Brian King will replace Mitch Zeller as head of the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP). He will take over the position on July 3 after spending more than a decade at the Centers for Disease Control.
King was most recently the Deputy Director for Research Translation in the Office on Smoking and Health (OSH) within the National Center for Chronic Disease Prevention and Health Promotion at the Centers for Disease Control and Prevention (CDC).
“After a robust executive search, I have selected Dr. Brian A. King as FDA’s new Center for Tobacco Products Director,” Califf tweeted. “Dr. King brings extensive and impressive expertise in tobacco prevention and control and has broad familiarity with FDA from his more than 10-year tenure at CDC.”
The move comes just days after the FDA submitted a status report for products that currently have a premarket tobacco product application (PMTA) under review. The regulatory agency states that it expects to have resolved 63 percent of the applications set out in its original priority by June 30, 2022, and 72 percent of the applications in its original priority set by the end of this year. However, the agency does not expect to complete its review of timely submitted applications until June, 2023.
During a House subcommittee meeting after the release of the report, Califf said the agency needs more resources to speed up its review of e-cigarettes and is avoiding making hasty decisions that could incite lawsuits from the industry.
“This is an industry that has amazing capabilities on the legal front,” Califf said. “If we make one single error in the process, we can be set back for years in these applications.”
Many vaping industry leaders say they are discouraged by the announcement and that “there is no longer any hope for flavored products other than tobacco.”
Matt Meyers, the controversial leader of Campaign for Tobacco Free Kids and an anti-nicotine advocate, called King a “legend” and an “icon.”
In his role at the CDC, King was responsible for providing scientific leadership and technical expertise to CDC/OSH, the lead federal agency for comprehensive tobacco prevention and control. King joined the CDC in 2010 as an Epidemic Intelligence Service Officer, before which he worked as a Research Affiliate in the Division of Cancer Prevention and Population Sciences at Roswell Park Comprehensive Cancer Center in Buffalo, New York. During his time at Roswell Park, his primary research focus related to tobacco prevention and control.
King has worked for over 15 years to provide sound scientific evidence to inform tobacco control policy and to effectively communicate this information to key stakeholders, including decision makers, the media, and the general public.
He has authored or co-authored over 200 peer-reviewed scientific articles pertaining to tobacco prevention and control, was a contributing author to the 50th Anniversary Surgeon General’s Report on Smoking and Health, was the lead author of CDC’s 2014 update to the evidence-based state guide, “Best Practices for Comprehensive Tobacco Control Programs,” and was the senior associate editor of the 2016 Surgeon General’s Report, “E-cigarette Use Among Youth and Young Adults” and the 2020 Surgeon General’s Report, “Smoking Cessation.”
He was also the Senior Official for CDC’s emergency response to the 2019 outbreak of e-cigarette, or vaping, product use-associated lung injury (EVALI).
King holds a PhD and MPH in Epidemiology from the State University of New York at Buffalo. King will replace Zeller who retired in April. There has not been an official announcement from the FDA.
In a speech on the Senate floor, U.S. Senator Dick Durbin blasted the U.S. Food and Drug Administration for its delays in complete its public health review of e-cigarette premarket tobacco product applications (PMTAs). The deadline for FDA to finish reviewing e-cigarette applications was September 9, 2021, more than eight months ago.
On June 13, the regulatory agency submitted an update on the agency’s review of e-cigarette applications and stated it will not finish reviewing e-cigarettes until July 2023 and products under review may continue being sold.
“These companies have flooded the market with addictive devices. Companies like JUUL, partially owned by the tobacco companies, understand that they’ve promoted their products to children,” Durbin said, according to a release from his office. “For years none of these products were legally authorized. Who was supposed to be the cop on the beat? The Food and Drug Administration, but they were nowhere to be found.”
In March, Durbin led a bipartisan letter with 14 of his colleagues calling on FDA to finish its review of e-cigarettes immediately; reject applications for e-cigarettes, especially kid-friendly flavors, that do not prove they will benefit the public health; and clear the market of all unapproved e-cigarettes.
“I am calling on the FDA to immediately halt its enforcement discretion and remove all unauthorized e-cigarettes from the market,” Durbin stated. “Don’t allow JUUL and other tobacco companies one more day of endangering our children. Stop cowering before Big Tobacco’s highly paid lawyers.”
The U.S. Food and Drug Administration has submitted a status report for products that currently have a premarket tobacco product application (PMTA) under review. The regulatory agency states that it expects to have resolved 63 percent of the applications set out in its original priority by June 30, 2022, and 72 percent of the applications in its original priority set by the end of this year. However, the agency does not expect to complete its review of timely submitted applications until June, 2023.
“The FDA’s progress largely reflects the review priorities that the agency established in 2020, when review began. Given the large influx of concurrent applications, the FDA prioritized review of applications from manufacturers with the greatest market share at the time because decisions on those applications were expected to have the greatest impact on public health,” the report states. “As a result, the FDA allocated significant resources to review applications from the five companies whose brands represented over 95 percent of the e-cigarette market at that time: Fontem (blu), JUUL, Logic, NJOY, and R.J. Reynolds (Vuse).”
During a House subcommittee meeting after the release of the report, the head of the FDA said the agency needs more resources to speed up its review of e-cigarettes and is avoiding making hasty decisions that could incite lawsuits from the industry.
“This is an industry that has amazing capabilities on the legal front,” FDA Commissioner Robert Califf said. “If we make one single error in the process, we can be set back for years in these applications.”
In the order requiring the FDA to submit status reports, the Maryland court stated that covered applications are limited to applications for products that are sold under the brand names JUUL, Vuse, NJOY, Logic, Blu, SMOK, Suorin or Puff Bar. Additionally, any product with a reach of 2 percent or more of total “Retail Dollar Sales” in Nielsen’s Total E-Cig Market & Players or Disposable E-Cig Market & Players’ reports.
To determine which applications are for products sold under the listed brand names, the FDA used its internal PMTA database, which organizes applications by manufacturer, according to the agency. The FDA searched its database for the brand names to identify the manufacturers related to each relevant brand name and then searched its database to identify applications submitted by the manufacturers.
The FDA stated that it had conferred with the plaintiffs in the case who agreed that only one brand beyond those listed meets the 2 percent threshold. That brand was not identified. Of those applications the FDA deems requiring status reports, the agency stated that it had identified 240 covered applications. The agency estimates that its best forecast, based on current information, the FDA will take action on:
51% of covered applications by June 30, 2022;
52% of covered applications by September 30, 2022;
56% of covered applications by December 31, 2022;
56% of covered applications by March 31, 2023; and
100% of covered applications by June 30, 2023.
The agency also states that not every covered application has an equal potential impact on the public health. For example, more than 25 percent of the covered applications are for products not currently on the market.
The FDA identified two applications for products sold under the relevant brand names where the applicant stated that the products were not on the market as of August 8, 2016. The FDA also identified three other applications for products sold under the relevant brand names where the applicant did not state whether the products were on the market as of August 8, 2016. The FDA has not included information about these five applications in the current status report.
“Also, some e-cigarette devices consist of a small number of components, resulting in a small number of individual product applications for the entire system. A disposable prefilled device, for example, could constitute a single product, with one application. Other e- cigarette devices, by contrast, consist of many components, with separate tanks, coils, tubes, and pods, resulting in dozens of separate product applications for a single system,” the status report states. “Of the covered applications that the FDA anticipates will remain to be resolved beyond the end of 2022, more than half are for components of a limited number of e-cigarette device systems representing under 2.5 percent of the e-cigarette market. The FDA has made and will continue to make significant progress in reviewing and resolving applications for e-cigarette products to achieve the greatest impact on public health.”
The agency stated that it will file another status report by July 29, 2022, that will include any revisions to the estimates disclosed in the first report.
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.
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.”
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.
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.”
The U.S. Food and Drug Administration today issued warning letters to five companies for selling products labeled as containing delta-8 tetrahydrocannabinol (THC). The regulatory agency claims that the companies violated the Federal Food, Drug, and Cosmetic (FD&C) Act. It’s the first time the FDA has issued warning letters for products containing delta-8 THC.
“Delta-8 THC has psychoactive and intoxicating effects and may be dangerous to consumers. The FDA has received reports of adverse events experienced by patients who have consumed these products,” the agency stated in a release. “There are no FDA-approved drugs containing delta-8 THC. Any delta-8 THC product claiming to diagnose, cure, mitigate, treat, or prevent diseases is considered an unapproved new drug.”
The states that it has not evaluated whether “these unapproved drug products” are effective for the uses manufacturers claim, what an appropriate dose might be, how they could interact with FDA-approved drugs or other products, or whether they have dangerous side effects or other safety concerns, according to the statement.
“Delta-8 THC is one of over 100 cannabinoids produced in the Cannabis sativa L. plant but is not found naturally in significant amounts. Concentrated amounts of delta-8 THC are typically manufactured from hemp-derived cannabidiol (CBD) and have psychoactive and intoxicating effects,” the release states. “Products containing delta-8-THC are available in varying forms, including but not limited to candy, cookies, breakfast cereal, chocolate, gummies, vape cartridges (carts), dabs, shatter, smokable hemp sprayed with delta-8-THC extract, distillate, tinctures, and infused beverages.”
The warning letters address the illegal marketing of unapproved delta-8 THC products by companies as unapproved treatments for various medical conditions or for other therapeutic uses. The letters also cite violations related to drug misbranding (e.g., the products lack adequate directions for use) and the addition of delta-8 THC in foods, such as gummies, chocolate, caramels, chewing gum and peanut brittle.
“The FDA is very concerned about the growing popularity of delta-8 THC products being sold online and in stores nationwide. These products often include claims that they treat or alleviate the side effects related to a wide variety of diseases or medical disorders, such as cancer, multiple sclerosis, chronic pain, nausea and anxiety,” said FDA Principal Deputy Commissioner Janet Woodcock. “It is extremely troubling that some of the food products are packaged and labeled in ways that may appeal to children. We will continue to safeguard Americans’ health and safety by monitoring the marketplace and taking action when companies illegally sell products that pose a risk to public health.”
The FDA recently published a consumer update expressing concerns about the potential health effects of delta-8 THC products. The FDA has received adverse event reports involving products containing delta-8 THC from consumers, healthcare practitioners and law enforcement, some of which resulted in the need for hospitalization or emergency room treatment, according to the agency.
The FDA states that it is also aware of an increasing number of exposure cases involving products containing delta-8 THC received by national poison control centers and alerts issued by state poison control centers describing safety concerns and adverse events with products containing delta-8 THC.
In addition to the violations related to FDA-regulated products containing delta-8 THC, several of the warning letters outline additional violations of the FD&C Act, including marketing CBD products claiming to treat medical conditions in humans and animals, promoting CBD products as dietary supplements, and adding CBD to human and animal foods.
“CBD and delta-8 THC are unapproved food additives for use in any human or animal food product, as the FDA is not aware of any basis to conclude that the substances are generally recognized as safe (GRAS) or otherwise exempt from food additive requirements,” the release states. “One of the letters expresses concerns regarding CBD products marketed for food-producing animals, and the potential safety concerns related to human food products (e.g., meat, milk, eggs) from animals that consume CBD, as there is a lack of data on safe CBD residue levels.”
The FDA issued warning letters to:
ATLRx Inc.
BioMD Plus LLC
Delta 8 Hemp
Kingdom Harvest LLC
M Six Labs Inc.
The FDA has previously sent warning letters to other companies illegally selling unapproved CBD products that claimed to diagnose, cure, mitigate, treat or prevent various diseases, in violation of the FD&C Act. In some cases, there were further violations because CBD was added to food products. The FDA has not approved any CBD products other than one prescription human drug product to treat rare, severe forms of epilepsy, according to the agency.
The FDA has requested written responses from the companies within 15 working days stating how they will address these violations and prevent their recurrence. Failure to promptly address the violations may result in legal action, including product seizure and/or injunction.
The Vapor Technology Association (VTA) has again met with the U.S. Food & Drug Administration’s Center for Tobacco Products (CTP) to help clarify any questions the regulatory agency may have surrounding synthetic nicotine.
VTA representatives met with dozens of CTP regulators from seven different offices inside CTP to confront any concerns about premarket tobacco product applications (PMTAs) for synthetic products that are due on May 14, according to a VTA email.
Credit: Opolja
During the meeting, several speakers joined the VTA in shedding light on how synthetic nicotine is manufactured, its purity, and its similarities and differences compared to tobacco-derived nicotine. Dr. Bill Jackson, PhD (Organic Chemistry), Dr. David Johnson, PhD (Physical Analytical Chemistry), Dr. Ray McCague, PhD (Organic Chemistry), and Dr. Willie McKinney, PhD (Inhalation Toxicology), all have experience in synthetic products and shared that expertise with the regulatory agency.
Johnson and McKinney also have extensive experience with the FDA having previously served on FDA’s Tobacco Products Scientific Advisory Council, according to the VTA.
“As with our first meeting, we are encouraged by the level of engagement by the CTP’s Office of Science on this issue,” the VTA stated in a release. “And, we greatly appreciate the participation of numerous FDA scientists from the various responsible divisions within the office with whom we were able to share our scientific knowledge and advanced thinking on the key issues.”
The VTA is hoping to continue to engage the FDA to help the agency better understand the nature of synthetic nicotine, according to Tony Abboud, executive director of the VTA.
“Our work is not done. These meetings, and the additional meetings that we are working on, are just part of VTA’s multi-pronged strategy to ensure the proper and full assessment of synthetic nicotine PMTAs,” said Abboud. “If your company is manufacturing products containing synthetic nicotine and is serious about regulatory compliance, or if your retail operation wants the ability to continue to diversify its retail offerings with synthetic nicotine products, or if you want to have continued access to innovative products containing synthetic nicotine, you should strongly consider being engaged in our strategic efforts.”
The ban on menthol cigarettes is closer to becoming a reality. After years of discussion, the U.S. Food and Drug Administration has instituted a proposed rule to place a ban on menthol combustible cigarettes and flavored cigars. Whether the menthol ban will also cover next-generation tobacco products, such as e-cigarettes, has not yet been clarified.
“The authority to adopt tobacco product standards is one of the most powerful tools Congress gave the FDA and the actions we are proposing can help significantly reduce youth initiation and increase the chances that current smokers quit. It is clear that these efforts will help save lives,” said FDA Commissioner Robert M. Califf, M.D. “Through the rulemaking process, there’s an important opportunity for the public to make their voices heard and help shape the FDA’s ongoing efforts to improve public health.”
When finalized, the FDA states that the proposed menthol product standard will:
reduce the appeal of cigarettes, particularly to youth and young adults, decreasing the likelihood that nonusers who would otherwise experiment with menthol cigarettes would progress to regular smoking; and
improve the health and reduce the mortality risk of current menthol cigarette smokers by decreasing cigarette consumption and increasing the likelihood of cessation.
The FDA states that the proposed product standards are based on clear science and evidence establishing the addictiveness and harm of the products. Many organizations were quick to condemn the regulatory agency for proposing the rule that is opposed by all major law enforcement, civil rights and criminal justice reform organizations. Opponents of the menthol ban say that evidence clearly shows that banning menthol products will do nothing to reduce combustible cigarette smoking rates but will lead to an increase in people purchasing products on the black market.
Credit: FDA
“This misguided proposal will have disastrous impacts on public health and public safety. It will do nothing to reduce smoking rates and instead make the United States less safe.” said Tim Andrews, director of Consumer Issues for Americans for Tax Reform (ATR). “It is unfortunate that as violent crime rates rise across the country, the FDA chooses to divert valuable police resources to pursue an unnecessary ban on menthol products.”
Andrews argues that a menthol ban exposes “vulnerable members of minority communities to conflict with law enforcement, and their purchases could also fund sophisticated international criminal syndicates.” According to the U.S. Department of State, illicit tobacco’s links to funding terrorist organizations already present a “serious threat” to national security. “This policy would worsen the problem while also depriving state governments of excise revenue, putting state government programs at risk,” says Andrews.
Richard Marianos, a senior law enforcement consultant who has served more than 27 years at the U.S. Bureau of Alcohol, Tobacco, Firearms and Explosives and who is now a consultant and adjunct lecturer at Georgetown University, says that in many foreign markets, such as Asia, companies are creating products to make mentholated cigarettes, because those types of products are not covered by the rule.
“They are flavor packets you just slide into a pack of cigarettes. You buy your cigarettes, you put that in there and by the time you get home, the whole pack is mentholated. They also have these – it’s like a little Tic Tac box with a round, small, little mint … but what it does is you put it into the filter, shake, crush and now it’s a menthol cigarette,” said Marianos. “Are we eventually going to be asking border protection to now start looking for minty flavor packets or Tic Tac boxes when they have to concentrate on biological and nuclear threats? When you overlook public safety surrounding this matter, you’re creating an unhealthy situation, not just for smokers, but anybody who’s out there.”
Marianos says that a menthol ban will create a greater level of diversion and criminal activity with high-value targets overseas, it’ll bring more organized crime into the United States. It’ll also create a greater market for border countries to begin manufacturing menthol and bring it into the United States.
“There was one investigation in particular, I remember, where the individual said on a wire that once they banned menthol cigarettes in the United States, you can pave the roads in gold because of the boost in sales of black market and DIY menthol cigarettes,” he said. “Prohibition doesn’t work. Your quality of police work goes down; they can’t concentrate on violent crime as much and it creates a greater wedge between themselves and the community.”
Guy Bentley
Guy Bentley, director of Consumer Freedom Research for the Reason Foundation, said that similar bans have had minimal effects on tobacco consumption in other countries such as Canada and the U.K., adding that a menthol ban is likely to lead to more policing in minority communities, more incarceration, boost black market sales and undermine criminal justice reforms in the U.S.
In an email to Vapor Voice, Bentley explained that a recent study funded by the Norwegian Cancer Society in partnership with the Polish Health Ministry found that in Poland – the EU state with the largest pre-ban menthol share – found “mixed evidence” that the ban is working as intended.
Bentley argues the FDA and Biden administration should apply a harm reduction model, educating the public about safer alternatives to conventional cigarettes and the latest smoking cessation options. Andrews concurs with Bentley, adding that the proposed rulemaking will inevitably lead to further growth of illicit markets, put members of minority communities in danger and divert law enforcement resources away from real crime.
“It ignores best practice expert recommendations on how to reduce smoking rates through proven harm reduction technologies, is a disaster for public health, and will make all Americans less safe,” Andrews said. “If the Biden Administration truly cared about the American people, they would junk this anti-science and genuinely harmful proposal immediately.”
Beginning May 4, 2022, the public can provide comments on these proposed rules, which the FDA will review as it considers future action. The agency also will convene public listening sessions on June 13 and June 15 to expand direct engagement with the public, including affected communities.
The public will have the opportunity to submit either electronic or written comments directly to the dockets on the proposed rules through July 5, 2022. Once all the comments have been reviewed and considered, the FDA will decide whether to issue final product standards.
The FDA also states that it cannot and will not enforce against individual consumers for possession or use of menthol cigarettes or flavored cigars. If the proposed rules are finalized and implemented, FDA enforcement will only address manufacturers, distributors, wholesalers, importers and retailers who violate the rules.
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 
