Bidi Vapor Wins Appeal Against FDA Marketing Order

On August 23, 2022, the 11th Circuit Court ruled that the FDA's Marketing Denial Order (MDO) against Bidi Vapor's non-tobacco flavored e-cigarettes was "arbitrary and capricious" because the FDA did not take into account Bidi Vapor's comprehensive marketing and sales access restriction plan included in their PMTA.

Eric Mosser, President and Chief Operating Officer of Kaival Brands, stated that distribution in the ENDS market has always been challenging, especially in compliance with FDA policies and procedures. As the exclusive distributor of Bidi Vapor products in the United States, this is a significant event for their partners as many have been waiting for this decision before expanding distribution. This paves the way for potential revenue growth for the company, but they are also pleased that the appellate court recognizes the importance of adult-oriented marketing plans and strict sales and access restrictions in addressing youth access issues. They believe that responsible marketing, adult-oriented packaging, restrictive online access, and compliance with existing laws and regulations can prevent marketers of illegal and counterfeit products from engaging in harmful behaviors.

In the majority opinion, the court stated that the FDA needs to take into account relevant marketing strategies and plans that address the entry and restrictions of minors in the PMTA, rather than simply ignoring them as inadequate in history. The court ruled that "the FDA relies on its experience as the main excuse for refusing to consider marketing and sales access restriction plans.

Although most people are focused on the FDA's failure to review Bidi's marketing plans and sales and access restrictions, many are also pointing out that the FDA did not consider key evidence regarding Bidi Vapor's application, including "product information, scientific safety testing, literature review, consumer insights research, and detailed information regarding the company's youth access prevention measures, distribution channels, and adult-focused marketing practices," which "are only aimed at existing adult vapor product users, including current adult smokers, and Bidi Vapor's most advanced anti-counterfeit authentication system and retailer monitoring program.

At the time of the release of this news statement, the FDA had not yet announced its specific plan. The agency may appeal the decision or conduct a scientific review of Bidi Vapor's non-tobacco flavored devices' PMTA. The court's ruling "remands" or sends the application back to the FDA for action. Dissenting judges sided with the FDA and its argument that, even though it acknowledged not reviewing Bidi Vapor's marketing plan or other evidence submitted, it did not see any marketing or access plan that could reduce young people's opportunities or non-tobacco flavored e-cigarette products having an advantage in decreasing smoking among existing smokers over tobacco-flavored e-cigarette products.

We believe that Bidi Vapor has provided the FDA with a substantial, reliable, and robust scientific evidence through investigations, behavioral studies, and clinical trials of our BIDI Stick product. We are confident that science will prove the BIDI® Stick to be appropriate for the public health (APPH)," said Niraj Patel, Chief Scientific Officer and founder of Kaival Brands. "Following the FDA's initial administrative pause on the MDO, we view the subsequent judicial pause as a positive sign that the court has found merit in Bidi Vapor's arguments and has brought Bidi Vapor one step closer to a proper and comprehensive evaluation of non-tobacco flavored ENDS under the PMTA than the FDA. Bidi Vapor's victory in our case confirms our previous convictions, and we look forward to working with the agency through the scientific review process.

Honest Leadership

On September 9th, 2020, Bidi Vapor submitted PMTAs (pre-market tobacco product applications) for all 11 flavors of its BIDI® Stick, which include 9 ENDS flavors as well as mint and tobacco. The detailed application exceeds 285,000 pages and contains important information supporting the product's ability to protect public health, including reliable scientific data. It also supports the claim that Bidi® Stick provides an additional benefit of tobacco-flavor for adult smokers.

Despite submitting a scientifically rigorous PMTA and regularly informing the FDA of its ongoing clinical and behavioral studies, Bidi Vapor received an MDO in early September 2021 for its non-tobacco flavored pods and similar flavored ENDS products, along with almost all other manufacturers. On September 29, 2021, Bidi Vapor filed a petition for MDO review with the 11th Circuit Court of Appeals. The MDO was initially suspended administratively by the FDA, and after the administrative suspension was lifted in December 2021, the 11th Circuit Court of Appeals suspended the MDO on February 1, 2022. On May 17, 2022, oral arguments were heard in Miami, Florida.

On August 23, 2022, the Eleventh Circuit Court of Appeals issued a favorable ruling on the rehearing petition filed by Bidi Vapor. The ruling effectively overturned the Modified Risk Tobacco Product Order and allowed Bidi Vapor to continue selling all flavors of their BIDI® Stick in the United States. Currently, all ENDS products marketed without FDA authorization are subject to discretionary enforcement by the agency.

Since the release of MDO, Bidi Vapor has continued to augment its comprehensive PMTA with additional scientific support, including backing for its products in clinical and behavioral research as APPH. Bidi Vapor believes the FDA must now consider a stay of enforcement as part of a full scientific examination of its application.

Regarding BIDI VAPOR

Bidi Vapor is headquartered in Melbourne, Florida, and is committed to responsible, adult-centric marketing, strict youth access prevention measures, age verification standards, and sustainability through its BIDI Cares recycling program. Bidi Vapor's device, the BIDI® Stick, is a high-quality product made with premium components, UL-certified batteries, and technology designed to provide a consistent electronic cigarette experience for adult smokers aged 21 and over. Bidi Vapor also adheres strictly to all federal, state, and local guidance and regulations. Innovation is key to Bidi Vapor's mission, and the BIDI® Stick promotes environmental sustainability while providing a unique vaping experience for adult smokers.

Niraj Patel, the Chief Scientific and Regulatory Officer of Kaival Brands, owns and controls Bidi Vapor. As a result, Bidi Vapor and the Kaival brand are considered jointly controlled, with Bidi Vapor being deemed an affiliate.

Regarding KAIVAL BRANDS

The headquarters of Kaival Brands Innovations Group, Inc. is located in Grant, Florida (NASDAQ code: KAVL). The company is focused on incubating and growing innovative and profitable products into mature and dominant brands in their respective markets. Their vision is to internally develop, acquire, own or exclusively distribute these innovative products and grow each one into a leading market share brand with exceptional quality and recognizable innovation. Kaival Brands and Philip Morris International Inc. are the exclusive global distributors of products manufactured by Bidi Vapor.

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