Reagan-Udall report calls for FDA to “identify and address the policy and scientific questions that underpin its regulatory framework” and invest in “more substantial engagement with stakeholders and the public.”
Last month, the Reagan-Udall Foundation delivered a damning review of the Food and Drug Administration’s (FDA) performance as a tobacco regulator.
Reagan-Udall, an independent body responsible for helping the FDA advance its mission, was tasked by FDA Commissioner Robert Califf with investigating what is going wrong at the agency after a series of embarrassing missteps concerning the regulation of safer nicotine alternatives, like e-cigarettes, to traditional cigarettes. Reagan-Udall convened an expert panel and received input from an array of stakeholders and scholars, including Michelle Minton, a senior fellow at Reason Foundation.
The final report, which found FDA “struggled to function as a regulator in part due to some of its own policy choices,” likely made for uncomfortable reading at the agency.
Since 2009, all tobacco products have been regulated by the FDA. Products not on the market before Feb. 2007, like e-cigarettes, must undergo an expensive and time-consuming application process to be authorized for sale. Before they can be approved, each product must demonstrate to the FDA it is “appropriate for the protection of public health” for both users and non-users.
Guy Bentley – Reason Foundation – 2023-01-24.