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  • FDA Denies Marketing of Bidi Stick

    FDA Denies Marketing of Bidi Stick

    Image: tashatuvango

    The U.S. Food and Drug Administration issued a marketing denial order to Bidi Vapor for its Bidi Stick Classic e-cigarette. This product is a closed-system, disposable, tobacco-flavored e-cigarette device.

    “FDA has a key role to protect the public from the dangers of tobacco use,” said Matthew Farrelly, director of the Office of Science within the FDA’s Center for Tobacco Products (CTP). “Integral to that role, our tobacco application review process relies on scientific evidence that demonstrates a product provides a net benefit to public health that outweighs the known risks. The science in this application did not show that.”

    The FDA evaluates premarket tobacco product applications (PMTAs) based on a public health standard that considers the benefits (e.g., benefit from adult users of more harmful tobacco products completely switching) and risks (e.g., initiation among youth) of the product to the population as a whole. After reviewing the company’s PMTA, the FDA determined that the application lacked sufficient evidence to demonstrate that permitting marketing of the product would be appropriate for the protection of the public health, which is the standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act. Specifically, evidence submitted by the applicant did not demonstrate an overall net benefit to people who use tobacco products and lacked sufficient evidence to address health risks.

    “Bidi Vapor is disappointed by the FDA’s decision and is currently reviewing the opinion based on its merits,” said Niraj Patel, CEO of Bidi Vapor. “In the meantime, the decision only affects our Classic, or tobacco-flavored, product. Our remaining 10 flavors are still under scientific review and available for sale. At this time, we are investigating legal remedies and expect to have updates in the coming days. For now, we ask that our wholesale and retail partners direct their questions to our sales representatives.”

    “The center has made considerable progress in reviewing the massive volume of tobacco product applications submitted to the agency, thanks to the tireless efforts of our dedicated legion of civil servant scientists,” said Brian King, director of the CTP. “The center remains committed to processing submitted applications as expeditiously as possible while ensuring the utmost scientific integrity of the reviews.”

    To date, the FDA has authorized 23 tobacco-flavored e-cigarette products and devices. The distribution or sale of unlawfully marketed products is subject to compliance and enforcement action.

  • MDO Stay Boosts Kaival’s Results

    MDO Stay Boosts Kaival’s Results

    Photo: crizzystudio

    Kaival Brands Innovations Group reported revenues of $3.8 million for the third quarter of fiscal year 2022, up from $3.2 million for the same period of 2021. Gross profit was $442,100 compared to a loss of $84,300 for comparable 2021 period.

    Kaival attributed its improved revenues in part to an August court ruling that set aside a marketing denial order issued by the U.S. Food and Drug Administration to the company’s nontobacco flavored Bidi Stick e-cigarettes. Arguing that the agency had insufficiently considered Kaival Brands’ marketing and sales access restriction plans, the U.S. Court of Appeals for the Eleventh Circuit ordered the FDA to further review Kaival’s premarket tobacco product applications, allowing the company to continue to market its products.

    Eric Mosser

    “The recent 11th Circuit ruling in favor of Bidi Vapor alleviated a significant barrier to our adult-focused B2B sales efforts, which we believe will once again allow us to materially scale our business, grow revenue, move toward net profitability in the future and increase shareholder value,” said Kaival Brands President and Chief Operating Officer Eric Mosser in a statement.

    Mosser added that the company is working with Philip Morris to expand international distribution into new global markets. In June, Kaival Brands Innovations Group’s subsidiary, Kaival Brands International (KBI), entered into a licensing agreement with Philip Morris Products (PMP) for the development and distribution of electronic nicotine-delivery system products outside the U.S.

    “We expect to begin recognizing revenues from this international licensing agreement in our fiscal fourth quarter,” said Mosser.

    In July, Kaival announced the launch of PMP’s Veeba vapor product in Canada, with royalties due to KBI pursuant to the international licensing agreement.

  • Kaival Expects Boost From Court Ruling

    Kaival Expects Boost From Court Ruling

    Photo: Kaival Brands Innovations Group

    Kaival Brands, the U.S. distributor of products manufactured by Bidi Vapor, expects sales of its Bidi Stick vapor product to benefit from a recent court decision instructing the U.S. Food and Drug Administration to take another look at the company’s premarket tobacco product applications (PMTAs).

    On Aug. 23, the U.S. Court of Appeals for the 11th Circuit granted petitions for review filed by Bidi Vapor, Diamond Vapor and four other companies challenging the FDA’s rejection of their e-cigarette applications. According to Chief Judge William Pryor, the agency didn’t properly assess the companies’ marketing and sales-access-restriction plans designed to minimize youth exposure and access.

    This ruling effectively reverses the marketing denial orders and allows Bidi Vapor to continue to market all flavor varieties of the Bidi Stick in the United States. The company submitted PMTAs for all 11 flavor of its Bidi Stick prior to the Sept. 9, 2020, PMTA deadline.

    “As the exclusive U.S. distributor of Bidi Vapor’s products, this [ruling] 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, in a statement.

    “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.”

    At press time, the FDA had not announced how it would respond to the court ruling. The agency could appeal the ruling or put Bidi Vapor’s PMTAs for its nontobacco-flavored devices into scientific review.

  • Kaival Brands Reports Quarterly Results

    Kaival Brands Reports Quarterly Results

    Photo: Song about Summer

    Kaival Brands’ revenues decreased by approximately $15.7 million in the second quarter of fiscal year 2022, compared to the same period of fiscal year 2021. Compared with the first quarter of 2022, however, revenues rose 11 percent.

    Gross profit in the second quarter of fiscal year 2022 was approximately $387,700, or approximately 12.7 percent of revenues, net, compared to approximately $6.3 million gross profit, or approximately 34.6 percent of revenues, net, for the second quarter of fiscal year 2021.

    In February 2022, Bidi Vapor was granted a judicial stay on the marketing denial order (MDO) previously issued by the U.S. Food and Drug Administration prohibiting the marketing and sale of nontobacco flavored Bidi Sticks, which had significantly impacted Kaival Brands’ revenues in previous quarters.

    As a result of the grant of the judicial stay of the MDO, the company’s revenues increased in the second quarter of fiscal 2022, as compared to the first quarter of fiscal 2022. Kaival Brands expect this trend to continue as renewed distribution ramps up and sales of nontobacco flavored Bidi Sticks increase, subject to the court ruling in Bidi Vapor’s favor in the pending merits-based case, and subject to the FDA’s enforcement discretion.

    “Our results demonstrate strong execution and resiliency in our business, as revenues in the second quarter of fiscal year 2022 rose 11 percent as compared to revenues in the first quarter of fiscal year 2022,” said Kaival Brands founder and CEO Niraj Patel in a statement.

    “The recently announced international licensing agreement with Philip Morris Products, a wholly owned affiliate of Philip Morris International, is a major milestone in the company’s efforts to expand the global sales and distribution of the Bidi Stick. From a balance sheet perspective, the international licensing agreement has the potential to generate substantial returns on capital for the company, given the low cash investment needed to reach a significant number of potential new consumers.”

  • Kaival and PMI Sign Distribution Agreement

    Kaival and PMI Sign Distribution Agreement

    Photo: khwanchai

    Kaival Brands Innovations Group, the U.S. distributor of all products manufactured by Bidi Vapor, has reached an agreement with Philip Morris Products (PMP), a wholly owned affiliate of Philip Morris International, for the development and distribution of electronic nicotine-delivery system (ENDS) products in markets outside of the U.S., subject to market (or regulatory) assessment.

    The company’s recently formed wholly owned subsidiary, Kaival Brands International (KBI), entered into a licensing agreement with (PMP) on June 13, 2022. The agreement grants to PMP a license of certain intellectual property rights relating to Bidi Vapor’s premium ENDS device, known as the Bidi Stick in the U.S., as well as potentially newly developed devices, to permit PMP to manufacture, promote, sell and distribute such ENDS device and newly developed devices in international markets outside of the U.S.

    The parties believe this agreement promotes their joint vision of a smoke-free future.

    “We believe that in addition to the Bidi Stick having wide acceptance among legal-age nicotine users in the United States, Bidi Vapor’s numerous decisions around design; responsible adult-oriented marketing and stringent youth-access prevention measures; and sustainability bolstered its appeal to PMI,” said Niraj Patel, CEO of Kaival Brands, in a statement.

    “We, along with PMI and Bidi Vapor, share the vision of a smoke-free future. The Bidi Stick offers legal-age nicotine users a high-quality alternative to cigarettes that satisfies their taste preferences. Further, we, along with Bidi Vapor, are committed to prioritizing the appropriate regulation and responsible commercialization, inclusive of taking the necessary measures to make sure these products do not appeal to unintended audiences, including youth. By example, Bidi Vapor does not engage in direct online sales to consumers and requires age verification contracts with our distributors and retailers.

    “While Bidi Vapor continues to pursue the U.S. Food and Drug Administration premarket tobacco product authorization, cooperation with a major multinational company like PMI, a leader in scientifically substantiated smoke-free products, opens doors on a global scale. Kaival Brands looks forward to a long, productive relationship with PMI to accelerate the end of smoking.”

    “We have previously mentioned our intention to broaden our current smoke-free product portfolio for adults who would otherwise continue to smoke cigarettes or use other nicotine products. This agreement supports that vision and is another step toward accelerating the delivery of a smoke-free future. We are excited to start our agreement with Kaival Brands—led by CEO Niraj Patel—who shares the same vision as we do, to accelerate the end of combustible cigarette smoking,” says PMI President of E-Vapor Ashok Rammohan.

  • Kaival Brands Reports ‘Challenging’ Year

    Kaival Brands Reports ‘Challenging’ Year

    Niraj Patel (Photo: Kaival Brands

    Kaival Brands reported revenues of approximately $58.8 million in the fiscal year that ended on Oct. 31, 2021. The company’s performance was worse than 2020, primarily due to the U.S. Food and Drug Administration’s marketing denial orders, which prevented Kaival Brands from marketing the nontobacco flavored Bidi Sticks in the United States toward the end of fiscal year 2021.

    In addition, the company faced increased competition, which it attributes to the lack of enforcement by federal and state authorities against subpar and low-priced vaping products that continued to enter the market illegally without FDA authorization.

    Net loss for fiscal year 2021 was approximately $9 million compared to net income of approximately $3.8 million for fiscal year 2020. The decrease in net income year-over-year was largely due to the decrease in revenues and the increase in operating expenses.

    “Fiscal year 2021 was a very challenging year, especially because of FDA’s marketing denial order, or MDO, for Bidi Vapor’s nontobacco flavored Bidi Stick ENDS [electronic nicotine-delivery system], which caused irreparable harm to both Bidi Vapor and Kaival Brands,” said Kaival Brands’ CEO Niraj Patel in a statement.

    “However, we were pleased that the court ultimately agreed to stay the MDO and that we were able to make key strategic decisions to stay in business and continue maturation of the company in 2021, including uplisting to Nasdaq and completing our first underwritten public offering.”