Tag: Bidi Vapor

Court Stays Bidi Vapor Marketing Denial Order
The U.S. Court of Appeals for the Eleventh Circuit has stayed the marketing denial order (MDO) issued by the U.S. Food and Drug Administration to Bidi Vapor in September 2021.
The Feb. 1, 2022, ruling allows Bidi Vapor and Kaival Brands to market and sell all of its Bidi Stick electronic nicotine-delivery systems (ENDS), including its tobacco, menthol and flavored products, while Bidi Vapor continues with its merits lawsuit compelling the FDA to place Bidi Vapor’s premarket tobacco product application (PMTA) for the flavored ENDS back under scientific review.
With the judicial stay decision going in favor of Bidi Vapor, the company expects many distribution partners to reestablish their previous sales volumes, with potentially new distribution chains added as well.
“We expect this judicial stay will result in a rebounding of Bidi Stick sales,” said Niraj Patel, president and CEO of both Kaival Brands and Bidi Vapor, in a statement. “Many wholesale and retail partners had discontinued or slowed purchases of the Bidi Stick until we heard back from the courts on the likelihood of our merits case succeeding. This is what our wholesale and retail partners have been waiting for.”
“We believe that Bidi Vapor has developed substantial, robust and reliable scientific evidence through, among other things, surveys, behavioral studies and clinical trials establishing support that the product is appropriate for the protection of the public health,” Patel said. “Following on FDA’s initial administrative stay of the MDO, we believe that this recent judicial stay is a good indication that the court finds some merit in Bidi Vapor’s arguments and puts Bidi Vapor’s PMTA one step closer to being properly and fully evaluated by FDA. We are extremely pleased with the court’s decision on this judicial stay order and continue to expect to be successful on the merits case as well.”
“The company believes that this decision signals a new milestone in the path toward providing adult smokers 21 and older with a viable alternative to combustible cigarettes. Distributors, wholesalers, retailers and adult consumers are all anxious to see positive outcomes not just for Bidi Vapor, but for the vaping industry as a whole. We believe in science-based regulation of ENDS and hope the courts will require FDA to adhere to the law as it reviews Bidi Vapor’s PMTAs,” Patel said.
February 3, 2022
FDA Stays Bidi Vapor MDO Pending Review
The U.S. Food and Drug Administration has issued an administrative stay of its marketing denial order (MDO) for nontobacco flavored bidi sticks, pending the agency’s review of Bidi Vapor’s request that the MDO be rescinded based on product-specific scientific evidence in its premarket tobacco product applications (PMTAs).
Bidi Vapor’s flavored Bidi Sticks may remain on the market without the threat of enforcement while the FDA reviews the company’s request.
Bidi Vapor, which is part of Kaival Brands, submitted PMTAs for all 11 flavor varieties of its Bidi Stick. The applications ran over 285,000 pages and contained information supporting the products as appropriate for the protection of the public health.
On Sept. 29, 2021, Bidi Vapor filed a Petition for Review with the U.S. Court of Appeals for the 11th Circuit, seeking judicial review of the MDO under the Tobacco Control Act, the Administrative Procedure Act as well as the U.S. Constitution.
“We appreciate FDA’s decision to stay, or put on hold, the MDO as it reconsiders its denial,” said Bidi Vapor Niraj Patel in a statement. “As we explained to the agency, Bidi Vapor submitted scientifically rigorous PMTAs that contained product-specific evidence demonstrating that the added benefit of our flavored Bidi Sticks to adult smokers outweighs any potential risks to youth, especially considering our stringent youth-access prevention measures and commitment to mature, adult-focused marketing.”
“That said, we are still seeking a formal, judicial stay from the appellate court pending the outcome of the lawsuit,” Patel noted.
The company has now filed a Motion for Stay Pending Review with the 11th Circuit Court of Appeals citing the “irreparable harm” it continues to suffer from the MDO.
Multiple companies have challenged their MDOs in recent weeks. In early October, the FDA rescinded MDOs it has issued to Turning Point Brands and Fumizer, placing their products back under review.
According to Filter, Triton, Bidi and Gripum recently received some temporary form of stay, and My Vape Order has demanded a recission due to the fact its PMTA includes some of the same data and studies that also appears in TPB’s applications.
October 28, 2021
Bidi Vapor to Market Product Despite MDO
Bidi Vapor will continue to manufacture and market its Artic (menthol) Bidi Stick in the United States despite receiving a marketing denial order (MDO) for the product, according to a trading update issued by Kaival Brands Innovations Group, the exclusive distributor of Bidi Vapor products.
As of Sept. 10, the U.S. Food and Drug Administration has issued MDOs for some 992,000 electronic nicotine-delivery system (ENDS) products from 168 companies. Bidi Vapor received an MDO for its nontobacco flavored Bidi Sticks, including its Artic (menthol) Bidi Stick.
The company, however, insists the FDA mischaracterized the Artic (menthol) Bidi Stick as flavored. Because its Arctic Bidi Stick is menthol, Bidi Vapor believes that this product is not subject to the MDO.
“This position is aligned with the FDA’s public statements and press releases stating that tobacco and menthol ENDS are not deemed flavored products subject to the MDOs,” the company wrote in a press note. “Accordingly, along with the Classic (tobacco) Bidi Stick, Bidi intends to continue to manufacture and market its Arctic (menthol) Bidi Stick for distribution by us.”
The company, which has historically derived nearly all its revenues from sales of flavored Bidi Sticks, appears willing to accept the risk of enforcement.
“If the FDA disagrees with Bidi Vapor’s position, issues a warning letter or takes other action against Bidi Vapor resulting in us not being able to distribute the menthol (Arctic) Bidi Stick in the United States, or consumers do not purchase the tobacco (Classic) or menthol (Arctic) Bidi Sticks, our revenues and, thereby our financial results and condition, would be materially adversely affected,” Kaival Innovations Group wrote in its news release.
For the three and nine months ended July 31, 2021, the Arctic (menthol) Bidi Stick constituted approximately 15.2 percent and 18.5 percent, respectively, of the company’s total Bidi Sticks sales.
September 15, 2021
Bidi Vapor Pushes for Synthetic Nicotine Ban

Photo: Andrii
Bidi Vapor is pushing for a ban on the marketing and distribution of synthetic nicotine in the United States, the company’s exclusive distributor, Kaival Brands Innovations Group, reported in a press release. The company, which manufactures a synthetic nicotine-based smokeless pouch, insists synthetic nicotine should be classified as an unapproved drug and thus be subject to applicable Food and Drug Administration drug regulations.
Bidi Vapor appears to be betting that a ban on synthetic nicotine pouches will benefit sales of its tobacco-derived nicotine pouch, which will be subject to the FDA premarket tobacco product application (PMTA) process before it can be distributed in the U.S. The reviewing process will further delay the launch of the tobacco-derived nicotine pouch, which had already been postponed due to Covid-19, according to Bidi Vapor.
Following the FDA’s rejection of numerous PMTAs earlier this month, many companies have set their sights on synthetic nicotine, a legal gray area. The FDA defines a “tobacco product” as anything “made or derived from tobacco that is intended for human consumption, including any component, part or accessory of a tobacco product”—a position suggesting that synthetic nicotine remains outside its remit.
Bidi Vapor is now taking the opposite approach.
“We believe that the delay in the distribution of the Bidi Pouch in the U.S. will lower revenues in the short term. However, we believe that in the longer term, the removal of all synthetic nicotine products in the U.S. market could prove to be a positive event for us,” the company wrote.
“Based on the FDA’s PMTA decisions related to disposable ENDS [electronic nicotine-delivery system] products, we anticipate that Bidi Vapor’s naturally derived nicotine products will remain on the market following the completion of the FDA’s PMTA process. Conversely, we believe that many other ENDS manufacturers are utilizing synthetic nicotine as a loophole to avoid the rigorous PMTA process and that if synthetic nicotine is deemed to be an unapproved drug, the FDA will need to regulate synthetic nicotine products as unapproved drugs or remove them from the market in order to enforce and bolster compliance requirements.”
September 15, 2021
Kaival Brands to trade on NASDAQ

Image: immimagery
Kaival Brands Innovations Group, the exclusive global distributor of products manufactured by Bidi Vapor, has been approved to list the company’s common stock on the Nasdaq Capital Market. The ticker symbol will remain unchanged, as “KAVL,” and the stock will begin trading on Nasdaq at the opening of the market on July 29, 2021.
“I am pleased to announce that the company has been approved to begin trading on Nasdaq,” said Niraj Patel, Kaival’s founder and CEO, in a statement. “This event represents another monumental milestone in our company’s short history.”
“We have worked diligently to achieve this goal and are humbled and grateful on the inclusion to the Nasdaq,” said Patel. “We are more enthusiastic than ever about being able to harness Kaival’s exciting potential.”
“Step by step, we continue our work to build a world-class global organization—our elevation to Nasdaq represents a very large strategic evolution for the company,” noted Eric Mosser, chief operating officer of Kaival Brands.
July 28, 2021
Kaival Restarts Pouch Production
Kaival Brands Innovations Group is restarting production of its Bidi Pouch ahead of an anticipated September launch.
The Bidi Pouch rollout had been delayed because of Covid-related manufacturing and supply chain constraints. Due to these complications and to prevent future bottlenecks, the company decided to move manufacturing in-house. One of the few pouch products on the market formulated without the Swedish Match formula, the Bidi Pouch provides a proprietary tobacco-free nicotine formulation packed in a convenient plastic can, according to Kaival Brands.
“I am pleased to confirm that we expect to take delivery of the pouch manufacturing machines to our warehouse the end of August and anticipate beginning production in September with our first run expected to yield up to 500,000 cans,” said Niraj Patel, founder and CEO of Kaival Brands and Bidi Vapor, in a statement.
“We are excited to launch distribution of the Bidi Pouch and have been working behind the scenes during Covid-based delays to secure initial distribution. To that extent, we are proud to announce that 8,000 points of distribution have been secured and are ready to receive our product,” said Eric Mosser, chief operating officer of Kaival Brands.
The company believes that the nicotine pouch category represents a significant market opportunity. The category has witnessed significant growth recently, with New York-based Nielsen reporting an increase in unit sales of 59.9 percent in U.S. convenience stores over the 52-week period ended June 19, 2021.
This growth is expected to continue as evidenced by publicly available material from MarketResearch.com in which it indicated that the global nicotine pouches market is expected to reach $32.8 billion by the end of 2026, with an expected compound annual growth rate of 54.9 percent through 2026.
July 23, 2021
Kaival Brands Secures Patents in China

Photo: vegefox.com
Kaival Brands Innovations Group has been granted two copyright protections and two patents by China.
The first patent, China Patent No. 202020067263.5, is a utility model patent and relates to the nozzle components of the Bidi Stick. The nozzle components play an integral role in delivering a consistent user experience. The second patent, China Patent No. 202030052391.8, is a design patent that covers the entire Bidi Stick product. Bidi Vapor has also secured copyrights for both the Bidi Stick and Bidi Cares names.
Kaival believes that the Chinese vapor market presents a considerable business opportunity. Statista data projects the China combustible cigarette market to top $220 billion in 2021. Vape products are quickly gaining market share in China, and if a mere 10 percent of combustible cigarette smokers transition to vape, China would be a $22 billion vape market opportunity. By comparison, Grandview Research anticipates the U.S. vape market to reach $7.4 billion in 2021.
“The copyright and patent protection representations received from China are the first step in our planned journey to introducing the Bidi Stick into one of the world’s largest markets for vape products, China,” said George Chuang, independent director of Kaival Brands, in a statement. “I look forward to advising the company in my role as a board member in interfacing with potential distribution partners in China.”
“Receiving two patents from China, along with copyright protections, should enhance our efforts to more effectively eliminate counterfeit players from the market, and being afforded these protections within a difficult market further validates our best-in-class product lineup,” says Niraj Patel, founder and chief executive officer of Kaival Brands and Bidi Vapor. “Both Bidi Vapor and Kaival Brands are adamant about exceeding compliance standards in every global market, and as such, our products are intended exclusively for adults 21 and over.”
Following the latest patents, Kaival has intellectual property protections in the United States, the European Union, Australia and China. “We believe this puts us in a strong position to pursue new global markets that we have already received regulatory approval to enter,” says Patel.
July 18, 2021
Kaival Splits Stock for NASDAQ Listing

Photo: Randy Harris
Kaival Brands, the exclusive global distributor of all products manufactured by Bidi Vapor, has implemented a 1-for-12 reverse split of its common stock, effective prior to the opening of the market on July 20, 2021. The reverse stock split was implemented by the company in support of its application to list on the NASDAQ Capital Market.
As a result of the reverse split at the 1-for-12 ratio, every 12 shares will be exchanged for one share of the common stock.
“We are excited for the new phase of Kaival’s capital markets development as we progress to listing on the NASDAQ,” said Niraj Patel, CEO of Kaival Brands, in a statement.
“Our board carefully considered the decision to effect the reverse split of our shares, which is critical for us to list on NASDAQ based on our current stock price. A reverse split is designed as an economically neutral, mathematical event that does not affect the intrinsic value of the company. While many companies execute reverse splits to avoid being delisted, our reverse split is in fact being done for just the opposite reason: to become qualified to list on the NASDAQ, which we believe will have many benefits for our company and shareholders.”
The reverse split is intended to increase the per share stock price of the company’s common stock in order to meet NASDAQ’s requirement that the company’s common stock be $4 or higher as of the listing date. Prior to listing its common stock on NASDAQ, the company’s application must be approved.
The company does not intend to issue fractional shares in connection with the reverse stock split. In order to avoid fractional shares of common stock, the number of shares issued to each stockholder will be rounded up to the nearest whole number in the event a stockholder would be entitled to receive less than one share of common stock as a result of the split. The reverse split will not affect any holder of the company’s common stock’s proportionate voting power, and all shares of common stock will remain fully paid and nonassessable.
July 15, 2021
Kaival and Bidi Vapor Continue Cooperation
Kaival Brands approved an amended and restated distribution agreement, which sets forth the terms of the formal relationship between Kaival Brands and Bidi Vapor. The newly amended and restated distribution agreement extends the previous one-year, annually renewable term to an initial term of 10 years, which automatically renews for another five-year term provided that Kaival Brands satisfies certain minimum purchase thresholds.
The newly amended and restated distribution agreement also provides Kaival Brands with a right of first refusal in the event Bidi Vapor receives an offer that would constitute a “change of control transaction” as well as a right of first refusal to act as the exclusive distributor of any and all future products of Bidi Vapor that arise out of or related to electronic nicotine-delivery systems (ENDS) and components related to ENDS, arise out of or relate to the synthetic nicotine industry, or arise out of or related to the tobacco-derived nicotine industry.
“We believe the amendments to the distribution agreement further bolsters the commitment between the two companies,” said Niraj Patel, president, CEO and chief financial officer, in a statement. “The relationship between Kaival Brands and Bidi Vapor during the past 12 months has been fruitful, with Kaival Brands generating approximately $100 million in revenues during the previous 12 months from the sale of the Bidi Stick and expanding its distribution of the Bidi Stick to more than 50,000 stores.”
April 22, 2021
Bidi Vapor Expands Internationally
Bidi Vapor successfully completed the regulatory process to enter seven additional international markets, bringing the total of new international countries open for distribution to 11.
These new international markets include Spain, France, Italy, Germany, the Netherlands, Austria and the Czech Republic. Previously, on March 31, 2021, Kaival Brands announced that Bidi Vapor obtained market authorization for four countries: Australia, New Zealand, Russia and the United Kingdom.
“We are very excited about pursuing our international opportunities,” said Niraj Patel, CEO of Kaival Brands, in a statement, noting how the countries posed both challenges and opportunities that the company is ready to take on.
Kaival Brands is the exclusive distributor for Bidi Vapor’s primary offering, the Bidi Stick, which is the subject of a premarket tobacco product application now under review with the U.S. Food and Drug Administration.
April 19, 2021