Comer Probes FDA’s Tobacco and Nicotine Regulatory Programs Riddled with Uncertainty

WASHINGTON—House Committee on Oversight and Accountability Chairman James Comer (R-Ky.) is conducting oversight of the Food and Drug Administration’s (FDA) regulation of tobacco and nicotine products through its Center for Tobacco Products (CTP). The CTP has failed to effectively define and administer its tobacco and nicotine regulatory programs, resulting in industry uncertainty and unsafe products reaching the marketplace. In a letter to Commissioner Robert Califf of the Food and Drug Administration, Chairman Comer is requesting documents, communications, and a staff-level briefing related to the CTP’s activities to ensure it is performing its regulatory function as intended.

“The Committee on Oversight and Accountability is conducting oversight of the Food and Drug Administration’s (FDA) regulation of tobacco and nicotine products through its Center for Tobacco Products (CTP). 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. 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,” wrote Chairman Comer.

An evaluation of CTP by the Reagan-Udall Foundation (RUF) stated that CTP is 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. Amidst unclear policies, stakeholders have even reported having to guess what the CTP’s regulations might be. Congressional oversight is needed to bring transparency to CTP’s lack of clear policies that have resulted in market uncertainty, unregulated products, and enforcement failures.

“We have deep concerns that CTP’s decisions have been influenced by political concerns rather than scientific evidence. Comments from FDA staff to RUF, which are no longer available on its website, reflect such concerns. For example, one commenter 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.’ Another stated, ‘scientific disagreement is frowned upon, if not entirely suppressed,’ while a third said leadership was ‘…unsupportive of a reviewer’s fundamental duty to provide an unbiased review using the best available science.’ FDA must clearly identify and publicize what scientific criteria are necessary for a product, to include [electronic delivery system (ENDS) products] and smokeless products, to be authorized through the PMTA pathway and—where appropriate—the subsequent [modified risk tobacco product applications (MRTPs)] pathway,” continued Chairman Comer.

Read the letter to Commissioner Califf here.