Bidi Vapor Wins Merits Case Against FDA

Federal Appeals Court sets aside Bidi Vapor’s Marketing Denial Order (“MDO”) for its non-tobacco flavored ENDS, and remands back to FDA for further review

MELBOURNE, Fla. — Bidi Vapor LLC, the manufacturer of the premium BIDI^® Stick electronic nicotine delivery system (ENDS), announced that the U.S. Court of Appeals for the Eleventh (11th) Circuit has ruled 2-1 in Bidi Vapor’s favor, granting its petition for review, and setting aside and remanding as arbitrary and capricious the U.S. Food and Drug Administration’s (“FDA”) order denying the Premarket Tobacco Product Applications (“PMTA”) for the non-tobacco flavored BIDI^® Sticks.

On August 23, 2022, the 11th Circuit held that FDA’s Marketing Denial Order (“MDO”) issued against Bidi Vapor’s non-tobacco flavored ENDS devices was “arbitrary and capricious,” primarily because FDA failed to consider the relevant marketing and sales-access-restrictions plans included in Bidi Vapor’s comprehensive PMTAs.

“Distribution in the ENDS market has been challenging to say the least, especially regarding compliance with FDA policies and procedures. As the exclusive U.S. distributor of Bidi Vapor’s products, this is a significant event for us and our downstream partners, as many awaited the decision before expanding distribution, and paves the way for potential revenue growth for our company” said Eric Mosser, President and Chief Operating Officer of Kaival Brands Innovations Group, the Grant, Florida-based, U.S. distributor of Bidi Vapor products.

“But more than that, we are glad the appellate court recognized the potential importance and direct effects that an adult-focused marketing plan and strict sales and access restrictions may have on addressing the youth access problem,” continued Mr. Mosser. “We strongly believe that the appeal to and illegal usage by youth can be significantly reduced, not by banning flavors which are necessary for adult smokers seeking non-combustible alternatives to cigarettes, but with responsible marketing, adult-oriented packaging, restrictive online access, and enforcement of the current laws and regulations to force out bad actors marketing illegal and counterfeit products.”

In the majority opinion, the Court stated that FDA needed to consider relevant marketing strategies and plans surrounding access and restrictions around minors included in the PMTAs, and not simply disregard those plans as historically insufficient. “The FDA offers its experience as its primary excuse for its refusal to consider the marketing and sales-access-restriction plans,” the Court’s majority ruled. “Experience fails as a justification…”

The majority also noted that administrative “efficiency” – i.e., quickly reviewing the many PMTAs submitted to FDA – was not an “excuse,” saying, “by definition, the requirement that federal agencies consider all ‘relevant factors,’ prohibits agency shortcuts.”

While the majority focused on FDA’s failure to review Bidi’s marketing plans and sales and access restrictions, the majority further noted, with respect to Bidi Vapor’s applications, that FDA also failed to consider key evidence including, among other things, “product information, scientific safety testing, literature reviews, consumer insight surveys, and details about the company’s youth access prevention measures, distribution channels, and adult-focused marketing practices,” which “target only existing adult vapor product users, including current adult smokers,” as well as Bidi Vapor’s state-of-the-art anti-counterfeit authentication system and retailer monitoring program

Leading with Integrity

Bidi Vapor submitted PMTAs for all 11 flavor varieties (nine flavored ENDS plus menthol and tobacco) of its BIDI^® Stick prior to the court-ordered September 9, 2020 PMTA deadline. The detailed applications ran over 285,000 pages and contained significant information supporting the products as appropriate for the protection of the public health – including robust and reliable scientific data supporting that its non-tobacco flavored BIDI^® Sticks provide an added benefit to adult smokers over tobacco-flavored ENDS.

Despite submitting scientifically rigorous PMTAs and keeping FDA informed about its ongoing clinical and behavioral studies, among other things, Bidi Vapor received an MDO for its non-tobacco flavored BIDI^® Sticks, along with nearly all other manufacturers of such flavored ENDS, in early September 2021. On September 29, 2021, Bidi Vapor filed a Petition for Review of the MDO with the 11th Circuit. That MDO was initially administratively stayed by FDA; after that administrative stay was lifted in December 2021, the 11th Circuit stayed the MDO on February 1, 2022. Oral arguments were heard on May 17, 2022 in Miami, Florida.

On August 23, 2022, the 11th Circuit ruled on the Petition for Review in favor of Bidi Vapor. This ruling effectively reverses the MDO and allows Bidi Vapor to continue to market all flavor varieties of the BIDI^® Stick in the United States. All ENDS product on the market today that do not have marketing authorization from FDA are subject to enforcement, at the Agency’s discretion.

Since its MDO was issued, Bidi Vapor has continued to supplement its comprehensive PMTAs with additional science, including clinical and behavioral studies supporting that its products are APPH, which Bidi Vapor believes FDA must now also consider on remand as part of a full scientific review of its applications.

ABOUT BIDI VAPOR

Based in Melbourne, Florida, Bidi Vapor maintains a commitment to responsible adult-focused marketing, strict youth access prevention measures and age-verification standards, as well as sustainability through its BIDI^® Cares recycling program. Bidi Vapor’s device, the BIDI^® Stick, is a premium product made with high-quality components, a UL-certified battery and technology designed to deliver a consistent vaping experience for adult smokers 21 and over. Bidi Vapor is also adamant about strict compliance with all federal, state, and local guidelines and regulations. At Bidi Vapor, innovation is key to its mission, with the BIDI^® Stick promoting environmental sustainability, while providing a unique vaping experience to adult smokers.

Niraj Patel, Chief Science and Regulatory Officer of Kaival Brands, owns and controls Bidi Vapor. As a result, Bidi Vapor and Kaival Brands are considered under common control and Bidi Vapor is considered a related party.

For more information, visit www.bidivapor.com.