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.”
The Montana Senate heard a measure to limit local government and the Department of Public Health and Human Services from regulating vaping products this week. Bill sponsor Rep. Ron Marshall (R-Hamilton) says vaping and alternative nicotine products are meant to get people away from tobacco.
Proponents say House Bill 137 would keep small businesses open by stopping counties from introducing flavor bans on vape products, according to NBCMontana. Opponents say these products aren’t any less dangerous than cigarettes and are too easily accessible to minors.
The bill Marshall proposed is House Bill 137. According to the official legislation, House Bill 137 will prevent and stop any further regulation on nicotine and vapor products by local and county governments. Health Boards and the Montana Department of Public Health and Human Services are also prohibited from further regulating flavored e-cigarettes and vapor products unless the policies match entirely different regulatory standards that deal with non-tobacco and non-combustible nicotine-containing products.
Marshall, a vape shop owner, and his business partner are former members of the Montana Smoke-Free Association. This bill moves to executive action, when the committee will vote whether to send it to the Senate floor.
If Health Canada has its way, this year vaping will be dealt three knockout blows that will see, not just the end of the business as we know it, but an increase in smoking-related deaths nation-wide, says Ian Irvine, a professor of economics at Concordia University.
Ottawa is recalibrating the delicate equilibrium between harm reduction and youth use of nicotine. It plans to introduce a mandatory limit on nicotine concentration in e-cigarettes and to ban most flavours. Maximum permissible content is currently at 66 milligrams per millilitre; the new limit will be 20. Eventually, we will see strike three: excise taxes.
Ian Irvine, courtesy Concordia University
Harm reduction tries to induce smokers to switch to nicotine products with greatly reduced toxins, particularly if they are habituated or even addicted to nicotine. Public Health England has repeatedly stated that the toxins in e-cigs are at most five per cent of those in regular cigarettes. The toxins that cause cancer come from the burning of tobacco at 700 degrees Celsius. But vaping devices heat rather than burn. Nicotine is not the health demon. It does cause habituation. But it’s the burning that shortens lives.
In an article for the Regina Leader-Post, Irvin explains that e-cigarettes are not harmless. The health problem vaping poses is that between five and 10 per cent of teens are regular vapers and nicotine is bad for the developing brain. But while a pack-a-day smoker will on average lose 10 years of life, an equally indulgent vaper might lose just one. Most adults who drink moderately, gamble, like sugar too much, or exercise insufficiently might think one year off a normal lifespan a reasonable price to pay to indulge a passion or need.
As for adult smokers, people considering a transition from smoking to vaping require a product yielding enough nicotine to satisfy their craving. Many potential switchers will not make the transition — and will end up dying prematurely — if they cannot get a strong enough nicotine substitute for their cigarettes. Canada has about 40,000 smoking-related deaths per year, so if even a small percentage of smokers don’t transition because of insufficient nicotine, that will mean thousands more deaths annually.
If Health Canada succeeds in introducing both a nicotine cap and a flavour ban on vaping, smoking rates will continue to be higher than necessary and many thousands of unnecessary deaths will folllow.
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.
The U.K. Vaping Industry Association (UKVIA) has unveiled a landmark package of recommendations to government, aimed at maximizing the public health benefits of vaping and bolstering ambitions for a “Smokefree 2030.” The document, A Blueprint for Better Regulation, urges government to use its post-Brexit independence to become a world leader in harm reduction.
The U.K.’s Tobacco and Related Products Regulations (TRPR) are currently being reviewed, with a crucial consultation due to close on March 19. The resulting decisions made by government are set to shape public health and smoking cessation policy for years to come.
Former Health Minister Norman Lamb, also a former chair of Parliament’s science and technology committee, praised the recommendations.
The TRPR review offers a great opportunity to improve public health across the U.K. by tackling misinformation about vaping.
“I welcome the launch of the UKVIA’s Blueprint document responding to the government’s consultation—the TRPR review offers a great opportunity to improve public health across the U.K. by tackling misinformation about vaping.
“It also presents an opportunity for the industry to build on the evidence-based approach, which the government has consistently taken on vaping products, and to support smokers who want to switch to a less harmful product.”
“The current public consultation on TRPR and SPoT is an ideal opportunity to highlight how less harmful products have improved public health,” said former Labour MP Kevin Barron, who is also a former chair of Parliament’s health and social care select committee.
“The current lowest recorded smoking rates have been achieved by numerous avenues including switching from tobacco to less harmful products. The opportunity to bring in legislation to further encourage the move to products that can satisfy an addiction using products 95 percent less harmful than burning tobacco should not be missed.”
The opportunity to bring in legislation to further encourage the move to products that can satisfy an addiction using products 95 percent less harmful than burning tobacco should not be missed.
Developed by the sector’s leading businesses, the recommendations aim to help adult smokers quit, while increasing vaping’s economic contribution and even addressing environmental concerns. The UKVIA Blueprint, among other things, calls for:
The use of government-approved, expert health claims on products, to encourage smokers to switch
Greater opportunities to engage with smokers, as current restrictions also deter those who may otherwise make the switch
The extension of certain regulations to cover additional vaping products, such as non-nicotine e-liquids, thereby supporting a highly responsible industry
Product size changes that reduce prevalence of single-use plastic
John Dunne
“The recommendations published today are the result of intense collaboration among vaping’s leading experts and entrepreneurs,” said John Dunne, director general of the UKVIA. “This is truly a landmark moment in the history of our industry, which has grown to be a genuine market disrupter, and a route out of smoking for people all over the world. With the adoption of these recommendations, the U.K. could take its place as a progressive, global leader on public health.
“The government has claimed that post-Brexit regulatory independence will mean a new, and better, way of doing things. Now is the time for this pledge to become a reality. By embracing this evidence-based approach, we can empower consumers, revitalize businesses and put the ‘Smokefree 2030’ ambition within our grasp.”
Lawmakers in Ceredigion county, Wales want vaping and e-cigarettes to be treated the same as combustible cigarettes and be banned in public areas like schools, playgrounds and hospital grounds, according to reports.
Credit: Krystian Graba
New legislation came into force from March 1 banning smoking from school grounds, hospitals and play areas, with Welsh Government leaving the decision on vaping up to local authorities, according to Nation CYMRU. Ceredigion county councilors recommended that the same new rules banning smoking be the same for those using alternatives such as vapes and e-cigarettes but added that the same level of enforcement would not be possible.
Chairman of the healthier communities overview and scrutiny committee said on Monday, March 8 that seeing people vaping in playgrounds, combined with the different flavors available, could be “drawing children in.” He added he was a “little disappointed” the current legislation did not go further in allowing enforcement of vaping restrictions.
Cllr Bryan Davies supported this and said that vaping should be treated the same as smoking. Questions were raised about how the legislation covered council land leased by community councils and how enforcement would be resourced.
The council will be the enforcement body for premises while the police will enforce the ban on smoking in cars with children. The committee approved the report, adding that consideration be given to including vaping on any signage indicating where smoking is banned.
It is recommended that “steps are taken to ensure all Local Authority smoke-free settings comply with the new legal requirements.” It also noted the additional enforcement requirements on public protection services and “further recommends necessary changes to the Constitution to reflect the implementation of the Smoke-free Premises and Vehicles (Wales) Regulations 2020.”
Millions of vapers could feel forced to return to smoking if national governments adopt a proposal from the World Health Organization (WHO) on e-cigarettes, warns the Coalition of Asia Pacific Tobacco Harm Reduction Advocates (CAPHRA)
A new report published by WHO’s tobacco regulatory committee recommends nearly all vapes—especially “open systems”—be banned. It also demands existing restrictions on cigarettes be applied to emerging products, presumably so smokers won’t learn about them.
In the open system, which is the preferred way of vaping for many people across Asia, the consumer manually refills the liquid to be vaporized. According to the WHO, this system allows for the addition of substances which could make the product more harmful.
“The latest recommendation from WHO defies all logic,” said Nancy Loucas, the executive coordinator of CAPHRA, in a statement. “If countries adopt the recommendation to ban open-system vapes, years of hard work by ex-smokers as well as good public policy will be rendered meaningless.”
“Let there be no doubt: vapers will then go back to cigarettes, which is the worst possible outcome.”
“Banning any product is not the answer, nor is applying blanket cigarette rules to all emerging products. Bans encourage the black market. Bans do not allow for proper consumer protection,” Loucas said.
CAPHRA is calling on governments to adopt evidence-based, common sense regulations for all vaping products.
“Just last week, the U.K.’s leading health agency, Public Health England (PHE), concluded that nicotine vaping products were the most popular aid used by smokers trying to quit,” Loucas said.
“On the one hand, you have a local public health agency looking into the evidence and ways in which smokers can be encouraged to quit smoking and vape, and on the other you have a global agency stuck in their old ways of believing prohibition is the answer to everything.”
“WHO’s attitude to e-cigarettes has been devastating for millions and millions of smokers and vapers alike all around the world,” Loucas said.
CAPHRA said it’s only through regulating products can vapers remain protected, encouraged to stop smoking, and as a result, achieve good public health outcomes.
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.
In July 2020, Puff Bar announced that it would cease all online sales and distribution in the U.S. until further notice. However, the brand resumed sales on its website last month with a changed product. To get around the ban, Puff Bar is now using tobacco-free nicotine, according to The Wall Street Journal.
Credit: Puff Bar
The U.S. Food and Drug Administration (FDA) has started investigating Puff Bar’s redesigned fruit-flavored disposable vaporizers because of the changes, reports The Hill. The regulatory agency said it was aware of Puff Bar’s actions but would not say whether the agency’s ban was still applicable, citing the ongoing investigation.
In mid-2020, the FDA told Puff Bar to stop selling its fruity vaporizers as part of a broader crackdown on underage vaping. In a letter to Puff Bar, the FDA’s Center for Tobacco Products said Puff Bar products hadn’t been authorized for sale by the agency and that the company had made unauthorized claims on its website that its vaporizers were less harmful than traditional cigarettes.
In early 2020, the Trump administration banned fruity flavored e-cigarettes in reusable devices like Juul, the blockbuster brand that helped trigger the teen vaping craze in the U.S. Under that policy, only menthol and tobacco flavors were allowed for those devices. But the flavor ban did not apply to disposable vaping products like Puff Bar, which is offered in more than 20 flavors, including pina colada and pink lemonade.
Following the ban, Puff Bar quickly emerged as the vape of choice among young people. Puff Bar has fallen to No. 3 in the disposable category this year, after Bidi Stick and Blu, according to Nielsen data.
It’s unclear who owns Puff Bar. Previous owners include Cool Clouds Distribution in California and DS Technology Licensing in China.
