The U.S. Food and Drug Administration today issued decisions on several R.J. Reynolds Vapor Company for several Vuse branded e-cigarette products, including the authorization of six new tobacco products through the premarket tobacco product application (PMTA) pathway. It’s the second and third Vuse branded device to garner an marketing approval. The company’s top selling Alto device is still under PMTA review.
The FDA issued marketing granted orders (MGO) to for the Vuse Vibe and Vuse Ciro e-cigarette devices and accompanying tobacco-flavored closed e-liquid pods. For each device, two versions of the power units were authorized to reflect different battery manufacturers described in the company’s applications. In total, the products receiving MGOs include:
2 Vuse Vibe Power Units
Vuse Vibe Tank Original 3.0%
2 Vuse Ciro Power Units
Vuse Ciro Cartridge Original 1.5%
The authorization allows the products to be legally marketed in the U.S. The FDA also issued marketing denial orders to R.J. Reynolds Vapor Company for multiple other Vuse Vibe and Vuse Ciro e-cigarette products, presumably for flavors other than tobacco. Any of those products currently on the market must be removed or FDA may take enforcement action, according to the FDA.
Neither the Vibe or Ciro device is popular with vapor consumers. Many consider the products old and outdated technically, unlike Njoy’s Ace device that was granted marketing orders in April. This marks the fourth and fifth vaping product brands (Vuse has 3 seperate products under the Vuse name) to receive an MGO from the FDA. In October 2021, the FDA issued its first marketing granted orders to Vuse Solo. In late March, the agency approved several Logic products for sale in the U.S.
Vuse Vibe / Photo: RJR Vapor
“Under the PMTA pathway, the applicant must demonstrate to the agency, among other things, that marketing of the new tobacco product would be appropriate for the protection of the public health.
“The authorized Vuse products were found to meet this standard because, among several key considerations, chemical testing was sufficient to determine that overall harmful and potentially harmful constituent (HPHC) levels in the aerosol of these products is lower than in combusted cigarette smoke,” the FDA explained. “Further, data provided by the applicant demonstrated that participants who had used only the authorized Vuse Vibe and Vuse Ciro products had lower levels of exposure to non-nicotine HPHCs compared to the dual users of the new products and combusted cigarettes.
“Therefore, these products have the potential to benefit adult smokers who switch completely or significantly reduce their cigarette consumption.”
The FDA said it considered the risks and benefits to the population as a whole, including users and non-users of tobacco products, especially youth. This included review of available data on the likelihood of use of the product by young people. For the authorized products, the FDA determined that the potential benefit to adult smokers who switch completely or significantly reduce their cigarette use would outweigh the risk to youth – provided that the company follows post-marketing requirements to reduce youth access and youth exposure to their marketing.
The authorization imposes strict marketing restrictions on the company to greatly reduce the potential for youth exposure to tobacco advertising for these products, according to the agency. “The FDA will closely monitor how these products are marketed and will act as necessary if the company fails to comply with any applicable statutory or regulatory requirements, or if there is a notable increase in the number of non-smokers—including youth—using these products,” it wrote.
Credit: RJRVC
The FDA may suspend or withdraw a marketing granted order issued under the PMTA pathway for a variety of reasons if the agency determines the continued marketing of a product is no longer “appropriate for the protection of the public health,” such as if there is a notable increase in youth initiation.
Before making marketing decision documents available to the public, the FDA must redact trade secret and confidential commercial information (CCI) and ensure documents posted to the FDA website are accessible to everyone. For these reasons, the full decision summary for marketing authorizations may not be posted to the MGO webpage until after the order issuance date, according to the agency.
In the interim, to provide as much information as possible at the time of order issuance, the FDA is making redacted versions of the order letter and the “Executive Summary” section of the decision summary available to broadly explain the public health rationale for authorization of these products.
The two weeks ended April 9, 2022, was the first time Vuse surpassed Juul to become the No.1 e-cigarette brand in the U.S., according to Nielsen. The company had a market share of 35 percent, driven by the Vuse Alto, which represents more than 90 percent of Vuse’s 2021 revenues in the U.S. Vuse has been narrowing the gap with Juul since Dec. 2021.
Several analysts reported on May 3 that Vuse had barely edged past Juul in the Nielsen analysis of convenience store data that covers the four-week period ending April 23. Vuse was at a 34.8 percent market share, while Juul was at 34.4 percent.
It was the first time Vuse held the top market share in the Nielsen report since November 2017. However, for the past 52 weeks, Juul remains ahead 36.6 percent to 30.5 percent.
By comparison, Juul held a 74.6 percent U.S. e-cig market share as recently as May 2019, which is when a series of regulatory actions led to product-reduction concessions by Juul Labs. In the Neilsen report released May 3, NJoy dropped from 3.2 percent to 3.1 percent, while Fontem Ventures’ blu eCigs was at 2.1 percent, down from 2.3 percent.
Juul overtook Vuse as market leader in 2017. Juul, founded in 2015, captured a 68 percent share of the U.S. vaping market within 3 years while Vuse’s market share had reduced to 10 percent from all-time high of 44.2 percent in 2016, according to a press release from Bluehole New Consumption.
While the Juul and Vuse products differ in many ways, one major difference is that the Juul and Vuse Alto products use diferent coils. Juul products use a traditional cotton coil, while Vuse Alto has adopted a FEELM ceramic coil. In 2018, Vuse entered into partnership with FEELM, the flagship atomization brand for SMOORE and launched Vuse Alto later that year. SMOORE has been instrumental in every approved vaping product (Vuse, Logic and Njoy) brand.
Credit: Feelm
In 2021, Vuse announced its status as the No.1 global vaping brand with a full year value share of 33.5 percent in the top five vapor markets (the U.S, Canada, France, Germany and the UK), according to Bluehole. The five markets represent approximately 75 percent of total industry vapor revenue for closed-system products.
Time is running out for companies that want to keep their synthetic nicotine products on the market. Manufacturers of non-tobacco nicotine (NTN) products on the market as of April 14, 2022 that wish to continue to market their products are required to submit a premarket tobacco product application (PMTA) to the U.S. Food and Drug Administration by May 14, 2022.
The May 14 deadline is only for applicants submitting electronically, as required by the FDA. Applicants can, however, request a waiver from the FDA to submit a PMTA in a different format. An application submitted in hard copy must be received by FDA no later than 4:00 p.m. EDT on Friday, May 13.
The FDA received from the U.S. District Court of Maryland a 14-day extension to file the first premarket tobacco product application (PMTA) status reports required by the Court’s revised remedial order on April 29.
“The extension request is supported by good cause. Compiling the information needed for the status report has required considerable time and effort, and Defendants have been working with Plaintiffs to resolve any ambiguities about which applications will be covered in the status report,” the motion states.
The new law additionally provides that an NTN product with a tobacco-derived “previous version” that received a negative action on a PMTA from the FDA, such as a refuse to file or marketing denied order, may not continue to be marketed after May 14, 2022, without receiving a marketing granted order from FDA.
Such products must be removed from the market, even if a new PMTA is submitted, until the marketing granted order is received, according to the agency. Products on the market after July 13, 2022 without an FDA marketing granted order are in violation of section 910 of the FD&C Act and may be subject to FDA enforcement.
For products not on the market on April 14, 2022, a PMTA must be submitted to FDA and marketing authorization received before the product can be sold in the United States.
All nontobacco nicotine is now subject to the same regulations as tobacco-sourced nicotine in the U.S.
By Timothy S. Donahue
It was both expected and unexpected. Everyone in the vaping industry knew that at some point the U.S. Congress and the Food and Drug Administration were going to decide on how to handle synthetic and nontobacco nicotine. It was generally believed that regulation would appear in an appropriations bill in September, meaning vaping advocates thought they had time to fundraise and prepare for a battle.
They did not. Instead, the language for changing the definition of the Tobacco Control Act (TCA) to include all nicotine products was buried on page 1,861 of the 2,741-page omnibus spending bill that was signed by President Joe Biden in March. How the rider found its way into the omnibus has caught the ire of many in the industry who say major tobacco companies are seizing the vaping industry away from the small business owners who got it started.
Senator Richard Burr was allegedly approached by R.J. Reynolds and Juul Labs representatives about getting the synthetic nicotine rider in the omnibus that at the time was winding its way through Congress. Burr joined forces with fellow senators Dick Durbin and Patty Murray and Representative Frank Pallone to get the nontobacco nicotine language into the omnibus, according to two Senate sources familiar with the discussions, as reported by Bloomberg Law.
Azim Chowdhury
Azim Chowdhury, a partner with the law firm Keller and Heckman, said he interprets the rule to mean that all synthetic products already on the market or newly marketed within 30 days after the enactment date can continue to be marketed during the 60-day period following the enactment date. The law became effective on April 14, and manufacturers will have until May 14, 2022, to either submit a premarket tobacco product application (PMTA) to the FDA for each vaping product that contains synthetic nicotine or pull their products from the market.
Manufacturers that submit PMTAs to the agency by the May 14 deadline can continue marketing their products until July 13, 2022. Beyond that date, all products must be removed from retail stores unless the FDA has issued a marketing authorization, according to Chowdhury.
“We do not anticipate FDA authorizing any synthetic nicotine products by the end of the 90-day period, though they may take another Fatal Flaw (the term Fatal Flaw was used by the FDA for PMTA submissions that didn’t have specific studies and were subsequently denied) approach to quickly deny applications,” said Chowdhury. “Significantly, the rider in its current form indicates that a synthetic nicotine version of a product that already went through the PMTA process and is subject to a refuse-to-accept, refuse-to-file, marketing denial order (MDO) or withdrawal of a marketing order would have to come off the market as of the effective date—i.e., after 30 days of the law’s enactment.
“In simpler terms, for products that were previously formulated with tobacco-derived nicotine—and the only change was a switch to synthetic nicotine—and whose PMTAs have already been refused or denied, those products will effectively be banned on the effective date—30 days after enactment—with no opportunity to submit a new PMTA. This is Congress’ way of punishing companies whose PMTAs were denied and then, in their view, sought to circumvent the law by switching to synthetic nicotine.”
MIchelle Minton / Credit: Competitive Enterprise Institute
Michelle Minton, writing for the Competitive Enterprise Institute, states that given the FDA’s sluggish track record, many of the applications may not even be reviewed, let alone approved, in that time, which would make the bill a de facto prohibition on those products. “FDA has made it painfully clear that there is no way for those companies to earn its approval,” Minton said. “All it will do is guarantee that companies and consumers are pushed in ever-greater numbers toward a growing illicit market where there are no consumer protections and no age restrictions—or back to smoking.”
Stately response
Beyond the PMTA conditions, if a marketing order is granted, manufacturers of synthetic nicotine products are also subject to all the regulations for tobacco products. Keller and Heckman interpret this to include all additional TCA requirements, including tobacco product establishment registration and product listing; ingredient listing; ensuring that labeling is compliant, including required warning statements; and health document submissions, among others.
Many states had already started to ban synthetic nicotine unless a product gets marketing approval from the FDA. Legislation has been introduced in four state capitals and enacted in one state, Alabama, that effectively bans all products containing synthetic nicotine. Patrick Gleason, vice president of state affairs at Americans for Tax Reform, said Alabama, then Mississippi, Maryland and Georgia, were the first states to introduce legislation effectively banning synthetic nicotine products. However, he says there will be no need for more state legislation to ban synthetic nicotine now that the federal government has added it to the TCA.
Yaël Ossowski
Yael Ossowski, deputy director of the Consumer Choice Center, said that making companies ask permission to sell harm reduction products in the 21st century is “asinine.” Using “sleight of hand” during an emergency government funding bill to “castigate millions of vapers and the entrepreneurs who make and sell the products they rely on,” he noted, is the definition of active harm.
“Only the largest and most powerful vaping and tobacco companies can afford the lawyers and the time necessary to complete the paperwork necessary to pass the FDA’s process, meaning thousands of hardworking American business owners will now be forced to close, depriving millions of adult consumers of harm-reducing options. Many will be forced back to cigarettes,” said Ossowski. “Synthetic nicotine is an innovative method of providing nicotine independent of tobacco, and millions of American adults now use these products as a less harmful method of consuming nicotine. A backdoor bureaucratic power move like this represents a sledgehammer to the men and women of our country who have sought out vaping devices to kick their cigarette habit.”
There is no sell-through period for retailers of synthetic nicotine products if the manufacturer does not file a PMTA with the FDA by May 14. While some manufacturers plan to end sales of their synthetic products by the deadline, as Ossowski suggests, others plan on submitting robust and timely applications. Patrick Mulcahy, CEO and co-founder of Streamline Group, parent to the Streamline Vape Co., wrote in an email that his company has been working toward a solution to navigate the regulatory landscape for newly deemed synthetic nicotine products.
“We have recently contracted with Accorto Regulatory Solutions to manage, submit and deliver a complete set of premarket tobacco [product] applications. To date, their track record of applications submitted have received zero MDOs. Their commitment to submitting a complete and robust PMTA is the level of service Streamline aims to provide the market with our current and future line of products,” he said.
“Streamline’s goal during this process is a commitment to provide full transparency, informational updates and other news related to these regulatory requirements as we progress through the various phases of the PMTA,” Mulcahy stated, adding that market confidence is a top priority for Streamline Group, which was submitting PMTAs for its Juice Head brand e-liquids, disposables and nicotine pouches along with its NIIN brand e-liquid and pouches.
Organized approach
April Meyers, SFATA
April Meyers, owner of Connecticut-based Northeast Vapor Supplies and CEO of the Smoke-Free Alternatives Trade Association (SFATA), told Vapor Voice that her organization believed the industry would have more time to hold discussions with legislators on the Clarifying Authority Over Nicotine Act of 2021 (HR 6286) introduced by Representative Mikie Sherrill in December of last year. SFATA members were aware of the mounting pressure on the subject of synthetic nicotine and had been developing strategies to counter the pressure.
Given the inclusion of vapor in the Prevent All Cigarette Trafficking (PACT) Act in the 2021 omnibus, the nonprofit vapor industry advocacy group was not completely surprised to learn that HR 6286’s language had been included in the 2022 omnibus bill, according to Meyers.
“We went immediately to work educating our members on the issue, executing a call to action and making a volley of calls to sources at the Capitol, including our contacts at the freedom caucus,” said Meyers. “Those sources confirmed that a handful of large vapor companies and several Big Tobacco companies were in support of the measure. We were also informed that the House and Senate votes would move quickly and that there was little opportunity to get the provision removed. This was discouraging, to say the least, but did not dissuade us from acting. This industry has learned to mobilize quickly and has achieved several victories under similar circumstances.”
Meyers said that while the sponsors of the synthetic nicotine rider claimed the intent was to close a loophole on synthetic nicotine-derived products from large companies now popular among youth, the rule, and others like it, are very unlikely to have that intended effect. Instead, she said, consumers using these products as a harm reduction option will suffer alongside all the small businesses that have always operated in full compliance with federal, state and local laws.
“The FDA created a problem by overregulating a product used by millions of adults who find vaping a safer alternative to smoking. When a market in high demand is overregulated, gray and black markets emerge where there are no regulations requiring safe products or ID checks. The vapor industry is incredibly resourceful,” Meyers said. “SFATA believes our government should have learned its lesson from the 1920s that prohibitionist policies never work. In this country, and particularly, this industry, where there is a will, there is a way. Despite the attempt to bring the vapor industry to heel, adults have been vaping flavored products in the U.S. for [nearly 15 years]. It is delusional to think that will be snuffed out with the signing of a law. Our fear is that this will pave the way to a growing illicit trade market while simultaneously increasing smoking rates across the country as studies have already demonstrated in localities with flavor bans.”
Tony Abboud, VTA
Tony Abboud, president of the Vapor Technology Association (VTA), said that everyone who understands anything about PMTAs knows that an application cannot be filed within the 90-day time frame, particularly because the FDA requires at least six months of scientific data for such an application. He said the new rule could become a de facto ban on synthetic nicotine that would have some unintended consequences.
The VTA hired economic research firm John Dunham & Associates to evaluate the negative economic impacts that a synthetic nicotine ban would have in the U.S., according to Abboud. The results included 16,100 lost jobs, over $800 million in lost wages and $2.5 billion in lost economic output. It would also cost the U.S. more than $500 million in yearly taxes.
Amanda Wheeler
Amanda Wheeler, owner of Jvapes and president of American Vapor Manufacturers, said during the 103rd annual meeting of Vapor Voice’s parent company, TMA, that she hopes the FDA offers “some kind of enforcement discretion” to small businesses, especially those manufacturers that are trying to follow the rules.
“I can only plead with the FDA at this point not to repeat the mistakes of 2020 and 2021, finding an arbitrary reason to toss all of those applications out on their ear. The consequences this time are even more dire,” said Wheeler. “We have this serious handicap on our hands as far as the time frame … I think we need to treat businesses equitably and recognize that there is only so much that people can do in 60 days. And enforcement discretion would be the thing that’s most helpful to prevent companies from having to look for an alternative solution.”
A bill banning flavored e-cigarettes and other tobacco products failed to make it past key Democratic state senators Tuesday.
Members of the Senate appropriations committee voted down the bipartisan proposal, HB22-1064, on a 5-2 vote, according to Colorado Public Radio. Three Republicans were joined by Democratic state Sens. Robert Rodriguez and Rachel Zenzinger in voting no.
The bill had been heavily lobbied and one of the session’s most high-profile and closely watched bills. But Gov. Jared Polis said he opposed it and said the issue should be handled at the local level.
Rep. Kyle Mullica, a Democrat from Northglenn, said he hoped the measure would help prevent young people from getting hooked on flavored vaping products.
“We’ve already seen a whole generation become addicted and (the bill) was going to do something about that and was going to make sure that we took a stand here in Colorado and that we put the health of our kids first,” said Mullica, one of four sponsors. “It’s a little disappointing not seeing it get passed.”
Senate President Steve Fenberg signaled the demise of the bill with reporters earlier in the day. The Senate’s top Democrat said he didn’t think there was time left in the calendar given everything else lawmakers had to finish.
On Monday, the bill was still alive and moving through the Senate. The finance committee advanced it on a 4-1 vote.
Postal regulations and shipping bans create major roadblocks for smokers trying to quit combustibles.
By Maria Verven
As the saying goes: When the going gets tough, the tough get going.
Thanks to the Preventing Online Sales of E-Cigarettes to Children Act that passed last year, retailers have had to hustle to deliver vapor products to their customers.
All the major shipping vendors, from the U.S. Postal Service (USPS) to the leading nongovernmental carriers—UPS, FedEx, DHL—have stopped shipping vaping products containing nicotine or cannabis to avoid violating the 2007 Prevent All Cigarette Trafficking (PACT) Act.
Although some alternative logistic solutions have emerged and the USPS has made some exceptions for business-to-business shipments, delivering vapor products to consumers remains a huge challenge—especially for customers who live outside of major metropolitan areas.
Some smaller retailers simply called it quits.
“We stopped shipping when the USPS ban went into effect,” said Char Owen, CEO of Cloud 9 Vapor Shop. Cloud 9’s two shops in Seguin, Texas, and Kenedy, Texas, are 40 miles and 60 miles, respectively, from San Antonio. She said the software to track shipments was too expensive, adding that some quotes were as high as $100,000. Even quotes that were closer to $20,000 put this option out of reach.
“And if we didn’t use software, we would have to hire a person to keep up with it, and that wasn’t within our reach either,” she said. “We are two small stores, and we’re not big shippers, but our stores are in areas where customers might have to travel over an hour to get to us. With current gas prices, it would absolutely be cheaper to ship; however, we can’t afford that option anymore.”
While Owen said her stores haven’t taken a big hit, the PACT Act had a huge impact on the customers they used to send shipments to. “It’s the remote vaper that got hurt in this case,” she said.
Exceptions to the rule
Credit: Hakinmhan
It’s rare, but business and regulatory exemptions to the PACT Act have been made.
Pure Labs, parent company for Halo vaping products, sought and obtained approval by the USPS to ship e-liquid and other vaping products to other compliant businesses. The approval allows Syndicate Global Distribution and Halo Wholesale Direct to ship Halo electronic nicotine-delivery system (ENDS) products directly to their brick-and-mortar retail customers—a huge win for Halo.
“Halo’s tobacco and menthol vape products are in demand by adult consumers throughout the country, and we are excited to have USPS solidify the supply chain,” said Kevin Dietz, director of Halo brand sales, adding that several of Halo’s ENDS products are in the final stages of the U.S. Food and Drug Administration’s premarket tobacco product authorization process.
Unique challenges
Filling the shipping void are companies such as X Delivery, which promises to satisfy all PACT Act requirements, including verifying the purchaser’s age and obtaining a signature from an adult aged 21-plus upon delivery. Other restrictions—such as the maximum weight requirement (no more than 10 pounds), requisite stickers indicating that the package contains a “tobacco” product and a notice that the recipient is required to pay taxes on the purchase—must be met.
“All shipping has unique challenges. The fact that the national carriers opted out of shipping vape products shows us that they’re only interested in the drop-and-run delivery model,” said Paul Vinuelas, chief logistics officer for X Delivery. “We are dedicated to ensuring compliance and protecting youth from obtaining these products. While it may take a bit more effort to perform our deliveries and audit them for PACT Act compliance, we think it’s worth it.”
While they only began shipping vapor products in late 2020, X Delivery worked closely with vape companies to build a fully compliant service. An application programming interface helps streamline the shipping process and sync data in real-time across various platforms. They’ve also connected empty warehouses, local delivery services and other supply chain assets to their sophisticated system in an effort to speed and simplify the flow of information.
When Vinuelas spoke to Vapor Voice (“Stand and Deliver,” Issue 2, 2021) last May, he said X Delivery could ship products to consumers in about 90 percent of the U.S. He was cautiously optimistic that the company could eventually increase coverage to include the entire country.
“Our long-term goal is to be the No. 1 shipping carrier for D2C e-commerce brands,” Vinuelas said. “We understand the relevant laws in detail and are determined to be a good partner to vape and e-cigarette merchants.”
A misguided law
Credit: blr60
Shipping vapor products with X Delivery comes at a cost, which is why smaller retailers, such as Cloud 9, decided to restrict sales to its brick-and-mortar locations. Other retailers, including Five Pawns, had to reengineer the way they handle all shipping.
“The problems started as soon as the PACT Act was enacted,” said Jay Oku, head of business development for Five Pawns. Oku said Five Pawns reengineered their shipping logistics to comply with the “misguided law introduced by our out-of-touch 88-year-old California career politician, Diane Feinstein.
“When we were prohibited from shipping via USPS, UPS and FedEx, we were forced to use a third-party logistics service,” Oku said. But even with this service, he said that delivery to all areas—even areas in Five Pawns’ own California backyard—remain problematic.
“The fact that each shipment requires a signature from an adult on the premises has caused frustration with many customers. Our customers are forced to make arrangements to have someone of age at home midday for several days so [that] they don’t miss their shipments,” he said, adding that some shipments are taking 15 days or more.
“These companies don’t have effective tracking data, so customers have no idea when their order will arrive,” Oku explained. “Many [customers] reported shipments being delivered in an unmarked van as late as 9:30 p.m. We have elderly customers completely inconvenienced, frightened of strangers coming to their door at night and ultimately fearful they may no longer be able to get their e-liquid.”
Regardless of the workaround shipping solutions devised by vape companies, challenges will continue to mount as anti-vaping legislation continues to be popular with misinformed politicians.
“While we understand and agree with the need for reasonable and responsible regulation, our concern is that these overarching regulations and restrictions will push vapers back to deadly combustible tobacco products,” said Maggie Gowen,vice president of retail marketing and communications for AMV Holdings. AMV Holdings is the largest operator of specialty brick-and-mortar vape stores in the U.S., with over 120 retail locations, as well as the parent company for numerous major e-liquid brands, including Alohma, Kure, MadVapes and MAXX.
“We have a lot of customers in rural areas and other areas with shipping restrictions who are very upset that they can’t purchase their vapor products like before,” Gowen said. “Excessive shipping costs due to the PACT Act requirements just added to their frustration. At what point will these vapers simply give up and revert back to combustible tobacco because they cannot access vapor products? That is our biggest fear.”
AMV Holdings conducted a large behavioral study and found that nearly 90 percent of its customers were former smokers with an average age of 37 years; roughly half had been smoking for 10 years or longer before they started vaping. A third of them had tried traditional nicotine-replacement therapies to quit, and over half had tried to quit cold turkey.
“Our data tells the story of a group of adults—not minors—desperate to quit smoking, who ultimately found vaping and were able to successfully kick the cigarette habit using ENDS products,” Gowen said.
Vapers are the victims
Credit: Nasibli
Public health and the smokers trying to quit ultimately carry the burden of limited shipping options and all-out bans for mailing vapor products. “What we’ve seen unfold over the last year cannot accurately be characterized as ‘unintended consequences,’” said Gregory Conley, president of the American Vaping Association, a nonprofit advocacy group.
“No member of Congress who pushed for this law took the time to understand its implications for small businesses. From conversations on the Hill, it was painfully clear that the sponsors were ready and willing to see the industry and its adult consumers take some pain.
“In the era of TikTok and Snapchat, and despite dealers who don’t hold business licenses or collect excise taxes, very few teenagers have been stopped from accessing vaping products by this law,” Conley said. “Like with most anti-vaping policies, the primary victims are adult smokers and ex-smokers just trying to live in peace.”
The story isn’t over, however. Business owners are searching for solutions. “For years, we have had to fight tooth and nail for the rights of our consumers,” said Schell Hammel, president of The Vapor Bar, a Dallas area retail store chain, and director of Chapter Relations for the Smoke-Free Alternatives Trade Association. “This stand by the shipping companies is just one other way to make it harder to get these products to those who need them to stay successful.
“We will always find a way,” Hammel continued. “We are a resourceful bunch, and no matter what, we will continue to fight for our consumers’ rights and those who are able to keep their doors open to serve them.”
The original “Vaping Vamp,” Maria Verven owns Verve Communications, a PR and marketing firm specializing in the vapor industry.
Romania is more progressive when it comes to vaping than many of its neighbors.
By Norm Bour
Romania, a country of just under 20 million people, is considered progressive when it comes to vaping. As a member of the European Union, it follows the Tobacco Products Directive, which has been in force for almost a decade now.
Romanian law prohibits the use of e-cigarettes on public transport and e-cigarette sponsorship and restricts much of the advertising of vaping products. A text-only health warning is required to cover 30 percent of the product package, according to tobaccocontrollaws.org.
The country has a high percentage of smokers, estimated to be about one-quarter of the population, which is dropping. Whether those former smokers have quit nicotine entirely or moved to vaping is hard to determine. As in many places, vaping is embraced primarily by the mid-20s to mid-30s age groups, with about 3 percent of the population being vapers.
Remarkably, at a time when the popularity of vaping is increasing throughout Europe, only 1.5 percent of Romanians under the age of 24 vape. Overall, it appears that about 2 percent of the Romanian population has taken up the habit. This creates many new opportunities for budding entrepreneurs.
With a growing number of shops in the capital city of Bucharest, I visited two of them to get a better feel for their perspectives. I also wanted to know if the shops were getting business from Turkey, just a few hundred miles away, where vape shops are illegal.
Florin Mincu is an early innovator in the vapor business. He opened Vaper’s Paradise in 2010.
“My taxi driver from the airport was smoking, and I saw him put what I thought was a lit cigarette in his shirt pocket. “‘Whoa,’ I said, ‘what did you just do?’ He explained that it was an e-cigarette, and he bought it from a black market guy selling them out of his trunk,” said Mincu. “I knew this was important, so within two hours, I had the taxi driver take me to meet this person. Remember, these were the days before true vape shops. I used the products he was selling and quit smoking in two months, and that is when I opened my first shop.”
When I hear stories like this, I wonder if I would have been so impulsive, but Mincu did not hesitate. Now, a dozen years later, he has two shops. In his main shop, with only 20 square meters (215 square feet) of space, he earns upward of $50,000 in revenue. In the Romanian context, this is a hugely successful shop.
We spoke about the government’s attitude and support of vaping, and he said they are “about 50 percent in,” which means they don’t support it, but they don’t outlaw it either. Fortunately, the country is pro-tobacco, so when he opened his shop, authorities assumed it was just another tobacco business.
After talking with Mincu, I spoke with another shop owner who requested anonymity, but both shops said the average age of their customers is about 30. As in many countries, no one under 18 is permitted inside the vape shop.
Vaper’s Paradise carries single-use and disposable kits, but the store is still pretty “old school,” with big mods and the heavy vapor products featuring prominently in its collection. Because of that, Vaper’s Paradise carries an impressive assortment of liquids, including American-made Five Pawns and Got Vape. Mincu prefers the U.K. brands, especially Nasty Juice, since it offers better pricing, great flavors and enjoys great popularity among his customers.
He also favors Nasty Juice because it burns cleanly and the cotton lasts much longer, and he’s a fan of U.K.-made Kilo but says this product is tougher to get now.
“About half our customers are getting into the disposables, but I have a large YouTube following, and they know I have a sophisticated taste for liquids, so they follow my advice,” he claimed. “Quality and flavors are what keep our customers happy, but even more important, any RDA [rebuildable dripping atomizer] hardware must be easy to use.”
Mincu does a lot of RDA builds and is always trying to improve the quality of the products. By trial and error, he developed his own technique, which he teaches to others. The coil has a very specific sound—and quality—when he gets it right.
They call it “polita,” which may not be a real word, but the sound it makes is very real.
He also said that many reviewers go into too much detail when evaluating hardware. “It’s not required to spend an hour on an atomizer,” he griped. “They are not that complicated! I try to keep my reviews short and tight and keep reader’s already short attention spans.”
Both shop owners agree that the Romanian vapor market is driven by flavors—a universal reality that makes the Food and Drug Administration policy so restrictive for their colleagues in the United States. When asked about the future potential for vaping in Romania, both entrepreneurs I spoke with were bullish and said they planned to open new shops in 2023.
Mincu has a big vision and is planning a shop about five times larger than his current outfit. He also has a robust online presence, and when asked about that bleed-over business from Turkey, where there are no legal shops, he said, “Absolutely. You cannot keep products out of people’s hands today. If someone wants something, they will find a way to get it, and we should know by now that telling someone that a product is illegal will only make them want it more.”
Mincu gets a lot of airline employees and pilots from different countries that are more restrictive about vaping products. And although Romania has vaping industry trade groups, Mincu has not joined any of them because “they don’t want to change, and they avoid new technology”—a common complaint shared by vapor industry representatives in many countries.
Mincu and I finished up our conversation by speaking about hemp, CBD and cannabis. Hemp and CBD still operate in a regulatory gray area in Romania, and even though Mincu has received offers to sell those products, he does not. It’s not worth the risk, he says, since CBD cannot contain THC, which remains illegal in Romania. However, Mincu expects this to change in the next few years.
Norm Bour is the founder of VapeMentors and works with vape businesses worldwide. He can be reached at norm@VapeMentors.com.
Innovations in technology and regulation could help ease the concerns surrounding youth access to vaping products.
By Timothy S. Donahue
Most tobacco control experts agree that vaping is safer than smoking combustible cigarettes. The primary concern for anti-vaping groups, legislators and regulatory officials isn’t where e-cigarettes fall on the continuum of risk, it’s about preventing youth access to nicotine products. The best way to prevent youth access is through innovation, according to vapor industry experts. Technology and regulatory policies will both be required for the vaping industry to satisfy its skeptics.
Technological innovations have been the vaping industry’s primary contribution to battling youth access. Several companies have developed devices that use biometrics, such as fingerprint and facial recognition. The OBS Cube FP Kit, for example, uses fingerprint recognition to prevent unauthorized use. However, a 2020 review by ecigclick.com found the fingerprinting function complicated to configure. “The instruction manual is total pants … it really is,” the reviewer wrote. “So far I haven’t worked out how to use the fingerprint stuff, there are diagrams in the book which relate to bugger all on the actual device.”
Juul Labs launched its C1 in Canada in 2019. The device paired with an Android smartphone to limit who could use it and to provide monitoring of what and how often the user vaped. Juul says the C1 could only be used if people got through age-verification and facial-recognition checks. The C1 also had a system that could be set to automatically lock when it was not being used or away from the phone to which it was linked.
Credit: Juul Labs
Juul Labs then launched the JUUL2, which had many of the same child safety features as the now discontinued C1. The JUUL2 also can recognize and authenticate proprietary JUUL2 pods when they’re attached, limiting the ability to use counterfeit pods or refill pods with other substances, such as THC.
Steven Yang, senior director of FEELM R&D, says that FEELM has incorporated designs into its products that prevent misuse by children, for example, by requiring the user to follow a specific sequence of procedures to activate the device.
“With a number of industry’s leading patents, FEELM is exploring ways to integrate Bluetooth, fingerprint, airflow switch, sensor and other electronic technologies to create a child lock on products,” he says, adding that many Chinese vaping industry leaders have already adopted ID verification and facial recognition technologies.
“FEELM’s strategic partner and China’s leading vape brand, RELX, has initiated Sunflower Systemin 2019. Based on AI and big data, the Sunflower System is integrated into different scenarios, such as RELX chain stores and the RELX app to prevent minors from purchasing vaping products,” explains Yang. “The Sunflower System has been extended to all RELX chain stores in China, to ensure each purchase order is traceable. Moreover, through big data and GPS, the Sunflower Systemcan automatically filter the addresses that do not meet the legal requirements of opening a vape store—for example, near schools.”
Project Sunflower consists of adopting ID and facial recognition technologies to ensure that only adults can purchase products in its China stores, according to RELX. Minors are not allowed to enter RELX stores, and in-store face-scanning cameras send alerts to RELX store staff if a suspected minor enters the store. Any suspected minor that is not able to present legal, valid ID proving his or her age is asked to leave the RELX store.
Upon purchasing a product, RELX customers also need to verify their age through a facial recognition process that matches the customer’s face with the photo on the customer’s Resident Identity Card,” says a RELX representative. “This process is to ensure that the person in the store is using their own valid identification and not attempting to impersonate an adult.”
While facial-recognition measures are widely used and accepted in China, they may encounter resistance elsewhere. Chris Howard, vice president, general counsel and chief compliance officer for E-Alternative Solutions, a U.S. based e-cigarette manufacturer, says that consumers have generally accepted biometric controls in phones, tablets and other devices that use fingerprints or faces to unlock the screens.
Those who are tech savvy would likely welcome such an alternative in their vaping products, he says. However, traditional cigarettes don’t have any electronic controls to prevent unlawful use, so if vaping regulations follow tobacco rules that would limit these types of innovations.
“The idea that such a requirement would be necessary for vapor products to receive marketing orders seems unlikely. It is important to remember that adult smokers may be unwilling to deal with an electronically locked tobacco product,” says Howard. “While some may enjoy the novelty, many may just use a tobacco product—likely higher risk—that is easier to use. Many questions surround the use of biometrics in products. There are legal privacy issues which would increase the cost of such devices.”
Manufacturers must also remain aware of regulatory restrictions in the markets they operate, according to Yang. FEELM has developed protocols to help retailers and distributors keep in compliance with local guidelines. Yang says the company attaches clear warning labels on its closed-system vaping devices and includes language in user manuals stating that the products are intended for use only by adults.
“We also focus to ensure that the retail stores in which our products are sold have mechanisms in place to verify the age of the consumers purchasing products manufactured by us so as to comply with local laws and regulations in relation to age restriction,” Yang says. “Moreover, our website and our major customers’ web stores require visitors to enter their age before entering the websites.”
Regulatory response
Taxation has long been the preferred deterrent to youth access by regulators. Studies suggest, however, that increasing taxes don’t always have the desired impact. Instead, these measures discourage combustible smokers from switching to a safer alternative, according to a study by Steve Pociask and Liam Sigaud for the American Consumer Institute, Center for Citizen Research. The researchers state, “overzealous or poorly designed restrictions [like tax increases] on vaping, combined with misleading information about e-cigarettes’ actual health risks, are deterring smokers from pursuing a potentially life-saving alternative.”
Tim Andrews, director of Consumer Issues for Americans for Tax Reform, says the evidence is clear that increasing taxes on reduced risk tobacco alternatives will do nothing to reduce youth access, but will punish adult vaping consumers, leading many back to deadly combustible cigarettes. He says one example is when the state of Minnesota imposed a tax on vaping products. It was determined that it prevented 32,400 additional adult smokers from quitting smoking, according to Andrews.
“Paradoxically, by creating a booming black market, which, by definition, possesses none of the rigorous age verification processes required by legal retailers, vapor taxes may increase not decrease youth access. This is similar to how evidence shows in states where cannabis is illegal, it is easier for high school students to purchase cannabis than beer. Increasing taxes on vaping will create a boon for smugglers—and will hurt everyone else,” he says. “Youth vaping has plummeted in recent years due to increased enforcement of existing law (according to the U.S. Centers for Disease Control and Prevention, only 3.1 percent of high school students vape daily). Adequate and appropriate enforcement of existing law—not increasing taxes—is what will continue to drive this number down.”
The recent Population Assessment of Tobacco and Health (PATH) study suggest Tobacco 21 laws are having the intended effect. Howard suggests that while limiting the minimum age of sale is seemingly effective, “it remains an open question as to whether any additional innovation is required, as additional time may show that youth access has been sufficiently curbed.”
Other innovative regulatory responses to youth vaping have had mixed results. Outside taxation and Tobacco 21 laws, any effectiveness seems hard to prove. Research suggests that there are few studies available that show what impact differing regulatory actions have on youth vaping. A study published in BMC Public Health, Policies that limit youth access and exposure to tobacco: a scientific neglect of the first stages of the policy process, examined 200 international peer-reviewed articles. The researchers found that scientific evidence on the policy process for youth-prevention initiatives were scarce.
“The processes influencing the adoption of youth access and exposure policies have been grossly understudied. A better understanding of the policy process is essential to understand country variations in tobacco control policy,” the researchers wrote. They then went on to suggest that “policymakers can adopt and implement various supply-side policies to limit youth access and exposure to tobacco, such as increasing the minimum age of sale, limiting the number or type of tobacco outlets, or banning the display of tobacco products.”
Credit: Balakley PB
Howard questions whether regulations limiting the number of tobacco outlets/vape shops or display bans would materially impact youth access. “Which companies should lose their business licenses? Should only major chains, with arguably more control over storefronts, be permitted to sell tobacco products?” Howard asks. “How will removal of businesses prevent youth from obtaining tobacco products? Yes, there will be less stores to find products, but that doesn’t mean youth vaping will decline. During the ‘youth vaping epidemic,’ Walmart, arguably the largest retail footprint in the U.S., removed vapor products from its stores—is there evidence of reduced youth vaping as a result? Finally, banning tobacco product displays may impact youth exposure to products, but would also reduce adult smokers’ exposure to different, potentially less harmful, products.”
Incentivizing success
There may be more innovative options to consider in controlling youth access. Another potential avenue to curb youth access may be to require manufacturers to offer incentives to retailers to maintain good practices. B2B sales discounts or incentives for meeting certain standards is likely to go a long way toward limiting youth access, according to Howard.
“Manufacturers can incentivize limiting the number of products in a transaction to prevent straw sales, passing compliance checks, tobacco sales training and participating in the We Card program to encourage retailers to ‘up their game’ in preventing youth access,” he says.
States are slowly becoming more innovative in their regulatory approach to youth vaping. Hawaii, for example, is considering the passage of a law that would require its Department of Health (DOH) to coordinate with its Department of Education (DOE) to establish a “take back” program for students to “voluntarily dispose of electronic smoking devices, flavored tobacco or synthetic nicotine products, and tobacco products in their possession.” If passed, the rules would also require DOH and DOE to coordinate quarterly meetings with students on addressing the youth vaping epidemic.
Many industry experts agree that the vaping industry, tobacco control community and regulators should be working together to solve the problem of youth uptake. However, that seems unlikely. It could be argued that the world’s most prominent regulator, the FDA’s Center for Tobacco Products (CTP), should be bringing stakeholders together to seek out common solutions to these problems. That hasn’t happened, according to Howard.
“It appears CTP felt compelled to use a club, as opposed to a scalpel, to excise youth vapor use. Banning flavored pods and blanket denials of millions of [premarket tobacco product applications] PMTAs for flavored products through sweeping [market denial orders] MDOs removed most industry stakeholders in just about a month,” says Howard. “While much of this was thrust upon CTP by outside forces, it is hard to imagine, when they can completely control the issue, why would CTP now resort to compromise solutions?
“CTP and the tobacco control lobby both detest those bad actors that market their products without regard to this important issue. Companies that actively follow the rules detest these bad actors, too. CTP, tobacco control and the ethical side of the industry should join forces to root these bad actors out.”
Hong Kong’s chief executive, Carrie Lam Cheng Yuet-ngor’s term may mostly be remembered for her role in the ban on the import and sale of e-cigarettes and other alternatives that has just become law. The ban, first proposed seven years ago, was watered down in 2018 to the permissive regulation that applies to tobacco products.
Opposition to the backdown from medical and education authorities prompted Lam to switch to proposing the full ban in her policy address that year, according to a story in the South China Morning Post. It took lawmakers until last October to pass legislation without exemptions and concessions of one kind or another. Evidence of the effect on consumption of e-cigarettes and the like is that the law has forced some shops selling these products to close.
The most persuasive argument against outlawing the “new tobacco products” was that they were a not so harmful alternative that helped nicotine addicts quit smoking tobacco and perhaps stop altogether. But health minister Sophia Chan Siu-chee said many surveys that supported it were sponsored by tobacco companies.
Essentially the argument hinges on the lack of knowledge of the long-term effects of e-cigarettes and other alternatives, especially on those who begin smoking at a young age. The smoking rate in Hong Kong has fallen to about 10 percent of people aged 15 and above. Ultimately, the prospect of a non-smoking society seems dependent on youth breaking the generational cycle of addiction by not taking up the habit in the first place.
Lam announced in April that she would not seek reelection. Her successor is expected to be picked in May. Hong Kong media have reported this week that Chief Secretary John Lee, the city’s No. 2 leader, is likely to enter the race to succeed Lam.
Shenzhen-based Aspire Global has applied to U.S. regulators to withdraw its New York Stock Exchange (NYSE) listing application. The move comes as Beijing clamps down on the growth of vaping companies, mandating pre-approval for IPOs and restricting foreign investment.
The company filed a withdrawal request to the Securities and Exchange Commission on Monday, without providing a reason for the decision in its filing, according to the South China Morning Post. It had originally planned to sell 15 million shares at $7 to $9 each, and had applied to trade on the Nasdaq exchange under the ticker “ASPG.”
Aspire kicked off its Nasdaq listing application last June, and updated its draft prospectus in January this year. The company was expected to raise $135 million. Its withdrawal comes as recent rules introduced in China make expansion and distribution more challenging for e-cigarette manufacturers.
Other rules introduced last month include a ban on foreign investors in a sector that once attracted venture capital giants such as Sequoia Capital and IDG. Manufacturers and retailers must also get a license before they can produce and market their products. The government banned online advertising in late 2019, and sales in shops are restricted.
Over half of Aspire Global’s sales in 2021 were generated from Europe, with China and the U.S. accounting for 18.5 percent and 10 percent respectively, according to the company’s draft prospectus. In the U.S., Aspire has been marketing its cannabis vaping product, Ispire, since late 2020. “Our strategy is … directed at increasing our e-cigarette vaporizer technology products and developing our cannabis vaporizer technology products,” the company stated in its draft prospectus.
The two weeks ended April 9, 2022, was the first time Vuse surpassed Juul to become the No.1 e-cigarette brand in the U.S., according to Nielsen. The company had a market share of 35 percent, driven by the Vuse Alto, which represents more than 90 percent of Vuse’s 2021 revenues in the U.S. Vuse has been 
Shenzhen-based Aspire Global has applied to U.S. regulators to withdraw its New York Stock Exchange (NYSE)