FDA Wins SWT Menthol Vape Appeal as Court Upholds PMTA Rejection
The U.S. appeals court upheld the FDA’s rejection of SWT Global Supply’s menthol-flavored vape marketing application, ruling that the company failed to provide sufficient evidence to prove that the product would benefit public health.
Eighth Circuit Court Upholds FDA Decision on SWT Vape Application
According to U.S. media outlet Law360 on June 13, the U.S. Eighth Circuit Court of Appeals ruled on June 12 against SWT Global Supply Inc.’s legal challenge to the U.S. Food and Drug Administration (FDA) over the rejection of its menthol-flavored vape marketing application.
The court determined that the FDA’s decision was not “arbitrary or capricious,” meaning the agency acted within its regulatory authority when denying the application.
The three-judge panel noted that the U.S. Supreme Court’s recent decision supporting the FDA in the case involving Turning Point Brands and White Lion Investments addressed many of the arguments raised by SWT in its appeal.
FDA Rejected SWT’s PMTA Over Public Health Evidence Concerns
In May 2023, the FDA rejected SWT’s Premarket Tobacco Product Application (PMTA) for menthol-flavored vape products.
The agency stated that SWT failed to provide sufficient evidence demonstrating that the potential benefits for adult users outweighed the risks of youth initiation and use. The FDA also determined that SWT’s proposed marketing plan did not provide adequate measures to prevent young people from accessing the products.
SWT Challenged FDA’s PMTA Review Standards
During its appeal, SWT argued that the FDA had changed its PMTA review standards without proper notice.
The company claimed that the agency had introduced new requirements, including demands for long-term scientific data and comparative studies, while also failing to properly explain why its youth access prevention strategy was insufficient.
SWT also argued that the FDA did not adequately consider differences between open-system and closed-system vape products when reviewing the application.
Court Says FDA Has Authority to Require Scientific Evidence
The appeals court rejected SWT’s arguments, stating that the FDA had not changed its existing regulatory approach.
The court noted that under the Tobacco Control Act and FDA guidance documents, the agency has broad authority to determine what scientific evidence is necessary when reviewing tobacco product applications.
The judges also found that rejecting applications without sufficient comparisons to tobacco-flavored products did not violate previous FDA policies.
FDA Never Guaranteed Approval for Menthol-Flavored Vapes
The court further clarified that the FDA had never promised automatic approval for menthol-flavored vape products.
Although the FDA’s 2020 enforcement guidance prioritized action against certain unauthorized flavored vape products, the document did not indicate that menthol-flavored products would receive automatic marketing authorization.
The court ruled that the FDA’s decision to apply similar scrutiny to menthol-flavored products was reasonable, particularly because menthol flavors may increase product appeal among teenagers.
Youth Access Concerns Remain Central to FDA Vape Decisions
The court agreed with the FDA’s assessment that SWT’s marketing plan was insufficient to prevent youth access.
The FDA argued that point-of-sale restrictions proposed by SWT would not effectively stop teenagers from obtaining vape products, as many young users do not purchase products directly from retail locations.
The court concluded that SWT failed to provide innovative measures capable of addressing these concerns, and therefore the FDA’s rejection decision was neither unreasonable nor unsupported.
SWT Continues Legal Challenges Against FDA Vape Regulations
SWT Global Supply has another similar legal dispute involving the FDA that previously reached the U.S. Supreme Court.
That case has since been returned to the Fifth Circuit Court of Appeals, where judges requested additional information before further proceedings.
The latest ruling highlights the continued challenges faced by vape manufacturers seeking FDA marketing authorization, particularly for flavored products. The FDA continues to require companies to demonstrate that their products are appropriate for the protection of public health before receiving approval to enter the U.S. market.
