The Reagan-Udall Foundation, an independent nonprofit 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” recently released its report Operational Evaluation of Certain Components of FDA’s Tobacco Program. The report was commissioned by FDA Commissioner Robert Califf in July, 2022 amid ongoing controversy over the agency’s handling of premarket tobacco product applications (PMTAs) for electronic nicotine delivery systems (ENDS) and a lack of enforcement against unlawful ENDS.

The Foundation solicited feedback from numerous internal and external stakeholders, including FDA employees, industry, and public health groups. Feedback was solicited via an online stakeholder portal, three days of virtual meetings, and one-on-one interviews with current and former FDA staff. The report focuses on four key areas: Regulations & Guidance, Application Review Process, Compliance & Enforcement, and Communication with the Public and Other Stakeholders.

Much of the contents of the report will come as no surprise to the industry stakeholders who have been navigating the premarket review process. The report observes that the Center for Tobacco Products (CTP) has failed to outline consistent standards by which it will evaluate PMTAs and other premarket review submissions, and has changed its review standards without adequate notice, making it difficult for applicants to prepare responsive applications. In particular, the report recommends that CTP clarify how it is applying the “appropriate for the public health” standard mandated by the Tobacco Control Act. This lack of clarity, the report points out, has led to the wave of litigation that is taxing the CTP’s already sparse resources meant to deal with the hundreds of applications still pending before the agency.

In addition, the Foundation’s panel observes that “the Agency has not been transparent regarding the reasons it has failed to clear the market of illegal products, or even whether its policy preference is to do so, contributing to stakeholder frustration and, in some situations, additional litigation.” The report recommends, for instance, that the agency disseminate a list of legally marketed products to make clearer to distributors and retailers which products can be sold and which cannot.

The following is a selection of the 12 recommendations made by the report:

  1. 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 the Center’s strategic objectives and plots an operational roadmap of the steps CTP will take over the next five years to achieve those objectives.
  • CTP should increase its use of the Tobacco Products Scientific Advisory Committee (TPSAC) to obtain expert input on scientific issues and policy development, including regulations, guidance, and data needs for effective product regulation.
  • CTP should develop a more clear and predictable framework for high-quality PMTA and MRTP application submission and reviews by, among other things, simplifying, standardizing, documenting, and publicly disseminating review procedures.
  • 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 violations, should be pursued.
  • 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.

While it is unclear if or when CTP will attend to these recommendations, at the very least scrutiny of CTP’s practices is increasing.  While CTP has recently started to more aggressively enforce premarket authorization requirements for ENDS companies, there is still much work to do, including enforcement against other deemed tobacco products that have not sought or received premarket authorization.  And FDA’s vaunted “public list” of deemed products with timely premarket submissions leaves much to be desired, leaving distributors and retailers with sparse information to determine whether particular tobacco products are compliant.  And it is clear, given the proliferation of litigation regarding FDA’s premarket determination and the lack of public information regarding FDA’s review standards, FDA has a long way to go to meet the Reagan-Udall Foundation’s and industry’s transparency goals.