The 5th Circuit Rebukes the FDA for Flouting the Law While Imposing a De Facto Ban on Flavored E-Cigarettes
The appeals court says regulators violated the Administrative Procedure Act when they tried to pull menthol vapes off the market.
Since 2020, when the Food and Drug Administration (FDA) began considering millions of applications from companies seeking permission to keep selling their nicotine vaping products, it has rejected almost all of them. All of the products it has approved are tobacco-flavored, reflecting the agency's conviction that other flavors, which are the ones that former smokers overwhelmingly prefer, are dangerously appealing to teenagers. Yesterday a federal appeals court said that pattern and the shifting regulatory criteria underlying it amount to an unacknowledged and probably illegal policy change: The FDA moved the goal posts for applicants without admitting it was doing that, let alone justifying its decision.
The U.S. Court of Appeals for the 5th Circuit was responding to a lawsuit by R.J. Reynolds Vapor Company (RJRV), which challenged the FDA's decision to reject an application for the company's menthol-flavored e-cigarettes while allowing tobacco-flavored versions to remain on the market. The court granted RJRV's request for a stay that bars the FDA from enforcing a "marketing denial order" it issued in January until the case is resolved. Explaining its reasoning, a unanimous 5th Circuit panel said the company was likely to prevail in arguing that the FDA had violated the Administrative Procedure Act (APA) in several ways.
"RJRV demonstrates that the FDA failed to reasonably consider the company's legitimate reliance interests concerning the need for longitudinal studies and marketing plans," 5th Circuit Judge Edith H. Jones writes. She adds that the FDA "failed to consider relevant evidence, inter alia, that youthful users do not like menthol-flavored e-cigarettes" and that it has "created a de facto rule banning all non-tobacco-flavored e-cigarettes without following APA notice and comment requirements."
To pass muster with the FDA, applicants must demonstrate that approval of their products is "appropriate for the protection of the public health"—the nebulous standard prescribed by the 2009 Family Smoking Prevention and Tobacco Control Act. In applying that standard, the 5th Circuit says, "the FDA inexplicably switched its position on menthol-flavored e-cigarettes in at least two crucial ways."
One change involved the kind of evidence that vaping companies had to submit. "Before the application deadline," Jones notes, "the FDA represented that long-term studies were likely unnecessary and that applicants had discretion to use [research on] 'products that consumers are most likely to consider[] interchangeable' when submitting 'comparative health risk data.'" In seeking approval for "flavored products (other than menthol)," the FDA told RJRV, it should submit evidence that the products "increase[d] the likelihood of complete switching among adult smokers relative to tobacco or menthol-flavored products."
The FDA "never told RJRV that similar evidence would be required" for its menthol Vuse Vibe e-cigarettes, Jones notes. The company "relied upon these representations when crafting its [applications] and supplemental filings." Yet when the FDA rejected the menthol application, it complained that "studies were not brand- or product-specific" and "thus did not demonstrate that [RJRV's] menthol-flavored new products are more likely to promote complete switching or significant cigarette reduction compared to tobacco-flavored products."
The FDA said RJRV's studies failed to "assess the impact of menthol-flavored ENDS [electronic nicotine delivery systems] on cigarette smoking switching behavior" such as "complete switching or significant cigarette reduction over time." It added that the company "did not submit evidence from a [randomized controlled trial] or cohort study showing that its menthol-flavored ENDS provide an added benefit to adult smokers in terms of complete switching or significant cigarette reduction over tobacco-flavored ENDS."
In other words, after indicating that manufacturers of menthol-flavored vapes did not need longitudinal or product-specific studies, the FDA suddenly decided that they did. "The lack of that evidence became the very basis on which the FDA denied RJRV's application," Jones notes.
The FDA's second about-face involved precautions aimed at preventing underage consumption. "Final guidance" that the FDA issued in 2020 "enumerated 'adequate measures' manufacturers could take 'to prevent minors' access' to ENDS," Jones writes. "These included: (1) age-verification barriers for retail websites; (2) enforcement monitoring programs with retailers; (3) a limit on the number of ENDS that can be purchased at once or over a period of time; and (4) a mystery shopper program." The guidance "also listed common ways manufacturers improperly target minors, such as advertising with 'social media influencers,' 'popular children's characters,' and kid-friendly 'cartoon or animated characters.'"
RJRV's application "accounted specifically for these and many more measures," Jones notes. Yet the FDA deemed the company's proposed "marketing restrictions and other mitigation measures" inadequate. "The only measures described as potentially effective were 'age-gating technologies that require user identification by fingerprint or other biometric parameters in order to unlock and use a tobacco product or geo-fencing technologies,'" Jones says. "These extreme measures were not listed in the 2020 Guidance."
In addition to contradicting its prior advice to manufacturers, the 5th Circuit says, "the FDA did not adequately address RJRV's evidence that substantial health benefits would accrue to adult and youth cigarette smokers alike who switched to menthol Vuse, while popularity among youth would remain low overall." Internal memos that came to light as a result of a separate but similar lawsuit by Logic Technology show that the Office of Science at the FDA's Center for Tobacco Products (CTR) initially agreed with that assessment but reversed its position after Brian King, who succeeded Mitch Zeller as the CTR's director in July 2022, objected.
The FDA's scientists originally recommended approval of Logic Technology's menthol-flavored products. Although the evidence was inconclusive, they thought it was reasonable to think that menthol cigarette smokers would be more inclined to try vaping products with similar flavors and therefore more likely to replace smoking with a much less hazardous nicotine habit. They also noted that menthol vapes were not very popular among teenagers.
The FDA's 2020 guidance cited 2019 data from the Monitoring the Future Study indicating that just 6 percent of 12th-graders who vaped Juul e-cigarettes reported using menthol-flavored pods. According to the 2022 National Youth Tobacco Survey, which was conducted after the FDA banned all cartridge flavors except for tobacco and menthol, 85 percent of adolescent vapers used vaping products "with flavors other than tobacco." The "fruit" category was by far the most popular, mentioned by 69 percent of respondents, compared to 27 percent for menthol.
"Based on new awareness and understanding" of King's position, however, the Office of Science "reassessed" and decided the boss was right. The upshot of that reversal was that all vape flavors other than tobacco, including menthol, would be treated as inherently suspect. The FDA would approve them only if manufacturers presented product-specific evidence that a particular flavor increased the likelihood that adult smokers would switch to vaping. It was not enough to show that the vast majority of former smokers who vape favor flavors other than tobacco.
When it rejected RJRV's menthol application, Jones says, "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." That "sudden turnabout," she adds, "further reinforces" the conclusion that the FDA's decision was "likely arbitrary, capricious, or otherwise unlawful."
The FDA's current position, the 5th Circuit says, amounts to a new "tobacco product standard" that was never formally proposed and therefore did not go through the "notice-and-comment rulemaking procedures" that the APA requires. "RJRV has adduced evidence that the FDA has effectively banned all non-tobacco-flavored e-cigarettes, pursuant to its new and secret heightened evidentiary standard," Jones writes, "without affording affected persons any notice or the opportunity for public comment."
The question of whether that de facto ban qualifies as a "substantive rule" is "not a close call," the 5th Circuit says. A 2021 FDA memo explained the "heightened evidentiary standard" for flavored ENDS, which allowed the agency to peremptorily reject nearly all of the applications it had received.
That memo was "binding on its face by mandating that applications contain 'the necessary type of studies,'" Jones writes. "It has been applied in a way that indicates it is binding….It took away the FDA reviewers' former discretion to consider individual [applications] solely on their merits and instead requires a cursory, box-checking review. Finally, it affected the rights of literally hundreds of thousands of applicants whose [applications] were denied."
Yesterday's order is not a final ruling on the merits of RJRV's case. It merely maintains the status quo, allowing the company to continue selling menthol e-cigarettes while its lawsuit is pending. RJRV still has to persuade the courts that the FDA's flavor ban is not just dubious on public health grounds but also inconsistent with the APA's requirements. Given the reasoning underlying the stay, however, the company probably will not have much difficulty making that case.
