Court rejects FDA rejection order for Blu/myBlu

Time： 2023-08-31

The FDA failed to conduct a proper analysis before rejecting Fontem US's premarket tobacco product application (PMTA) for certain e-cigarette products.

According to vaporvice news on August 30, the U.S. Court of Appeals for the DC Circuit found yesterday that the Food and Drug Administration failed to conduct proper analysis before rejecting some e-cigarette product applications.

The court's unanimous decision in Fontem US v. FDA upheld the regulator's decision to deny Fontem's application to sell flavored e-cigarette products, consistent with previous court precedent, but reversed the FDA's decision to deny Fontem's application to sell unflavored products.

This is the second time a circuit appeals court has accused the FDA of an "unexpected U-turn" in its review of e-cigarette product applications.

Fontem, the company behind the Blu and myBlu e-cigarette brands, argued that the FDA did not conduct a proper analysis before rejecting their application. The D.C. Circuit agreed with Fontem regarding its unscented product, ruling that the FDA "ignored the comprehensive public health review required by law."

The judge's opinion for the court pointed out that for Fontem's unscented products, the FDA also rejected Fontem's application on public health grounds.

"While the FDA found multiple 'deficiencies,' it failed to analyze the trade-offs required to make a public health finding. The agency also did not explain how the specific deficiencies related to the overall conclusion that Fontem failed to demonstrate that its unscented products were suitable to protect public health. relationship." The opinion pointed out. "The agency's denial therefore fails to comply with the requirements of the Tobacco Control Act."

The FDA rejected Fontem's unscented product solely on public health grounds. Under the order, FDA can promulgate regulations that impose consistent requirements on the ingredients and manufacturing of tobacco products.

"If the agency does so, Fontem's failure to meet these standards would be independent and sufficient grounds for denying the application, regardless of the overall public health consequences of Fontem's products," the order states. "But the agency has not yet exercised its regulatory authority. .Because FDA has chosen to pursue applications on a case-by-case basis on a public health basis, the full investigation required by regulation must be conducted."

According to the order, instead of conducting an overall assessment that Fontem had failed to show that its products would be beneficial to the public, the agency found five highly technical deficiencies. But nothing in the denial order explains how these defects relate to the overall public health consequences of Fontem's unscented products.

According to the order, the FDA made another serious mistake by failing to properly apply its public health investigation to Fontem's unscented products. In the initial defect letter, the FDA requested that Fontem provide certain information that would demonstrate that the information was sufficient for the agency to approve Fontem's product.

"Changing regulatory objectives without explanation is arbitrary and capricious. In its deficiencies letter, the FDA noted that Fontem could address issues with its application by providing specific information, which the FDA said was sufficient to obtain approval."

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