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

By Brian King, Director of FDA’s Center for Tobacco Products
June 29, 2023

In February, I announced the Center for Tobacco Product’s (CTP) “all-center” approach to responding to the evaluation of our center by an independent expert panel facilitated by the Reagan-Udall Foundation (RUF), including our plans to address the 15 recommendations outlined in the evaluation panel’s report. We immediately hit the ground running to implement the blueprint laid out in that statement. With multiple recommendations across different program areas within CTP, implementation is no small task. However, we have already made significant strides in putting our plans into action.

The following summarizes our progress and our next steps. A comprehensive list of status updates for each recommendation is available at the updated webpage, Actions to Address Recommendations from the Reagan-Udall Evaluation of CTP.

Cross-Cutting

One of the key overarching recommendations from the report was the creation of a new strategic plan, which is something CTP is fully committed to developing. I’m pleased to report that CTP is on track to issue proposed goals this summer, and to release the final plan by December 2023.

Over the last few months, leadership from across the center has met and had productive discussions about the direction and development of this important roadmap for our center, which will include ways to advance health equity across each program area. This effort has been facilitated by colleagues in the FDA Office of Operation’s Office of Planning, Evaluation, and Risk Management. As part of the development process, CTP is seeking input from staff. Public input is equally important, and we are on track to hold a public meeting in summer 2023 to seek stakeholder feedback about the strategic plan.

Another overarching recommendation from the report focused on transparency, which is a guiding principle that runs through all our efforts. Internally, the CTP Ombuds Office is leading the creation of an operational strategy to improve transparency and information sharing across all programmatic areas, including through the establishment of transparency liaisons. Externally, the center is planning for upcoming public meetings to gather stakeholder input. CTP also published a webpage of all the tobacco products-related citizen petitions received by the center to provide the public with information about such citizen petitions that is easy to access and user-friendly. In addition, the Requesting a CTP Speaker webpage was updated with a list of my public presentations and information on how to request a copy of my presentation slide decks.

Science and Application Review

The center has made considerable progress in reviewing the unprecedented volume of applications for more than 26 million tobacco products that have been submitted over the last three years — completing review of 99% of submissions to date. As part of those reviews, CTP has authorized 23 tobacco-flavored e-cigarette products and devices, which are currently the only e-cigarettes that may be lawfully sold or distributed in the United States.

We recognize there are opportunities to enhance the application review process and are committed to meaningfully engaging with stakeholders to solicit their feedback on this matter. Toward that end, CTP is currently planning a public meeting to take place in fall 2023 regarding the application review process. More information about this public meeting will be shared soon.

In the interim, CTP Office of Science leadership is committed to participating in conferences and external meetings to provide information on the review process and to answer questions. For example, representatives from the Office of Science have recently presented at meetings such as the Food and Drug Law Institute’s Nicotine Product Regulatory Science Symposium, the Tobacco Merchants Association Annual Meeting, and the E-Cigarette Summit. Preparation is also underway to, when appropriate, post on our website scientific memos developed from 2019 to present that may be helpful to applicants, and to develop new memos on various topics. 

We are also making progress addressing recommendations related to the Tobacco Products Scientific Advisory Committee (TPSAC). In May, for the first time in three years, the TPSAC met at FDA’s White Oak Campus to discuss the “Requirements for Tobacco Product Manufacturing Practice” proposed rule. The meeting was open to the public, and the proposed rule is currently open for public comment until Sept. 6, 2023. We are working to ensure the continued valuable input of the TPSAC, with the intent of holding at least one meeting per year, including broader scientific matters central to premarket evaluation.

Regulations and Guidance

The center is in the process of finalizing rules related to menthol cigarettes and flavored cigars, and continues to work toward publishing a proposed rule that would establish a maximum nicotine level to reduce the addictiveness of cigarettes and certain other combusted tobacco products. As noted above, CTP also recently proposed new requirements for tobacco product manufacturers regarding the manufacture, design, packing and storage of their products through the proposed rule, “Requirements for Tobacco Product Manufacturing Practice.” In addition to the TPSAC meeting described above, CTP held a tribal consultation on April 11 for Native communities to share their input and ask questions about the rule, and a public oral hearing on April 12 as an opportunity for the public to verbally comment on the proposed rule.

As recommended in the report, the center has initiated the process of creating a policy unit within the Office of the Center Director, which will be responsible for providing overall policy coordination across CTP. Additionally, the center is on track to publish a policy agenda by the end of the year and plans to seek stakeholder input on this topic during upcoming public meetings and through a Federal Register Notice.

Compliance and Enforcement

As I have noted several times in the past, CTP will not stand by as manufacturers, retailers, or distributors sell illegal products, especially those that are well-known to appeal to youth. From January 2021 through June 2023, CTP has issued more than 570 warning letters and taken several enforcement actions – including filing 13 civil money penalties, and, through the Department of Justice (DOJ), six injunctions to date for firms marketing illegal e-cigarettes. In the past few weeks, the center has taken swift action to curb the sale of illegal disposable e-cigarette products that appeal to youth. These actions include issuing warning letters to two firms responsible for the manufacturing, distributing, and importing of Esco Bars and Breeze, and to over 200 retailers for illegal sales of various types of Puff, Hyde, Elf Bar, and Esco Bars products. These brands all sell illegal disposable, flavored e-cigarettes that are known to appeal to youth. All of these actions are part of the center’s standing compliance and enforcement portfolio and commitment to enforcing the law across the entire supply chain – from manufacturers to retailers.

The DOJ is a critical partner in FDA’s compliance and enforcement efforts. Senior officials from the U.S. Department of Health and Human Services (HHS) Office of General Counsel (including FDA Office of Chief Counsel), FDA Office of the Commissioner, CTP, and DOJ are closely collaborating on issues related to enforcement. Additional discussions are expected to occur this summer.

In addition to discussions with DOJ, we are continuously meeting with 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. For example, CTP staff met with FTC in February and ATF in May to discuss how to best support enforcement actions. In May, in coordination with CBP and the U.S. Postal Service, FDA added additional firms marketing unauthorized tobacco products to an FDA import alert.

Along with these efforts, CTP continues to regularly review the compliance and enforcement program and seek ways to strengthen our processes, including exploring the potential need for statutory changes. For example, we are in current discussions with FDA’s Office of Legislation regarding the potential need for statutory changes.

We have also been working to increase transparency regarding compliance and enforcement through website updates, including making the website easier to use and understand. The center launched a webpage detailing its advisory and enforcement actions for unauthorized tobacco products and expanded a webpage with dedicated information on tobacco product retailer enforcement and investigations, including online investigations. Additionally, we are in the development phase of launching a searchable public database of all tobacco products with a marketing order from FDA. The database will improve the presentation of this information, building upon our Tobacco Product Marketing Orders page.

Public Education Campaigns

Rooted in science, FDA’s tobacco public education campaigns are critical to our public health mission. Our award-winning public education campaign, “The Real Cost,” helps prevent youth from tobacco initiation and use. Our newest campaign, “Next Legends” aims to educate American Indian and Alaska Native youth, ages 12-17, about the harms of e-cigarette use.

Feedback on our campaigns has always been of the utmost importance. For each campaign, CTP uses a variety of trusted research methods to ensure our message is effective and resonates with our target youth audiences. While we continually focus on the science when developing campaigns, CTP regularly works to identify and leverage opportunities to solicit input about the campaigns during stakeholder meetings. As a recent example, CTP staff presented and engaged with participants in a discussion about our campaign program at the 2023 E-Cigarette Summit in May. We are planning to broaden this effort soon with updates to our website by fall 2023, which will share additional opportunities for the public to provide input into our campaign development.

It is essential to continue to ensure that our public messaging, including any potential campaigns, are rooted in science. Toward that end, we continue to follow a rigorous, data-driven approach to inform our youth prevention campaigns, including “The Real Cost.” Initial data-driven efforts are also underway to assess potential messaging approaches on perceptions about the relative risk of tobacco products – among both intended (i.e. adults who smoke) and unintended (e.g. youth) audiences.

Resources

Fourteen years ago this month, Congress passed the Tobacco Control Act, which led to the creation of FDA’s Center for Tobacco Products. Since then, our dedicated staff has grown to approximately 1,100 talented individuals. CTP’s staff are our greatest resource and the ability to retain and recruit staff is critical.

Consistent with the recommendations in the RUF report to optimize hiring processes, CTP has established an interagency agreement with the Office of Personnel Management (OPM) to review and evaluate position descriptions and has begun utilizing these services. CTP is also working to establish an interagency agreement with OPM to assist with hiring, including posting job announcements and evaluating applicants, and is actively working to obtain these services as soon as possible. The agreements with OPM are designed to supplement the hiring resources for the center and to increase our capacity to hire the necessary talent from a diverse pool of excellent candidates to support our needs. CTP also worked with FDA and HHS to submit a new request for direct hire authority for the tobacco program to OPM.

We also continue to educate relevant stakeholders and to work with Congress on a potential framework for securing additional user fees from each regulated tobacco sector. The president’s fiscal year 2024 budget included FDA’s request for an additional $100M in user fees, indexed for inflation, and authority to include all deemed products among the tobacco classes for which FDA assesses and collects tobacco user fees.

Next Steps

I am proud of the significant progress the center has made to date in addressing the external evaluation recommendations, and I am confident that we’ll continue to make important strides in continuing to build and strengthen FDA’s tobacco program in the future. As always, we’re moving forward with our guiding principles of sound science, strategic partnerships, health equity, and clear communication and transparency. I will continue to provide updates about the center’s progress in responding to the RUF recommendations moving forward on a routine basis. For more detailed information about all of our progress, including planned actions and status updates, I encourage you to visit our webpage, Actions to Address Recommendations from the Reagan-Udall Evaluation of CTP.