The Reagan-Udall Foundation engaged an independent expert panel to evaluate the operational aspects of the U.S. Food and Drug Administration’s (FDA) tobacco regulatory program, as directed by FDA Commissioner Robert Califf’s public statement on July 19, 2022, according to the National Association of Tobacco Outlets (NATO).
In the statement, Commissioner Califf stated that “the agency has confronted a series of challenges that have tested our regulatory frameworks and stressed the agency’s operations, prompting me to take a closer look at how we do business.”
The expert panel selected by the Reagan-Udall Foundation was comprised of former FDA leaders and regulatory strategists as well as process improvement specialists, said NATO.
The expert panel did not review the actual tobacco-related policies put forth by the FDA’s Center for Tobacco Products (CTP), but rather carried out an evaluation process that focused on how the agency operates regarding the proposal and adoption of regulations and guidance, product application review, compliance and enforcement, and communication with the public and other stakeholders.
In December of 2022, the expert panel issued its report titled “Operational Evaluation of Certain Components of FDA’s Tobacco Program.” From an overall perspective, NATO said, the report included, in part, the following findings:
- The application of new tobacco regulations to an existing industry is difficult, and the FDA’s task has been made more difficult due to the large volume of product applications, changes in the FDA’s leadership and numerous lawsuits brought against the agency. Some of these challenges have resulted in part due to the FDA’s own policy choices.
- Industry members have experienced a lack of consistent implementation of the FDA’s tobacco policies, particularly with respect to less harmful tobacco products.
- The Family Smoking Prevention and Tobacco Control Act that authorized the FDA to regulate tobacco products was structured to create a pre-market authorization framework for tobacco products but, in reality, the FDA operates in a post-market regulatory environment.
- Since being created in 2009, the FDA’s CTP has issued 16 proposed rules/regulations, 16 final rules/regulations, 35 draft guidance documents and 50 final guidance documents as well as acted on 96% of some 8.9 million tobacco-derived nicotine product PMTAs with approximately 329,000 tobacco-derived nicotine products remaining under PMTA review.
Millions of tobacco products, primarily electronic cigarette and nicotine vapor products, have entered the market without pre-market authorization and remain on the market today, and other new products continue to enter the market without the required FDA authorization, said NATO. Based on its review, the expert panel has made a number of recommendations for the FDA to consider implementing to improve the operational aspects of regulating tobacco products. Some of these recommendations are as follows:
- The CTP needs to pivot from a reactive mode to a proactive mode by creating a strategic plan that identifies strategic objectives and puts into place operational changes over the next five years to achieve the objectives.
- The CTP should increase its use of the Tobacco Product Scientific Advisory Committee to obtain expert input on scientific issues and policy development, including regulations, guidance and data needed for effective product regulation.
- The CTP should develop a more clear and predictable framework for high-quality PMTA and Modified Risk Tobacco Product (MRTP) applications by setting scientific standards for such applications, simplifying and standardizing application review procedures, and providing more details in public summaries of orders authorizing or denying a product application.
- The FDA should seek higher level Biden Administration involvement to establish a multi-agency task force to make enforcement of the tobacco laws a government-wide priority, particularly to address the marketing of illegal tobacco products and the risks of youth tobacco use.
- The CTP should utilize public communications to provide greater transparency about the
agency’s approach to compliance and enforcement, including posting and maintaining a
list of legally marketed products to facilitate voluntary compliance and discourage the sale
of illegal products by manufacturers, wholesalers and retailers.
According to NATO, in response to the Reagan-Udall Report, FDA Commissioner Califf issued a public announcement which states that the CTP 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.”
