Court rules FDA rejection of Imperial Tobacco PMTA application invalid

According to US media reports, on August 29, the U.S. Court of Appeals for the District of Columbia Circuit ruled that the U.S. Food and Drug Administration (FDA) did not conduct a proper analysis when it rejected certain PMTA applications for Fontem U.S. (an Imperial Tobacco subsidiary responsible for the U.S. vape business under the myBlu brand) and its vaping products.

Although the court upheld the FDA’s decision to reject Fontem’s flavored vaping products, it overturned the agency’s rejection of Fontem’s non-flavored product applications—in other words, the court supported the ban on flavored vaping products, but found problems with the FDA’s handling of myBlu’s PMTA applications.

In the ruling, the judge wrote: “Although the FDA identified multiple ‘defects’ in Fontem’s application, the agency did not carry out the necessary balancing analysis to make a public health determination. The FDA also failed to explain how these specific defects related to its conclusion, such as how Fontem failed to show that its non-flavored products were appropriate for the protection of public health. Therefore, the agency’s denial did not satisfy the requirements of the Tobacco Control Act.”

According to the court, the FDA failed to correctly apply the public health inquiry to Fontem’s unflavored products, leading to another serious error. In its initial notice, the FDA asked Fontem to provide certain information, indicating that this information would be sufficient for the agency to approve Fontem’s products. However, in its denial order, the FDA changed its position and faulted Fontem for not providing information the agency had never clearly requested.

The judge wrote: “Changing regulatory goals without explanation is arbitrary and capricious. By stating in its letter that Fontem could address the application issues by providing specific information, the FDA indicated that such information would be sufficient for approval.”

This ruling may affect the FDA’s regulation of vaping products, especially the analysis and decisions involved in premarket tobacco product applications. It also provides further legal support for Fontem U.S. and similar companies.