According to US media Law360 on June 13, the US Eighth Circuit rejected SWT Global Supply Inc.'s legal challenge to the US FDA's refusal to approve itsmenthol-flavored e-cigarette for market on June 12, ruling that the FDA's decision was not "arbitrary or capricious.
A panel of three judges pointed out that the recent decision by the US Supreme Court in a similar case, "FDA v. Wages and White Lion Investments", supported the FDA. The case essentially covered most of the arguments raised in SWT's appeal.
According to reports, the FDA rejected SWT's pre-market tobacco product application (PMTA) in May 2023. The reason given was that the company failed to provide enough evidence to demonstrate that its menthol-flavored products have potential benefits for adult users that outweigh the risks for youth, and their marketing plan was not effective in restricting youth access to and use of the products.
In its appeal, SWT claimed that the FDA made changes to the PMTA standards without prior notification, such as requiring the submission of long-term study data and conducting comparative effectiveness tests, and failed to provide a reasonable explanation for denying its marketing plans, overlooking the differences between open and closed system e-cigarette products.
However, the court believes that the Supreme Court has clearly stated that the FDA has not changed its existing position. According to the Tobacco Control Act and guidance issued by the FDA, the agency has broad discretion to determine the types of scientific evidence required; rejecting applications that do not compared to tobacco-flavored products does not violate its previous policies.
The court also pointed out that the FDA has never promised to approve menthol-flavored e-cigarettes. Its 2020 guidance only stated that it would prioritize enforcement actions against non-tobacco, non-menthol-flavored products, but this does not automatically mean that menthol-flavored products will be approved.
The judge further determined that, although there are various types of e-cigarette devices, menthol-flavored plays a consistent role in attracting minors. Considering that mint flavor products are still attractive to minors, the FDA has decided to treat them the same as other flavored e-cigarette products, which is considered reasonable and consistent.
In the end, the court found that the FDA's determination that SWT's marketing plan was inadequate was neither arbitrary nor lacking in basis. The FDA pointed out that SWT's proposed sales point restrictions were not sufficient to prevent young people from accessing e-cigarettes, as most young people do not directly obtain products at sales points, and SWT did not propose any innovative solutions.
It is worth noting that another similar case involving SWT has been submitted to the Supreme Court of the United States. Currently, the case has been remanded to the Fifth Circuit Court of Appeals, with the court requesting supplemental materials this Wednesday.
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