The D.C. Circuit decided four administrative law cases last week. This post focuses on Cigar Association of America v. FDA. The district court (Mehta, J.) vacated an FDA regulation on the ground that it arbitrarily and capriciously applied to “premium cigars.” In an opinion by Judge Randolph, the D.C. Circuit agreed on the merits. But it reversed and remanded for briefing on the meaning of “premium cigars.” 

In 2016, the FDA promulgated a rule “deem[ing]” premium cigars to be “subject to” the Family Smoking Prevention and Tobacco Act of 2009. That rule triggered pre-market approval, disclosure requirements, age limits, health warnings, and restrictions on sales. In the preamble, the FDA faulted commenters for not including data about the risks of premium cigars. The district court then faulted the FDA for failing to respond to a study and a monograph cited by commenters.

The appeal presented three issues of note: the evidentiary burden in notice-and-comment rulemaking, remand without vacatur, and the process for defining an undefined term in an unlawful rule.

First, the opinion enforced the usual outer limits on an agency’s ability to shift the evidentiary burden to commenters. The panel concluded that the rule was arbitrary and capricious in two ways. First, it rested on a “false factual premise” that there was no evidence differentiating premium cigar smokers. Second, the FDA failed to consider relevant data by responding to the study and monograph. The FDA could shift the burden to commenters to identify support for exempting premium cigars. But consistent with black-letter administrative law, the FDA had to respond to commenters’ evidence.

Second, the panel held that the rule should be vacated. Judge Randolph is a longstanding critic of remand without vacatur in APA cases. Although the panel dutifully applied circuit precedent, it did clarify that remand without vacatur is not “automatically” required when user fees are involved. The court explained that, in this case, there was no need for “an unwinding of past transactions” and thus no problem vacating the rule.

Third, the panel dealt with the “concerning” fact that the FDA never defined “premium cigars,” even though it “was, or should have been, an issue in the rulemaking.” The D.C. Circuit remanded for briefing on a definition (or for the FDA to begin a new rulemaking).

The D.C. Circuit also decided three other cases. In Hecate Energy LLC v. FERC, it held that the petitioner lacked standing to challenge a regional transmission grid operator’s comprehensive reform package. In Human Rights Defense Center v. U.S. Park Police, the court held that FOIA Exemption 6 did not cover the names of officers involved in three settlements and that the district court erred by clawing back the inadvertent disclosure of two claimants’ names. And in America First Legal Foundation v. U.S. Department of Agriculture, the court held that agency strategic plans submitted to the White House are protected by the presidential communications privilege.