FDA's Tobacco Regulatory Efforts Face Congressional Scrutiny
A letter from the House of Representative's Committee on Oversight and Accountability requests documents and a briefing.
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.