Yesterday (April 2), Bidi Vapor LLC urged the Eleventh Circuit to reverse a U.S. Food and Drug Administration decision denying its application to market a disposable e-cigarette, saying the agency acted unlawfully. In oral arguments in Miami, attorney Eric Gotting told an appellate panel that the FDA’s decision was “arbitrary and capricious and unlawful,” and that the agency admitted adult smokers would likely switch to Bidi’s safer product—a disposable e-cigarette prefilled with tobacco-flavored e-liquid—but still denied the application.
In January 2024, the FDA issued a marketing denial order (MDO) for the tobacco-flavored Bidi Stick-Classic disposable vape. The decision came while the agency was continuing a court-ordered second review of marketing applications for flavored Bidi Vapor products. The FDA said Bidi’s premarket tobacco application “did not demonstrate an overall net benefit to people who use tobacco products and lacked sufficient evidence to address health risks.”
Bidi believes the FDA violated the Administrative Procedure Act and hopes to build on its record of successfully contesting adverse FDA decisions. In August 2022, the 11th Circuit set aside the original MDOs issued for its 10 non-tobacco-flavored products. That ruling put the 10 PMTAs back into scientific review and allowed those flavors to remain available for sale pursuant to the FDA’s compliance policy for deemed tobacco products.