Recent Projects – FDA

In 2023, the U.S. Food and Drug Administration (FDA) modified its Risk Evaluation and Mitigation Strategies for mifepristone to remove an in-person dispensing requirement (2023 REMS). That action is the subject of this litigation, in which Louisiana argues that the 2023 REMS was arbitrary and capricious. Following the change in presidential administration, the FDA chose not to defend the action on the merits. Instead, in September 2025, Health and Human Services Secretary Robert F. Kennedy, Jr., and then-FDA Commissioner Martin A. Makary stated that the FDA’s decision suffered from a “lack of adequate consideration” and announced that it would reconsider the 2023 REMS. Our amicus brief, filed in the U.S. Court of Appeals for the Fifth Circuit, explains that these statements should receive no weight in the Court’s analysis because they postdate the agency’s decision, are outside the administrative record, and are conclusory and fail to grapple with the agency’s prior findings. 

Policy Integrity submitted comments to the FDA regarding its proposal to require front-of-package (FOP) nutrition labeling. FDA proposes to require FOP nutrition labeling to help consumers evaluate food products at a glance. We submitted comments urging FDA to expand on its explanation of its statutory authority for the proposed rule and to bolster its analysis of how the rule will deliver net benefits for consumers and public health.

The Food and Drug Administration (FDA) is proposing to place new, more effective health warning labels on cigarette packages and advertisements. We submitted comments supporting the proposal and suggesting ways the agency can strengthen its assessment of the new labels’ costs and benefits.

In February, the Food and Drug Administration (FDA) proposed a rule that would strengthen regulations for sunscreen products. We submitted comments explaining how FDA can improve its analysis of the rule’s impacts.

As part of a larger plan to revise regulations on tobacco and nicotine, the U.S. Food and Drug Administration (FDA) is considering limiting the nicotine content of combusted cigarettes in an effort to make them less addictive. In response to FDA’s advance notice of proposed rulemaking on this potential policy, our comments offered advice, drawing from recent economic scholarship, on how the agency could assess a nicotine limit’s costs and benefits.

Federal agencies continue to request the public’s suggestions for rules to repeal or reform, tacitly implying that most regulations stifle economic growth. In comments to several agencies, we argue that regulatory review should consider the public benefits of regulation, not just the costs to regulated industries, and should prioritize review of rules for which actual costs and benefits diverge significantly from predicted costs and benefits. We also recommend that agencies develop prospective plans for regulatory review going forward. The agencies for which we recently filed comments include Small Business Administration, Department of Transportation, National Credit Union Administration, Food and Drug Administration, and Customs and Border Control Bureau.

We recently submitted comments in response to the Food and Drug Administration’s (FDA) proposed rule to restrict the use of sunlamps used for artificial tanning. We concluded that although the proposed rule takes a significant step in reducing the risks of artificial tanning, the FDA should strengthen the justification for this proposed rule.

Policy Integrity recently submitted public comments to the Food and Drug Administration (FDA) on its proposed rule to deem certain tobacco products, such as electronic cigarettes and cigars, subject to regulation. We believe the FDA may be dramatically understating the benefits from consumer behavior changes due to regulation of new tobacco products.