input from internal FDA staff and stakeholders, CTP will implement a robust external engagement plan to obtain public input on the strategic plan.
- Effective immediately, CTP will routinely communicate with stakeholders and the public about progress related to the strategic plan, including through regular updates to our webpage. Updates will include information related to development, strategic goals, release, and status of center activities to address each objective within the strategic plan.
- A Listening Session: Developing FDA’s Center for Tobacco Products’ Strategic Plan was held on Aug. 22 to seek public comments on the proposed goal areas or on any other areas that CTP should consider related to the development of the strategic plan. Over 550 people attended the listening session and 59 people provided a verbal public comment. In addition to the listening session, the public had the opportunity to submit electronic or written comments to the Federal Register docket by Aug. 29, 2023. Over 2,400 comments were submitted to the Federal Register docket.
- Updates have been published to communicate progress on developing the strategic plan, including through website updates and public facing presentations. The first update was published in summer 2023 and the second in fall 2023.
CTP should improve the overall transparency of the tobacco program, particularly with respect to the regulatory process and its scientific underpinnings.
- By spring 2023, CTP will develop an operational strategy that facilitates a culture of enhanced transparency and information sharing, both internally within CTP and externally with stakeholders and the public.
- Effectively immediately, CTP will initiate activities to enhance transparency and information sharing across all programmatic areas, including establishment of internal transparency liaisons within each CTP office. These transparency liaisons 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.
- The CTP Ombuds Office is leading and has initiated the development of an operational strategy to enhance transparency, including steps to establish transparency liaisons across the center.
- The Requesting a CTP Speaker webpage has been updated with a list of CTP Director King’s presentations and information on how to request a copy of the presentations.
- To provide the public with more easily accessible and user-friendly information about tobacco product-related citizen petitions, CTP published a webpage of all the tobacco products-related citizen petitions received by the center.
- Regular updates about tobacco product authorization decisions and progress on tobacco product premarket review continue to be provided to the public through multiple means, including press releases, emails, website updates, and social media outreach.
- To share the latest center updates with the public, CTP routinely publishes statements, sends email updates, and posts on social media on topics such as premarket review, compliance and enforcement, and other center news. Find the latest updates in the CTP Newsroom.
CTP should increase its use of the TPSAC to obtain expert input on scientific issues and policy development, including regulations, guidance, and data needs for effective product regulation.
- Effective immediately, CTP will work to increase use of TPSAC to obtain input on scientific issues related to its regulatory authorities; the next meeting will be held by fall 2023, with a goal of holding one or more TPSAC meetings per year. CTP will reassess and update the center’s 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 May 2023, the TPSAC met at FDA’s White Oak campus to discuss the “Requirements for Tobacco Product Manufacturing Practice” proposed rule. More information about this meeting, including meeting materials, is included on the webpage Tobacco Products Scientific Advisory Committee Meeting - 05/18/2023.
- Efforts are currently underway to reassess and update criteria for convening TPSAC and plan additional TPSAC meetings, including on broader scientific matters central to premarket evaluation, with the goal of holding one or more TPSAC meetings per year.
CTP should develop a more clear and predictable framework for high-quality premarket tobacco product application (PMTA) and modified risk tobacco product (MRTP) application submission and reviews.
- Effectively immediately, CTP will undertake several actions to develop a more efficient framework for high-quality reviews, including: working internally and through engagement with external stakeholders to better communicate on scientific issues and practices to support efficiency, effectiveness, and transparency; hiring additional dedicated personnel to enhance program management and implementation, including for application review; and increasing internal communication to improve mechanisms for scientific engagement and deliberation.
- By the end of 2023, CTP will conduct a public meeting to explain current review processes and solicit external feedback; and explore options for providing more transparent and timely dissemination of information, as appropriate. In addition to a public meeting, future means of communication will include continued convening of webinars and issuance of guidance to industry. Beginning in spring 2023, CTP staff will present in public forums about our scientific processes. By spring 2023, we will resume the posting of scientific policy memos and reviewer guides, when appropriate.
- CTP hosted a two-day public meeting on the premarket tobacco product application process on Oct. 23 and 24, 2023 on the FDA White Oak Campus in Silver Spring, Maryland.
- FDA hired additional, dedicated personnel to enhance program management and implementation, including a Premarket Tobacco Product Application (PMTA) coordinator and Substantial Equivalence (SE) coordinator. These new coordinator positions were established to work with Office of Science senior leadership and serve as staff who are dedicated to developing and refining program priorities, setting goals, and coordinating implementation across the office.
- Preparation has begun to publish additional scientific memos developed from 2019 to present, when appropriate. Office of Science staff have identified all memos from 2019 to present, are currently reviewing these scientific policy memos, and are developing a plan for posting the memos online, where appropriate. New memos are also under development on various topics.
- FDA is engaging with external stakeholders to better communicate on scientific issues and practices to support efficiency, effectiveness, and transparency. Center staff will continue to attend public meetings to provide information on the review process and answer questions. Staff have recently presented at meetings such as the Food and Drug Law Institute Nicotine Product Regulatory Science Symposium, the Tobacco Merchants Association Annual Meeting, the E-Cigarette Summit, the Next Generation Nicotine conference, the Tobacco Science Research Conference, and the Cooperation Centre for Scientific Research Relative to Tobacco Smoke-Techno Conference.
Consider clarifying in formal policy CTP’s plans for triaging its substantive reviews to conserve resources when there are certain critical sections of the application that can be indicative of whether all sections of the application merit review.
- By spring 2023, CTP will initiate efforts to provide additional information about the center’s process for premarket reviews, including through presentations at symposiums, conferences and meetings where the center engages with stakeholders. CTP will also host at least one public meeting in 2023 to describe the processes for premarket review and provide an opportunity for stakeholder input.
- Effective immediately, CTP will explore additional options to structure reviews to be more flexible and less resource intensive, and so that efforts are more efficient. This includes continuing to explore topics for which a streamlined review could be implemented and including this issue in the public meeting to engage stakeholders in the discussion.
- During the public meeting on the premarket tobacco product application review process held in October 2023, staff from the Office of Science presented on topics related to the process and responded to questions received from stakeholders.
- As part of the center’s ongoing efforts to assist applicants, new resources were created to help applicants prepare and submit premarket applications and amendments:
- A fact sheet that provides quick tips for completing form FDA 4057a.
- A video that shares an overview of the CTP Portal and how to use it.
- An FDA Tobacco Product Application Tips - Premarket Tobacco Product Applications webpage provides in-depth information on how to complete the premarket tobacco product application (PMTA) forms to submit and amend pending applications.
- A product form validator tool allows applicants to verify the data in their Form 4057b and pinpoint necessary corrections before submitting.
- CTP updated form FDA 4057b to streamline submissions, reduce duplication of products in internal systems, and improve data quality for data reporting and analysis. The center also updated and reorganized form FDA 4057 to reduce the burden on applicants and include additional instructions for clarity. The current versions of each form are available on the Preparing and Submitting a PMTA webpage.
- CTP is continuously exploring options to make reviews more flexible and less resource intensive.
CTP should evaluate and redesign the current policy development program to create a more effective approach to achieving the regulatory review and enforcement goals that CTP establishes.
- Effective immediately, CTP will initiate the FDA hiring process to create a policy unit within the Office of the Center Director that would be responsible for providing overall policy coordination and issues management across CTP.
- By the end of 2023, CTP will develop, publish, and maintain a comprehensive policy agenda of rules and guidances that are in development or planned for development; development of the policy agenda will begin by February 2023, with an anticipated completion date of no later than December 2023. As part of developing this policy agenda and developing the strategic plan, CTP will solicit stakeholder feedback on potential rules and guidances related to the application review process, policies related to compliance and enforcement matters, and on ways to increase efficiency during the application review process. CTP will undertake an evaluation and redesign of our policy development program to create a more efficient approach to meeting CTP’s strategic plan. Following the initial publication, CTP will update the policy agenda annually.
- Effective immediately, CTP will explore alternative approaches to increasing transparency and opportunities for stakeholder feedback, which will be a focal point of action in redesigning the policy development program. Examples may include utilizing more public meetings when rolling out proposed rules to increase understanding of the proposals and utilizing advance notices of proposed rulemaking (ANPRM) to provide opportunities to engage stakeholders earlier in the rulemaking process.
- CTP has made meaningful progress on the development of a policy unit within the Office of the Center Director. FDA advertised nationwide for the position of Associate Director for Policy and Partnerships, and review of the applications is underway. 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.
- A policy agenda is on track to be published by December 2023.
- A public oral hearing was held in April 2023 as an opportunity for the public to verbally comment on the agency’s proposed rule “Requirements for Tobacco Product Manufacturing Practice.”
FDA should seek higher-level administration involvement to establish an interagency task force to make enforcement of the tobacco laws a government-wide priority, particularly to address the marketing of illegal products and the risks of youth use.
- Effective immediately, FDA will begin planning to convene a summit related to enforcement with senior officials from U.S. Department of Health and Human Services (HHS) Office of General Counsel (OGC) (including FDA Office of Chief Counsel), FDA Office of the Commissioner, CTP, and Department of Justice (DOJ).
- Effective immediately, FDA plans to continue activities with other government agencies and organizations to enhance enforcement and compliance activities. In addition to DOJ, these agencies and organizations include, but are not limited to: U.S Customs and Border Protection, the U.S. Postal Service, the Federal Trade Commission, Bureau of Alcohol, Tobacco, Firearms and Explosives, as well as with our compliance and enforcement partners at the state/local/territorial/tribal levels.
- Meetings continue to occur between CTP and federal partners – including the Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), the Federal Trade Commission (FTC), and U.S. Customs and Border Protection (CBP) – to discuss opportunities for sharing information and leveraging resources to support enforcement actions.
- CTP staff met with FTC in February 2023 to share information to support enforcement actions.
- CTP staff met with ATF in May 2023 and agreed to share information on a case-by-case basis regarding certain compliance activities and advisory and enforcement actions. CTP has since established standing recurring meetings with ATF to share information and leverage resources to support enforcement actions.
- CTP staff and the Tobacco Tax and Trade Bureau are collaborating on work related to laboratory activities on a case-by-case basis including tobacco product method development and product testing.
- Collaborative efforts related to imports continue to occur among CTP, CBP, and the U. S. Postal Service. FDA continues to add firms marketing unauthorized tobacco products to an FDA import alert. For example, in May 2023, FDA added all Esco Bars and Elf Bar products to the import alert.
- Senior officials from the HHS Office of General Counsel (including FDA Office of the Chief Counsel), FDA Office of the Commissioner, CTP, and DOJ met in July 2023 to continue ongoing discussions and close collaboration on issues related to enforcement.
The agency should consider whether statutory changes to provide streamlined processes for tobacco enforcement, including increased consequences for Tobacco Control Act (TCA) violations, should be pursued.
- Effective immediately, CTP will consider whether statutory changes are needed to assist CTP 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.
- Compliance and enforcement processes continue to be reviewed to identify areas to strengthen the program, including exploring the potential need for statutory changes.
In addition to pursuing formal enforcement through DOJ, FDA should explore alternative approaches to achieving compliance.
- Effective immediately, CTP will 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. CTP has begun planning some of these activities.
- Updates have been provided to the center’s compliance and enforcement webpages to share information, improve user experience, and increase transparency. For example, CTP is now publicly reporting more process and outcome data related to the online retailer investigation program. In March 2023, an expanded public webpage was launched with information on tobacco product retailer enforcement and investigations, including online investigations. This webpage provides information about inspections and investigations, and instructions on searching the FDA-wide warning letter database.
- In August 2023, CTP updated its Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers guidance to provide clarifying language related to violations of the Federal Food, Drug, and Cosmetic Act involving the manufacture, sale, and/or distribution of a new tobacco product that lacks the required marketing authorization.
- Multiple significant actions have been taken to achieve compliance outside of judicial enforcement actions through DOJ:
- In February 2023, FDA filed civil money penalty (CMP) complaints against four tobacco product manufacturers for manufacturing and selling e-liquids without marketing authorization for the first time in the agency’s history. FDA continues to file CMP complaints against additional tobacco product manufacturers for manufacturing and selling e-cigarette products without marketing authorization, with 35 being issued as of Oct. 20, 2023.
- In May 2023, CTP issued warning letters to firms responsible for two popular flavored, disposable e-cigarette products—Shenzhen Innokin Technology Co. Ltd. who make Esco Bars products and Breeze Smoke, LLC who import and distribute Breeze products.
- In May 2023, CTP issued warning letters to 30 retailers, including one distributor, for illegally selling tobacco products as part of a nationwide effort to crack down on the sale of unauthorized e-cigarettes that are popular with youth, including Puff and Hyde brand e-cigarettes.
- In June 2023, CTP issued warning letters to 189 retailers for selling unauthorized tobacco products, including Elf Bar products. The warning letters were the result of a coordinated nationwide retailer inspection effort conducted over several weeks in summer 2023.
- In July 2023, CTP issued warning letters to three distributors for selling and/or distributing multiple unauthorized e-cigarette products including the popular and youth-appealing e-cigarette products Elf Bar/EB Design and Puff Max.
- In August 2023, CTP issued warning letters to 15 online retailers for selling and/or distributing unauthorized e-cigarette products packaged to look like youth-appealing characters, school supplies, toys, and drinks.
- In mid-September 2023, CTP issued warning letters to 15 online retailers and 3 manufacturers and/or distributors for selling or distributing unauthorized e-cigarette products, including those marketed under the brand names Elf Bar, EB Design, Lava, Cali, Bang, and Kangertech.
- In late September 2023, CTP issued complaints for CMPs against 22 retailers for the illegal sale of Elf Bar/EB Design e-cigarettes. This is the first time the agency is seeking CMPs for the maximum amount ($19,192) against retailers for this type of violation. CTP also announced the issuance of 168 warning letters to brick-and-mortar retailers for illegally selling Elf Bar/EB Design products, which were the result of a coordinated nationwide retailer inspection effort conducted through the month of August.
CTP should enhance its use of public communications to provide greater transparency about the agency’s approach to compliance and enforcement, including prominently posting and maintaining a list of legally marketed products to facilitate voluntary compliance and discourage the sale of illegal products by manufacturers, distributors, wholesalers, and retailers.
- Effective immediately, CTP will be more transparent about its compliance and enforcement activities and its development of any new enforcement priorities. CTP 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, enhance FDA’s Tobacco Product Marketing Order webpage, and develop a searchable public database of all tobacco products that have an FDA marketing order. This work has already been initiated, and the new web content will begin to be posted by spring 2023.
- In February 2023, the center launched a webpage detailing its advisory and enforcement actions for unauthorized tobacco products. CTP continues to update this webpage with the latest actions on a routine basis. The center is 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.
- In June 2023, the Tobacco Product Marketing Order webpage was updated to better organize information on all pathways to market and to present existing information in a clearer way for stakeholders. Planning is underway for further updates to the marketing orders webpages, including a searchable public database of all tobacco products with a marketing order from FDA. The center has begun the necessary planning for this database and awarded an information technology contract in July 2023 for its development.
The center should ensure that the workplan and goals for the Office of Compliance reflect any new priorities that the center adopts as a result of its evaluation of additional enforcement approaches.
- By the end of 2023, CTP’s Office of Compliance and Enforcement will develop a new strategic plan related to this recommendation and it will be in alignment and in coordination with CTP’s new 5-year strategic plan; development has been initiated.
- Efforts continue to develop a new center-wide strategic plan, which will include compliance and enforcement elements. The strategic plan is on track to be released by December 2023.
The center should solicit broad public input as it continues to develop its tobacco public education campaigns, which are critical to the public health mission.
- By spring 2023, CTP will develop and implement a plan to develop, publish, and promote CTP resources that describe the mechanisms CTP currently uses to solicit and consider public input on its campaigns, including formative research with campaign audiences, consultation with stakeholders, Federal Register notices, engagement at conferences, and analysis of social media posts. CTP will leverage opportunities to solicit and consider public input during upcoming public meetings on topics relevant to CTP campaign and public education strategy.
- Effective immediately, CTP will begin exploring a collaboration with an external entity known for scientific rigor and objectivity to develop and test a credible, sustainable, and comprehensive process for soliciting and considering public input on CTP’s campaign program. Feasibility of this approach will be determined within 3 months.
- Opportunities continue to be identified and leveraged to solicit public input during stakeholder and public meetings. For example, CTP presented and engaged participants in a discussion about CTP’s campaign program at the 2023 E-Cigarette Summit in May.
- An update to the public education webpages is presently underway to be completed by fall 2023. Updates will include information that documents the importance of, and opportunities to provide, input into CTP’s campaign program. These opportunities for public input will also be advertised during campaign presentations and promoted on the center’s social media channels.
- Additionally, CTP is pursuing research to assess potential messaging approaches on perceptions about the relative risks of tobacco products among intended and unintended populations. In August 2023, a Notice of Funding Opportunity was published by the National Institutes of Health, in coordination with CTP, for “Public Health Communication Messaging about the Continuum of Risk for Tobacco Products.” In September 2023, a Pre-Application Webinar for Public Health Communication Messaging about the Continuum of Risk for Tobacco Products was held for all prospective applicants interested in the funding opportunity.
FDA should secure the agile hiring authorities and salary flexibility of the 21st Century Cures Act for the tobacco program to improve its ability to recruit, hire, and retain personnel with the needed skills to effectively meet its public health mandate around tobacco. FDA should also work with the Office of Personnel Management to develop solutions to facilitate hiring professionals that match the program’s needs.
- Effective immediately, FDA will continue to work with Office of Personnel Management (OPM) to develop solutions to facilitate and expedite hiring professionals that match CTP’s needs.
- Effective immediately, CTP will continue to engage with FDA, HHS, and OPM to identify solutions to facilitate more timely and efficient hiring of qualified and diverse professionals that match the center’s needs. Toward this end, CTP is currently partnering with OPM to potentially establish an Intra-Agency Agreement for additional hiring support. In addition, FDA is working with HHS to submit to OPM a new request for direct hire authority for the tobacco program.
- An interagency agreement has been established with OPM to review and evaluate position descriptions, and the center continues to utilize these services to expeditiously review position classifications.
- Efforts are also underway to establish an interagency agreement with OPM to assist with hiring by posting job announcements and evaluating applicants. This agreement would supplement the existing FDA hiring resources. CTP expects to have this interagency agreement in place by the end of 2023.
- CTP has been in discussions with OPM and HHS about our request 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.
The agency should continue to pursue securing user fees from each sector regulated by the center, including, for example, electronic nicotine delivery systems.
- FDA has pursued securing user fees for all products CTP regulates. In order to incorporate all deemed products into the tobacco user fee methodology and provide for an increase in user fees assessed and collected, FDA will work with Congress to modernize the tobacco user fee framework.
- Since fiscal year 2020, FDA has requested an additional $100M in user fees, indexed for inflation, in our annual budget and authority to include all deemed products among the tobacco classes for which FDA assess tobacco user fees.
- CTP has worked with appropriate FDA offices to educate relevant stakeholders, including Congress, about the beneficial impact that securing additional user fees for all regulated tobacco products would have on CTP’s ability to meet its regulatory mandate. An additional $100 million in user fees is critical for CTP to bolster tobacco regulatory activities across a variety of program areas, including increasing compliance and enforcement efforts, hiring more staff to handle the large volume of complex product applications, maturing CTP’s research programs to support regulatory priorities, and expanding formative research and public education campaigns.
- Continued efforts are underway to meet with and educate relevant stakeholders, including Congress, on a potential framework for securing user fees for all products CTP regulates.
- Consistent with the president’s fiscal year 2024 budget, FDA 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 assess and collects tobacco user fees.