Tag: Bidi Vapor

Kaival Brands Poised for Growth With Bidi Stick

Photos: Kaival Brands Innovations Group
After the win of its merits case against the FDA, Kaival Brands and Bidi Vapor are back on track.
By Stefanie Rossel
The year 2022 has been both challenging and exciting for Kaival Brands Innovations Group. The Melbourne, Florida, USA-based company is the exclusive distributor of products manufactured by Bidi Vapor, which is best known for its Bidi Stick vape pen, a disposable electronic nicotine-delivery system (ENDS).
In September 2021, Bidi Vapor received a marketing denial order (MDO) from the U.S. Food and Drug Administration for its nontobacco-flavored Bidi Sticks. The company had submitted premarket tobacco product applications (PMTAs) for the product’s nine flavor varieties plus a tobacco and a menthol variant.
In response to Bidi Vapor’s petition for review, the FDA stayed the MDO until December 2021, after which the order was again stayed by the 11th Circuit Court of Appeals. On Aug. 23, 2022, Bidi Vapor won its merits case against the FDA. Granting Bidi Vapor’s petition for review, the 11th Circuit ruled that the MDO was “arbitrary and capricious,” primarily because the FDA failed to consider the relevant marketing and sales access restriction plans included in Bidi Vapor’s PMTAs.
Eric Mosser
At the time of writing, the FDA had yet to announce how it would move forward following the 11th Circuit’s decision. “FDA could seek to appeal the decision by requesting ‘en banc’ review, or a review by the entire 11th Circuit,” explains Eric Mosser, president and chief operating officer of Kaival Brands Innovations Group. “Or they might even try to petition the Supreme Court to review the decision. Regardless, we anticipate being able to continue selling and marketing our flavored products for the duration of any potential appeal, subject to FDA enforcement discretion. It is also possible FDA will simply follow the court’s instructions and review Bidi’s nontobacco PMTAs instead of trying to appeal.”
Flavors, insists Mosser, are a critical matter of public health, and Kaival is adamantly opposed to illegal underage use of tobacco and vape products. “The company has focused on limiting access via contracts with partners prioritizing retailers’ age verification policies, secret shopper audits, repackaging devices to better align with FDA guidance, no use of social media or influencers and no consumer-facing advertising,” he says. “The company even discontinued its online direct sales to consumers—while we had state-of-the-art verification practices, company leaders realized online access was a way that underage youth in general were gaining access to vaping products and decided to eliminate that potential for the Bidi Sticks.”
According to the most recent National Youth Tobacco Survey, Bidi Vapor was not among the top brands that appeal to youth. In 2021, among students who currently used e-cigarettes, Puff Bar was the most commonly reported usual brand (26.8 percent) followed by Vuse (10.5 percent), Smok (8.6 percent), Juul (6.8 percent) and Suorin (2.1 percent).

Niraj Patel
Victory for Vaping
The 11th Circuit’s decision is a victory not just for Bidi Vapor and Kaival Brands but for the entire vaping and tobacco harm reduction industry, according to Mosser—especially for those companies who have been rigorously following the FDA guidelines in their attempts to obtain market authorization. “We at Kaival Brands have done so on the belief that the FDA will follow the science and allow solid evidence to guide their decisions. If that is the case, then the company is on solid ground, and we are hopeful FDA will ultimately agree that our products, including our nontobacco flavored products, are appropriate for the protection of the public health.”
The PMTA for the company’s tobacco-flavored Classic Bidi Stick is currently undergoing Phase III scientific review. There is no timeline for this process, says Niraj Patel, chief science and regulatory officer for Kaival Brands Innovations Group and president and CEO of Bidi Vapor. The Arctic Bidi Stick, which Bidi Vapor maintains is a menthol product, was characterized as a flavored product by the FDA and subjected to the MDO that was vacated. “Barring an appeal, we anticipate that FDA will soon begin the scientific review of the Arctic Bidi Stick PMTA along with our other nontobacco-flavored products,” says Patel.
Patel founded both companies. With a wholesale distribution network of more than 54,000 stores across the United States, Kaival Brands helped Bidi Sticks, which entered the market prior to 2016 under a different brand name and with limited success, to become the fastest-growing and now No. 1 disposable vape brand in the U.S. market. Despite the MDO, the Bidi Stick is still the bestselling disposable ENDS product based on retail sales for the 52-week period ending on Aug. 27, 2022, Nielsen data shows, according to the companies.
Kaival Brands, which commenced business operations in March 2020, generated a cumulative $100 million in revenues in less than a year. In July 2021, Kaival Brands’ stock began trading on the Nasdaq. In April 2022, the company announced the expansion of additional wholesale and retail accounts, a move expected to increase the reach of Bidi Sticks by about 28,000 stores and to make up for the losses the company experienced in the wake of the MDO.
Difficult Times
In fiscal year 2021, which Patel described as “very challenging,” Kaival Brands reported a net loss of $9 million compared to net income of approximately $3.8 million for fiscal year 2020. In a press release, Patel said the MDO had caused “irreparable harm to both Bidi Vapor and Kaival Brands.”
The greatest revenue loss occurred in the last two quarters of fiscal year 2021, between the lifting of the FDA’s administrative stay and the ordering of the judicial stay, when the company was unable to market its Bidi Sticks. Revenues for fiscal year 2021 were approximately $58.8 million compared to $64.3 million in the prior fiscal year. 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, but revenues rose 11 percent compared with the first quarter of 2022, suggesting further recovery.
The 2021 year also presented challenges to Kaival Brands’ attempted foray into the modern oral nicotine market, a category that is still a niche but that has recently grown dramatically. The global nicotine pouches market size was valued at $1.5 billion in 2021. Grand View Research expects it to increase at a compound annual growth rate (CAGR) of 35.7 percent from 2022 to 2030.
Bidi Vapor had planned to introduce its Bidi Pouch in February 2021, but due to the Covid-19 pandemic, the launch had to be postponed. In September 2021, the company said in a press release that the launch would be further delayed while the company reformulated the product to utilize tobacco-derived nicotine and sought FDA marketing authorization. The company had originally envisioned the pouch to contain synthetic nicotine but pivoted following concerns about the legality of nontobacco-derived nicotine.
Congress subsequently changed the definition of a “tobacco product” to include synthetic nicotine products, with the FDA requiring manufacturers of nontobacco nicotine products to submit PMTAs by May 14, 2022. As of July 13, 2022, any new synthetic nicotine product that has not received premarket authorization from the FDA cannot be legally marketed. “We did not launch our nicotine pouch product,” Patel says. “Due to concerns with synthetic nicotine, we decided to focus on tobacco-derived nicotine and will launch in the U.S. only after we obtain FDA PMTA marketing authorization.”
Cooperating with PMI
In June 2022, Patel handed over the management of Kaival Brands to Eric Mosser. The leadership change had always been a part of the plan, according to Mosser. “I was preparing for the leadership role, which was set to occur as soon as plans for international expansion solidified. International distribution came sooner than later once Philip Morris International decided to license technology from Bidi Vapor and now also has distribution rights in certain markets outside the United States.”
Two weeks earlier, Kaival Brands’ newly created wholly owned subsidiary, Kaival Brands International, had entered into a licensing agreement with Philip Morris Products (PMP), a wholly owned affiliate of PMI. The agreement grants to PMP a license of certain intellectual property rights relating to Bidi Vapor’s premium ENDS device, the Bidi Stick, as well as potentially newly developed devices to permit PMP to manufacture, promote, sell and distribute such ENDS devices and newly developed devices in international markets outside of the U.S. Patel called the agreement a major milestone in Kaival Brands’ efforts to expand the global sales and distribution of the Bidi Stick.
Kaival Brands, in turn, announced the launch of Veeba, PMI’s first disposable e-cigarette utilizing Bidi Vapor’s intellectual property, in Canada in late July. PMI’s new product is now the lowest-priced disposable vape on the Canadian market. Mosser says he anticipates revenues through royalties paid by PMP, pursuant to the licensing agreement, in the fourth fiscal quarter. “I see Kaival Brands reclaiming its previous revenue growth trajectory and expanding into additional market segments with new innovative products that we exclusively distribute or own, not only here in the U.S. but also in profitable global markets.”
Disposable e-cigarettes are a growth market. According to report from Future Market Insights, the global disposable e-cigarette market size is expected to be valued at $6.34 billion in 2022. The overall demand for disposable e-cigarettes is projected to grow at a CAGR of 11.2 percent between 2022 and 2032, totaling around $ 18.32 billion by 2032.
Stefanie Rossel is Tobacco Reporter’s editorial contributor. An experienced trade journalist, she combines sharp reporting skills with in-depth knowledge of the tobacco and vapor industries. Prior to joining Tobacco Reporter, Stefanie was editor-in-chief at Tobacco Journal International, where she worked for a decade. Fluent in English, German and French, Stefanie covers tobacco news around the world. She is based in Germany.

October 27, 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
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
Court of Appeals 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 FDA had previously issued an administrative stay to Bidi Vapor, however, the agency rescinded that stay in December.
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
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
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 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 challenges 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
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
Bidi Vapor to Market Menthol Sticks 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 products from 168 companies. Bidi Vapor received an MDO for its non-tobacco 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) Bid 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, 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 Wants FDA to Ban Synthetic Nicotine Products

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 PMTA’s earlier this month, many companies have set their sights on synthetic nicotine, a legal grey 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 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