How one independent e-cigarette maker followed the FDA's review process to the bitter ENDS
MELBOURNE, Fla., Sept. 17, 2021 (GLOBE NEWSWIRE) -- Bidi Vapor, LLC, the maker of the premium e-cigarette BIDI® Stick, today disclosed its journey through the Premarket Tobacco Product Application (PMTA) process to extend the public debate over flavors in electronic nicotine delivery systems or ENDS.
In 2019, a federal court judge in Maryland gave the U.S. Food and Drug Administration (FDA) an arbitrary deadline of one year to review all timely submitted PMTAs and decide the fate of ENDS. When that random, logistically impossible deadline of Sept. 9, 2021, arrived, the agency made the most expeditious choice: It threw the baby out with the bathwater.
It issued marketing denial orders or "MDOs" to virtually all PMTAs for flavored vaping products.
While expressing disappointment, Niraj Patel, president and CEO of the Melbourne, Florida-based Bidi Vapor, said, "In the end, the FDA is not going to support an industry that won't take responsibility. Neither will the public."
The decision, which will essentially take flavored ENDS products off the U.S. market, may indeed keep some young people from either trying or actively using vaping products. But in doing so, the decision will carry with it the cost of millions of adult smokers losing access to perhaps the most viable alternative to combustible cigarettes ever invented. In the same move, the FDA also unleashed the floodgates of illicit, subpar and potentially hazardous product within an industry that the agency was trying to regulate. Like any other prohibition, the established demand for flavored ENDS products will now undoubtedly grow unchecked, creating the need for a new level of enforcement without funding from properly administered taxation.
Of any company that tried to serve the adult smoker—people with lifelong addictions to traditional, combustible cigarettes—Bidi Vapor, an independent e-cigarette manufacturer, probably made the most honest attempt at balancing the needs of hardcore, adult smokers with the concern of enticing young people, non-users and worse, minors, to initiate vaping and start down the road of habitual nicotine consumption.
San Francisco-based JUUL already made all the key mistakes back in 2018. The meteoric popularity of JUUL's compact, pod-based device was, in turn, met with a catastrophic embrace by minors. From 2017 to 2019, the percentage of teenagers who said they vaped nicotine in the past 12 months roughly doubled for eighth graders from 7.5% to 16.5%, for 10th graders from 15.8% to 30.7%, and for 12th graders from 18.8% to 35.3%, according to the University of Michigan's Institute for Social Research, Ann Arbor, Mich. While the numbers have leveled off, they remain high.
Clearly, the damage was done.
But for those wanting to fulfill the real potential of ENDS, the task that was already in motion—meaning the thoughtful distribution of a non-combustible nicotine-delivery option for adult smokers—became crystal clear in method and scope.
Almost in tandem, the FDA itself laid the groundwork for science to support what seemed to be the logical next steps. It developed its PMTA process to evaluate the potential risks and benefits of ENDS, placing the burden of research on the backs of ENDS manufacturers.
While mapping a seemingly good-faith path, the FDA paved a hard and bumpy road. Applicants would have to compete with the likes of Big Tobacco, which could spend millions of dollars to conduct the research and develop thoroughly supported applications. In its own case, Bidi Vapor was determined to stay in the game and help pioneer this burgeoning industry.
It was a path that most players could logistically start, trusting that the agency would abide by its word and evaluate the proven benefits of ENDS to consumers that solid science—practical, irrefutable evidence—could uncover.
On Sept. 9, 2021, the FDA changed its direction.
Through the eyes of one entrepreneur, Bidi Vapor, this is how vaping as originally intended died.
Technology, Transition and Hope
Like any lasting technology, ENDS grew organically to fit a need. In this case, it was to create an alternative way to deliver nicotine to adult tobacco users, while removing the tar and carcinogens that came with burning tobacco and inhaling smoke.
In 2013, Niraj Patel, whose grandfather had started with a small tobacco business in India, had graduated with a pharmaceutical degree in his home country and then a chemical degree from the Florida Institute of Technology. Watching the developments of this new, less harmful, nicotine-delivery method motivated him to manufacture and market what he would eventually brand the BIDI® Stick, a disposable ENDS product that came in 11 flavor varieties including tobacco and menthol.
The device wasn't successful at first. When it hit the market in 2014, it floundered among a myriad of emerging products and vaping methods before the public even figured out what it wanted. If a smoker did want to switch, would he or she choose an open system, a closed system, something self-contained, something palm-sized or something resembling a cigarette?
At one point, Patel tried to switch the purpose of his device, replacing his nicotine formulation with a hemp-based cannabidiol or CBD option. Still, success was elusive.
Through this time, he remained hopeful, believing that his original nicotine-based idea and the device he created would have its day.
Where the Story Begins
The true success of the BIDI® Stick would start in 2020, nearly five years after the product was first introduced to the market. A confluence of events, including the maturation of the e-cigarette market in the United States and the coming together of key business partners within the Bidi circle, led to the remarkable growth of the BIDI® Stick.
Kaival Brands Innovations Group, Grant, Florida, became the sole, global distributor of Bidi Vapor products, while QuikfillRx, LLC, also doing business as QRx Digital, Jacksonville Beach, Florida, took over marketing and sales. Kaival Brands offered a platform of brand development that allowed Bidi Vapor to take advantage of emerging market forces, while at the same time, QRx Digital and its retail- and tobacco-centric team gave the devices themselves an opportunity to build momentum within both online and retail channels.
Through this collaboration, the new leadership team built a return-to-market plan on the foundation of the product's original intent, helping the hardcore, adult smoker with alternatives to combustible cigarettes. At the same time, leadership forged a larger vision. It included not only a commitment to keeping its products out of the hands of minors, but to promoting its "consistent puff" technology and high-quality parts, as well as a recycling program capable of reusing those high-quality components.
Initial success would build both online and at brick-and-mortar stores. Online, Bidi Vapor started selling direct to age-verified adult consumers through its own website and then partnering with GoPuff, a Philadelphia-based online retailer. Bidi Vapor kept its word to protect minors by instilling five levels of age verification in its processes, which included signature upon delivery as well as phone calls to verify consumer identity. In the case of GoPuff, the retailer had its own signature-based, age-verification policy that satisfied Bidi Vapor's internal standards. These ID-based, direct-to-consumer channels built Bidi Vapor's presence in the market.
The momentum growing from online led to acceptance from major convenience chains, such as Richmond, Virginia-based GPM Investments and several business units in the Circle K chain. As its popularity at retail grew, Bidi Vapor developed assurances that partners would abide by strict age-verification policies. It created a Retailer and Wholesaler Pledge, supported with training videos and on-site verification using a Bidi-sponsored mystery shop program. By the end of 2020, Bidi Vapor became one of the top three selling disposable e-cigarette brands, according New York-based Nielsen.
The FDA: A Moving Target
From the beginning, the FDA said it would make further decisions about the future of vaping based on science. In a media briefing held on March 15, 2018, Mitch Zeller, director for the FDA's Center for Tobacco Products (CTP) made positive remarks about the "continuum of risk," where certain nicotine-delivery methods presented greater risks than others. He said, "[As for] figuring out a way to transition people who are currently getting their nicotine from the deadliest and most harmful form [being combustible cigarettes]; for those who are still going to be seeking nicotine, we understand that we absolutely have a responsibility to make it available in alternative and less harmful ways."
The FDA said applicants must prove that their products are "appropriate for the protection of public health," a standard that considers how the product will impact both current smokers and non-smokers. In announcing the FDA's plan for tobacco regulation, Zeller wrote, "the FDA is committed to striking an appropriate balance between protecting the public and fostering innovation in less harmful nicotine delivery."
Since the announcement of the PMTA process in 2016, the agency held workshops and webinars, encouraging participation along a timeline that appeared to acknowledge the difficulties of meeting its standards. At Bidi Vapor, Patel welcomed the application process, following the FDA guidance from the beginning. The company instilled and documented manufacturing processes based on agency guidance, as well as conducting ingredient and component testing to meet FDA standards. While burdensome, Patel was optimistic that adhering to everything the agency asked would provide a pathway for his products.
Like hundreds of other vaping manufacturers, Bidi Vapor submitted its PMTA prior to the Sept. 9, 2020 deadline, eventually turning in a 285,000-page document covering all 11 of its flavor varieties. Its PMTA submissions allowed Bidi Vapor to continue marketing and selling BIDI® Sticks into a greater number of retail outlets, largely convenience stores, over the next several months.
Through the PMTA process, Bidi Vapor even decided it could further hone its own market practices. Upon reviewing the names it gave its products, the company decided in 2020 to undergo a complete renaming process, replacing original terms with single-word, generic names like "Arctic," "Solar," and "Summer." While the original names were not illegal, officials wanted to make certain their products complied with FDA's goal of ensuring that ENDS products did not resemble kid-friendly foods, drinks and other products that are often marketed and/or appealing to youth.
During this time, the FDA continued to communicate its intended direction even after that initial September 2020 deadline, issuing a draft guidance on tobacco product perception and intention (TPPI) studies in October of 2020. It acknowledged that it "should provide more specific guidelines concerning youth perceptions, measuring intentions to use, addressing perceived benefits, considering effects on bystanders, assessing relapse and dual use, conducting qualitative studies, addressing null findings, and comparing proposed products to products currently commercially available."
Right off the bat, the timing was off. The TPPI studies that the agency now wanted would take manufacturers at least six months or longer to complete, even though the FDA released its new guidance a full month after its Sept. 9, 2020, deadline.
Yet despite the backward timing, Patel and the Bidi Vapor team took it as a positive sign. The inference was that the FDA's review process had overlapped the true timetable for the FDA to complete its PMTA evaluations. So through written amendments, Bidi Vapor informed the FDA that it would initiate such studies, understanding that with the amendment process, the FDA itself created a safety valve for what the future may hold.
So the company went ahead with the research, believing it still had not only time but options. It could take a moment, understand the new guidelines, and then initiate the proper studies. And they did so. They gathered the appropriate, reputable scientific and legal teams to start several clinical, "actual use and perception", and intention studies that the experts said would take several months to complete. As the studies progressed through protocol development, internal review board approvals, recruitment and data gathering, all information was provided to the FDA via amendments to Bidi Vapor's PMTAs, as the FDA indicated would be needed for market authorization. Eventually, the additional effort would cost $3.5 million and take eight months to complete.
Initial analysis of consumer "intention and perception" surveys and clinical-trial data showed every indication that Bidi Vapor could prove that its products, all 11 flavor varieties, could meet the FDA's newest standards, according to researchers involved in the company's multiple studies.
Even as Zeller of the CTP began to raise questions about the ability of e-cigarettes to actually transition hard-core smokers, Patel of Bidi Vapor was seeing positive signs. While holding off on publicizing specifics, he said the emerging research from Bidi Vapor's studies would address that very issue.
Much anticipation surrounded the next FDA milestone of Sept. 9, 2021, when a Maryland court had ordered the agency to complete its review of all properly submitted PMTAs. Most people in the industry believed the task would be Herculean.
When Zeller of the CTP updated the public in February 2021, he said the FDA had processed PMTAs for more than 4.8 million products from 230 companies. No one believed the agency could conduct a truly thorough review of each PMTA in a year's time, especially if it allowed additional research resulting from its October 2020 TPPI guidance to come in as part of its review.
So when Bidi Vapor, like dozens of other vaping companies, received a marketing denial order or MDO letter from the FDA regarding its flavored ENDS in early September 2021, the news was a blow.
Patel and the Bidi Vapor team, based on numerous statements from FDA officials, had expected a "deficiency letter" from the FDA, which would note areas the company would need to address to improve its PMTA. The deficiency letter would give them an opportunity to properly present the results of its new clinical, actual use and TPPI research. Instead, the FDA sent a form letter, saying that Bidi Vapor's original PMTA did not prove that flavors served to benefit adult smokers, and that if it had proven such a benefit, that benefit also needed to outweigh the potential harm to underage youth.
Not only did the time, money and resources that went into the original PMTA seem like a waste, but the extra work at developing new data that the FDA asked for a full month after the original September 2020 deadline seemed irrelevant.
It appeared that because the industry could not predict the FDA's thinking prior to September 2020, it was out of luck. The target moved without anyone knowing and any chance of having hit it never actually existed.
The Evolving Controversy
Of course, Bidi Vapor's leaders knew that the business of ENDS generally, and more specifically flavors, was an uphill battle. The surge in underage use of e-cigarettes with the rise of JUUL between 2017-2019 created a public uproar among parents and lawmakers, leading many states to ban flavored ENDS and in some states e-cigarettes altogether. The additional health scare of e-cigarette or vaping use-associated lung injury (EVALI) and deaths that the U.S. Centers for Disease Control and Prevention (CDC) later attributed to the addition of Vitamin E acetate to black market tetrahydrocannabinol (THC) e-liquids, only fueled the paranoia. The CDC eventually determined that e-cigarettes as whole were not to blame, but that news came with little fanfare.
Then with the onset of COVID-19, a new issue emerged. As the negative publicity around e-cigarettes melded with the strange, new reality of lockdowns and large segments of the U.S. population working from home, a sudden rise in the purchase of traditional, combustible cigarettes started to reveal itself. Altria Group, the Richmond, Virginia-based maker of Marlboro cigarettes, reported a significant rise in cigarette consumption, running counter to declining trend lines going back several years.
Prominent researchers, lawyers and scholars who had worked for anti-tobacco groups began to publicly call for a "balance" between the needs of adult smokers and keeping youth from vaping.
In an article published on May 15, 2021, in the American Journal of Public Health, Kenneth Warner, dean emeritus at the University of Michigan's School of Public Health, said that the potential of vaping to increase smoking cessation has been largely overshadowed by media coverage and policies that focus on the potential risk vaping represents for teens.
Warner and 14 other past presidents of the Society for Research on Nicotine and Tobacco co-authored an article that argued that the media, legislators and the general public have developed a negative view of e-cigarettes because of the heavy emphasis public health organizations have placed on protecting kids from vaping, while ignoring the potentially substantial benefits of e-cigarettes in helping adult smokers transition away from cigarettes.
Where the loudest, anti-vape voices zeroed in on youth appreciating flavors, other established and equally valid statistics began to reemerge. The same national studies showed that curiosity was a major factor in youth trying e-cigarettes. Access was also an overlooked issue, with social sources like friends and family and the ease of online purchasing making the narrative more complex. Similarly, evidence around adult smokers and their needs began to garner more attention, including the importance of flavors, simplicity of use, and the actual inhalation experience. The scales were beginning to shift.
A New Problem: Synthetics
Compounding the situation, however, was the ever-present specter of illicit activity, which in the vaping space meant counterfeit products, noncompliant manufacturers and the issue of synthetic nicotine, or e-liquid formulations derived from non-tobacco sources.
The FDA's unpredictability and lack of enforcement action during the pandemic created a moment of lawlessness in the vaping space, allowing for "bad actors" to flood the market with subpar, mislabeled and potentially hazardous product, specifically synthetic nicotine disposable ENDS. In many cases, these manufacturers used marketing practices that blatantly pandered to youth. These included products named with fruity or dessert flavors, products that failed to contain the proper amount of liquid or nicotine strength as labeled on the packaging or products shipped into the country illegally to avoid custom fees and state taxes.
For Bidi Vapor, integrity was always an issue. Since its inception, it had been concerned about counterfeit products. So much so that the company developed tamper-resistant packaging and placed multiple ways of authentication on each stick.
In the field, Bidi Vapor witnessed a vast array of illegal activity firsthand, bringing lawsuits against web platforms that served as online distribution hubs for counterfeiters and specific companies that (through third-party analysis) appeared to openly mislabel product.
Leadership at Bidi Vapor took it upon themselves to research the illicit activity, test product on store shelves and communicate their findings to multiple federal and state agencies, including the FDA, the U.S. Customs and Borders Protection (CBP) and the Bureau of Alcohol Tobacco and Firearms and Explosives (ATF). They even approached local authorities, holding meetings with attorneys general from Alabama, Georgia and Florida to follow up on the illegal activity.
Another important aspect contributing to the behavior that the FDA obviously did not intend was the use of synthetic nicotine. Many of the players failing to abide by established FDA guidelines for labeling and marketing to youth did so under the guise of "tobacco-free" nicotine. These companies openly flaunted the rules and seemed to do so without impunity.
Bidi Vapor found itself at once competing with noncompliant companies while trying itself to uphold what it believed to be the FDA's mission.
Science and Opportunity
While the public has no sympathy for smokers or vape companies, Bidi Vapor trusted in the standards and good faith that the FDA said it would exercise once given the authority over a complex but important new industry. Vaping has the potential to save lives.
Clifford Douglas, who worked extensively with anti-tobacco groups, including the American Cancer Society, said in a March 2021 essay that an "intractable, internecine warfare" exists between the anti-tobacco camp and those in the tobacco-harm reduction or THR community.
The industry is in the middle of what Douglas called two "pandemics," one being COVID-19 and the other being an "ideological polarization." He quoted colleague Steven Schroeder, M.D., who said the polarization "misrepresents scientific findings, and misleads the public, the media, and health professionals about the science."
In the case of Bidi Vapor, this small vaping company accepted the opportunity to offer up science. It followed the guidelines. It developed its own vision of how a vaping manufacturer can act as a true corporate citizen.
In addition to its commitment to age-verification and limiting access of vaping products to minors, it developed its Integrated Sustainability Strategy Report as an increased commitment to its recycling program and roadmap towards reducing its carbon footprint.
As a result of the Prevent All Cigarettes Trafficking Act (PACT Act) of 2021 and concerns over youth access online (with studies showing underage youth able to access e-cigarettes online 94%-97% of the time, according to the Campaign for Tobacco-Free Kids), Bidi Vapor discontinued its own online direct-to-consumer option in favor of the GoPuff platform, which retains a signature-based, ID-delivery system.
But most importantly, Bidi Vapor entered the market with the intent of bringing adult smokers 21 and over a high-quality product that can offer a truly viable option to combustible cigarettes. Its formulation, design and go-to-market strategies should have been tailor-made for FDA authorization, but through some combination of public pressure, bad timing and rushed decision-making, may soon become just another chapter in the failed promise of vaping.
Bidi Vapor remains committed to demonstrating that all 11 flavors of its BIDI® Stick are appropriate for the protection of the public health. The company has continued to update and amend its PMTA submissions as data from its ongoing studies comes in, moving ahead with immediate plans to request the agency continue to permit the marketing of the flavored BIDI® Sticks while the FDA properly reviews its PMTAs, including all amendments. Now that the deadline has passed, the company will continue to market its tobacco and menthol varieties and is exploring additional remedies it declined to elaborate on.
In a letter to the industry, Patel expressed his disappointment but also a renewed optimism. In addition to announcing a commitment to global expansion, he said: "While the FDA's PMTA process is disappointing, it will create a new, competitive landscape - a supply-and-demand imbalance which we ultimately believe will benefit us."
While maintaining professional integrity is not making the journey easier, Patel said for him, it's the only way. "In the end, the energy we put out is the energy that returns."
ABOUT BIDI VAPOR
Based in Melbourne, Florida, Bidi Vapor maintains a commitment to responsible marketing, supporting age-verification standards and sustainability through its BIDI® Cares recycling program. The Company's premier device, the BIDI® Stick, is a premium product made with medical-grade components, a UL-certified battery, and technology designed to deliver a consistent vaping experience for adults 21 and over. Bidi Vapor is also adamant about strict compliance with all federal, state, and local guidelines and regulations. At Bidi Vapor, innovation is key to our mission, with the BIDI® Stick promoting environmental sustainability, while providing a unique vaping experience to adult smokers.
For more information, visit www.bidivapor.com.
For additional questions about this press release, email Angel Abcede, press manager, QRx Digital for Bidi Vapor, LLC at firstname.lastname@example.org.
Image 1: BIDI Stick
BIDI Stick, a premium e-cigarette
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