Tag: Bidi Vapor

Kaival Brands Appeals MDO of Tobacco Bidi Stick

A recent marketing denial order issued for a tobacco-flavored Bidi Stick only applies to one Bidi device. The company, Bidi Vapor, currently has 10 other flavors still in the U.S. Food and Drug Administration’s premarket tobacco product application (PMTA) process.
Bidi Vapor’s “Classic” tobacco-flavored Bidi Stick ENDS device is the only product affected. Kaival Brands, parent to Bidi Vapor, holds the worldwide license to distribute products made by Bidi Vapor.
In response to the MDO, Bidi Vapor filed a petition requesting that the U.S. Court of Appeals for the 11th Circuit review the MDO, which Bidi Vapor believes was, among other things, “arbitrary and capricious, in violation of the Administrative Procedure Act.” Bidi Vapor will also be seeking a stay of the MDO pending the outcome of the litigation.
“Bidi Vapor disagrees with the FDA’s decision and is taking immediate action accordingly,” said Niraj Patel, the founder and CEO of Bidi Vapor and Chief Science Officer and founder of Kaival Brands. “In the meantime, it is important to note that the decision only affects the ‘Classic’ or tobacco-flavored Bidi Stick. The remaining ten Bidi Stick flavors are still under FDA scientific review and remain in distribution in the United States through Kaival Brands, subject to the FDA’s enforcement discretion.”
Bidi Vapor has a history of successful outcomes when contesting adverse FDA decisions, having received a favorable 11th Circuit ruling in August 2022 that set aside the original MDOs received for its 10 non-tobacco flavored products, according to a press release.
“While we are disappointed with the FDA’s decision, we are in close contact with Bidi Vapor and laser-focused on selling the Bidi Vapor products that we are permitted to,” said Barry Hopkins, executive chairman of Kaival Brands. “Like Bidi Vapor, we are fully committed to the legal and responsible use of our products. Moreover, we are committed to increasing Kaival Brands’ revenues by strengthening our existing business and also diversifying our product portfolio, as evidenced by the intellectual property we acquired in May 2023 from GoFire, Inc.”
January 29, 2024
FDA Issues MDO for Tobacco-Flavored Bidi Stick
The U.S. Food and Drug Administration has issued a marketing denial order (MDO) to Bidi Vapor LLC for its Bidi Stick classic e-cigarette. The Bidi Stick is a closed-system, disposable, tobacco-flavored vaping 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 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 company must not market or distribute this product in the United States or they risk FDA enforcement action. The company may submit a new application to the agency for review that addresses these deficiencies.
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, an FDA press release states. 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.
“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.”
Kavial Brands, the manufacturer of Bidi Stick, is expected to appeal the decision.
China-based Shenzhen IVPS, the parent to SMOK brand vaping devices, filed an appeal with the New Orleans, Louisiana-based U.S. Court of Appeals for the Fifth Circuit after it received an MDO and was joined in the suit by a Dallas, Texas-based distributor of the SMOK products that were denied marketing.
on Jan. 3, the U.S. Court of Appeals for the Fifth Circuit ruled that the FDA acted “arbitrarily and capriciously” in rejecting the premarket tobacco product applications (PMTA) of Wages and White Lion Investments, doing business as Triton Distribution, and Vapetasia for approval to sell their products in the United States.
The 9-5 decision by the New Orleans-based 5th U.S. Circuit reversed a July 2022 decision by a three-judge panel of that court.
The agency “sent manufacturers of flavored e-cigarette products on a wild goose chase,” telling them what would be needed to approve their products, and then denying all applications, the court said in an opinion by Judge Andrew S. Oldham. The FDA “never gave petitioners fair notice that they needed to conduct long-term studies on their specific flavored products,” Oldham wrote.
January 23, 2024
Kaival Brands Promotes Hopkins to CEO, President

A former Altria executive has been promoted to CEO and resident of Kaival Brands Innovations Group, Inc. The company announced that it has expanded the role of Executive Chairman Barry Hopkins to include the additional positions.
Former CEO and president, Eric Mosser, has been appointed CEO and president of Kaival Brands International, a Kaival Brands Innovations Group’s subsidiary with an international licensing relationship with Philip Morris Products S.A., a wholly owned affiliate of Philip Morris International Inc.
Niraj Patel, founder and chief science officer of Kaival Brands, said that from the beginning he has envisioned a diverse platform that could “capture the tailwinds” generated by the company’s core offering, the BIDI Stick electronic nicotine delivery system (ENDS) product.
“Barry understands this vision, the importance of regulatory compliance and youth access prevention, and has done an exceptional job since joining Kaival Brands. He has eagerly taken on increasing levels of responsibility, leveraging his decades of experience in management in our industry,” said Patel in a press release. “His appointment as Interim CEO and president was a natural progression, and we look forward to potentially expanding our excellent management team further during 2024 with a permanent CEO and/or president as our needs dictate.
“Having Barry in this position now is particularly important since we are at a significant inflection point, as we remain hopeful that FDA will soon complete its review of the pending premarket tobacco product application (PMTA) for the tobacco-flavored BIDI Stick Classic. If we receive a marketing granted order for this product, we will have significant momentum in the new year with the ability to continue to transition adult cigarette smokers, drive revenue and grow our company.”
According to a recent U.S. Food and Drug Administration announcement, the agency’s next status report regarding its review of the still-pending PMTAs for major brands and market share leading ENDS products is due to be filed by January 22, 2024 with the U.S. District Court in Maryland.
Although FDA has not indicated publicly which PMTAs it is prioritizing for review, Kaival Brands is hopeful that the BIDI Stick Classic will be included in the January status report. The company also anticipates the PMTAs for the other 10 BIDI-branded SKUs will remain in scientific review, according to Patel.
Recently, the Kaival Brands has been encouraged by the coordinated efforts of the FDA, U.S. Customs and Border Protection, and other government agencies to increase their coordinated focus on enforcement. The company believes it has been hurt by illicit vaping products flooding the market, and it is now preparing to scale along with other legal products, assuming increased enforcement continues alongside the January announcement by the FDA.
“Hopkins will spearhead the company under the direction of the Board of Directors with a continued focus on accelerating revenue growth, improving operational efficiencies and executing Kaival Brands’ strategic growth and diversification initiatives, while remaining in compliance with applicable state and federal regulations.
“The company, alongside BIDI Vapor (the maker of the BIDI Stick), is also continuing to focus on working with Philip Morris to accelerate the international distribution of ENDS products using BIDI technology (which Philip Morris markets under the brand name ‘VEEV Now’), as part of Philip Morris’s plan to deliver a smoke-free future.”
December 29, 2023
Bidi Vapor Calls for Removal of Non-Compliant Vapes

Credit: Iama Sing
During a recent webcast, Bidi Vapor leadership called on the U.S. Food and Drug Administration to do more to stop the flood of non-compliant vaping products from entering the market.
In a recently produced webcast, “Vape Update: Getting Noncompliant Devices Off the Market,” Bidi Vapor executives detailed current enforcement activities the agency has been ramping up throughout the industry and touched on potential solutions, such as tracking scan data to identify unlawful companies.
“It’s a major public health concern when these illicit, noncompliant and non-regulated products are overtaking the legal products,” said Niraj Patel, CEO of Bidi Vapor. “These illegal products used to be in just mom-and-pop stores, but now, these products are breaking into the franchise market, and showing up in the Nielsen numbers. But this list also puts pressure on the FDA and all other law enforcement agencies to do their jobs.”
Data from Nielsen, a New York-based data-collection firm, has the ability to provide the information needed to make a larger impact on the illicit market, according to Russell Quick, president of Bidi Vapor’s marketing firm, Kaival Marketing Services, reports CStoreDecisions.
Photo: Kaival Brands Innovations Group
“Law enforcement can now track the supply chain,” Quick said in the webcast. “We can identify the distributors and retailers that are selling these non-compliant, illegal, illicit products. So both federal and state level authorities can issue warnings, fines, civil penalties or even harsher monetary penalties to these companies that are participating in and distributing these illegal products.”
Bidi Vapor also produced two related infographics on illicit vape products and the illicit market to accompany the webcast. To download the graphics: “How to Spot Illicit Vape” and “Rise of Illicit Vape.”
The full webcast can be found here.
November 30, 2023
Kaival Brands: Scan Data Key to Beating Back Black Market

At a conference of administrators, attorneys, and businesspeople on tobacco regulation, Russell Quick, president of Kaival Marketing Services, said regulatory agencies can use the same data in a recently published ranking of disposable vape devices as a “roadmap” to identifying companies marketing illegal vaping products.
Quick, whose company markets the Bidi Stick brand of electronic nicotine delivery system (ENDS), spoke at the Tobacco and Nicotine Products Regulation and Policy Conference sponsored by the Food and Drug Law Institute (FDLI) in Washington, D.C.
He said a ranking from New York-based Nielsen shows 10 of the 11 named disposable ENDS were not compliant with the U.S. Food and Drug Administration’s regulatory processes, according to a press release.
Thirty-four companies were named in a lawsuit filed in October by Altria subsidiary NJOY over non-compliant products.
“Scan data now is at our fingertips … and you can literally pull this data to see which retailers are selling which non-compliant product and which wholesalers are distributing [these products] — that’s one good way to revolutionize vape enforcement,” Quick told the roughly 200 attendees during a panel discussion. “What’s really hurting the industry are illegal, non-compliant bad actors in the U.S. vaping market undermining the potential of e-cigarettes to help adult smokers quit.”
Quick said that if law enforcement agencies started using scan data to call out illegal activity, the vaping industry could ultimately regulate itself. “Most major stakeholders already follow the rules,” Quick said, “but non-compliant companies take a major share of the market.”
For its part, Bidi Vapor submitted premarket tobacco product applications (PMTAs) to the FDA for all 11 of its flavored devices, which are currently under scientific review.
During the PMTA evaluation period, Bidi Vapor can market its Bidi Stick products, subject to FDA enforcement discretion.
November 14, 2023
Kaival Brands Reports Flat Quarterly Revenues

Photo: wichayada
Kaival Brands Innovations Group reported revenues of $3 million in the second quarter of fiscal 2023, down from $3.1 million in the comparable 2022 quarter. Gross loss was $100,000 compared with a gross profit of $400,000 in the prior-year period.
While sales were slightly down versus the prior year quarter due to customer credits, discounts and rebates, Kaival believes that continued U.S. Food and Drug Administration enforcement of noncompliant electronic nicotine-delivery system products has allowed the company to position its Bidi Stick as a compliant alternative subject to FDA enforcement discretion. The company believes this should also help in securing new orders for the Bidi Stick.
“We remain excited and confident in the future of Kaival Brands,” said Eric Mosser, president and CEO of Kaival Brands, in a statement. “Over the past four months, we signed new broker and distribution agreements for our core Bidi Stick distribution business, focusing on partners that share our vision of regulatory compliance and youth access prevention. We believe we have positioned ourselves for increased sales in the second half of the year.”
In addition to its quarterly results, Kaival announced the renewed distribution of its Bidi Stick in Circle K convenience stores. “As of this week, we have activated over 1,000 new Circle K locations, with the goal of ramping up to 5,000 this year,” said Mosser.
The company also announced the initial shipment of Bidi Sticks to over 900 Kwik Trip and Mapco locations.
June 15, 2023
Kaival Brands Signs Sales Agreement With Major Broker

Photo: Bidi Vapor
Kaival Brands Innovations Group, the U.S. distributor of all Bidi Vapor products, has entered into a sales broker agreement with a prominent U.S. broker to expand access to Bidi Vapor products from its current foundation of convenience store distribution into new retail channels, including discount, grocery and mass merchandisers.
Eric Mosser
“As we look to push distribution into more channels beyond the convenience stores, we are excited to announce a new agreement that gives us potential access to over 40,000 new locations,” said Eric Mosser, president and chief operating officer of Kaival Brands, in a statement. “We believe this agreement, along with our recent announcement of other new distribution agreements, further validates our reputation as a good actor providing adult consumers with the highest quality vape experience possible, and we look forward to working with all of our commercial channel partners to expand our revenue opportunities.”
“We are excited to further increase the reach of Bidi Vapor and its premium vaping device, the Bidi Stick, into potentially more distribution opportunities throughout multiple retail channels,” stated Russell Quick, president of QuikfillRx, the company’s third-party sales and marketing vendor. “With our feet firmly in the convenience store space, it is time not only to grow our existing footprint but to extend into more channels, like dollar and grocery stores, that meet our robust identification verification and youth access prevention requirements.”
March 13, 2023
Kaival Brands Signs New Distribution Agreements

Photo: Bidi Vapor
Kaival Brands Innovations Group, the exclusive U.S. distributor of Bidi Vapor products, has entered into agreements representing potential new distribution to approximately 13,500 locations.
Under the terms of the agreements, Bidi Vapor’s Bidi Stick will initially be activated in 700 locations, with another 1,500 locations expected within the next 90 days. All of the new locations meet Kaival Brand’s and Bidi Vapor’s requirements for customer identification verification and youth-access prevention.
“We are excited to announce these significant new distribution agreements, totaling up to 13,500 new locations, as we look to continue the ramp up of marketing and sales activity for Bidi Stick. Since Bidi Vapor succeeded in its merits case against the FDA vacating FDA’s marketing denial order for ENDS products in August 2022, we have seen a resurgence of interested retailers and potential distributors,” said Kaival Brands President and Chief Operating Officer Eric Mosser in a statement.
“While the FDA continues to move slowly in enforcing against bad actors, major retailers are showing their commitment to e-cigarettes as a category and using corporate discretion to select brands that are committed to youth-access prevention and responsible marketing of adult products. We believe our products fit squarely in this category, and we are hopeful that this positioning will lead to greater revenues for Kaival Brands during 2023.”
“We are excited to increase the reach of the Bidi Stick by up to 13,500 new stores,” stated Russell Quick, president of QuikfillRx, which operates under the name Kaival Marketing Services. “These new agreements represent an immediate impact of 700 new locations to start and we believe represents a vote of confidence that retailers have in us and our products.”
March 8, 2023
Kaival’s Fiscal 2022 Hit by Marketing Denial Order

Photo: Kaival Brands
Kaival Brands Innovations Group reported revenues of $3 million for the fourth quarter that ended Oct. 31, 2022, compared with revenues of $100,000 million for the prior fourth fiscal quarter. Revenues for the full fiscal year were approximately $12.8 million, down from $58.8 million for fiscal year 2021.
Kaival attributed the full-year decrease to the U.S. Food and Drug Administration’s marketing denial orders (later overturned), which temporarily prevented the company from selling its products, and to increased competition in general, which Kaival suspects resulted from lax enforcement by federal and state authorities against subpart and low-priced vaping products that continued to enter the market illegally without FDA authorization.
“Fiscal 2022 was an exceptionally challenging year for us, primarily due to regulatory action by the FDA that was ultimately overturned in August,” said Kaival Brands President and Chief Operating Officer Eric Mosser in a statement.
“For a portion of fiscal 2022, we were prohibited from selling our flavored Bidi Sticks, and our 2022 revenues reflect the significant extended impact of this. The good news is that this impediment is behind us. Moreover, despite the challenges, we accomplished several important milestones during the year which we believe has laid the foundation for renewed growth and progress in 2023, including expanding existing sales channel relationships and initiating significant new ones. We expect and hope that the FDA will continue to pull bad actors from the marketplace, paving the way for companies like ours to provide our products to adult smokers deserving of premium e-cigarette product and experience.”
February 6, 2023
Bidi Parent Inks Deal for Marketing, Sales Strategy

Kaival Brands Innovation Group, parent to Bidi Stick vaping products, today announced it has reached a three-year extension agreement with QuikfillRx, the third party vendor responsible for executing Kaival Brands’ marketing and sales strategies.
As part of the agreement, QuikfillRx will be rebranded as Kaival Marketing Services (KMS) to more properly reflect the commitment of KMS to the success of Kaival Brands, according to a press release.
“We are happy to continue our service with Kaival Brands and its commitment to responsible marketing,” Russell Quick, president of KMS, stated in the release. “Our combined efforts at preventing underage use of vaping devices and focus on the needs of legal-age smokers looking for an alternative to combustible cigarettes, stands as a model for the industry.”
In February 2022, the U.S. Court of Appeals for the Eleventh Circuit stayed a marketing denial order (MDO) issued by the U.S. Food and Drug Administration to Bidi Vapor in September 2021 for its non-tobacco flavored Bidi Stick products. The FDA had previously issued an administrative stay to Bidi Vapor, however, the agency rescinded that stay in December 2021.
Kaival Brands 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.
The three-year extension with KMS was executed in preparation to support the anticipated improved sales volumes arising from this decision and the increase of Bidi Stick sales and marketing activities.
In addition to monthly cash payments, which will be lower than during the initial term of the agreement, and a one-time upfront vested common stock option award, KMS will be eligible to receive performance-based common stock option awards from Kaival Brands.
Eric Mosser, president and chief operating officer of Kaival Brands, stated that KMS has been an integral part of the Kaival story since its inception.
“Their industry knowledge and expertise, experience working with our team, and unmatched around-the-clock service is best in class,” he said. “As part of ongoing corporate efforts in anticipation of increasing sales activity following Bidi Vapor’s merits case win, it became clear that reaffirming our relationship with KMS was an important step to manage growth.”
November 15, 2022