I.      Reagan-Udall Report

In July 2022, the Food and Drug Administration (FDA) Commissioner, Dr. Robert Califf, released a public statement saying the agency “has confronted a series of challenges that have tested our regulatory frameworks and stressed the agency’s operations.” As such, Commissioner Califf was “prompt[ed] . . . to take a closer look at how [FDA does] business.” To this end, Commissioner Califf commissioned external agency experts to conduct a comprehensive evaluation of the Agency’s Center for Tobacco Products (CTP), given the growing concerns from a chorus of industry and public health stakeholders about CTP’s approach to the regulation and enforcement of tobacco products. In Commissioner Califf’s statement, he noted that CTP has “greater challenges . . . ahead as we . . . navigate complex policy issues and determine enforcement activities for an increasing number of novel products that could potentially have significant consequences for public health.” The external agency experts selected to conduct the comprehensive evaluation of CTP was The Reagan-Udall Foundation (Reagan-Udall or the Foundation)^[1]. Reagan-Udall formally began its operational evaluation of CTP in September 2022.

A.      The Report

In December 2022, Reagan-Udall published their final operational evaluation (Reagan-Udall Report or Report) of CTP, titled, Operational Evaluation Of Certain Components Of FDA’s Tobacco Program (hereinafter the “Report”). The Report includes fifteen recommendations across four program areas: Regulations and Guidance, Application Review, Compliance and Enforcement, and Communication with the Public and Other Stakeholders. Id. at 2. The Foundation’s recommendations for each program area are detailed in the following sections.

1.      Regulations and Guidance

The Report notes that CTP has been active since its creation, “issuing numerous advance notices of proposed rulemaking, proposed rules, final rules, and guidance documents.” However, the Foundation heard from stakeholders that they felt that “certain foundational requirements are still lacking.” Id. at 17. The two primary concerns among the stakeholders were the “lack of clarity regarding how the Agency is applying the [Appropriate for the Protection of the Public Health] standard” and the need for “more specific guidance on the factors CTP weighs while evaluating applications.” Id. Stakeholders provided a laundry list of areas where they would like “more specific guidance,” including modified risk tobacco products; standards for the maximum yields of specific toxicants; testing, reporting, and possible disclosure of tobacco product constituents, ingredients, and additives; nicotine levels in combustible tobacco products; and science needed to support product applications. Id.  

The Report particularly notes that “regulations and product standards [are] time-consuming and resource-intensive,” while guidance documents take less time to craft and can be used to “convey FDA’s expectations for matters where a binding regulation may not be needed or where the Agency’s thinking is evolving and is not yet ripe for inclusion in a binding regulation.” Id. However, the Report goes on to warn that CTP’s process for regulations and guidance development and publication is, at “the outset,” insufficiently informed, “about the needs of CTP staff and various stakeholders.” Id. As such, CTP needs to “strengthen the quality and usefulness of its policy development function by gathering more input from staff and the public at the front end of the process.” Id.

To this end, the Report made one recommendation—albeit with several additional caveats. The Report recommends that 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 the Center establishes.” Id. In particular, the policy development program should:

• Collaboratively develop, publish, and maintain a comprehensive policy agenda listing foundational and other regulations and guidances needed to implement the Tobacco Control Act, including timeframes for development.

• Create an elevated CTP Office of Policy, incorporating the current Office of Regulations functions, with broader responsibility and authority to provide strategic policy leadership and direction across all Center functions.

• Use regulations strategically to prescribe categorical principles and standards to reduce the need for case-by-case determinations in application reviews and compliance and enforcement matters.

• Review and expand the use of existing guidance to provide clarity, predictability, and transparency concerning scientific standards for application review, and update the guidance as the science and CTP’s application of that science evolves. Id. at 17-18.

2.      Application Review

The Report Panel heard from stakeholders that the Agency’s review process needed a “new approach.” Id. at 18. The Report goes on to note that some application processes are “perceived” as working well, such as the SE pathways, while others, such as the PMTAs, are generally perceived by stakeholders to be “ineffective and problematic.” Id. Concerns among stakeholders ranged from discontent with inadequate guidance and the “unsustainable” need for PMTA filings on every new product, especially considering that “thousands of product variations exist” and stakeholders’ belief that applications are handled inconsistently. Id. at 18-19. The Report specifically noted that the Panel did not receive “significant feedback concerning the SE or EX REQ pathways.” Id. at 19.

The Report continues by describing that because of the litigation surrounding the Deeming Rule’s finalization in 2016 —discussed in earlier chapters—CTP was “unable to issue PMTA regulations describing the requirements for submissions in advance of the deadline for application submission.” Id. As a consequence, CTP’s ability to review applications was compromised. Id.

To address these concerns, the Report made two sweeping recommendations that advance the general goal of “accelerat[ing], intensif[ing] and expand[ing] [CTP’s] efforts to establish regulatory policies and scientific standards for application review.” Id. at 20.

First, CTP “should develop a more clear and predictable framework for high-quality PMTA and MRTP application submission and reviews…” Id. at 19:

• Prioritizing timely development and completion of policies and scientific standards necessary for high-quality submissions.

• Simplifying, standardizing, documenting, and publicly disseminating review procedures.

• Further developing operations management capabilities.

• Clarifying supervisory roles and responsibilities for ensuring review quality and developing a process for the review team to timely identify novel or complex scientific issues that merit senior management attention or consultation with specialized subject matter experts.

• Providing more details in public summaries of Marketing Granted Orders and summaries at regular intervals of deidentified reasons why Marketing Denial Orders were issued to provide applicants more insight into CTP’s regulatory decision-making process. Id.

Secondly, CTP should “[c]onsider clarifying in formal policy the Center’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.” Id.

3.      Compliance and Enforcement

The Report spent a considerable length discussing and offered a number of recommendations concerning the current regulatory and enforcement environment. Id. at 21-22. The Report details that while the FDA has been busy addressing individuals who do not comply with the requirements of the TCA, “millions of [tobacco] products have entered the market without pre-market authorization and remain on the market today.” Id. at 21.

The Report continues to say that while companies have and continue to evade enforcement via a number of practices, CTP’s current inability to independently bring injunction or seizure cases^[2] creates an ultimately cumbersome and disjointed process. Id. at 22. While CTP can impose civil money penalties for TCA violations, the Report notes that this process is “cumbersome,” and the penalties may be “insufficiently low.” Id.

The Report’s final observations regarding CTP’s compliance and enforcement actions were critical of the Agency’s lack of transparent communication “regarding the reasons it has failed to clear the market of illegal products” and the seeming misalignment of CTP’s Office of Compliance and Enforcement’s actions with CTP’s largest enforcement priority— “illegal products on the market.” Id. at 23.

The Report makes five recommendations:

• 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.

• The Agency should consider whether statutory changes to provide streamlined processes for tobacco enforcement, including increased consequences for TCA violations, should be pursued.

• In addition to pursuing formal enforcement through DOJ, FDA should explore alternative approaches to achieving compliance.

• 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.

• 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. Id.

4.      Communication with the Public and Other Stakeholders

A significant theme of the Report is the need for CTP to engage with the public and stakeholders. The Report notes that CTP’s role is not only protection via regulation but also via educating the public, “especially young people.”^[3] The Foundation heard from many stakeholders who wanted clarifying communication from CTP regarding vaping, harm reduction, and the relative risk of tobacco products, particularly as it pertains to “help[ing] adult consumers make informed decisions.”^[4] Stakeholders also expressed discontent regarding CTP’s lack of “clear communication about its plans to address products marketed without the required PMTA.” Id. at 26.

To advance CTP’s communication with the public and stakeholders, the Report made three recommendations:

• CTP should obtain public input during the development of the Strategic Plan and communicate with stakeholders and the public about the Center’s strategic objectives as well as key messages, and metrics for measuring plan effectiveness.

• 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.

• CTP should improve the overall transparency of the tobacco program, particularly with respect to the regulatory process and its scientific underpinnings. Id. at 26-27.

B.      CTP’s Response to the Reagan-Udall Foundation Evaluation Report

On February 24, 2023, Brian King, the Director of FDA’s Center for Tobacco Products, released a press release titled, An All-Center Approach: CTP’s Response to the Reagan-Udall Foundation Evaluation Report (the “CTP Response”). CTP’s response broadly summarizes the center’s review of the Report’s recommendations and details CTP’s responses and next steps. In conjunction with the press release, CTP also launched a new website titled, Actions to Address Recommendations from the Reagan-Udall Evaluation of CTP, which provides more details about CTP’s plans for addressing the recommendations.

1.      Cross-Cutting Responses

Effective as of the press release’s publication, CTP is initiating the development of a comprehensive 5-year strategic plan. A central tenet of the plan will be a focus on advancing health equity as a means of addressing “tobacco-related disparities across CTP’s programmatic portfolio.”

Additionally, taking a cue from stakeholder comments, CTP plans on being “transparent about . . . key activities” by appointing “internal transparency liaisons within each CTP Office” and sharing routine updates on the strategic plan’s development. CTP anticipates issuing interim strategic goals by Summer 2023 and a final strategic plan to the public by December 2023.

2.      Responses to Science and Application Review Recommendations 

According to the press release, CTP has started developing a more efficient framework for high-quality tobacco product application reviews in response to the Report’s observation and recommendation. Part of this effort will include posting scientific policy memos and reviewer guides and holding more frequent meetings of the Tobacco Products Scientific Advisory Committee (TPSAC)^[5]. CTP also recently announced that the Office of Science has appointed a new Director, Dr. Matthew Farrelly.  

3.      Responses to Regulations and Guidance Recommendations

CTP announced that effective immediately, CTP was initiating a new hiring process to create a new policy unit within the Office of the Center Director. This new unit would “be responsible for providing overall policy coordination across CTP.” Additionally, in a node to the Report’s heavy focus on transparency, CTP plans to “develop, publish, and maintain a comprehensive policy agenda of rules and guidances that are in development or planned for development at the center.” CTP noted that an initial policy agenda was expected by the end of 2023, with reports made annually thereinafter.

4.      Responses to Compliance and Enforcement Recommendations

In the release, CTP touted the number of warning letters, permanent injunction filings, and the Center’s first-ever civil money penalty complaints. However, drawing on the Report’s observation that FDA does not have independent litigation authority, the release notes that FDA will be convening a summit of officials from the Department of Health and Human Services (HHS), FDA, and DOJ. Moreover, CTP plans to consider if statutory changes are needed for CTP to enforce the law fully and if alternative approaches to achieve compliance (i.e., outside DOJ assistance) are possible.

CTP also plans to create a new website that will contain all “enforcement activities for products that are illegally marketed without FDA authorization,” as well as create a searchable database for tobacco products that have an FDA marketing order. Additionally, CTP plans to be in contact with trade groups and other industry stakeholders in order to “keep them apprised of the development of new enforcement priorities and updates, and enhance FDA’s Tobacco Product Marketing Order webpage.”

5.      Responses to Public Education Campaigns Recommendations

While in their response, CTP draws attention to current public education campaigns they are conducting, they do recognize that “there are always opportunities for continued improvement.” Without describing specifics, CTP plans to “explore new ways for soliciting and considering public input on our campaign program” and 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.”^[6]

FOOTNOTES

[1] The Reagan-Udall Foundation, formally known at the Reagan-Udall Foundation for the Food and Drug Administration, is an independent 501(c)(3) organization created by Congress “to advance the mission of the FDA to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety.” About Us, Reagan-Udall Found. for the Food & Drug Admin., https://reaganudall.org/about-us (last visited Mar. 8, 2023).

[2] The Report states, “[t]he U.S. Department of Justice (DOJ) is charged with bringing injunction or seizure cases on behalf of FDA.” Id. at 22.

[3] The Report stresses that the CTP “could use its communications function more strategically to achieve its overall public health goals.” Id. at 26.

[4] In the additional discussion regarding the recommendations, the Report noted that stakeholders’ “[v]iews on CTP’s public education campaigns varied.” Id. at 26-27.

[5] The Tobacco Products Scientific Advisory Committee (TPSAC) advises the Agency’s Commissioner on responsibilities as they relate to the regulating tobacco products. See Tobacco Products Scientific Advisory Committee, U.S. Food & Drug Admin. (Sept. 26, 2022), https://www.fda.gov/advisory-committees/committees-and-meeting-materials/tobacco-products-scientific-advisory-committee.

[6] CTP Response.