A three-judge panel of the U.S. Court of Appeals for the D.C. Circuit on December 10 unanimously rejected an Administrative Procedure Act (APA) challenge to the Food and Drug Administration’s (FDA) process for approving new e-cigarette products. An e-cigarette manufacturer joined with an e-cigarette advocacy group to sue the FDA, arguing that the agency violated the APA by not providing an easier pathway for new e-cigarette products to be approved for marketing and sale.
The court ruled that requiring companies to show that selling an e-cigarette product was consistent with public health did not fail the APA’s arbitrary-or-capricious test, which instructs courts reviewing agency actions to invalidate those they find to be “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.” The judges argued in the opinion that the plaintiffs’ “wholesale objection is to Congress’ design, not to any arbitrariness on the FDA’s part in carrying it out.”
Judge Cornelia T.L. Pillard, and Obama appointee, wrote the opinion for the D.C. Circuit panel. The other judges on the panel were Judith Rogers, a Clinton appointee, and David Sentelle, a Reagan appointee.
Click here to learn more about the Administrative Procedure Act.
Click here to learn more about the D.C. Circuit.
Click here to read the full opinion.