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Third Circuit Upholds FDA Ban on Menthol E-Cigarettes

Author: Patrick J. McNamara|February 22, 2024

FDA’s Policy Change on Menthol E-Cigs

Third Circuit Upholds FDA Ban on Menthol E-Cigarettes

FDA’s Policy Change on Menthol E-Cigs

Court room behind text

The Third Circuit Court of Appeals recently ruled in Logic Technology Development LLC v. FDA that the U.S. Food and Drug Administration (FDA) was within its rights to change course on menthol-flavored e-cigarettes. Logic Technology Development LLC filed suit after the agency denied its application to market menthol-flavored electronic nicotine delivery systems (ENDS), arguing that the denial was a violation of the Administrative Procedure Act (APA).

The Tobacco Control Act requires any tobacco product not on the market before February 15, 2007, to receive approval from the FDA. Only if the FDA concludes that “permitting such tobacco product to be marketed would be appropriate for the protection of the public health” (health-appropriate) can the product be approved.

When considering such an application, the FDA is statutorily required to conduct a balancing test to determine whether an ENDS is health-appropriate and, thus, whether it can remain on the market. As part of this analysis, the agency must assess: The risks and benefits to the population as a whole, including users and nonusers of the tobacco product, and take into account— (A) the increased or decreased likelihood that existing users of tobacco products will stop using such products; and (B) the increased or decreased likelihood that those who do not use tobacco products will start using such tobacco products. In essence, the greater the risk of the new tobacco product to non-smokers, especially children, the greater the benefit to smokers that the manufacturer must demonstrate.

In 2020, the FDA began taking aggressive action to remove fruit- and dessert-flavored ENDS from the market based on studies showing that flavored e-cigarettes were a driving force behind the youth vaping epidemic. Under its new approach, the FDA’s Office of Science could only approve fruit- and dessert-flavored ENDS if the evidence showed that the benefits were greater than tobacco-flavored ENDS.

The FDA initially did not prioritize enforcement of menthol ENDS. As a result, the FDA’s Office of Science’s “preliminary” recommendation was to approve Logic’s Premarket Application because it believed there was a “potential benefit” to adults who smoked menthol-flavored cigarettes. However, in 2022, the FDA began to question whether menthol-flavored ENDS were appropriate for the protection of public health. The Director of the Office of Science ultimately concluded that “the approach to menthol-flavored ENDS should be the same as with other flavored ENDS concerning the evidence of adult benefit.” Under that approach, as with fruit and similar characterizing flavors, the Center could only approve a menthol-flavored ENDS “if the evidence showed that the benefits…were greater than tobacco-flavored ENDS.”

Applying this new policy, the FDA issued a Marketing Denial Order for Logic’s menthol-flavored ENDS on October 26, 2022. In support, it cited additional studies and market data regarding menthol ENDS, particularly studies showing that the removal of one flavored product option prompted youth to migrate to another ENDS that offered flavor options.

Logic subsequently filed suit. It argued that the denial was a violation of the APA, claiming it was arbitrary and capricious for the FDA (1) to apply the same regulatory framework to menthol that it used to assess the appropriateness of sweeter flavors, (2) to ultimately reject its applications for its menthol-flavored ENDS to remain on the market, and (3) to do so without granting Logic a transition period following that decision.

The Third Circuit upheld the FDA’s denial by a vote of 2-1. In reaching its decision, the appeals court found that the FDA applied a regulatory framework consistent with its statutory mandate, provided a reasoned explanation for its denial, and based its decision on scientific judgments that the court may not second-guess.

“As enforcement actions removed those flavors from the market, the FDA reasoned, other flavors like menthol could become yet more popular as kids turned to the remaining islands of flavor in the e-cigarette market,” Judge Cheryl Ann Krause wrote. “Stripped of the hyperbole that the FDA laid down a blanket anti-menthol policy, the record reflects nothing more than the application to menthol-flavored ENDS of the same regulatory framework and evidentiary standard that the agency had applied previously to other non-tobacco flavored ENDS.”

The Third Circuit agreed with the FDA that it was well within its authority to change its position on Logic’s application as the scientific evidence changed, noting that its preliminary approval was subject to change.

“The Office of Science’s tenuous preliminary support for Logic’s premarket application withered in the face of its own evolving understanding of the scientific evidence,” Judge Krause wrote. “This is not the sort of ‘changed course’ that can trigger a heightened burden for the FDA, nor does it expose some ‘secret’ and nefarious anti-menthol policy, as Logic contends. Crediting that argument would penalize the Center for engaging in the ‘ongoing dialogue’ and deliberation that is supposed to be the hallmark of reasoned agency decision-making.”

In his dissenting opinion, Judge David J. Porte argued that the Third Circuit should have adopted the approach taken by the Fifth Circuit, which held that the FDA’s policy shift was not adequately explained to ENDS manufacturers.

“Because the FDA’s decision to treat menthol ENDS like other flavored ENDS rather than tobacco was a policy change, the FDA was required to supply a reasoned analysis,” he wrote. “To survive the arbitrary and capricious standard of review, the FDA must first have acknowledged that it changed its menthol policy and then provided a reasoned analysis for the change that addressed Logic’s reliance interests and considered available alternatives. It did not do so.”

The Third Circuit’s decision, of course, may not be the final word. Logic may now ask for an en banc rehearing with all Third Circuit judges, or request a hearing by the Supreme Court.

Third Circuit Upholds FDA Ban on Menthol E-Cigarettes

Author: Patrick J. McNamara
Court room behind text

The Third Circuit Court of Appeals recently ruled in Logic Technology Development LLC v. FDA that the U.S. Food and Drug Administration (FDA) was within its rights to change course on menthol-flavored e-cigarettes. Logic Technology Development LLC filed suit after the agency denied its application to market menthol-flavored electronic nicotine delivery systems (ENDS), arguing that the denial was a violation of the Administrative Procedure Act (APA).

The Tobacco Control Act requires any tobacco product not on the market before February 15, 2007, to receive approval from the FDA. Only if the FDA concludes that “permitting such tobacco product to be marketed would be appropriate for the protection of the public health” (health-appropriate) can the product be approved.

When considering such an application, the FDA is statutorily required to conduct a balancing test to determine whether an ENDS is health-appropriate and, thus, whether it can remain on the market. As part of this analysis, the agency must assess: The risks and benefits to the population as a whole, including users and nonusers of the tobacco product, and take into account— (A) the increased or decreased likelihood that existing users of tobacco products will stop using such products; and (B) the increased or decreased likelihood that those who do not use tobacco products will start using such tobacco products. In essence, the greater the risk of the new tobacco product to non-smokers, especially children, the greater the benefit to smokers that the manufacturer must demonstrate.

In 2020, the FDA began taking aggressive action to remove fruit- and dessert-flavored ENDS from the market based on studies showing that flavored e-cigarettes were a driving force behind the youth vaping epidemic. Under its new approach, the FDA’s Office of Science could only approve fruit- and dessert-flavored ENDS if the evidence showed that the benefits were greater than tobacco-flavored ENDS.

The FDA initially did not prioritize enforcement of menthol ENDS. As a result, the FDA’s Office of Science’s “preliminary” recommendation was to approve Logic’s Premarket Application because it believed there was a “potential benefit” to adults who smoked menthol-flavored cigarettes. However, in 2022, the FDA began to question whether menthol-flavored ENDS were appropriate for the protection of public health. The Director of the Office of Science ultimately concluded that “the approach to menthol-flavored ENDS should be the same as with other flavored ENDS concerning the evidence of adult benefit.” Under that approach, as with fruit and similar characterizing flavors, the Center could only approve a menthol-flavored ENDS “if the evidence showed that the benefits…were greater than tobacco-flavored ENDS.”

Applying this new policy, the FDA issued a Marketing Denial Order for Logic’s menthol-flavored ENDS on October 26, 2022. In support, it cited additional studies and market data regarding menthol ENDS, particularly studies showing that the removal of one flavored product option prompted youth to migrate to another ENDS that offered flavor options.

Logic subsequently filed suit. It argued that the denial was a violation of the APA, claiming it was arbitrary and capricious for the FDA (1) to apply the same regulatory framework to menthol that it used to assess the appropriateness of sweeter flavors, (2) to ultimately reject its applications for its menthol-flavored ENDS to remain on the market, and (3) to do so without granting Logic a transition period following that decision.

The Third Circuit upheld the FDA’s denial by a vote of 2-1. In reaching its decision, the appeals court found that the FDA applied a regulatory framework consistent with its statutory mandate, provided a reasoned explanation for its denial, and based its decision on scientific judgments that the court may not second-guess.

“As enforcement actions removed those flavors from the market, the FDA reasoned, other flavors like menthol could become yet more popular as kids turned to the remaining islands of flavor in the e-cigarette market,” Judge Cheryl Ann Krause wrote. “Stripped of the hyperbole that the FDA laid down a blanket anti-menthol policy, the record reflects nothing more than the application to menthol-flavored ENDS of the same regulatory framework and evidentiary standard that the agency had applied previously to other non-tobacco flavored ENDS.”

The Third Circuit agreed with the FDA that it was well within its authority to change its position on Logic’s application as the scientific evidence changed, noting that its preliminary approval was subject to change.

“The Office of Science’s tenuous preliminary support for Logic’s premarket application withered in the face of its own evolving understanding of the scientific evidence,” Judge Krause wrote. “This is not the sort of ‘changed course’ that can trigger a heightened burden for the FDA, nor does it expose some ‘secret’ and nefarious anti-menthol policy, as Logic contends. Crediting that argument would penalize the Center for engaging in the ‘ongoing dialogue’ and deliberation that is supposed to be the hallmark of reasoned agency decision-making.”

In his dissenting opinion, Judge David J. Porte argued that the Third Circuit should have adopted the approach taken by the Fifth Circuit, which held that the FDA’s policy shift was not adequately explained to ENDS manufacturers.

“Because the FDA’s decision to treat menthol ENDS like other flavored ENDS rather than tobacco was a policy change, the FDA was required to supply a reasoned analysis,” he wrote. “To survive the arbitrary and capricious standard of review, the FDA must first have acknowledged that it changed its menthol policy and then provided a reasoned analysis for the change that addressed Logic’s reliance interests and considered available alternatives. It did not do so.”

The Third Circuit’s decision, of course, may not be the final word. Logic may now ask for an en banc rehearing with all Third Circuit judges, or request a hearing by the Supreme Court.

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