Critics of FDA’s Tobacco Program Vindicated by Reagan-Udall Foundation Review

On Monday, the Reagan-Udall Foundation released a highly anticipated report evaluating the Food and Drug Administration’s Center for Tobacco Products (CTP). The report highlights a stunning lack of direction and transparency within CTP that hinders the agency’s ability to effectively protect public health.

The Reagan-Udall panel called out a number of FDA’s failures in their report that AP News described as “blistering”. CTP’s regulation of tobacco and reduced-risk nicotine products is described as “reactive and overwhelmed”, and the report explicitly stated that CTP has “struggled to function as a regulator.”

Americans for Tax Reform submitted written comments to Reagan-Udall and Tim Andrews, ATR’s Director of Consumer Issues, spoke in front of the panel at a Reagan-Udall session in October. In the submissions, ATR focused on FDA’s lack of transparency and predictability and called out FDA’s atrocious handling of the six-million-plus Premarket Tobacco Product Applications (PMTA) that have been submitted for vaping products. The report agreed with ATR, calling on CTP to “provide clarity, predictability, and transparency.” ATR’s recommendation that CTP adopt product standards which was also recommended in in the Reagan-Udall report. Further, the report said that FDA must do better regarding PMTAs in addition to developing a comprehensive plan of priorities, direction, goals, and objectives.

The panel recognized that FDA’s regulatory ineptitude is “in part due to some of its own policy choices”. The report correctly asserted that the policy issues CTP deals with have “profound social impacts” and noted “at times, a lack of clarity about the distinction between, and the intersection between, policy and science has created controversy within CTP.” Memos obtained just last week by Filter’s Alex Norcia showed just that, as CTP’s Office of Science recommended authorizing a menthol-flavored vaping product before CTP Director Brian King stepped in, ultimately resulting in FDA denying the product’s marketing authorization.

The report makes clear that FDA is failing to fulfill their mandate to protect public health due to their own mistakes and internal issues. Oversight of FDA’s Center for Tobacco Products must be a priority for the new Republican House Majority in order to reestablish public trust in the agency and improve public health.