The Committee on Oversight and Accountability is investigating the Food and Drug Administration’s regulation of tobacco and nicotine products through its Center for Tobacco Products (CTP).
The recent evaluation of the CTP by the Reagan-Udall Foundation found that the center has not clearly set out the most basic elements of its tobacco and nicotine regulatory programs, according to a March 28 letter from Chairman of the Committee on Oversight and Accountability James Comer (R-Kentucky) to FDA Commissioner Robert Califf.
“This has resulted in confusion, inefficiency, litigation and suspicions of political interference,” Rep. Comer said. “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 also said politics influenced the CTP’s decisions, rather than science, and he demanded the FDA provide a well-publicized list of authorized tobacco products for retailers to reference.
The FDA did not respond to CSP’s request for comment on the letter Thursday. In February, CTP Director Brian King laid out changes the center planned on making in response to the Reagan-Udall report.
In his letter, Comer highlighted the FDA’s failure to meet the court-mandated timeline of reviewing premarket tobacco product applications (PMTAs). The FDA received applications covering nearly 6.7 million products, most e-cigarettes, by the Sept. 9, 2002, deadline, and even more after the deadline and after the agency was given authority over non-tobacco nicotine products. The FDA said it has made determinations on more than 99% of applications at this point.
But, as Comer states, more than 30 companies have filed legal actions over the FDA’s marketing denial orders (MDOs). One court found the agency’s denials on electronic nicotine delivery system (ENDS) products to be arbitrary and capricious, claiming the FDA did not adequately consider the companies’ marketing plans. The lack of transparency results in substantial market uncertainty, proliferation of unregulated products and enforcement failures, he said.
“CTP appears to be unable to perform its basic functions and ensure that Americans have access to products that have the potential to lower the rate of smoking-related disease and death,” Comer said.
Retailers also need a well-publicized list of authorized tobacco products, he said.
“Publishing a list of authorized and—if reflective of FDA enforcement discretion decisions—products with pending PMTAs, is an obvious step FDA can and should take immediately. We also urge FDA to devote the necessary resources to take those products most attractive to underage users off the market as quickly as possible,” Comer said.
He also stated “deep concerns” that the CTP’s decisions have been influenced by political concerns rather than scientific evidence, based on comments from FDA staff collected by the Reagan-Udall Foundation.
One commenter, for example, said: ““[i]n cases where reviews are finished and scientific decisions are made, they are also overruled by political agendas and pushed to change decisions.”
Comer requested six sets of documents from the FDA, including all FDA staff comments submitted to the Reagan-Udall Foundation and documents that describe the specific analytic process FDA uses to apply the “appropriate for the protection of public health” standard. It also asked to schedule a meeting with the committee no later than April 4.
The Committee on Oversight and Accountability is the principal oversight committee of the U.S. House of Representatives and has broad authority to investigate any matter at any time under the rules of the House.
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