Panel Offers Critique of FDA’s Tobacco Unit

FDA Issues Proposed Rule for Premarket Tobacco Product Applications

Back in July 2022, U.S. Food and Drug Administration (FDA) commissioner Robert M. Califf ordered an external review of the FDA’s tobacco unit [read more here]. A report of that review, carried out by the Reagan-Udall Foundation, was released on Dec. 19, 2022. The panel was tasked with assessing the tobacco program’s regulatory processes and agency operations relating to regulations and guidance, application review, compliance and enforcement and communication with the public and other stakeholders.

According to the report, the FDA’s tobacco unit is “reactive and overwhelmed” and its inconsistent regulation efforts have led to new programs, including the spread of unauthorized e-cigarette products. The panel made the recommendation that the FDA’s leaders needs to work on clarifying its goals and objectives. It was also implied that the morale of the FDA’s staff is suffering due to the agency’s lack of focus.

In a press release, FDA commissioner Califf issued the following statement:

“Over the next several weeks, Center for Tobacco Products leadership will closely review the report’s findings and recommendations, in consultation with the Commissioner’s Office, to determine next steps and will provide an update by early February. Importantly, since joining the FDA as the director for the Center for Tobacco Products in July, Brian King, Ph.D., M.P.H., has continued to build on the work of his predecessors while also implementing changes to best position the center for success moving forward.

“This work is particularly critical as we focus on preventing initiation, while also helping people quit, especially the deadliest form of tobacco use, combustible tobacco products. Despite meaningful declines in cigarette use over the past several decades, nearly 500,000 Americans still die every year from cigarette smoking. Additionally, with more than 3 million youth reporting current use of a tobacco product in 2022, and e-cigarettes being the most used product, we risk another generation becoming addicted to these products. 

“While we consider potential improvements to our operations and processes for tobacco product regulation, we are committed to communicating any changes with clarity and transparency for our many stakeholders. For the FDA to build on this work in the ever-evolving tobacco marketplace, it’s also critical to ensure CTP has what it needs to adequately and efficiently address the recommendations in the report. 

“We’ve made important progress and reached science-based regulatory decisions across a broad array of products in the 13 years since Congress tasked the FDA with regulating tobacco products. And as I’ve noted previously, even greater challenges and opportunities lie ahead as we determine how the agency will navigate complex policy issues and determine enforcement activities for an increasing number of novel products that could potentially have significant impact on public health.

“The hardworking and talented individuals in CTP, and across the FDA, deserve the best support possible so they can fulfill their strong commitment to public health – and the American public that we serve. It is my belief that this effort will continue strengthening the FDA and better position the agency to deal with the many immediate public health issues related to tobacco products we are facing, while preparing for challenges and opportunities in the future.”

The panel also commented on the ongoing barrage of legal litigation that the FDA has had to deal with. More money is needed so that the agency can handle these lawsuits stemming from missed deadlines and its slow review of e-cigarette applications.