House Oversight Committee Will Probe FDA Tobacco Regulation

The powerful U.S. House Oversight and Accountability Committee will investigate the practices of the FDA Center for Tobacco Products (CTP). The chairman of the committee, Kentucky Republican Representative James Comer, announced the probe today.

In a letter to FDA Commissioner Robert Califf, Rep. Comer cited multiple reasons for the investigation, most based on criticisms leveled in the recent Reagan-Udall Foundation evaluation of the agency’s tobacco regulatory programs. That evaluation found numerous shortcomings in the CTP’s processes and communications to stakeholders and the public.

“A recent evaluation of CTP by the Reagan-Udall Foundation (RUF) found that CTP has not clearly set out the most basic elements of its tobacco and nicotine regulatory programs,” Comer wrote to Commissioner Califf. “This has resulted in confusion, inefficiency, litigation, and suspicions of political interference. CTP has fostered uncertainty in the marketplace and has allowed unsafe and unregulated products to proliferate. Therefore, we seek documents and information regarding CTP’s activities to enable transparency and to ensure the CTP is performing required functions.”

Comer specifically asks the FDA to provide:

·FDA staff comments to the Reagan-Udall evaluation
·All communications with the White House and Department of Health and Human Services (HHS) regarding tobacco or nicotine policy
·Documents and communications between the FDA and the Centers for Disease Control and Prevention (CDC) regarding CTP policies
·Documents and communications between the FDA and “public health advocacy groups” regarding CTP policies
·All documents that describe the specific analytic process FDA uses to apply the
“appropriate for the protection of public health” standard
·All documents and communications related to FDA’s enforcement efforts to remove
illegally marketed tobacco or nicotine products from retail locations

The committee will almost certainly hold public hearings in the coming months, possibly offering vaping industry and consumer advocates an opportunity to explain how the FDA’s chaotic regulatory process has hurt small businesses and people who use low-risk nicotine products. Hearings could also explain how the agency responded to political pressure from groups like the Campaign for Tobacco-Free Kids and their allies in Congress and the White House.

Many of the questions Comer wants answered are familiar to vapers and tobacco harm reduction (THR) advocates. He cites concerns over the agency’s mysterious standards for product authorization; political interference with the CTP’s scientific decisions; and the FDA’s refusal to “accurately communicate information regarding the relative risk that products, to include ENDS and smokeless products, pose—and do not pose—to the adult nicotine product user population.”

Comer repeatedly refers in his letter to “tobacco and nicotine products,” consciously separating vaping and other non-combustible products from the actual tobacco-containing products the CTP was created to regulate. The agency granted itself authority to regulate all products containing tobacco-derived nicotine (and defined them as “tobacco products”) with its 2016 Deeming Rule.

In his letter to Califf, Rep. Comer notes “deficiencies in FDA’s enforcement capabilities,” calling for the agency to publish a list of authorized products and products under review that retailers can consult. He also urges the FDA to “devote the necessary resources to take those products most attractive to underage users off the market as quickly as possible.”

Comer, a farmer and former state agriculture commissioner, represents a tobacco-producing western Kentucky district. Kentucky is the second-largest tobacco-growing state, after North Carolina. Comer has been an advocate for tobacco and hemp farmers since being elected to Congress in 2016.