Bidi Vapor LLC urged the 11th Circuit Court of Appeals to overturn the FDA’s decision denying its application to sell single-use vapes, calling the decision “arbitrary and arbitrary.” Bidi Vapor previously successfully challenged the FDA’s market denial order for 10 of its non-tobacco-flavored products, allowing them to re-enter the scientific review stage and continue to be sold.
Key points:
1. Bidi Vapor LLC urged the 11th Circuit Court of Appeals to overturn the FDA’s decision to deny its application for single-use vapes, arguing that the decision was illegal.
2. The FDA rejected Bidi’s application for tobacco-flavored disposable vapes on the grounds that the application failed to demonstrate the overall net benefit of the product and lacked sufficient evidence to address health risks.
Bidi Vapor Appeals FDA Denial of Disposable Vape Application
In August 2022. Bidi Vapor successfully overturned the FDA’s market denial order for 10 of its non-tobacco-flavored products, allowing them to re-enter the scientific review stage and continue to sell.
Bidi Vapor LLC is urging the 11th Circuit Court of Appeals to overturn the U.S. Food and Drug Administration’s (FDA) decision to deny its application to sell single-use vapes, saying the agency acted illegally.
During oral arguments in Miami, attorney Eric Gotting told the appeals panel that the FDA’s decision was “arbitrary and arbitrary, as well as unlawful.” He noted that the agency acknowledged that adult smokers might switch to Bidi’s safer single-use vape product – a vape pre-loaded with tobacco-flavored liquid – but still rejected Bidi’s application.
In January 2024, the FDA issued a Market Denial Order (MDO) for tobacco-flavored Bidi Stick-Classic disposable vapes. The decision comes as the agency continues its court-required second review of Bidi Vapor’s marketing applications for other flavoring products. The FDA said the premarket tobacco application for Bidi “does not demonstrate an overall net benefit for tobacco product users and lacks sufficient evidence to address the health risks.”
Bidi believes that FDA has violated the Administrative Procedure Act and looks forward to building on its past success in challenging adverse FDA decisions. In August 2022, the 11th Circuit Court reversed market denial orders (Mdos) for 10 of its non-tobacco-flavored products. This ruling puts 10 PMtas (Pre-Market Tobacco Product Applications) back in the scientific review stage and allows these flavors to continue to be sold under the FDA’s Tobacco Product Compliance Policy.
