Bidi Vapor LLC Appeals FDA Decision on E-Cigarette Application

Key Points:

Bidi Vapor LLC urges the Eleventh Circuit Court of Appeals to overturn the FDA's decision to reject its disposable e-cigarette application, arguing that the decision is unlawful.

The FDA rejected Bidi's application for its tobacco-flavored disposable e-cigarette, citing a lack of evidence demonstrating overall net benefit and insufficient evidence to address health risks.

In August 2022, Bidi Vapor successfully overturned the FDA's Marketing Denial Orders（MDO） for its 10 non-tobacco flavored products, allowing them to re-enter the scientific review phase and continue sales.

According to a recent report by Tobacco Reporter, Bidi Vapor LLC is urging the Eleventh Circuit Court of Appeals to overturn the decision by the U.S. Food and Drug Administration (FDA) to reject its application to sell disposable e-cigarettes, claiming that the agency's actions are illegal.

During the oral debate in Miami, lawyer Eric Gotting told the appeals panel that the FDA's decision was "arbitrary and capricious, and illegal." He pointed out that the agency acknowledged that adult smokers might switch to using Bidi's safer disposable e-cigarette product - an e-cigarette pre-filled with tobacco-flavored e-liquid, but still rejected Bidi's application.

In January 2024, the FDA issued a Market Denial Order (MDO) for the tobacco-flavored Bidi Stick-Classic disposable e-cigarette. This decision came as the agency continued to seek a second review of market applications for other flavored products from Bidi Vapor. The FDA stated that Bidi's premarket tobacco application "failed to demonstrate a net benefit to overall tobacco product users and lacked sufficient evidence to address health risks.

Bidi believes that the FDA violated the Administrative Procedure Act and is hopeful to establish a basis for challenging unfavorable decisions by the agency, as it has done successfully in the past. In August 2022, the Eleventh Circuit Court of Appeals overturned the market denial order (MDO) for its 10 non-tobacco flavored products. This decision has allowed these 10 PMTAs (premarket tobacco product applications) to undergo scientific review again and permits the sale of these flavors to continue under the FDA's tobacco product compliance policy.