The FDA’s first premarket approval of a mentholated vape product reflects poorly on the agency’s authorization process.
By Stefanie Rossel
On June 21, the U.S. Food and Drug Administration for the first time authorized nontobacco-flavored vape products through its premarket tobacco product application (PMTA) pathway. The agency issued marketing granted orders (MGO) for two Njoy Ace menthol flavor pods and two disposable e-cigarettes, Njoy Daily Menthol 4.5 percent and Njoy Daily Extra Menthol 2.4 percent. The news was hailed as a “significant decision” and a “watershed moment for the sector” that will have a “huge and significant impact” on the global reduced-risk products market.
Upon closer inspection, however, the authorization is less of a breakthrough than these superlatives suggest. Instead, it again highlights the many problems with the agency’s authorization process for electronic nicotine-delivery systems (ENDS) and novel nicotine products.
Lindsey Stroud, senior fellow with the Taxpayers Protection Alliance, describes the recent FDA authorization as a small step in the right direction in what has otherwise been a regulatory nightmare. “While allowing the sale of a nontobacco-flavored ENDS, FDA seems to understand that adults who use menthol-flavored combustible cigarettes should have access to products which are significantly less harmful,” she says. “Unfortunately, the FDA still continues to deny the sale of all other flavored ENDS, despite their effectiveness in helping adults quit smoking and remain smoke-free.”
Stroud is also concerned about the informal market. “Despite FDA not having issued authorization orders for flavored ENDS, a large, unregulated marketplace exists in the United States—99.9 percent of which are nontobacco flavored,” she says. “FDA must recognize the role that other flavors play in tobacco harm reduction because denialism isn’t stopping the flourishing non-FDA-authorized ENDS marketplace.”
Jeffrey Smith, a senior fellow in harm reduction at the R Street Institute, says he welcomes any action by the FDA Center for Tobacco Products (CTP) that supports reduced-risk options for those who smoke. “Unfortunately, in the grand scheme of things, the awarding of an MGO to the four Njoy menthol variants is unlikely to be a sign of a significant shift in the decision-making process at the CTP,” he says. “If the regulatory environment does not change through external pressures, it is unlikely that the actions of the CTP will evolve in a swift and effective manner.”
Gray Market to Persist
While optimists may detect a new willingness to approve reduced-risk products (RRPs) in the CTP’s recent product authorizations, few expect the regulatory floodgates to open to an avalanche of product approvals.
“Since the awarding of the Njoy menthol products, there haven’t been any additional actions or signals that more may be coming,” says Smith. “The only additional communications I have seen from the CTP since the Njoy announcement was a letter from the FDA to the clerk of the Supreme Court informing the court that the CTP had granted a marketing order to four menthol-flavored e-cigarette products. The case is the Logic v. FDA, where Logic is arguing that the CTP had adopted a blanket policy of rejecting menthol-flavored products.”
Stroud says the menthol announcement is a positive development but notes that the FDA remains opposed to any flavors that don’t exist in traditional tobacco products. “Dr. Brian King, director for the Center for Tobacco Products, is very anti-flavor, if not anti-vape,” she says. “Going back to at least 2015 and his time at the CDC [Centers for Disease Control and Prevention], King has been first to tout the Bloomberg party line that ‘flavors hook kids.’ This is in direct contrast to U.S. youth survey data, which finds flavors as one of the least-cited reasons why youth vape. FDA must recognize the role of flavors, their appeal to adults who smoke and how flavors help to reinforce a negative taste—literally—associated with combustible cigarette smoke. Until FDA recognizes this, the U.S. ENDS market will remain a large gray market.”
Unlike most other vape products that have received FDA authorization to date, the Njoy menthol variants are technologically up to date and relatively popular with consumers. “According to Altria’s first-quarter 2024 report, Njoy made up 4.3 percent of the U.S. retail market, but this will likely grow as Njoy is now the only menthol-flavored—and nontobacco-flavored—ENDS product legally permitted to be for sale in the U.S.,” says Stroud.
She is undecided about the FDA decision’s potential impact on the global RRP landscape. “I would imagine that with FDA recognizing the importance of menthol, most countries would follow the agency’s findings,” she says. “Unfortunately, due to a de facto flavor ban in the U.S., there is precedent for countries to restrict flavors, despite them not experiencing a huge surge in youth vaping as the U.S. did in 2019.”
“The awarding of a marketing granted order to the four Njoy menthol variants is unlikely to be a sign of a significant shift in the decision-making process at the CTP.”
Depressing Number
Nicotine companies have long lamented the FDA’s product authorization process, which they say is needlessly time-consuming and costly and favors deep-pocketed players over less generously resourced applicants. Stroud and Smith believe the process can be streamlined only through external interventions.
To illustrate the challenge, Stroud recalls the tremendous technological progress in ENDS products, which went from cigalikes to larger open systems, back to pods and then on to disposables. “The FDA’s draconian regulations don’t account for the technological improvement that has been applied to ENDS,” she says. “FDA and Congress could reform the Tobacco Control Act [TCA] in a huge way if they pushed the predicate date further ahead than February 2007. Requiring ENDS to undergo extensive testing and a massive bureaucratic application process is not only a farce to public health, but it restricts innovation and competition, which is very un-American.”
With Congressional assistance and a reworking of the TCA, the FDA could establish a notification process for new products and then focus on post-market surveillance to monitor the public health effects of the new products, according to Shroud.
“The FDA must also recognize what percentage of youth is permittable,” she says. “No other consumer good in America has been forced to deal with so much scrutiny that even one kid using the product is one kid too many. While youth vaping was a problem in 2019, it declined by more than 60 percent in the years since—all while the non-FDA-authorized ENDS market grew exponentially. FDA must recognize that adults are using these products and that their use is associated with a 10 percent decrease in cigarette units sold in America in 2023. That’s a win for public health. FDA must reform the process so we can accelerate even further declines in smoking.”
As of June 21, the FDA had authorized more than 16,000 tobacco products—mostly cigarettes and cigars, according to Stroud. “Twenty-seven MGOs for ENDS is a depressing number and makes up less than 1 percent of authorized products,” she says. “Worse, only 49 products have been authorized by FDA using the PMTA pathway. FDA’s own budget is problematic; it’s entirely funded by user fees paid for by only six classes of tobacco products and not from e-cigarettes. There is more of an incentive to authorize the products that are paying for a $275,000 annual salary, as made by the CTP director in 2023, than authorizing products that pay nothing. While FDA has been asking Congress for years to be able to collect user fees on products including e-cigarettes, they refuse to issue orders—and instead denied tens of millions of products. That could have been a lot of fees and would have funded a significant amount of surveillance while also recognizing tobacco harm reduction. It is something the agency must recognize if the mission is to reduce smoking.”
Significant Ruling
Smith says it is important to educate those affected by the failing 99.999 percent of all PMTA applications about the recent changes in the regulatory landscape and how those changes may lay a foundation for the significant changes necessary at the CTP.
“The first is the recent announcement by the Supreme Court where the Chevron Deference has been overturned,” he says. “This action by the court will now require that regulatory agencies follow the letter of the law and that the regulators would now have little leeway in the interpretation of how to apply regulatory law.
“The Chevron Deference has allowed the CTP to define the meaning of ‘appropriate for the protection of public health’ when conducting a review of the PMTAs and MRTPAs [modified-risk tobacco product applications]. Now, post-Chevron, if the Tobacco Control Act does not clearly outline the actions and process of enforcement of regulatory oversight in a manner that allows for the regulatory agency to action the law, the law will have to be amended to clarify the process, so legislators will have to work to make the law actionable … not the regulators that monitor the marketplace.”
Second, according to Smith, the Supreme Court may review four relevant lawsuits—Triton, Magellan, Lotus and Logic. Such a review may trigger action to change the TCA. “If the court decides to hear at least one of these cases, then the likely outcome is a requirement that the TCA be clarified so that the CTP will only enforce actions defined in the TCA,” says Smith. “If the TCA isn’t clear as to how to enforce it, then the law should be amended. Depending on how the policies are modified by the legislative branch, we may see shifts in the way that CTP reviews all tobacco and nicotine products, leading to a more effective regulatory environment. However, how the legislators refine the TCA will determine if the regulatory environment improves in a manner that supports the reduced-risk product marketplace.”
