FDA's Tobacco Regulatory Efforts Face Congressional Scrutiny

WASHINGTON, D.C. — The U.S. House of Representative's Committee on Oversight and Accountability plans to conduct an oversight investigation of the regulation of tobacco and nicotine products by the FDA's Center for Tobacco Products (CTP), according to a March 28 letter to FDA Commissioner Robert Califf from Rep. James Comer, committee chairman.

In July 2022, the Reagan-Udall Foundation reviewed the operational aspects of regulating tobacco products and how the CTP proposes and adopts regulations and guidance, reviews product marketing applications, obtains compliance and undertakes enforcement, and communicates with the public and other stakeholders. Among the recommendations from that review were that the FDA shift from a reactive to a proactive approach.

The House committee letter states that the CTP has not clearly stated the most basic elements of the FDA's tobacco and nicotine regulatory programs, according to a brief by the National Association of Tobacco Outlets (NATO). The result has been "confusion, inefficiency, litigation and suspicions of political interference."

"CTP has fostered uncertainty in the marketplace and has allowed unsafe and unregulated products to proliferate," Comer stated in the letter.

The letter also called out "severe deficiencies in [the] FDA's enforcement capabilities," noting that if products are allowed to enter or stay on the market without authorized application, the regulatory effort would appear "pointless." If unlawful products remain available, the FDA's failure to remove them could be misinterpreted as authorizing lawful marketing, according to NATO.

On behalf of the committee, the letter requests that the FDA provide certain documents and schedule a briefing of committee staff on these issues.

The full letter is available here.

On March 29, the FDA published on its website a more detailed action plan in response to the Reagan-Udall Foundation report's recommendations. The FDA intends to:

• Create and implement a five-year strategic plan with a goal of releasing the plan by December 2023;
• Obtain public input on the strategic plan;
• Develop a strategy for enhanced transparency and information sharing within both the FDA and with the public;
• Develop a more efficient framework for high-quality premarket tobacco product application product reviews;
• Solicit public feedback on potential policies related to compliance and enforcement;
• Convene a summit of the U.S. Department of Health and Human Services, the FDA and the Department of Justice to discuss enforcement issues; and
• Develop additional content for the FDA's website to effectively educate industry and encourage voluntary compliance with the FDA's premarket tobacco product application requirements.