The total number of warning letters issued by the U.S. Food and Drug Administration (FDA) to e-liquid manufacturers for illegally marketing vapor products now stands at 80 in 2021. The FDA issued four more warning letters for marketing illegal vapor products. Kidney Puncher, Vapor Gold, Violet Vapor and Voltage Vapor all received letters on March 26 and those letters were posted to the FDA’s website on April 1.
The FDA states that the company’s failed to submit premarket tobacco product applications (PMTA) by the required Sept. 9, 2020 deadline. The FDA also states that “the violations discussed in this letter do not necessarily constitute an exhaustive list” and companies should quickly address any products that violate the same rules as the product mentioned in the letter.
Kidney Puncher has more than 1,000 products registered with the FDA; Vapors Gold has more than 500; Voltage Vapor has more than 1,500 products registered; and Violet Vapor has more than 4,900 products listed with the regulatory agency.
Companies that receive warning letters from the FDA have to submit a written response to the letter within 15 working days from the date of receipt describing the company’s corrective actions, including the dates on which it discontinued the violative sale, and/or distribution of the products. They also require the company’s plan for maintaining compliance with the FD&C Act in the future.
The total is now 73 in 2021. The U.S. Food and Drug Administration (FDA) issued four more warning letters for marketing illegal vapor products. Morin Enterprises Inc. d/b/a Ecig Crib, Nicoticket LLC, Bouji Moj Oyeeb, Inc. d/b/a MasterMix E-Liquid all received letters on on March 26 and those letters were posted to the FDA’s website today, March 30.
Credit: Sandy Millar
The FDA states that a review of the ecigcrib.com website revealed that the company “manufacture and offer for sale or distribution to customers in the United States e-liquid products without a marketing authorization order “including: E Cig Crib – Planet of the Grapes E Liquid and E Cig Crib – Cotton Candy E Liquid.” Nicoticket’s letter states the website “nicoticket.com revealed that you manufacture and offer for sale or distribution to customers in the United States e-liquid products without a marketing authorization order including: Nicoticket Wakonda and Nicoticket The Virus.” Bouji’s letter states that a review of “mastermixeliquid.com revealed that you manufacture and offer for sale or distribution to customers in the United States e-liquid products without a marketing authorization order including: MasterMix E-Liquid – Mango and MasterMix E-Liquid – Maraschino Cherry.”
The FDA also states that “the violations discussed in this letter do not necessarily constitute an exhaustive list” and companies should quickly address any products that violate the same rules as the product mentioned in the letter. “Your firm is a registered manufacturer with 1,433 products listed with FDA. It is your responsibility to ensure that your tobacco products comply with each applicable provision of the FD&C Act and FDA’s implementing regulations,” the letter states.
Bouji has over 31,500 products listed with FDA. Nicoticket is a registered manufacturer with over 6,800 products listed with FDA and E-cig Crib is a registered manufacturer with over 4,700 products listed with FDA.
Companies that receive warning letters from the FDA have to submit a written response to the letter within 15 working days from the date of receipt describing the company’s corrective actions, including the dates on which it discontinued the violative sale, and/or distribution of the products. They also require the company’s plan for maintaining compliance with the FD&C Act in the future.
The U.S. Food and Drug Administration (FDA) issued its 70th warning letter this year to a company the regulatory agency says is violating marketing rules. Vintage Vapors received the letter on March 22 and the FDA posted the information on its website on March 25.
The FDA states that it determined the company did “manufacture, sell, and/or distribute to customers in the United States Vintage Vapors Unflavored Tobacco 03MG 30/70 e-liquid product without a marketing authorization order.” Premarket tobacco product applications (PMTA) were due to be submitted to the FDA by Sept. 9, 2020.
The FDA also states that “the violations discussed in this letter do not necessarily constitute an exhaustive list” and companies should quickly address any products that violate the same rules as the product mentioned in the letter. “Your firm is a registered manufacturer with 1,433 products listed with FDA. It is your responsibility to ensure that your tobacco products comply with each applicable provision of the FD&C Act and FDA’s implementing regulations,” the letter states.
Companies that receive warning letters from the FDA have to submit a written response to the letter within 15 working days from the date of receipt describing the company’s corrective actions, including the dates on which it discontinued the violative sale, and/or distribution of the products. They also require the company’s plan for maintaining compliance with the FD&C Act in the future.
Jarvis Vaping Supply (JVS), parent to four of 21 Ohio-based Vapor Station vape shops, announced that its premarket tobacco product application (PMTA) has been accepted by the U.S. Food and Drug Administration (FDA). James Jarvis, co-owner of JVS with his wife Gerri, announced the receipt of the acceptance letter on his Facebook page. The acceptance includes all 998 SKUs submitted to the FDA for authorization, James confirmed in a text.
“I’m so proud of my wife … she spent so many late nights, so many hours, frustration, stress and a lot of patience went into this,” James wrote. “She helped many others once she finished ours on top of this.”
JVS is a wholesale vaping supply store. Alongside the four Vapor Station retail stores in and around Columbus, Ohio, James also serves as president of the Ohio Vapor Trade Association, and both Gerri and James are avid advocates of the vapor industry.
Gerri and James Jarvis
While James continued to run the business, Gerri worked day and night over six months to fill out PMTAs for 998 products (SKUs). In the end, she dumped roughly 3 million pages off at the FDA. With just the help of a Facebook group called PMTA Sharing, Gerri was able to climb the PMTA mountain without any help from firms experienced in submitting PMTAs. The Jarvis’ were among 1,600 vapor company representatives who joined this and other private groups to help them navigate the PMTA process.
“With Covid-19 hitting right in the thick of the PMTA process, money was so tight that we needed to be careful with spending. Thanks to the help of the Facebook group, we were confident that we could turn something in to the FDA,” Gerri said in a recent interview with Vapor Voice.
After submitting JVS PMTAs, Gerri then went on to help her friend Jason Gang of Westside Vapor as well as several other small companies negotiate the PMTA process, including Dripology, Vapor Generation, KL Labs and E Cig Cafe. Gerri said Westside Vapor’s PMTAs for its 1,800 products totaled over 6 million pages. Westside Vapor also received an acceptance letter according to James, but that has not yet been verified.
The US Food and Drug Administration (FDA) issued three more warning letters to vapor industry companies on March 19. The latest announcement total brings the count to 69 letters this year for companies selling vapor products without gaining regulatory approval through the agency’s premarket tobacco product application (PMTA) process, according to the agency’s website.
The latest letters were issued to Arizona-based Vapor Outlet, Vapor Tech Hawaii and the Vaporium in Illinois. In its letter to Vaporium, the FDA stated that the company continues to “manufacture, sell, and/or distribute to customers in the United States The Vaporium 6mg Red White and Blue 70/30 30 ML e-liquid product” without a marketing authorization order.
“Your firm is a registered manufacturer with 19,860 products listed with FDA. It is your responsibility to ensure that your tobacco products comply with each applicable provision of the FD&C Act and FDA’s implementing regulations,” the letter states. “Failure to adequately address this matter may lead to regulatory action, including, but not limited to, civil money penalties, seizure, and/or injunction.”
Companies that receive warning letters from the FDA have to submit a written response to the letter within 15 working days from the date of receipt describing the company’s corrective actions, including the dates on which it discontinued the violative sale, and/or distribution of the products. They also require the company’s plan for maintaining compliance with the FD&C Act in the future.
Many of the FDA’s letters so far have gone to local vape shops that manufacturer their own e-liquid in the store. For example, Vapor Tech Hawaii’s letter states that the FDA has determined that it “manufacture, sell, and/or distribute to customers its Vapor Tech Hawaii Waikikiwi 100ML 3mg e-liquid product” without a marketing authorization order. On March 16, the company issued three letters to stores owned by the Louisiana-based Little Town Vaping for selling house brand e-liquids.
The U.S. Food and Drug Administration has accepted all of Nicopure Labs’ Halo products’ premarket tobacco product applications (PMTA) for the substantive scientific review phase.
Just over six months after submission, Nicopure Labs’ PMTAs for Halo Turkish Tobacco E-liquid, Halo Triton II Starter Kit, Halo ZERO Starter Kit and all supporting consumable components have been accepted and advanced to the final phase, substantive scientific review, by the FDA. Halo FDA accepted premarket tobacco product applications include:
Halo Tribeca Tobacco e-liquid
Halo SubZero Menthol e-liquid
Halo Turkish Tobacco e-liquid
Halo Fusion Unflavored Tobacco e-liquid
Halo Triton II Starter Kit (and supporting consumable components)
Halo ZERO Starter Kit (and supporting consumable components)
“Halo’s more than 12 years of commitment to producing the highest quality vaping products available for adult consumers has been our organization’s mission for more than a decade,” said Jeffrey Stamler, co-founder of Nicopure Labs, in a statement. “We believe in science, and we believe in transparency; we are honored to continue to work with the FDA, and as always, in the best interest of the industry and the most important thing of them all, our loyal customers.”
Vapor Voice, in partnership with TMA, has created a tool to track PMTA submissions as they make their way through the review process.
By Timothy S. Donahue
The world is waiting. When premarket tobacco product applications (PMTA) were due to the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) on Sept. 9, 2020, the vapor industry wanted to know what companies had submitted the required data and could remain in the U.S. market legally. In response, the CTP stated it would release a list of products that may continue to be sold during the review process.
Nearly five months later, the CTP has yet to produce anything to help the retailers, wholesalers, manufacturers and suppliers. In late January 2021, CTP Director Mitch Zeller said that the FDA would release the information in the “coming weeks.” Zeller has also said that “thousands” of PMTAs were submitted. Meanwhile, the CTP has stated that before making such a list available, the agency needs to ensure that publishing any such information complies with federal disclosure laws.
The CTP did finalize PMTA and substantial equivalence rules (SE) meant to guide how a manufacturer can seek a marketing order for electronic nicotine-delivery systems (ENDS). The text of the final rule was published long after the provisional PMTA submissions were due. Then, nearly a week after its posting, the new Biden administration froze all new and pending rules introduced in the last part of the Trump administration, including the just-finalized PMTA rule. The rule was removed from the Federal Register prior to its effective date.
“While a memo from the White House chief of staff ordered the withdrawal of any rules that did not publish by noon on Jan. 20, 2021, and the PMTA and SE final rules were withdrawn, this does not impact the FDA’s review of PMTAs or SEs that the agency has received,” an FDA spokesperson told Vapor Voice. “The agency continues to process the large number of submissions received and has already begun reviewing many applications. In the coming weeks, the FDA intends to provide a more detailed update on the agency’s progress since the Sept. 9, 2020 deadline.”
The FDA spokesperson says the agency will work closely with the new administration to advance appropriate regulations and policies that were withdrawn and are in line with the agency’s public health mission.
To help stakeholders gain some visibility on this crucial issue, Vapor Voice partnered with data specialists TMA to locate and confirm who has submitted PMTAs and at what stage the application is in in the regulatory process. The PMTA list can be found here.
Because there is no central, publicly available database, the information had to be pieced together from multiple sources, according to TMA research assistant Karen Pace. Several organizations issued press releases as their PMTAs moved through the process. Many others did not. Pace says that Vapepmta.com, an online resource also attempting to collect PMTA information, has been a valuable resource in her research.
“Not all of the press releases are as specific as others,” says Pace. “I tried to research those that had minimal information. Sometimes that worked, sometimes I could not find anything more. Then I found Vapepmta.com. The site was extremely helpful and is where I gathered most of the information. It was still a challenge to gather information on the total number of submissions a company had and the actual products submitted.”
It was also difficult to know what brands and how many flavors or nicotine strengths (or even if a submitted product used a freebase or salt nicotine) a company submitted. Pace says the only way to know for sure about some submissions was to go to the source. “We checked corporate websites and also called or emailed the companies directly to verify submissions,” she says. “It is something we will continue to do moving forward as we update the listing.” In the end, Pace choose to list companies individually and list the brands submitted when possible. “We are going to need help from the industry in keeping the information accurate and up to date,” she says.
The Vapepmta.com team built and operates its platform and has no affiliation with the FDA or any other company. Dan Daniel Racowsky has been in the industry for more than five years and says limited information and confusion around PMTAs led the group to take on the task of building a PMTA listing.
“It wasn’t very challenging to gather data upfront. After launching, we gained some publicity and were flooded with inquiries from brands asking to be included in our database,” Racowsky said. “Somewhat of a challenge has been keeping our data as accurate as possible. We’re in direct contact with the majority of brands listed on our platform, and most are pragmatically keeping us informed on their PMTA’s progress.”
The list is a solid source for interested parties, however, it is impossible for VV/TMA to guarantee its complete accuracy. While many companies have confirmed the accuracy of their listings, in some cases we have not been able to reach the applicant.
“We put in a lot of effort to validate these submissions, but there are still some companies that haven’t returned calls or emails to confirm their listing,” says Taco Tuinstra, editor-in-chief for Vapor Voice. “We note those instances in the list.”
If you note inaccuracies in your listing, please send an email to pmta@vaporvoice.net and we will be pleased to update the information.
Methodology explained
Thousands of manufacturers and importers submitted premarket tobacco product applications (PMTA) to the U.S. Food and Drug Administration (FDA) by the Sept. 9 deadline to keep their products on the U.S. market. But which products exactly are under review and how all those submissions have fared in the process is less clear. A comprehensive list promised by the FDA has yet to materialize.
In the absence of an official database, Vapor Voice decided to create its own tracker. As a news outlet, we already receive many press releases relating to PMTA submissions. In addition, we continuously monitor corporate websites, social media platforms and other industry sources. Individually, the pieces of information gathered during those endeavors make for interesting news announcements; taken together, they provide a coherent dataset to track PMTAs.
Of course, this approach has its limits. The data is self-reported, and at present, we cannot fully verify the veracity of all claims made in the announcements used to compile the list. The quality of the information that reaches us also varies greatly, from exact counts in all list categories to more general statements on a brand or brand family without further elaboration. As per our protocol, these issues are noted in the list. While we cannot present our dataset as a representative sample, we believe that, after capturing information on 180 companies, it paints as coherent a picture as possible.
Our tracker lists company, brand family, brand styles and PMTA stage. We view it as a “living document” that will be updated as new information becomes available. To that end, the tracker also includes a tool for user input. If the status of your application has changed or if you notice inaccuracies, we invite you to share that information with our editors, who will be pleased to make the required updates.
Keeping in mind the limitations of our tracker, we recommend using this tool to gain directional understanding of the volume of submissions for which the FDA’s Center for Tobacco Products is processing and as a starting point in a comprehensive due diligence search regarding products. We also strongly recommend that any retailer gain certification of products in their inventory from the manufacturer and rely upon advice of counsel as to appropriate due diligence and safe harbor.
On March 12, the U.S. FDA issued warning letters to 13 firms who manufacture and sell unauthorized e-liquids. The regulatory agency advised the companies that selling products lacking a premarket authorization is illegal, and therefore cannot be sold or distributed in the U.S.
Credit: Isaiah Rustad
The firms did not submit a premarket tobacco product application (PMTA) by the Sept. 9, 2020 deadline, according to a press release from the FDA. The firms receiving warning letters are VapinUSA-WI, LLC d/b/a VapinUSA, Vapor Springs, LLC, Vapor Cigs, LLC, Vegas Vapor Emporium, LLC, Vape 911, The Philosopher’s Stone, LLC, The Clean Vape, Tooters Vape Shop, Cloudchasor LLC, Boardwalk Elixir, LLC, Dieselbycg-Hometown Vape Lounge, Blue Lab Vapors LLC, and Revolution Vapor LLC.
“While each warning letter issued today cites specific products as examples, collectively these companies have listed a combined total of more than 75,000 products with the FDA,” the statement reads.
Following an initial set of such warning letters announced earlier this year, FDA has continued to issue additional warning letters for products that failed to submit a PMTA.
Per a court order, applications for premarket review for certain deemed new tobacco products on the market as of Aug. 8, 2016—including e-liquids—were required to be submitted to FDA by Sept. 9, 2020. For companies that submitted applications by that deadline, FDA generally intends to continue to defer enforcement for up to one year pending FDA review, unless there is a negative action taken by FDA on the application.
Many small vapor manufacturers are attempting to overcome the FDA’s rigorous PMTA requirements.
By Maria Verven
A process that was built for billion-dollar tobacco manufacturers has posed onerous challenges for small e-liquid manufacturers. With the enormous work of pulling together premarket tobacco product applications (PMTAs) for the U.S. Food and Drug Administration behind them, vapor manufacturers are now gearing up for the formal substantive review phase when the regulatory agency will conduct in-depth evaluations of the applications’ requisite scientific studies.
Many relied on help from the PMTA Sharing Group on Facebook to meet the challenge of submitting a separate application for every flavor in every nicotine level in every size bottle, sending literally millions of pages to the FDA. In addition, every PMTA had to contain a plethora of research into the product’s relative health risks for current users and nonusers as well as whether marketing the new product would be appropriate for the protection of public health (APPH).
A full assessment of how users consume their products over time as well as the potential for addictiveness, abuse and misuse was also required. And for those who missed the Sept. 9 deadline and/or failed to meet these requirements? In January 2021, the FDA issued warning letters to 10 e-liquid manufacturers that failed to submit PMTAs by the deadline, advising them that it is now illegal for them to sell their products in the U.S.
Vapor Voice took on the task of asking several vapor industry experts and business owners for their perspectives on the current situation.
A daunting process
Lindsey Stroud, policy analyst with the Taxpayers Protection Alliance, a Washington, D.C.-based nonprofit think tank dedicated to educating the public on the government’s effects on the economy, said many of her clients are still in the thick of the testing process.
Lindsey Stroud
“The process was daunting—among my clients and the folks I assisted, I probably worked on 100,000 to 200,000 individual products. Several of my clients made it past the first step, but there are many more to come,” she said. “AVM (the newly formed American Vapor Manufacturers) is really a genius idea when it comes to these small e-liquid companies. In getting more small businesses involved, the price of testing can slowly come down.
“In the aftermath of the vaping-related lung illnesses (EVALI) in late 2019, it’s imperative that regulatory agencies know what’s in the products and their effects on the U.S. population. The FDA is bound by law to apply the PMTA equally to all manufacturers, regardless of size. Still, the testing requirements for each and every liquid is unduly burdensome for small e-liquid manufacturers that offer hundreds of flavors, often with many flavor components found in numerous companies’ flavorings.
“Currently, if a manufacturer sells a strawberry e-liquid in 20 different nicotine strengths and three different bottle sizes, the FDA requires them to test all those products (20 products times three bottle sizes would mean 60 tests for just one flavor), which is inefficient, daunting and expensive. The FDA has shifted and made the PMTA requirements less burdensome; for example, [the] FDA now allows companies to submit a single PMTA instead of individual applications for each of their products
“Ideally, I would prefer the FDA to allow a flavor manufacturer to have only three tests per flavor—their zero nicotine option, their lowest nicotine option and their highest nicotine option.”
Phase 3: Substantive review
The team at North Carolina-based Bantam Vape worked with highly qualified labs to conduct the in-depth, product-specific and non-product-specific testing needed for their PMTAs, according to Bantam Vape spokesperson Anthony Dillon.
Anthony Dillon
Offering 21 “uniquely crafted flavors” created by chemists and flavorists in different nicotine levels and sizes, Bantam conducted storage and stability testing, toxicity testing and pharmacokinetic and topography studies as well as submitting an extensive review of available literature on its products. After hearing that the PMTAs for Bantam’s products were initially accepted and filed by the FDA last fall (indicating that the FDA had finished its preliminary review) the Bantam team is now waiting for the formal substantive review phase to commence.
“We invested significant resources into the foundation of our PMTA submissions, and we continue to invest resources in the PMTA process and post-market surveillance,” Dillon said. “We worked with reputable, like-minded industry players to share key costs to significantly improve efficiencies, which can help us continue selling our high-quality vape at an attractive price point.
“The PMTA process has certainly impacted the entire e-liquid industry—from manufacturers to retailers to consumers. We believe the PMTA process, though complex and resource-intensive, provides a benchmark for all e-liquid manufacturers, something that the industry, up until now, was lacking. E-liquid companies undergoing the PMTA process must evolve to remain on the market long term. Bantam is, and has always been, committed to developing and manufacturing high-quality, adult-use e-liquid products consistent with FDA guidance and applicable laws. That goal has not changed.
“With any new process, there are kinks to be ironed out. The PMTA is no different. Wherever possible, we are committed to working with the FDA to streamline and improve the process, and we will also work with our retailers and consumers to help them better understand this complex but necessary process. Currently, our biggest challenges are not due to the regulations but the need for transparency in the process and for enforcement against those that are not in compliance with FDA guidance and applicable laws.
“The PMTA process provides a benchmark for all e-liquid manufacturers—something that the industry was lacking. We are proud of and confident in the e-liquid products that are going through the PMTA process, and we look forward to Bantam’s products being enjoyed by adult consumers for years to come.”
Exceptions for artisan cigars
Established in February 2014, 906 Vapor is located in a small community in Michigan. While at one time, they had about $250,000 in annual revenues, sales plummeted to about $180,000 last year due to a state flavor ban and the EVALI scare. One of 906 Vapor’s first customers, Mark Slis bought the store in October 2015. They currently carry over 100 e-liquid flavors using freebase and salt nicotine, along with kits, tanks and mods, a line of disposables and miscellaneous batteries and accessories.
Mark Slis
Since 906 Vapor does not manufacture e-liquids, Slis didn’t have to submit any PMTAs; however, he helped the small Michigan juice manufacturers whose e-liquids he carries submit their PMTAs. Slis lobbied in Michigan, suing the state, health and human services and Governor Whitmer to stop last year’s flavor ban. He also organized a state trade organization and lobbied against flavor bans and other anti-vaping bills in the state’s house and senate, assisting various national organizations in their efforts.
“The required testing places a massive and completely unnecessary burden on all manufacturers,” Slis said. “The proper regulatory response is to set standards, since all e-liquids utilize the exact same four ingredients with variation only in the specific flavoring(s) used. The ingredients have already been thoroughly studied and tested and found to be safe for human consumption. Only product standards should now be required.
“Requiring duplicate testing for each of the 419 million flavors registered with the FDA and duplicate testing for each and every nicotine level for the same flavor is a transparent attempt by the FDA to eliminate the electronic cigarette industry—not regulate it. The FDA has already made it abundantly clear where they stand on independent, small vapor manufacturers. They refused to talk to vapor manufacturers and denied them any relief. Yet when artisan cigar manufacturers lobbied the FDA for a realistic approval pathway and assistance, the FDA not only granted them an indefinite exemption from the PMTA; they offered to spend taxpayers’ money to conduct the prohibitively expensive testing on their cigars.
“In effect, [the FDA] will bend over backward to ensure deadly combustible products remain on the market while regulating smoking cessation out of existence.”
Concerning job losses
A member and vice president of the American Vaping Manufacturers (AVM) Association, a member of the Smoke-Free Alternatives Trade Association (SFATA) and the U.S. Vaping Association (USVA), Char Owen owns a small line of wholesale e-liquids called Unchained as well as two brick-and-mortar stores in Texas called Cloud 9 Vapor Shop that opened in December 2013.
Char Owen
“Absolutely no consideration has been given to small business owners except a short PMTA extension during this pandemic,” Owen said, adding that although she contracted Covid-19 in December, she continued to help small businesses while combatting the illness. “There’s no process for notifying the FDA to request an extension when your family has been affected by Covid[-19]. A large company doesn’t need this, but most small companies are one-person shops or only have a few employees.”
With over 800 e-liquid recipes, Owen ended up submitting PMTAs for over 332,000 SKUs to the FDA. As of this writing, all her PMTAs had been received but had not yet been accepted. They held a listening session with the FDA to obtain feedback on a testing protocol that Owen said could significantly cut the cost of testing.
“The FDA said they will not be creating a simplified pathway for small business,” Owen said. “Testing requirements will put an unnecessary burden on them. These businesses have been selling the same product for many years. I’ve been selling the same product for eight years with zero complaints that our products have caused harm.
“Using standard testing methods and one of the handfuls of testing labs, the testing requirements would cost me over $9 billion dollars. The market, however, will narrow to only those owned by large tobacco, which sells closed pod systems extremely high in nicotine sold in grocery stores and convenience stores. They are the only ones that can afford the PMTA process.
“The problem is SKU inflation. In the FDA’s definition, my 800 products equal 332,000 products, or a 41,400 percent inflation of product SKUs. Something as simple as offering a different bottle size—common in our industry—is a major factor in testing costs, even though the original recipe is still the same. In vitro and in vivo studies could be withdrawn since these products have been on the market for almost 10 years. Just the high range of nicotine could be tested, and if those tests are acceptable, then obviously any lower nicotine levels would be acceptable.
“Vapor shops cater to an over-21 clientele and mainly offer open system e-liquids. They employ a more hands-on approach to helping adults off-ramp from combustibles. We support, educate and help smokers convert to noncombustibles. Because of this support, we see a much higher rate of success than is reported by the FDA, which includes consumers who purchase at convenience stores and big chains. Mainly, we are just trying to help people stay off combustible cigarettes in our local communities.
“It’s important to realize that this industry was founded by small business. The FDA’s requirements, together with a lack of a streamlined process, could cost over 100,000 people their jobs. We already have a huge job loss in the U.S. It’s the last thing we need.”
The original “Vaping Vamp,” Maria Verven owns Verve Communications, a P.R. and marketing firm specializing in the vapor industry.
Kaival Brands Innovations Group, the global distributor of all Bidi Vapor products, announced its premarket tobacco product application (PMTA) has moved the substantive review phase of the regulatory process. Bidi’s disposable e-cigarettes, Bidi Stick, comes in 11 flavor varieties, according to a press release.
Substantive Review is where the scientific review of the U.S. FDA’s regulatory process is undertaken. The company received its acceptance letter, the first step, on Feb. 9. The FDA will determine if Bidi products meet the criteria for “appropriate for the protection of the public health” established in the Tobacco Control Act. The agency issues marketing orders that authorize the continued marketing and sale of products meeting the criteria.
“Seeking an order for the continued marketing of Bidi Sticks in the United States is a long process. But it was always our goal to provide a premium vaping experience and an option to traditional, combustible tobacco that meets the needs of every adult smoker,” said Niraj Patel, the president and CEO of Kaival Brands. “This substantive review phase is where months of extensive information collection and hard work gathering together 285,000 pages of science-based evidence will pay off, as we continually put consumer health and the environment first.”
Bidi Vapor also announced they have discontinued their online direct-to-consumer (DTC) sales through its website as of February 22, 2021. The company will allow sales through gopuff.com. “With a long history of distribution of alcoholic beverages, goPuff has pioneered a very stringent and dynamic compliance program and age-gating process,” the release states.
“We are extremely excited to partner with one of the fastest growing and most secure online delivery services in the country,” stated Kaival Brands’ Chief Executive Officer, Niraj Patel. “More importantly, goPuff’s commitment to protecting minors and stringent procedural implementations will allow Kaival Brands to focus on our rapidly developing additional wholesaler distribution agreements.”
While Kaival Brands will continue its business-to-business (B2B) online sales to retailers, it believes its decision to halt online DTC sales specifically through www.bidivapor.com will set an example for the industry and help reduce the larger problem of underage access to vaping devices. “The decision also bolsters its commitment to brick-and-mortar retail, which Kaival Brands believes to be a stronger age-verification distribution model than online sales,” the release states.
