Tag: Kaival Brands Innovation Group

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
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
Kaival Brands’ MDO Stay Boosts its Quarterly 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.
“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.
September 13, 2022
Vapor Makers Prevail Over FDA in PMTA Denial Suit

Credit: Tanasin
A split 11th Circuit on Tuesday told the U.S. Food and Drug Administration it shouldn’t have denied six e-cigarette companies’ premarket tobacco product applications (PTMAs) to sell flavored vaping products without first taking a look at their marketing and sales plans designed to minimize youth exposure and access.
The U.S. Court of Appeals for the Eleventh 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 in a 2-1 decision. According to Chief Judge William Pryor, the agency didn’t assess “the companies’ marketing and sales-access-restriction plans designed to minimize youth exposure and access.”
The court explicitly labeled the FDA’s decision-making as “arbitrary and capricious.” Prior legal decisions have determined that FDA action must consider all relevant factors in order to be legally justifiable. In the case of these vape manufacturers, the court ruled that the FDA had not performed such consideration.
“These tobacco companies submitted survey information from their customers about smoking cessation, literature reviews, scientific studies about switching to e-cigarettes, smoking cessation, and the role of flavors, and details about its marketing and youth-access-prevention plans,” notes the court in its opinion. “For example, Diamond uses technology for its online sales that relies on public records to verify a purchaser’s age.”
Vapor industry advocates welcomed the decision. Gregory Conley, director of legislative and external affairs at the American Vapor Manufacturers Association said that while court ruling does not order the FDA to grant PMTAs—and that the agency is likely to deny the applications in the future—the companies involved could end up in the queue for review in 2025, which keeps them in business.
“Additionally, this leaves the door open for further litigation on these and other PMTAs,” Conley wrote on Twitter. “The FDA’s vague and undefined ‘appropriate for the protection of public health’ standard has long been open for attack. This is just the start.”
The 11th Circuit decision follows revelations that forced the FDA to admit to not considering all evidence when issuing marketing denial orders (MDOs) to vape products made by Juul and Turning Point Brands. In the interests of public health, future FDA decision-making must engage with all available evidence, not just evidence that leads to their preferred outcomes.
The court also recognized relevant distinctions between closed/cartridge systems and the e-liquids used in open systems. The court also found that the FDA’s refusal to review marketing plans was “error and not harmless” (disagreeing with Fifth and DC Circuits).
All petitioners’ appeals were granted, denial orders vacated and remanded.
In her dissent, Judge Robin Stacie Rosenbaum wrote that anyone who knows all the relevant facts of this lawsuit probably already knows how this case will eventually end.
“The Majority faults the FDA for not considering the companies’ proposed restrictions on kids’ use. And to be sure, the FDA said that factor would be relevant,” stated Rosenbaum. “But even assuming that the FDA erred when it didn’t consider the Companies’ proposed marketing and access-restriction plans, the FDA’s framework for evaluating pre-market tobacco product applications leaves no room for doubt that the FDA will deny—in fact, under the Family Smoking Prevention and Tobacco Control Act, must deny—the applications on remand. To paraphrase the Borg, then, remand is futile.”

August 24, 2022
Licensing Agreement Brings Leadership Changes at Kaival

Photo: adragan
Kaival Brands Innovations Group Founder and CEO Nirajkumar Patel will transition to chief science and regulatory officer. Eric Mosser, the company’s current chief operating officer, will become president and remain COO. Mosser will serve as the company’s principal executive officer for purposes of its filings with the Securities and Exchange Commission. Patel will remain on the board of directors for Kaival Brands.
The management changes follow the company’s recently announced international licensing agreement with Philip Morris Products (PMP) on June 13, 2022.
The agreement grants to PMP a license of certain intellectual property rights relating to Bidi Vapor’s premium electronic nicotine delivery system (END”) device, 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 markets outside of the U.S.
“What Mr. Patel has accomplished, from initial concept to an international distribution agreement with Philip Morris is extraordinary,” said Mosser in a statement. “With unwavering belief and integrity, he established himself as a true visionary within the vaping category.
Mr. Patel has been both inventor and salesman, developing a product and everything that goes around it to make it successful. We have grown from a no-name brand to the No. 1-selling self-contained disposable ENDS device in the U.S based on the Nielsen retail sales data for the 52-week period ending June 4, 2022, according to a recent Goldman Sachs’ Equity Research Report.”
The transition will allow Patel to focus on developing new products and expanding the Bidi Vapor product portfolio, which is directly related to the new agreement with PMP, and allow Mosser to focus on expanding sales distribution channels and increasing the revenues and profits of Kaival Brand.
“My passion for the business is in creating, designing and delivering new products for adult tobacco users to the market,” said Patel. “Mr. Mosser understands the core values, mission and goals of the Company, and I am confident he will take Kaival Brands to new levels.”
The management changes are effective immediately, with roles and responsibilities to transfer over the coming weeks.
June 27, 2022
Kaivel and PMI Reach Global 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.
June 14, 2022
Kaival Grows Bidi Vapor Distribution by 28,000 Stores
Kaival Brands Innovations Group, the distributor of all products manufactured by Bidi Vapor, LLC, today announced the expansion of additional wholesale and retail accounts. The move is expected to bring the Bidi Vapor disposable e-cigarette’s reach to approximately 28,000 additional stores, according to a press release.
“We are encouraged by growing sales volumes in our second fiscal quarter generated by both established wholesalers and retailers selling the BIDI Stick in new stores, as well as new wholesale and retail accounts being added to our distribution network,” Niraj Patel, CEO of Kaival Brands said. “We anticipate the activation of approximately 3,900 new store locations over the next 45 days, including one new major retailer having already placed orders totaling more than $1.1 million.”
Credit: Bidi Vapor
The expansion represents a positive development for the company since the U.S. Food and Drug Administration issued its marketing denial order (MDO) to Bidi Vapor this past September, as it did for about 96 percent of all manufacturers of flavored electronic nicotine-delivery systems (ENDS).
In February 2022, the U.S. Court of Appeals for the 11th Circuit granted Bidi Vapor a judicial stay of the MDO, pending the resolution of Bidi Vapor’s ongoing merits-based litigation. In effect, the judicial stay means that the MDO, which covered the non-tobacco flavored BIDI Sticks, is not legally in force.
Accordingly, Kaival Brands anticipates marketing and selling all 11 flavored BIDI Sticks, subject to the FDA’s enforcement discretion, while Bidi Vapor continues with its merits case challenging the legality of the MDO, according to the release.
“This was a significant event not only for Kaival Brands and Bidi Vapor, but the entire industry,” said Patel of the court decision. “The judicial stay granted in February allowed us to resume sale of all 11 flavored products in the BIDI Stick lineup. We are eager to return our flavored products to the shelves of retailers that comply with the Prevent All Cigarette Trafficking Act so adult consumers can enjoy their preferred flavors once again. As a result of the judicial stay, we expect revenues to resume an upward trajectory as renewed distribution ramps up and sales of flavored BIDI® Sticks increase.”
The company states that the FDA’s new authority over products using synthetic nicotine will only bolster Kaival Brands’ market position, as more retailers understand the “nearly insurmountable compliance hurdles facing those manufacturers of non-compliant” synthetic products.
“Products in the vaping industry should be developed and placed in the market under a high degree of supervision, such as the FDA’s PMTA process or the FDA’s drug-approval process,” continued Patel. “We anticipate that as the FDA begins enforcement against illegally marketed and synthetic-nicotine vaping products, there may be an increased demand for compliant and legal vaping products, such as the BIDI Stick.”
April 19, 2022
Kaivel Brands Announces Partnership With Koupon
Kaival Brands Innovations Group, Inc., parent to Bidi Vapor, has announced its partnership with Koupon to create an electronic engagement program involving Koupon’s digital promotion platform. The partnership will offer customers who purchase the Bidi Stick, a disposable vaping device, digital opportunities based on their purchases, according to a press release.
The partnership will offer incentives to specific customers based on purchasing habits, allowing users 21 and older of vaping products the opportunity to experience the Bidi disposable device.
“Working with Koupon will facilitate a greater communication with adult users of our products,” said Niraj Patel, president and CEO of Kaival Brands, Melbourne, Fla. “We hope to better understand their needs and facilitate the purchase of our premium product.”
The press release states that the program aims to better serve its adult customer base, involving assessment of consumer insights and digital offers for Bidi Vapor products, off. Age-verified adult consumers can access digital promotions powered by Koupon’s technology and redeem them at retail outlets within Bidi Vapor’s distribution network.
The device could also help Bidi Vapor in adhering to the U.S. Food and Drug Administration’s after marketing surveillance requirements if Bidi’s PMTA were to be approved. The FDA granted an administrative stay to Bidi’s PMTA in October.
In addition, integrated security identifies or limits age-restricted content. “Koupon’s age-restriction policies align with our goals,” Patel said. “We have always focused on keeping our products out of the hands of minors.”
December 6, 2021
Third-Quarter Report Causes 43% Drop in Kaival Stock
Kaival Brands Innovations stock was up slightly today as the company’s stock value has decreased sharply after the U.S. Food and Drug Administration issued the company marketing denial orders for some of its Bidi Stick flavored products. It’s third-quarter report results sent them even lower. Shares (NASDAQ: KAVL) were down 43 percent to $2.58 after the company reported Q3 earnings results.
Credit: Argus
Tuesday, the company announced its third-quarter report, which stated that the company earned drastically lower revenues of $3.4 million for the three months ended July 31, 2021, compared to $32.4 million for the three months ended July 31, 2020.
The company now expects revenues for the year to be approximately $68 million, as compared to previous guidance of $400 million. The company stated that now that 93 percent of the vaping market has been eliminated by the FDA, the company expects Bidi Vapor’s market share to, at a minimum, reach pre-premarket tobacco product applications (PMTA) levels, according to Market Watch.
“We believe that the [PMTA] process undertaken by the [FDA] has had a significant impact on the e-cigarette industry. Prior to the September 9, 2021 court-ordered deadline for the FDA to make PMTA determinations for pending applications, we believe that many retailers and distributors were reluctant to take on new inventory, the statement reads. “We believe these retailers were concerned with the potential for being left with inventory that after September 9, 2021 could be ruled adulterated or misbranded by the FDA and, thus, illegal to sell.”
The FDA, which had faced a Sept. 9 deadline to declare which e-cigarettes can remain on the market, said last week that it needed more time before making a decision on products from Juul Labs Inc. and other companies.
In August, Kaival said that it expressed strong support of “enforcement of rules and regulations governing the electronic nicotine delivery systems industry” and that it exceeded stringent FDA compliance mandates.
Bidi Vapor also announced it 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 company said Tuesday that it believes 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 it. Based on previous FDA decisions, it said it expects that Bidi Vapor’s naturally derived nicotine products will remain on the market following the completion of the FDA’s premarket tobacco application process.
September 16, 2021