U.S. Fifth Circuit Demands FDA Be Held Accountable for De Facto E-Cigarette Ban

According to foreign media reports, the Fifth Circuit noted that the U.S. Food and Drug Administration has 'not approved ' a single application to market non-tobacco-flavored e-cigarettes. This means it has denied more than 355,000 such applications, equal to 99% of all applications submitted on time.

The court further pointed out that the FDA’s actions amount to a pattern. "The FDA has established a de facto rule banning all non-tobacco-flavored e-cigarettes without following the APA’s notice-and-comment requirements," the Fifth Circuit said, referring to the Administrative Procedure Act.

In this case, Reynolds Tobacco submitted an application to the FDA in 2020 to begin marketing various e-cigarette products. After ruling in 2021 that the company could market tobacco-flavored products, the FDA decided in January to deny the company’s application to market menthol products.

The U.S. Food and Drug Administration has proposed banning menthol cigarettes and flavored cigars in order to promote "health equity

The Fifth Circuit wrote: "The FDA inexplicably changed its position on menthol e-cigarettes in at least two key respects."

The FDA had previously indicated that Reynolds Tobacco did not need to submit long-term studies showing that its menthol e-cigarettes were more likely than tobacco-flavored e-cigarettes to help smokers quit. However, the lack of such evidence became the basis for the FDA’s denial of Reynolds Tobacco’s application."

Writing for the panel, the judge stated: "Reynolds Tobacco’s marketing plan specifically detailed these and additional measures," but the FDA still found them insufficient. The panel also included Judge Carolyn King and Judge Jerry Smith.

In addition, Jones wrote that "in dismissing Reynolds Tobacco’s evidence in its denial order, the FDA ignored its prior statements about the low prevalence of menthol e-cigarette use among youth and the substantial benefits to smokers switching from combustible cigarettes. This abrupt reversal further strengthens the possibility that the order was arbitrary, capricious, or otherwise unlawful."

The judges also determined that the U.S. Food and Drug Administration appeared to have adopted a de facto standard for e-cigarettes that excluded any non-tobacco flavor. Buried under thousands of applications for approval, the FDA circulated a memorandum nicknamed the "fatal flaw" memo to help speed up the process and deny most applications. It did so without the notice-and-comment procedures required under U.S. law.

Although the U.S. Food and Drug Administration has successfully defended some denial orders, its most notable retreat came last year in a case involving e-cigarette company JUUL. After denying the company’s applications to market all of its products, the FDA was sued and, following intervention by the U.S. Court of Appeals for the D.C. Circuit, was forced to reconsider its decision.