A new advocacy group has form to small vapor industry manufacturers navigate the U.S. Food and Drug Administartion’s (FDA) premarket tobacco product appliucation (PMTA) process.
The American Vapor Manufacturers Association (AVM) was founded by two vapor business owners, Amanda Wheeler and Char Owen. Both have been longtime advocates for the vaping industry and have helped hundreds of other vapor business owners submit PMTAs. Wheeler will serve as president of the new organization, and Owen vice president.
Amanda Wheeler / Credit: RMSFA
“The founders of AVM have demonstrated a long standing commitment to our industry and have a proven track record of working hard for small business. Our President, Amanda Wheeler, has represented our industry at the federal regulatory level since June of 2019. At that time, Amanda began her journey by preparing a request to HHS and FDA to develop a small business PMTA pathway that was signed by 1,453 businesses,” the AVM website reads. “Amanda also collaborated with esteemed industry attorney Azim Chowdhury to develop a small business PMTA proposal. Since that time, Amanda has worked tirelessly to engage with HHS, FDA, the Trump Administration, and members of Congress to advocate for the small business proposal and the work that our co-founder, Char Owen has done to get over 200 businesses to the point they were able to submit pre-market tobacco applications for over 1.7 million products.”
Owen also began advocating for the vapor industry’s ability to participate in the PMTA process in June of 2019. “Char was motivated by the desire to honor her father’s memory, since he passed away from lung cancer due to a lifetime of smoking. Char had a conviction that there could be a viable path forward for small businesses to participate in the PMTA process,” the site states. “She set about her work to bring crowdsourced tools to small businesses that needed assistance preparing the documents necessary for successful PMTA submission. Over 200 businesses came together under Char’s leadership to successfully complete the requirements necessary to have PMTA’s successfully submitted and accepted.”
Other media outlets have reported that the AVM intends to create a vapor product testing lab specifically for small manufacturers. Labs have been overburdened since the PMTA guidelines were announced and a Maryland judge set Sept. 9 as the deadline to submit applications to the FDA.
Pyxus International has appointed Robert George, Carl Hausmann, Cynthia Moehring and Richard Topping to its board of directors effective Oct. 12, 2020. These individuals join previously announced board members Holly Kim, Patrick Fallonand Pieter Sikkel.
“The addition of the new members to Pyxus’ board of directors is a key milestone in its transformation strategy,” said Sikkel, who also serves as president and CEO of Pyxus, in a statement. “We believe this mix of directors brings proven financial and operational track records and diverse perspectives that will contribute to Pyxus’ future success, and we look forward to working with this group of proven leaders to accelerate the company’s growth.”
George brings extensive financial and operational experience in public, private and private equity-backed diversified industrial businesses. Most recently, he served as executive vice president, chief financial officer and corporate development for Esterline Technologies. Prior to joining Esterline, George held various leadership positions with Zurn Industries and Elgin Electronics. He is a member of the board of directors of Advanced Integration Technology.
Hausmann brings more than 35 years of experience in the agribusiness and food industries. He retired in June 2012 as managing director of global government and corporate affairs of Bunge Limited, having spent a decade serving in executive roles with Bunge affiliates in North America and Europe. Prior to joining Bunge, Hausmann served as chair and CEO of Cereol and held various leadership positions with Continental Grain Co. in Europe, South America, Africa and the United States. Following his retirement from Bunge, Hausmann served as a member of the board of directors of Pyxus International’s predecessor, Alliance One International, from June 2013 to August 2018.
Moehring is the founder and executive chair of the Business Integrity Leadership Initiative at the University of Arkansas Sam M. Walton College of Business. She brings more than 25 years of experience as a strategic senior executive, including 20 years at Walmart where she served as senior vice president, U.S. chief ethics and compliance officer and senior vice president, global chief ethics officer, among other leadership positions. She has broad experience in many areas, including enterprise risk management, effective global governance practices, mergers and acquisitions, IPOs, diversity and inclusion and sustainability.
Topping has four decades of experience in the tobacco industry. He has held a variety of global leadership positions throughout the supply chain, working with both tobacco leaf merchants and cigarette manufacturers. He most recently worked with Japan Tobacco International and its predecessor companies and served as vice president of global leaf sourcing prior to retiring in June 2018. Topping has wide-ranging global expertise, from both the merchant and cigarette manufacturer perspective, in leaf sourcing and procurement strategies, logistics, operations and sales throughout North and South America, Europe, Asia and Africa.
In the run up to the revision of the European Tobacco Products Directive (TPD), scheduled for 2021, the European Tobacco Harm Reduction Advocates (ETHRA) have launched a major survey to examine nicotine use in Europe.
Among other questions, the poll asks adult consumers about their views on possible regulatory changes. How would users react to increased taxes, flavor bans or to the legalization of snus? Is there a need for greater access to product information? Would lifting the container restriction on e-liquids have any impact? What is missing for people who want to quit smoking?
Available in Danish, Dutch, English, Finnish, French, German, Italian, Portuguese, Spanish and Swedish, the questionnaire will be open until Dec. 31, 2020.
In addition to evaluating the TPD, the European Commission is preparing proposals to amend its Tobacco Excise Directive to harmonize definitions and tax treatment of new products, including vapor, in 2021.
The European Parliament will debate the proposed TPD changes in May 2021.
The ETHRA offers tobacco harm reduction advocates in Europe a platform for exchanging information and sharing experiences.
Royal College of Physicians of Ireland (RCPI) has called for a ban on all flavorings for e-liquids available for purchase in Ireland. The group says its goal is to protect children from the device that simulates tobacco smoking.
The RCPI Policy Group on Tobacco has welcomed the latest findings from a Health Research Board (HRB) review of e-cigarettes and is seeking the introduction of a ban on all flavorings, apart from tobacco flavoured e-liquid. The group is also calling for increased regulation and future taxation on e-cigarettes, according to the Irish Medical Times.
An HRB review into e-cigarette use found that e-cigarettes were associated with adolescents starting to smoke tobacco cigarettes, which could potentially lead to serious harm.
“These findings have important public health ramifications and do not support recommending e-cigarettes as a smoking cessation tool,” stated Prof Des Cox, chair of the RCPI Policy Group on Tobacco.
They recommended that people use nicotine replacement therapies and/or medications prescribed by their general practitioner instead of e-cigarettes when trying to quit smoking.
“We are concerned about the finding of adolescents who use e-cigarettes being at increased risk of starting tobacco smoking. It is still legal for minors to purchase e-cigarettes in Ireland. Our group is calling for the introduction into legislation of the Tobacco Products Bill that was promised by the previous government,” Cox said. “The findings also show that when it comes to stopping smoking e-cigarettes are no more effective than nicotine replacements therapies, and because e-cigarettes aren’t regulated their safety is not yet known. What we do know is that worryingly they can cause burns, injuries, and lung damage.”
The Royal College of Physicians in the U.K. has released several studies that found vaping to be 95 percent safer than smoking combustible cigarettes. There was a move to debunk the theory, but several health experts agree with the group.
Vampire Vape has sent its best-selling flavor into space. The U.K.-based e-liquid manufacturer sent its Heisenberg e-liquid into orbit on Sept. 18. A hydrogen filled balloon was launched, with a bottle of the liquid attached to it and eventual soaring up to 121,000 feet, before it popped and the deflated balloon and e-liquid returned to Earth.
Hydrogen was chosen due to its renewable energy properties, according to a press release.
The balloon’s journey was captured by a camera that was attached to the balloon, which recorded footage as it ascended into space and then descended back to Earth, where it reached an incredible speed of 250 miles per hour, the release states.
As the balloon came down, a parachute was deployed, ensuring a safe landing. The e-liquid bottle’s journey was monitored by a live radio tracking system and a satellite internet locator, and landed at a secret location. Vampire Vape worked with Sent into Space, leading experts in space-based marketing campaigns and stunts, to ensure safety and correct following of procedure.
The balloon expanded to the size of a double-decker bus as it made its journey through the stratosphere, the release states. The idea of sending the first ever e-liquid into space was devised by Vampire Vape founder Phil Boyle.
“In these testing times, the news is full of doom, gloom and negative stories – we wanted to create something unusual, creative and memorable, in the hope that it will make people smile. We also wanted to do something wacky and fun that our employees would love being part of,” said Boyle. “We’re always looking for ways to be innovative, forward thinking and different from our competitors, and are keen to reach new heights – what better way to do this than literally?! We’re thrilled that we’ve been able to pull this off and send our award-winning Heisenberg to new heights! I feel we have set the bar pretty high for whatever is next for Vampire Vape in the future. “
Philter Labs launched its Phreedom filtration device that allows users to inhale and exhale into the same mouthpiece, eliminating up to 97 percent of secondhand vapor and smell.
The filter is designed to work with 80 percent of the existing cartridges on the market, and it attaches to all 510 cannabis and CBD cartridges.
“The Phreedom represents a massive step toward a vaping culture free of exhaled vapor, pollutants and best of all, its associated shame,” said Philter Labs’ chief technology officer and inventor, John Grimm, in a statement.
“We wanted to provide a product that respects a person’s right to vape. The Phreedom is exactly that, with seamless integration for the majority of vape cartridges on the market and an enhanced experience focused on protecting people’s health, the health of the environment and the quality of the consumer experience.”
The Phreedom uses Philter’s patented Zero-5 technology to help eliminate secondhand vapor.
Philter offers other filtration devices, but the Phreedom is the first to allow users to inhale and exhale through the device.
With clearer information, more smokers would switch to lower-risk products.
By VV Staff
There are several reasons why people use nicotine. According to Neal Benowitz, professor of medicine, biopharmaceutical sciences, psychiatry and clinical pharmacy at the University of California San Francisco, those reasons include pleasure, stimulation and mood modulation. However, many users don’t understand the adverse effects and risks associated with different delivery mechanisms.
“Clearly, the decision involving long-term use of the drug for individuals or society depends, at least in part, on adverse health effects. For example, the casual use of cocaine or heroin are discouraged by society because they are hazardous to health,” explains Benowitz. “We know nicotine, per se, is much less hazardous than cigarette smoking, regardless of potential health concerns. That’s a successful argument for electronic nicotine-delivery systems [ENDS].”
Speaking at a panel titled, “The Future of Nicotine,” during the 2020 Global Tobacco & Nicotine Forum (GTNF) in September, Benowitz said that one of the major questions surrounding tobacco control is whether society can accept nicotine use if the harms were reduced. He says that possibility exists. “The FDA [U.S. Food and Drug Administration] can be a big part of making this happen … there is a misconception surrounding the harm of nicotine compared to combustible products,” which are more deadly than ENDS.
While acknowledging the validity of Benowitz’ point, Michael Cummings, professor of psychiatry and behavioral sciences at the Medical University of South Carolina, cautioned against the unintended consequences of regulation. Banning a specific delivery mechanism for nicotine, he said, presents a risk. Cummings referred to the FDA’s vision, formulated in 2017, of a world where cigarettes would no longer create and sustain addiction and where adults who need or want nicotine could get it from less-harmful alternative sources.
“But it seems like we’re going the wrong direction … If we adopt regulations to ban the sale of vaping products as some states and many countries around the world have done, what would be the effect? Well, the effect is that cigarette sales will go up,” said Cummings. “That’s a bad thing. Regulating vaping products like they’re cigarettes—which they’re not—banning flavors, banning internet sales … [these actions] would have a detrimental effect of actually driving up cigarette sales to the detriment of the lower-risk products.”
Also speaking during the GTNF panel, Clifford E. Douglas, director of the Tobacco Research Network and an adjunct professor of Health Management and Policy at the University of Michigan School of Public Health, said that consumers clearly need a much better understanding of the true nature, including the relative risk, of different tobacco and nicotine products.
“This includes the fact that nicotine is the root cause of the epidemic of tobacco-related illness and death because it hooks in smokers and keeps many smoking who otherwise would quit,” he explained. “While complete information on all the potential risks and benefits of [vapor products] is not yet available, there is sufficient information … to end deadly combustible tobacco use [which is] responsible for approximately half a million deaths a year and 30 percent of all cancer deaths in the United States.”
Asked by moderator Clive Bates, director of Counterfactual Consulting, whether there was a regulatory environment possible that incorporated the relative risk of the different types of nicotine-delivery systems, Stefanie Miller, managing director of FiscalNote Markets, said “no.”
“[There is] no trust among the general public for companies that produce a product containing nicotine, and that is largely based on a misconception around the difference between nicotine and combustible tobacco use. After predatory behavior and negligence of tobacco companies in the 20th Century, most people see this as very black and white. Tobacco companies are bad, and anti-tobacco efforts are purely good,” said Miller. “I think [everyone] who’s tuned in right now knows that the situation is far more nuanced and … the regulations are not accommodative of that nuance.”
Benowitz says that another major problem with the message on less-risky nicotine products is that there is very little science on the long-term effects of ENDS products. “We have an array of new products, any of which are inhalable,” he said. “We have a lot of short-term data that is promising in terms of reduced exposure in the short term, but we really don’t know about the future long-term consequences.”
Miller added that cigarette manufacturers could help change the misconceptions surrounding nicotine. It’s the large manufacturers who could make it a goal to end combustible nicotine-delivery systems. “If you’re really clear about setting a strategic goal, and then you do everything possible to accomplish it, you’re more likely than not to win,” she said. “I think that this is [an] important enough [goal] to try.”
Benowitz said that regulators need to help consumers better understand that the regulators support a shift to less-risky products. He says that only then can the goal of getting rid of combustible products be accomplished.
“We’re not doing this because nicotine is bad,” he said. “We’re doing this because nicotine sustains harmful cigarette smoking … there are other products that [can deliver] nicotine that are much less harmful.”
One of China’s most adamantly anti-smoking cities has vowed to stop selling e-cigarettes near schools and reduce children’s exposure to secondhand smoke at home as part of a new “smoke-free communities” campaign.
In a more focused update to its “smoke-free city” campaign launched in 2018, the southern metropolis of Shenzhen pledged Saturday to strictly prohibit the sale of not only tobacco products but also e-cigarettes within 50 meters of primary and middle schools, according to Sixth Tone’s sister publication The Paper.
The city is also aiming to reduce primary and middle schoolers’ exposure to secondhand smoke at home to below 20% while raising the proportion of “smoke-free families” to at least 50% in three years — though it’s unclear how the success rates will be measured. Some doctors believe that, because secondhand smoke can cause a variety of diseases in children, from asthma and pneumonia to lung cancer and sudden infant death syndrome, it is equivalent to child abuse.
The smoke-free communities campaign, jointly announced by Shenzhen’s civilization and tobacco control offices, will be enforced alongside the city’s official smoking control regulation, last updated in July 2019. While other Chinese cities have also taken steps to curb smoking and vaping, Shenzhen’s are widely regarded as the most comprehensive in the country.
A new version of synthetic nicotine eliminates the cancer-causing impurities in leaf-derived nicotine.
By Timothy S. Donahue
No tobacco-specific nitrosamines (TSNAs). A new synthetic nicotine coming to market has none of the possible cancer-causing impurities that are found in traditional leaf-derived nicotine. In November, eLiquiTech, a wholly owned subsidiary of Tobacco Technology Inc. (TTI), will release its newly patented SyNic synthetic (S)-nicotine. The announcement has the potential to revolutionize next-generation tobacco products, such as electronic nicotine-delivery systems (ENDS), oral nicotine-delivery systems and heat-not-burn (HnB) products.
SyNic USP/EP, SyNic nicotine bitartrate and SyNic polacrilex resin are manufactured in U.S. Food and Drug Administration (FDA)-registered facilities using current good manufacturing practices (cGMP). These products have confirmed purity levels of more than 99.9 percent, (S) levels of more than 99.7 percent and are free of TSNAs and carcinogens, according to eLiquiTech CEO George Cassels-Smith. “What is the value of noncarcinogenic nicotine base to any tobacco product manufacturer?” he asks. “What is a noncarcinogenic tobacco product portfolio worth to the tobacco consuming public? But high-purity, pedigreed natural nicotine will continue to have a large seat at the table nevertheless.”
SyNic got its start seven years ago when e-LiquiTech began working with U.K.-based Zanoprima Lifesciences with the goal of developing a unique and patented portfolio of synthetic nicotine products. The group wanted those products to cover the entire nicotine value chain with a focus on next-generation tobacco products.
E-LiquiTech, through TTI, is committed to Zanoprima to serve as SyNic’s global distributor and the manufacturer of record for synthetic nicotine bitartrate and synthetic nicotine polacrilex resin as well as proprietary SyNic e-liquid formulas. “Ensuring that synthetic nicotine is readily available is the right thing to do for our industry—and now also is the right time to do it,” said Cassels-Smith.
Zanoprima holds the patent and eLiquiTech maintains the exclusive rights for global distribution to the tobacco and ENDS industries, but the product won’t be available to everyone, according to Cassels-Smith.
“This will not be available directly to the consumer market. We will soon post a set of standards online that manufacturers must meet to purchase our synthetic nicotine,” he says. “This product is not intended to circumvent the rules governing the tobacco and ENDS industries nor evade regulation. We will not sell it to companies that have that intent.”
SyNic will refrain from entering the highly contentious U.S. vapor market until its potential customers can show they have an accepted for review premarket tobacco product application (PMTA) submitted to the FDA’s Center for Tobacco Products. “Our objective is to work with the FDA, not around it,” says Cassels-Smith.
When synthetic nicotine first appeared on the market in 2016, the product was marketed as being a potential way to circumvent the FDA’s proposed deeming rule for next-generation tobacco products. The FDA’s definition of “tobacco product” includes any product made or derived from tobacco, including any component, part or accessory of a tobacco product. E-liquids that do not contain nicotine or other substances made or derived from tobacco may still be components or parts and, therefore, subject to the FDA’s tobacco control authorities.
Cassels-Smith says that Zanoprima has filed multiple global patents for its technologies and has also begun the process of filing drug master files with the FDA for SyNic nicotine, SyNic bitartrate and SyNic polacrilex resin. “Coupled with e-LiquiTech’s exclusive distribution, competitive pricing and carrying the e-LiquiTech guarantee, these products will be available only to responsible partners operating within the regulatory guidelines of the global tobacco industry,” said Cassels- Smith. “The synthetic nicotine is cleaner than naturally derived nicotine because it has no TSNAs. These nitrosamines have the potential to turn into carcinogens. SyNic will not have any nitrosamines and is 100 percent carcinogenic-free by design.”
E-LiquiTech’s synthetic nicotine resembles its naturally derived cousin. Like a naturally derived liquid nicotine, e-LiquiTech’s new synthetic nicotine is more than 99 percent pure (S)-nicotine. This purity of (S)-nicotine has a better effect on the body, and SyNic carries fewer impurities than naturally derived nicotine that comes from leaf tobacco.
“Nicotine exists in nature in two forms, (R) isomer and (S) isomer. One is basically a mirror image of the other, but the nicotine desired by vapers and smokers alike is the (S)-nicotine alone. Naturally grown tobacco contains over 99 percent (S)-nicotine, and the rest is very little (R),” says Cassels-Smith. “The body considers (R)-nicotine a filler with substantially less physiological effect. It’s considered a waste product, and [the body] does not absorb it. SyNic is slightly superior to the (S)-nicotine content found in a naturally derived nicotine because of its higher levels of (S)-nicotine with qualified and quantified impurities.”
Traditionally, a problem for the producers of synthetic nicotine has been that the entire production process is both complicated and expensive. As a chiral molecule, nicotine is far easier to produce as a synthetic nicotine with equal amounts of both (R) isomers and (S) isomers compared to a nearly pure (S)-nicotine. “(R)-[nicotine]/(S)-nicotine requires additional refining processes, which [are] time consuming and expensive to convert it to a true synthetic (S)-nicotine,” explains Cassels-Smith. “Also, because (R)-nicotine has substantially [fewer] physiological properties, it takes twice as much 50/50 synthetic nicotine in an e-liquid to achieve parity with SyNic. Because SyNic has greater than 99.7 percent (S), it only needs half the amount of SyNic to create the same effect for users as current synthetic nicotine offerings on the market.”
Naturally derived nicotine and synthetic nicotine are identical on a molecular level. The differences are the individual or potential impurities. Nicotine derived from tobacco can contain potentially harmful impurities if it is not purified sufficiently. That can be very difficult and costly because the impurities appear structurally very similar to the nicotine molecule itself. But synthetic nicotine is virtually free of any impurities from the beginning and none are carcinogenic.
SyNic, by design, carries no heavy metals and contains no residual pesticides. Additionally, unlike tobacco-derived nicotine that uses harsh acids and chemical solvents in its process, SyNic, is produced using a “green chemistry” method. “Its manufacturing is environmentally friendly, and any solvent used is recovered completely before being recycled for future use,” explains Cassels-Smith. “The SyNic process makes the tobacco-derived nicotine process appear dirty by comparison.”
SyNic will help manufacturers meet the FDA’s goals by consistently creating high-quality nicotine to deliver to the consumer without the possibility of potential carcinogens, according to Cassels-Smith. “We will allow vaping products to have the cleanest delivery and the best delivery,” he says. “That isn’t going to happen with the old technology. SyNic is a new frontier and a perfect tool for this industry to reinvent itself. It is constantly developing and reinventing itself. This product can help make all tobacco products better.”
Because of its unique patented process, Cassels-Smith says SyNic can achieve price parity with tobacco-derived nicotine. He adds, however, that this synthetic product will always be marketed at a higher cost than naturally derived nicotine to ensure there will always remain a naturally derived pedigreed nicotine market where the tobacco farmer can sell his crops.
“We have a lot of respect for the natural product and foresee our synthetic nicotine being a compliment to those that wish to remain all natural. There is enough room in the market for everybody. SyNic, with its known qualities, will have a place at the table alongside pedigreed natural tobacco-derived nicotine. But there are issues with nicotine sourced from scrap and dust as traceability is impossible and controlling pesticide and heavy metal contamination is problematic,” Cassels-Smith explains. “I foresee a future requiring the tracing of [natural] nicotine’s origin from the seed and soil through the extraction process and also quantifying impurities, all in cGMP facilities.”
SyNic’s potential is unlimited in the number of products in which it could be used. Cassels-Smith says that he cannot think of a single nicotine product that could not benefit from SyNic. In a heat-not-burn product, for example, during the rod-making process, SyNic could augment the prevalent nicotine source—or even be the sole source.
“Zanoprima has adapted their SyNic technology and patented an extremely unique and stable nicotine salt that does not use organic acids and retains pH stability,” he says. “SyNic also has the potential for being associated with superior purity and shelf life stability in all tobacco products of the future. SyNic will raise the bar, and we are just scratching the surface. It is a great tool that emerges at the perfect time for every tobacco product designer. The portfolio of potential products that can utilize SyNic is infinite.”
The ‘Davids’ of the vapor industry prepare for war.
By Maria Verven
In many ways, Gerri and James Jarvis are the epitome of the Davids who are up against the Goliaths of the vapor industry.
Now that the U.S. Food and Drug Administration’s (FDA) premarket tobacco product application (PMTA) deadline of Sept. 9 has come and gone, the wait is on to see which products—and which Davids—will survive.
The PMTA battle plan
Gerri and James own Jarvis Vaping Supply, a wholesale vaping supply store, as well as four retail stores called Vapor Station in and around Columbus, Ohio. James is also president of the Ohio Vapor Trade Association, and both Gerri and James are avid advocates of the vapor industry.
The Jarvis’ first got into the industry after watching the growth of Westside Vapor, which was started by their friend, Jason Gang.
“My passion for the industry came from the loss of my grandmother when I was 16 due to smoking-related issues,” James said. “I saw how successful vapor was for Jason in his goal of quitting smoking. It really made me want to help others do the same thing.”
The Jarvis’ business was going gangbusters until media reports of e-cigarette or vaping product use-associated lung injury (EVALI). Now known to have been caused by the addition of vitamin E acetate, a product that isn’t used in any store-bought e-liquids, EVALI scared many customers away from vaping.
Vapor Station experienced a devastating 50 percent loss in sales from EVALI reports, and then Covid-19 hit, causing another major loss as stores had to close during the early months of the pandemic. “Unfortunately, during the pandemic, several people went back to smoking since cigarettes were so easy to get,” James said.
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.
But that wasn’t enough. She 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.
The waiting game begins
Now the wait begins. Encouraged by the successful FDA acceptance achieved by business colleagues at ECIG Charleston and Bad Drip, the Jarvis’ have high hopes for their PMTAs. All had used processes shared in the PMTA Sharing Facebook group.
They are also realistic, knowing that the FDA has received a flood of applications. The Jarvis’ are one of many e-liquid manufacturers and small vape shops that make their own e-liquids in dozens, if not hundreds, of flavors and in a variety of nicotine strengths and volumes. And each of these distinct products in every flavor and nicotine strength requires a separate PMTA.
The FDA publicly acknowledged that the market for vapor products is extremely large—“several orders of magnitude greater than anything the agency has experienced … The likelihood of [the] FDA reviewing all of these applications during the one-year review period is low.”
We asked Gerri to give us a glimpse inside the process of pulling together PMTAs for nearly 1,000 products. Here’s what she shared with Vapor Voice:
When did you start pulling together all the information you needed to complete the PMTAs?
As an industry, we’ve been working on this since August 2016, but we started really getting the paperwork together in March of 2020. I guess it took deadlines from the FDA to really hit us to get to the point of pulling together the PMTAs.
We currently offer 998 SKUs, or products. We provided information on and requested PMTA approval on every one of our products.
Please tell me all about the PMTA process: How long did it take? What sort of information did you provide?
I started working in March 2020 and worked pretty close to nonstop from July to September. The Facebook PMTA Sharing group helped me run the studies and programs to gather the needed data, such as underage studies, customer surveys and PMTA review literature.
In our customer survey of around 5,000 customers, we learned that 90 percent used flavors—and most preferred the fruit flavors. If those flavors go away, the majority—76 percent—said they would go to the black market or back to smoking. We have the weirdest industry in the world: Our business model is to get people to switch to vaping from smoking and then reduce their level of nicotine and eventually [get] off of vaping all together.
Why did you decide to do it on your own? How confident did you feel about the 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 do the initial submissions ourselves.
Please share what you can about the expense of pulling together the PMTAs.
For the preliminary review, we had to pay for programs such as the Environmental Assessment Generator and Cover Letter Generator and other environmental assessments. If the FDA accepts our initial applications, we will then move into the substantial review phase for the product testing analysis and safety information. The FDA has only accredited six labs, and the expenses are exorbitant: Each SKU could cost us anywhere from $84,000 to $480,000, depending on which lab we use.
That’s why we’re working to try to get some kind of reform through Congress by reaching out to our senators and congressional leaders and explaining that these costs will kill small businesses—all but about 5 percent of the industry. The costs are blowing their minds. If we can pass some type of reform, there are labs right here in Ohio that can do the testing for a whole lot less.
Please share your emotions during this process: Were you ever frustrated? Were you worried about what should or should not be included? Were you worried it might not pass or pay off in the long run?
During all the hours we were putting together the PMTA, there was always that thought in the back of our minds that all this work could be for naught. We had no clue if what we were putting together was going to be enough to get us to the next level of the process or not.
We were very stressed with all the work on the PMTAs while also running the day-to-day operation of our shops. We had very late nights when our systems stopped working and the generators were running slow. And to top it off, the FDA brought out a new system just nine days before the submission deadline.
What’s the status of your PMTA?
We are still waiting on the news. We know people who used the same process who were accepted, which gives us hope for our PMTAs. We were told we might have to wait up to 180 days to hear back from the FDA. There is no real timeframe established. We just have to sit and wait for the FDA to contact us. But we are encouraged by the fact that three or four companies in the PMTA sharing group have received acceptance letters.
I understand you’ve helped other companies navigate the PMTA process.
I helped our friend Jason Gang pull together the files to run the programs for the cover letters, description sheets and environmental assessments. I would stay up for hours making sure the files were correct.
And I completely fixed one company’s FURLS (files with product information that must be submitted to the FDA) so they could complete the filing. We spent hours on the phone and Facebook Live, helping walk them through the process.
What are your takeaways? What would you do the same? What would you do differently?
I learned that a lot of the process is repetitive. I would spend the same time helping others get to the finish goal. I would have started earlier and kept better records, such as more proof of the dates [that] our products went on the market.
How is business going now? Do you have any predictions for the future of your business?
Business online and at our vape shops has been terribly slow with Covid-19. We are hopeful that with all of our teamwork, this community of small independent businesses will grow stronger.
We need everyone to see the unrealistic, onerous and prohibitively expensive process we were thrust into and how hard we are working to save our technology for consumers, our employees and our businesses.
The original “Vaping Vamp,” Maria Verven owns Verve Communications, a PR and marketing firm specializing in the vapor industry.
