A federal appeals court has issued a scathing rebuke to the United States Food and Drug Administration (FDA) over its handling of applications to authorize vaping products. A ruling in a key case, issued on January 3, accused the FDA of sending vape manufacturers on a “wild goose chase” under the agency’s Premarket Tobacco Product Applications (PMTA) process—misleading applicants and failing to honor its own guidelines.
The Fifth Circuit Court of Appeals has reversed marketing denial orders (MDOs) issued by the FDA to Triton and Vapetasia, two mid-sized vape manufacturers, and ordered the agency to open new reviews into their PMTA applications.
But the long-running case, as Filter has reported, has much wider significance. It has been viewed as central to tobacco harm reduction advocates’ hopes of seeing a wide array of authorized vaping products on the US market to help people switch from smoking—including, in particular, the flavored products that are so important to many people making the switch.
To date, the FDA has authorized only a small number of tobacco-flavored products, made by large companies with the resources to meet onerous PMTA requirements. A chaotic process has seen millions of other applications rejected, and observers have noted that obtaining vape authorization is harder than is the case for new cigarettes, which actually kill.
The FDA “promulgated hundreds of pages of guidance documents”—”all with the (false) promise” that a flavored vape manufacturer had a chance of success.
The agency has yet to authorize a single non-tobacco flavored vaping product, and tobacco harm reduction advocates have long believed that this amounts to a blanket policy—a belief supported, for example, by Filter’s 2022 report that FDA hierarchy overruled their own scientists’ recommendation to authorize some menthol-flavored products.
The new court ruling—a majority decision by an en banc panel that reverses a July 2022 ruling by the same court—bolsters that case. It said the FDA acted “arbitrarily and capriciously” when it denied authorization of Triton’s flavored vaping products.
The agency had issued specific instructions on what was required for vape manufacturers to obtain authorization, claiming that marketing plans were a “critical” part of the process, Circuit Judge Andrew Oldham noted for the majority. The FDA “promulgated hundreds of pages of guidance documents,” hosted public meetings and presented information on its website—”all with the (false) promise” that a flavored vape manufacturer had a chance of success.
After months of receiving applications, the ruling continued, the FDA “turned around, pretended it never gave anyone any instructions about anything, imposed new testing requirements without any notice, and denied all one million flavored e-cigarette applications for failing to predict the agency’s volte face.”
The judges described the FDA’s antics as “regulatory switcheroos” and summarily rejected its justifications.
“Worse, after telling manufacturers that their marketing plans were ‘critical’ to their applications, FDA candidly admitted that it did not read a single word of the one million plans,” the ruling added.
Commenting on the FDA’s attempt to justify its actions, the judges wrote:
“FDA argues that its years’ worth of regulatory guidance was not worth the paper it was printed on because it was hedged with cautious qualifiers and never guaranteed that any particular submission would be granted. Second, and most disturbingly, the FDA argues that its capriciousness should be forgiven as harmless because the agency promises to deny petitioners’ applications even if we remand to make the agency follow the law.”
The judges described these antics as “regulatory switcheroos” and summarily rejected the FDA’s justifications.
“The Fifth Circuit’s decision underscores the need for FDA leadership to revise the agency’s overall approach to the PMTA process,” Eric Heyer, an attorney representing Triton, told Filter, “and to clearly and specifically communicate to applicants what scientific evidence will satisfy the [appropriate for the protection of public health] standard for non-tobacco flavored ENDS [electronic nicotine delivery system] products.”
“Millions of former smokers know that flavored ENDS products have been the best tool for them to end their combustible cigarette use,” he continued. “It’s time the FDA’s regulatory approach caught up with this real-world reality.”
Advocates have celebrated what they see as a stunning victory over an agency that obstructs tobacco harm reduction, when almost half a million people die of smoking-related causes in the US each year.
“Small businesses and their customers have been given a thin thread of hope that, perhaps, a horrible wrong will soon be righted.”
“I am excited about the ruling because it clarifies that the FDA must treat every manufacturer fairly and consider the entirety of their applications without randomly switching standards during the process,” advocate Skip Murray told Filter. “I heard a collective sigh of relief from consumers and business owners that a panel of judges has finally grasped how wrong this whole process has been.”
Murray once ran a vape shop, and was involved in an earlier, unsuccessful lawsuit against the FDA (she has also written for Filter). She related how numerous smaller vape manufacturers and shops have had to close thanks to the FDA’s labyrinthine regulatory processes, reducing harm reduction access for people in need.
“Small businesses and their customers have been given a thin thread of hope that, perhaps, a horrible wrong will soon be righted,” she said.
“We have long criticized the FDA Center for Tobacco Products’ [CTP] erratic and opaque approach to regulation,” Gregory Conley, director of legislative and external affairs for American Vapor Manufacturers, which represents smaller businesses, told Filter.
“This opinion could be a catalyst for meaningful reforms that would benefit both small business manufacturers and adult consumers,” he continued. “However, do not expect positive changes to happen overnight. CTP Director Brian King has spent the majority of his adult life advocating for flavor prohibition. Moreover, the Department of Justice holds considerable power in deciding what the next steps in litigation will be, and the department hates to be told no.”
“A win for public health.”
Other observers are also unsure about the practical impact of the ruling, and what, if anything, is to stop the FDA from arbitrarily rejecting the two companies’ applications once again, given the lack of clear baseline PMTA standards. An authorized flavored product would at least set some kind of bar for what’s required—but there isn’t one.
“The FDA’s next steps are uncertain—whether they will appeal to the Supreme Court or disregard the Fifth Circuit’s reprimand and find other reasons to deny applications,” Conley said. “If the latter occurs, manufacturers are likely to seek redress from the Fifth Circuit again. Given the court’s recent ruling and the tone of their opinion, any future decisions are likely not to favor CTP.”
Most observers agree that the future of US tobacco harm reduction looks brighter than it did before the decision.
Michael Siegel, a professor in the Department of Community Health Sciences at Boston University School of Public Health, tweeted that the ruling showed how the FDA had “improperly” rejected applications for flavored vapes. The ruling, he continued, “is a win for public health.”
Photograph by Nick Youngson via Pix4Free/Creative Commons 3.0