The FDA Center for Tobacco Products (CTP) will be the subject of an investigation by the influential U.S. House Oversight and Accountability Committee. Representative James Comer, a Republican from Kentucky and the committee's chairman, revealed the investigation today.
Rep. Comer gave several justifications for the probe in a letter to FDA Commissioner Robert Califf, the most of which were drawn from critiques made in the most recent Reagan-Udall Foundation assessment of the agency's tobacco control initiatives. Numerous flaws in the CTP's procedures and public and stakeholder communications were discovered throughout that review.
"CTP has not clearly set out the most basic elements of its tobacco and nicotine regulatory programs, according to a recent evaluation of CTP by the Reagan-Udall Foundation (RUF)," Comer wrote to Commissioner Califf. Confusion, inefficiency, lawsuits, and allegations of political meddling are the outcomes of this. CTP has increased market ambiguity and permitted the spread of dangerous and uncontrolled goods. Thus, in order to promote openness and make sure the CTP is carrying out its mandate, we are looking for records and information about its operations.
Comer requests that the FDA notably supply:
- Comments from FDA employees on the Reagan-Udall assessment
- All correspondence pertaining to tobacco or nicotine policy with the White House and the Department of Health and Human Services (HHS)
- Records and correspondence pertaining to CTP policy between the FDA and the Centers for Disease Control and Prevention (CDC)
- Records and exchanges of information about CTP policies between the FDA and "public health advocacy groups"
- All records outlining the precise analytical method the FDA employs in order to apply the "appropriate for the protection of public health" requirement
- All correspondence and records pertaining to the FDA's enforcement actions to take illicitly marketed nicotine or tobacco products out of stores
The committee will most likely host public hearings in the upcoming months, perhaps providing a platform for consumer advocates and the vaping industry to discuss how the FDA's disorganized regulatory framework has harmed small companies and users of low-risk nicotine products. Hearings may also shed light on the agency's response to political pressure from the White House, Congress, and organizations such as the Campaign for Tobacco-Free Kids.
Advocates for tobacco harm reduction (THR) and vapers are familiar with many of the questions Comer is posing. The FDA's reluctance 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" is one of the issues he raises, along with political meddling with the CTP's scientific judgments.
In his letter, Comer makes frequent references to "tobacco and nicotine products," purposefully drawing a distinction between the real tobacco-containing products that the CTP was designed to control and vaping and other non-combustible products. With its 2016 Deeming Rule, the agency gave itself the power to control all goods that contain nicotine derived from tobacco (and classified them as "tobacco products").
Rep. Comer highlights "deficiencies in FDA's enforcement capabilities" in his letter to Califf, urging the agency to release a list of approved products and items under review that shops can refer to. Additionally, he calls on the FDA to "devote the necessary resources to remove those products from the market as quickly as possible that are most attractive to underage users."
Comer is a farmer and a former commissioner of agriculture for the state of Kentucky. His district is in western Kentucky and produces tobacco. North Carolina is the largest state that grows tobacco, followed by Kentucky. Ever since he was elected to Congress in 2016, Comer has been an advocate for farmers growing tobacco and hemp.
