Litigation challenging FDA’s cursory denial of thousands of premarket tobacco product applications (PMTAs) continues. We have previously written about electronic nicotine delivery system (ENDS) manufacturers’ claims that the Food and Drug Administration (FDA) acted arbitrarily and capriciously by, among other things, denying their PMTAs without fully considering all elements of the applications. Numerous appeals of PMTA denials are pending before several different federal appellate courts, and decisions continue to trickle in.
In a recent twist, the Eleventh Circuit Court of Appeals split from the Fifth and D.C. Circuits and set aside plaintiffs Bidi Vapor and five others’ marketing denial orders, sending their applications back to FDA for reconsideration. The question before the court was whether it was arbitrary and capricious for FDA to deny the companies’ PMTAs without considering their marketing and sales-access-restriction plans – a required element of all PMTAs. The court took issue with the fact that FDA represented multiple times that “marketing and sales-access-restriction plans were relevant to its determination of whether the products were ‘appropriate for the protection of the public health.’” Then, in an internal memorandum brought to the court’s attention by the plaintiffs, the Office of Science indicated that, in order to efficiently move through the millions of applications it had received for flavored ENDS products, reviewers would not consider the marketing plans and instead focus on the presence or absence of randomized controlled trials or longitudinal cohort studies.
FDA justified its strategy by stating that it was not aware of access restrictions that “have been successful in sufficiently decreasing the ability of youth to obtain and use [ENDS].” Chief Judge Pryor, delivering the opinion of the court, compared FDA’s strategy to “a federal district court judge refusing to hear a convicted criminal defendant at sentencing about his reformation plans or the impact on his family because, in the judge’s experience, he found that those things do not matter.”
This decision breaks from the Fifth Circuit and the D.C. Circuit, which, on consideration of similar appeals by Wages and White Lion Investments and Prohibition Juice Co., respectively, each upheld FDA’s marketing denial orders despite FDA’s decision not to consider those companies’ marketing plans. Appeals of marketing denial orders are still pending before the Third, Fourth, Seventh, Ninth, and Tenth Circuits. The U.S. Supreme Court denied an emergency application for stay of enforcement of a marketing denial order, upholding a similar denial by the Sixth Circuit, but has yet to weigh in on the substance of any ENDS applicant’s appeal. The Supreme Court is more likely to take up the merits of one of these cases if the circuit courts of appeals are divided in their rulings, and the Eleventh Circuit’s opinion is the first instance of such a circuit split.
As the courts continue to issue decisions on appeals challenging FDA’s marketing denial orders, stay tuned for further developments.