On July 19, 2022, Food and Drug Administration (FDA) Commissioner Robert Califf issued a public statement directing the Reagan-Udall Foundation to engage an independent expert panel to evaluate the operational aspects of the FDA’s tobacco regulatory program.
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 carried out an evaluation process that focused on how the FDA’s Center for Tobacco Products (CTP) operates regarding the proposal and adoption of tobacco 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, 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, including the expansive regulation adopted in 2016 extending the agency’s regulatory authority to cigars, pipe tobacco, electronic cigarettes/vapor products, oral nicotine products and hookah tobacco.
Industry members have experienced a lack of consistent implementation of the FDA’s tobacco policies, particularly with respect to less harmful tobacco products and to finalize requirements and standards for reviewing pre-market tobacco applications (PMTAs).
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. That is, rather than not allowing new tobacco products with tobacco-derived nicotine to be sold while a PMTA is under review, the agency has exercised its enforcement discretion to permit such new tobacco products with tobacco-derived nicotine to be sold while the PMTA review process is taking place.
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.
Recommendations for FDA
Based on its review, the expert panel 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 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 clearer and more 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 task force could include the FDA, the Department of Health and Human Services, the Department of Justice, the Bureau of Alcohol, Tobacco, Firearms and Explosives, the Department of Homeland Security (Customs and Border Protection) and the Department of the Treasury (the Alcohol and Tobacco Tax and Trade Bureau).
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.
On Feb. 24, 2023, the FDA’s CTP issued a written response to the Reagan-Udall Foundation report recommendations, which included the following:
The CTP will initiate the development of a comprehensive five-year strategic plan with interim strategic goals published by the summer of 2023 and the full strategic plan to be released to the public by December 2023.
The CTP will hold more frequent meetings of the Tobacco Product Scientific Advisory Committee to obtain input on scientific issues related to regulatory tobacco products.
The CTP will convene a summit related to enforcement with senior officials from the Department of Health and Human Services, FDA and the Department of Justice.
The CTP plans to create a comprehensive webpage for all enforcement activities for products that are illegally marketed without FDA authorization.
FDA CTP Director Brian King stated in the response to the Reagan-Udall Foundation report that the agency is “committed to implementing these activities as expeditiously as possible” and that implementation “will not be at the expense of continued progress” on other FDA actions.
Thomas Briant is the executive director for the National Association of Tobacco Outlets (NATO). NATO’s mission is to enhance the business interests of retailers that sell tobacco products, support the legislative and regulatory interests of members, and encourage the expansion of the retail tobacco segment in a responsible manner.