Actions to Address Recommendations from the Reagan-Udall Evaluation of CTP
On this page:
- Background: Reagan-Udall Foundation (RUF) Evaluation
- CTP's Review of the Evaluation Report
- Recommendations, Actions, and Status Updates
Background: Reagan-Udall Foundation (RUF) Evaluation
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.
CTP's Review of the Evaluation Report
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:
- Cross-Cutting
- Science and Application Review
- Regulation and Guidance
- Compliance and Enforcement
- Public Education Campaigns
- Resources
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.
Recommendations, Actions, and Status Updates
The statements below summarize actions and status updates that have been completed by a specific date.
- Summer 2024
- February 2024 (2023 Year in Review)
- December 2023 (Strategic Plan Release)
- Fall 2023
- Summer 2023
- February 2023 (Initial Response)
To view current progress on each recommendation, please review the sections below.
Cross-Cutting
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.
Action:
- 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.
Status Update:
- The CTP Strategic Plan was released in December 2023. Development of the strategic plan was facilitated by a team from the FDA Office of Operation’s Office of Planning, Evaluation, and Risk Management.
- CTP continues to implement the strategic plan across all offices and divisions.
- 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.
Actions:
- 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.
Status Update:
- A Listening Session: Developing FDA’s Center for Tobacco Products’ Strategic Plan was held on Aug. 22, 2023, 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 updates were published in June 2023, October 2023, and February 2024.
CTP should improve the overall transparency of the tobacco program, particularly with respect to the regulatory process and its scientific underpinnings.
Actions:
- 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.
Status Update:
- As part of the development of an operational strategy to enhance transparency, the CTP Ombuds Team has conducted information gathering meetings with staff selected as transparency liaisons. Initial discussions have focused on strategies to enhance internal and external communication.
- The Office of Science has committed to increasing transparency through a number of actions, such as gathering expert and stakeholder input through public meetings; attending and presenting at conferences, workshops and industry-requested meetings; posting scientific policy memos and reviewer guides, when appropriate; launching the Searchable Tobacco Products Database; and convening a meeting of the Tobacco Products Scientific Advisory Committee (TPSAC) on June 26, 2024.
- 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.
Science and Application Review
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.
Action:
- 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.
Status Update:
- FDA continues to reassess and update criteria for convening TPSAC and planning additional TPSAC meetings, including on broader scientific matters central to application review. The goal is to hold one or more TPSAC meetings per year.
- On June 26, 2024, FDA held a TPSAC meeting at FDA’s White Oak campus to discuss the renewal of a risk modification order, submitted by Swedish Match USA, Inc. for General Snus products. Additional discussion about the conceptualization and measurement of consumer understanding within the broader modified risk tobacco products (MRTP) program also occurred.
- In May 2023, 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.
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.
Actions:
- 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.
Status Update:
- CTP began a phased approach to release regulatory science policy memos, as appropriate, with the first memos released in April 2024 and a subsequent release in May 2024. The memos posted to date provide a snapshot of the center’s internal thinking on certain topics within the premarket tobacco product application (PMTA) review process. The memos describe the internal roles and responsibilities for the review of specific scientific and marketing information. Additional memos on various topics are planned for posting.
- On Oct. 23 and 24, 2023, CTP hosted a two-day public meeting on the premarket tobacco product application process at FDA’s White Oak Campus. Video recordings and transcripts are available on the meeting website.
- 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. These coordinators have been leading internal workshops to develop goals for reviewing pending applications, including steps to develop materials to support a more efficient, sustainable premarket review pathway.
- 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 Annual Next Generation Nicotine Delivery USA meeting, the Food and Drug Law Institute (FDLI) Annual Conference, the FDLI Nicotine Product Regulatory Science Symposium, the Tobacco Merchants Association (TMA) Annual Meeting, 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.
Actions:
- 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.
Status Update:
- During the public meeting on the premarket tobacco product application (PMTA) 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. Video recordings and transcripts of the presentations are available on the meeting website.
- 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.
Regulation and Guidance
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.
Actions:
- 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.
Status Update:
- In March 2024, CTP announced that Natasha Phelps, J.D., was selected as the center’s associate director for policy and partnerships. This position is responsible for providing overall policy coordination and issues management across CTP. Phelps leads the policy unit within the Office of the Center Director.
- A policy agenda and strategic plan were published in December 2023, which the center is in the process of implementing.
- 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.”
Compliance and Enforcement
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.
Actions:
- 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.
Status Update:
- In June 2024, FDA and DOJ announced the creation of a federal multi-agency task force to combat the illegal distribution and sale of e-cigarettes. Along with FDA and DOJ, the task force will bring together multiple law enforcement partners, including the U.S. Customs and Border Protection (CBP); Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF); the U.S. Marshals Service (USMS); the U.S. Postal Inspection Service (USPIS); and the Federal Trade Commission (FTC), to coordinate and streamline efforts to bring all available criminal and civil tools to bear against the illegal distribution and sale of e-cigarettes responsible for nicotine addiction among American youth. Additional agencies may join the task force in the future.
- Meetings continue to occur between CTP and federal partners – including ATF, FTC, and CBP – to discuss opportunities for sharing information and leveraging resources to support enforcement actions.
- CTP staff met with FTC in February 2023 and January 2024 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.
- Actions have been taken in collaboration with other government agencies and organizations to enhance enforcement and compliance activities:
- In December 2023, FDA, in collaboration with CBP, announced the seizure of approximately 1.4 million units of unauthorized e-cigarette products.
- In December 2023, DOJ, on behalf of FDA, filed a complaint for a permanent injunction against Jessica M. Fitzgerald and Michelle L. Allen doing business as Vape Junkie Ejuice for manufacturing, selling, and distributing unauthorized e-cigarette products. This case represents the seventh time FDA has initiated injunction proceedings to enforce premarket review requirements for new tobacco products.
- In April 2024, FDA, in coordination with DOJ, announced that the U.S. Marshals Service seized over 45,000 unauthorized e-cigarette products valued at more than $700,000. This marked the first time judicial seizure authority was used for tobacco products.
- In June 2024, an FDA and DOJ action lead to an entry of consent decree of permanent injunction against a manufacturer of unauthorized e-cigarettes. The consent decree prohibits the manufacturer, Boosted LLC, and its owner, Cory Vigil, from manufacturing, selling, or distributing any new tobacco products until they meet certain requirements.
- In June 2024, FDA and CBP announced the seizure of 53,700 unauthorized e-cigarette products valued at more than $1.08 million.
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.
Action:
- 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.
Status Update:
- Compliance and enforcement processes continue to be reviewed to identify areas to strengthen the program, including exploring the potential need for statutory changes.
- The federal multi-agency task force to combat the illegal distribution and sale of e-cigarettes will focus on several topics related to strengthening enforcement, including investigating and prosecuting new criminal, civil, seizure and forfeiture actions using existing authorities, while also seeking innovative solutions to further address the regulation of e-cigarette products.
In addition to pursuing formal enforcement through DOJ, FDA should explore alternative approaches to achieving compliance.
Action:
- 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.
Status Update:
- 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 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 continues to be updated and provides timely information to the public about warning letters, CMPs, injunctions and import activities related to unauthorized tobacco products, as well as 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 (FD&C Act) involving the manufacture, sale, and/or distribution of a new tobacco product that lacks the required marketing authorization.
- FDA is currently working on, and expects to publish later in 2024, a draft guidance on civil money penalties for violations of the FD&C Act requirements that relate to tobacco products. This guidance intends to describe the agency’s approach to issuing Enhanced Civil Money Penalties (intentional violations), Continuous Enhanced Civil Money Penalties (intentional and other violations that continue after written notice), and multiple violations in a single complaint (either as a retailer, a manufacturer, or as both).
- FDA developed additional compliance training webinars with updates in multiple languages for various audiences. These include three webinars related to retail establishment inspections, two of these webinars with materials available in both English and Spanish, and a third for tribal jurisdictions. FDA also posted a new compliance training webinar for importers, which includes information about the premarket authorization requirements.
- While continuing to explore alternative approaches to achieving compliance, CTP has concurrently expanded the use of warning letters and civil money penalties (CMPs), targeting manufacturers, distributors, and retailers. Multiple significant actions have been taken to achieve compliance outside of judicial enforcement actions through DOJ:
- In February 2023, FDA filed civil money penalty complaints against four tobacco product manufacturers for manufacturing and selling e-liquids without marketing authorization for the first time in the agency’s history.
- 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 applicable 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.
- In November 2023, FDA issued a warning letter to Nic Nac Naturals, LLC for the marketing of their unauthorized dissolvable nicotine products, which the company describes as “nicotine mints” and resemble a pack of mints.
- In November 2023, FDA issued warning letters to seven online retailers for selling unauthorized e-cigarette products. The warning letters cite the sale of popular and youth-appealing disposable e-cigarette products marketed under the brand names Elf Bar, EB Design, Bang, Cali Bars, and Lava.
- In November 2023, FDA issued warning letters to seven online retailers for selling and/or distributing unauthorized e-cigarettes packaged to look like youth-appealing toys and drink containers, including milk cartons, soft drink bottles, and slushies.
- In December 2023, FDA announced the filing of CMP complaints against 25 brick and mortar and online retailers for the illegal sale of unauthorized Elf Bar, EB Design and other e-cigarette products
- In December 2023, CTP issued warning letters to 11 online retailers selling unauthorized e-cigarette products marketed under the brand names Lost Mary, Funky Republic/Funky Lands, Elf Bar/EB Design, Kangvape, Cali, and Breeze.
- In December 2023, FDA issued warning letters to three online retailers for selling and/or distributing unauthorized e-cigarettes that imitate packaging for bottles of alcohol.
- In January 2024, CTP issued complaints for CMPs against 21 retailers for illegal sales of Esco Bars e-cigarette products.
- In January 2024, FDA issued warning letters to 14 online retailers for selling and marketing unauthorized disposable e-cigarette products marketed under the brand names such as Elf Bar/EB Design, Lost Mary, Funky Republic, Cali Bar, Kangvape, and Lava Plus e-cigarette products.
- In February 2024, FDA issued complaints for CMPs against 20 brick and mortar retailers for the sale of unauthorized Elf Bar e-cigarettes.
- In February 2024, FDA announced the issuance of warning letters to five online retailers for selling unauthorized e-cigarette products under popular brand names such as Elf Bar/EB Design/EB Create, Funky Republic, Lost Mary, Hyde, Breeze, and Cali Bars.
- In March 2024, FDA announced the issuance of warning letters to 61 brick and mortar retailers for selling unauthorized disposable e-cigarette products marketed under brand names Elf Bar/EB Design and Lava.
- In April 2024, FDA issued warning letters to three online retailers for the sale of unauthorized, flavored ZYN nicotine pouches and announced the issuance of 119 warning letters to, and the filing of 41 civil money penalty complaints against, brick and mortar retailers that engaged in the underage sale of various flavors of ZYN nicotine pouches between October 2023 and February 2024.
- In April 2024, FDA announced the issuance of complaints for CMPs against 20 brick and mortar retailers and two online retailers for the sale of unauthorized e-cigarettes, including Elf Bar.
- In May 2024, FDA announced the issuance of warning letters to 14 online retailers for selling unauthorized e-cigarette products marketed under popular brand names such as Elf Bar/EB Design, Esco Bars, Funky Republic, Hyde, Kang, Cali Bars, and Lost Mary.
- In May 2024, FDA announced it is seeking CMPs from nine brick and mortar retailers and one online retailer for the sale of Elf Bar.
- In June 2024, FDA issued warning letters to six online retailers for selling unauthorized e-liquid products from the Bad Drip brand that imitate prescription drug bottles. The retailers were also warned for selling unauthorized flavored, disposable e-cigarettes, including those under the brand names Funky Republic and HQD.
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.
Action:
- 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.
Status Update:
- In June 2024, FDA updated the presentation of information about tobacco compliance check outcomes on the FDA website and expanded the information available. The newly-named Tobacco Compliance Check Outcomes database provides an enhanced user experience by housing results of all tobacco retail inspection outcomes in a single location.
- In March 2024, FDA launched the Searchable Tobacco Products Database, a user-friendly list of tobacco products—including e-cigarettes—that may be legally marketed in the United States. The database is designed to serve the public—especially retailers—by providing this key information in a single location, with easy-to-use search capabilities. The database is updated monthly with new products and documents.
- 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. In July 2024, the center published additional website content that further outlines and describes 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.
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.
Action:
- 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.
Status Update:
- A new center-wide strategic plan has been created, which includes compliance and enforcement elements. The strategic plan was released in December 2023.
- CTP continues implementation of the compliance and enforcement elements of the strategic plan to strengthen the compliance of regulated industry by utilizing all available tools and taking robust enforcement actions.
- CTP continues to make a comprehensive push to take action across the supply chain to remove unauthorized tobacco products, particularly e-cigarette products that are popular among youth, from the marketplace. The center uses a variety of tools to achieve compliance such as warning letters, increased CMPs, injunctions, and working with federal partners such as CBP and DOJ to seize illegal products.
Public Education Campaigns
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.
Actions:
- 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.
Status Update:
- Opportunities continue to be identified and leveraged to solicit public input during stakeholder and public meetings. For example, on June 11, 2024, CTP held a webinar to commemorate the 10th anniversary of “The Real Cost” youth tobacco prevention campaign, which also included a public question and answer session. In January 2024, CTP staff presented about youth cigarillo use at the Community Anti-Drug Coalitions of America (CADCA) conference and shared an update on the “Next Legends” campaign with the State of Alaska Tobacco Control program. CTP also engages with the public on an ongoing basis through the CTP exhibit booth and exhibited at 30 conferences in 2023.
- As a part of CTP's ongoing commitment to transparency and collaboration, the center launched a webpage that includes information on the public health education development process, how CTP works with subject matter experts, ways to provide input on public education efforts, and ways to connect with CTP staff who help develop public education efforts. These opportunities for public input are 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.
Resources
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.
Actions:
- 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.
Status Update:
- Interagency agreements have been established with OPM to review and evaluate position descriptions and to assist with hiring by posting job announcements and evaluating applicants. The center continues to utilize these services to expeditiously review position classifications and supplement the existing FDA hiring resources.
- CTP was granted direct hire authority in October 2023 for a period of two years. This authority allows CTP to hire qualified candidates more quickly for critical positions. CTP is working to maximize use of this authority by prioritizing and posting direct hire vacancies; educating hiring managers’ conducting outreach to diverse, qualified candidates; reviewing applications; and making selections.
- The President’s fiscal year 2025 budget includes a legislative proposal to extend 21st Century Cures hiring authority to the FDA tobacco program to most effectively meet its public health mandate.
The agency should continue to pursue securing user fees from each sector regulated by the center, including, for example, electronic nicotine delivery systems.
Actions:
- 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 assesses 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.
Status Update:
- 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 2025 budget, FDA is requesting an additional $114.2M in user fees, authority to include all deemed products among the tobacco classes for which FDA assesses and collects tobacco user fees, and future collections indexed for inflation.