Fifth Circuit Takes FDA to Task for Unlawful De Facto Ban on Flavored E-Cigarettes
The FDA’s crackdown on flavored e-cigarettes and vapes likely flouts administrative law, a panel of Fifth Circuit judges ruled Thursday.
In 2016, the Food and Drug Administration deemed e-cigarettes to be “tobacco” products, thus giving itself sweeping legal authority to regulate. Since then, it has set up roadblock after roadblock for companies attempting to get vaping products approved and especially those that are not tobacco-flavored, reflecting the agency’s concern that these products will end up in the hands of teenagers. But various courts throughout the country have begun to notice the agency inexplicably shifting its criteria for approval and moving its goalposts, suggesting an abuse of administrative procedures.
“The FDA admits that it ‘has yet to grant’ a single application to market non-tobacco-flavored e-cigarettes. This means it has denied over 355,000 such applications, which amount to 99% of all timely-filed (applications),” the Fifth Circuit ruling read.
The court further noted that the FDA’s behavior constitutes a pattern. “[The FDA] has created a de facto rule banning all non-tobacco-flavored e-cigarettes without following APA notice and comment requirements,” said the Fifth Circuit, referring to the Administrative Procedure Act.
In this case, R.J. Reynolds Vapor Company (RJRV) submitted an application to the FDA in 2020 to begin marketing various vaping products. After ruling in 2021 that the company could market tobacco-flavored products, the FDA decided to deny in January the company’s application to market menthol-flavored products.
The Fifth Circuit has issued a stay of the FDA’s denial order pending a review on the merits in this case. The judges said RJRV is likely to succeed on the merits.
“The FDA inexplicably switched its position on menthol-flavored e-cigarettes in at least two crucial ways,” wrote the Fifth Circuit panel.
“The FDA’s prior representations were that RJRV need not submit long-term studies showing that its menthol-flavored e-cigarette was more likely than a tobacco-flavored e-cigarette to cause smokers to quit. Yet the lack of that evidence became the very basis on which the FDA denied RJRV’s application,” wrote the Fifth Circuit, explaining that the FDA’s second position-switch involved precautions aimed at preventing young people from using the product.
“RJRV’s proposed marketing plan accounted specifically for these and many more measures,” but the FDA still deemed them insufficient, wrote Judge Edith Jones on behalf of the panel, which also included Judge Carolyn King and Judge Jerry Smith.
Furthermore, Jones wrote, “when rejecting RJRV’s evidence in the Denial Order, the FDA brushed over its prior statements about the low popularity of menthol-flavored e-cigarettes among youth and substantial benefits for cigarette smokers who make the switch. . . . This sudden turnabout further reinforces that the Order is likely arbitrary, capricious, or otherwise unlawful.”
However, the panel did not stop there. The judges also determined that the FDA appears to have adopted a de facto standard for e-cigarettes that precludes the use of any non-tobacco flavor. Inundated with thousands of requests for approval, the FDA circulated a memo, nicknamed “Fatal Flaw,” to help it speed up the process and deny most applications. It did this without going through the necessary notice-and-comment process mandated by the APA.
While the FDA has successfully defended some denials, it conceded defeat most famously last year in a case involving the e-cigarette company Juul. After denying the company the ability to market all products, the FDA was sued and forced to reconsider its decision after the D.C. Circuit Court of Appeals intervened. The agency is still reviewing the Juul case.
Writing in the Volokh Conspiracy about the RJRV case, law professor Jonathan Adler noted that “when courts look carefully at how the FDA has been considering these applications, they discover an agency acting in an arbitrary and procedurally deficient fashion. This was not the FDA’s first loss in an e-cig case, and it will almost certainly not be the last.”
Adler added that the case tees up a potential review of the FDA’s behavior by the Supreme Court.
“The Fifth Circuit expressly disagreed with the analyses of other circuits that have rejected challenges to FDA product denials, setting up the possibility of Supreme Court review,” Adler wrote, referring to the Supreme Court’s role in resolving issues that different appellate courts disagree on.
Jones and her fellow judges said that whatever the desired goal is and even if Congress agrees with that goal, administrative agencies must be held accountable.
“It is of highest public importance that federal agencies follow the law,” they wrote.
“In sum, ‘there is generally no public interest in the perpetuation of unlawful agency action,’ . . . and there is no evidence that ‘Congress’s policy choice’ included an exemption from mandatory federal administrative procedures,” the judges concluded.
