U.S. Court Backs FDA Ban on Bidi Vapor’s Tobacco-Flavored E-Cigarettes

On April 24, 2025, the United States Court of Appeals for the Eleventh Circuit ruled to uphold the decision by the US Food and Drug Administration (FDA) to deny authorization for Bidi Vapor LLC's tobacco-flavored e-cigarette product, Bidi Stick - Classic, to be marketed and sold. The court determined that the FDA's decision was not arbitrary or capricious, but rather based on reasonable considerations for public health.

The case stems from Bidi Vapor's submission of a Premarket Tobacco Product Application (PMTA) to the FDA for its Bidi Classic product in 2020. After review, the FDA issued a Marketing Denial Order (MDO) in January 2024, preventing the product from entering the market.

The FDA's decision to reject the listing of Bidi Classic is mainly based on three independent reasons, including the product's high abuse potential, incomplete research on extractable compounds, and lack of data on harmful ingredients compared to other products.

The Court of Appeals focused on reviewing the reason of "bias tendency" and determined that it was sufficient to support the FDA's refusal order.

The court noted that the FDA reasonably found that Bidi Classic has a high potential for abuse. The product contains a high concentration of nicotine at 60 mg/mL and utilizes nicotine salt technology to enhance flavor, which may increase the risk of addiction for users, particularly adolescents and non-smokers. The FDA cited Bidi Vapor's own research indicating that the product's abuse potential is similar to or even higher than traditional cigarettes.

Bidi Vapor argued in the appeal that the FDA's decision was arbitrary and did not fully weigh the potential benefits of their product in helping smokers transition. However, the appeals court found that the FDA did in fact consider relevant factors, but the evidence provided by Bidi Vapor did not effectively demonstrate that current smokers would likely switch to using Bidi Classic, thus realizing the potential benefits of reduced health risks.

The court pointed out that although tobacco-flavored e-cigarettes may pose lower risks to teenagers than other flavors, Bidi Vapor has still not proven that its products provide enough public health benefits to offset their high abuse risk.

The court also rejected Bidi Vapor's argument that the FDA had made a substantial change in policy or failed to conduct a necessary second round of toxicological review. The court found that the issue of abuse potential alone was sufficient grounds for rejection, and since this issue was not based on toxicology, the FDA did not need to conduct additional toxicological review.

In the end, the Eleventh Circuit Court of Appeals confirmed that the responsibility for proving that a product is suitable for protecting public health lies with the applicant, Bidi Vapor. Given that the company failed to adequately demonstrate that the benefits of its product outweigh its significant risks of abuse, the FDA's decision to reject it was supported by the court.

Bidi Vapor's request for reconsideration has been officially rejected.