The government in Portugal is discussing a new draft law regulating vaping and other tobacco product use. The new EU delegated act of the Tobacco Products Directive would be brought into the national legislation on heated tobacco products, including several provisions on vaping that have not been a part of the original delegated act.
Draft Law No. 88/XV aims to extend smoke-free areas’ restrictions to the use of vaping products – effectively banning vaping in outdoor spaces such as the terraces of bars and restaurants – and to restrict the sale of vaping products by banning online sales, according to an emailed press release.
Alberto Gómez Hernández, community manager of the World Vapers’ Alliance, said the measures represent a step backward in the adoption of an “open and evidence-based approach” to alternative nicotine products.
“Instead of making it more difficult for smokers to access safer nicotine products, Portugal should follow the steps of countries that are successfully reducing smoking rates by encouraging smokers to switch, such as the United Kingdom and Sweden,” he said. “Banning the online sale of vaping products leaves smoking as the only option for those who do not have alternative nicotine product outlets nearby.”
A new study has found that flavor bans boost sales of traditional combustible cigarettes. The study, E-cigarette Flavor Restrictions’ Effects on Tobacco Product Sales, concluded that restrictions on the sale of flavored nicotine vaping products could lead to significant increases in traditional cigarette sales.
“Given that combustible cigarettes are widely recognized as more harmful than vaping, the study’s findings raise pressing questions about the public health implications of such policies, according to a release from the Canadian Vaping Association (CVA). The group “urges Canadian governments to review the study’s findings and ensure that vapor product regulations are inline with harm reduction and Canada’s Drugs and Substances Strategy.”
Key Highlights from the study include:
Substitution to Cigarettes: For every 1 less 0.7 mL pod sold due to flavor restrictions, there’s an increase of 15 additional cigarettes purchased.
Rise in Cigarette Sales Over Time: While the short-term effects are less clear, the long-term correlation between vaping flavor policies and a surge in cigarette sales is robust. This surge occurs especially when such policies have been in place for a year or more.
Young Population at Risk: The relation between vaping flavor restrictions and increased cigarette sales isn’t limited to a particular age group. Alarmingly, there’s also a surge in sales for cigarette brands popular among underage youth.
The research firmly underscores the unintended consequences of restricting flavored product sales, according to CVA. While the research indicated that these policies do achieve their goal of reducing flavored product use, they inadvertently boost the sales of traditional cigarettes across all age groups.
Given the stark difference in health risks between cigarettes and vaping, the study contends that the overall health benefits of such policies may be minimal or even potentially harmful in the broader perspective.
Last week, lawmakers in the U.S. introduced the CARE For Moms Act in Congress. That bill would increase healthcare for expecting and new mothers, while also exponentially increasing the taxes for vaping, roll-your-own, cigars and other tobacco products.
The tobacco tax language in the CARE Act was copied and pasted out of the Tobacco Tax Equity Act, a bill that has been introduced as a rider in bills introduced in previous sessions of Congress but it failed to gain any traction, according to halfwheel.
That could change after Sen. Ron Wyden and Sen. Dick Durbin have now introduced the Tobacco Tax Equity Act of 2023 in the Senate as a standalone bill, while Rep. Raja Krishnamoorthi introduced the bill in the House of Representatives.
The tobacco tax-related language includes:
New taxes for e-cigarettes;
Doubling the tax on roll-your-own tobacco;
A more than 16x increase on pipe tobacco;
Doubling the tax on small cigars;
A massive tax hike for premium cigars;
For premium cigars, the language removes the existing federal excise tax of 52.75 percent, capped at 40.26 cents per cigar, and replaces it with a weight-based tax of $49.56 per pound.
Because it’s a weight-based tax, the difference between the existing tax and the new taxes would vary depending on how heavy the cigar is. For cigars robusto or larger, it would likely more than triple the current federal tax rate.
Environmental activists in Australia are calling for a national strategy to force manufacturers, importers and retailers of vaping products to take responsibility for the industry’s waste, especially the disposal of lithium-ion batteries.
Clean Up Australia says consumers are confused about how to responsibly dispose of their used products, which are variously classified as electronic waste or hazardous waste depending on where someone lives in Australia.
The lithium-ion batteries embedded in vaping products, especially disposables, have been blamed for an increasing number of hazardous fires at landfill sites across the island nation.
Pip Kiernan, the head of Clean Up Australia, said consumers should not be left to navigate the complexities of how local councils classify vaping waste, according to media reports.
“It’s a mess and it’s no wonder they are ending up as litter. There is an urgent need for national consistency,” she said. “It shouldn’t be this hard.”
Kiernan wants a mandatory solution that forces responsibility onto the vaping industry and favors something like the deposit on aluminum and glass containers in place around the country.
“The consumer pays 10 cents when they buy a drink, and they get it back when they return the beverage container,” said Kiernan. “So there’s a cash incentive for consumers to do it, and it’s very clear how to do it.”
“The more things change, the more they stay the same,” is an expression that has been around for almost two centuries, and it speaks to the fact that the small picture(s) of life may change, but the larger one does not. The vape industry and all the challenges and changes that have happened in the past decade are totally contrary to that famous saying.
A decade ago, the vape industry was the epidemy of the Wild, Wild West, full of vape shops springing up on every corner, and any/everyone creating e-liquids in their bathtubs at home. Regulation and competition changed all that and brought some semblance of “orderliness” to the market, but as state and federal regulations bombarded the industry, and with the FDA creating onerous and unattainable guidelines, the vape space has truly become one of survival.
I recently attended a vape event in Phoenix which brought together several dozen top manufacturers, distributors, and buyers, and universally everyone lamented the same concern: business is down.
Why is business down?
The reasons are many, including strict regulations, and now, even more enforcement of those regulations, but overall, the cause was much simpler. The huge COVID-19 rebound in 2020-22 put more money in consumers’ pockets and more time on their hands. Those issues combined created an artificial bubble that many thought would last. But time has passed. Add in the inflation that has pushed up food and other cost of living expenses, and some former necessities are now becoming unaffordable luxuries.
“It’s a balancing act between the addictive nature of some nicotine products and the limitations of buyer’s budgets,” said Jamie Reed with Simple Vape Supply from Orange County California. “I’ve been in the industry for over ten years, and this is evolution in its purest form and based around ’survival of the fittest.’”
Simple manufactures and distributes over 100 different assortments of nicotine cartridges, including disposables, including various iterations of CBD, Delta-8 and Kratom.
“It’s interesting,” Reed added. “When I got hired, I was told that there was an ‘expiration date,’ and we all knew that this industry might not last, and that the cream would rise (to the top). We planned to be one of those surviving companies, and we’ve been able to adapt to the times.”
Her company, along with many that are still around, were mostly run by rebels, radicals, and envelope pushers; and many have in fact changed accordingly, but some have merely learned how to “play the game” and outwardly appear to be toeing the line, but the reality may be different.
“We were aware that the COVID blip was a one-time event. People were home, they had government money to spend, and no one was checking in on them or requiring any urine tests. The Delta (8,10) boom really added to that, and everyone jumped on that bandwagon,” she said excitedly.
That line of CBD was an example of how the industry has and continues to push back. The FDA says you can’t do this, so the industry says, “F-you, then we’ll do that.”
With regulation eliminating or reducing product selection, almost any industry will do the same thing: adapt; repurpose, or reposition.
Of the dozens of people I spoke with at the event, the numbers (from shop owners and manufacturers) were pretty consistent, and most of them were down 20 to 30 percent. Many were saying that purchase sizes were lower than normal and a typical ten-thousand-dollar order was now half that. They saw some shops closing, but most were working on smaller revenues.
Manager J-K Thorne holds some of the flavored products that are no longer available at Wild Impulse vape shop. (Shane Hennessey/CBC)
Meanwhile, on the other side of the equation, vape liquid manufacturers who are trying to “play the game” right and submitting premarket tobacco product applications (PMTAs) to the U.S. Food and Drug Administration are frustrated at the amount of time it takes and how much money is being thrown into a (seemingly) dark hole.
I spoke with one of the owners of a large vape manufacturing business and distribution company in Idaho, and he shared some facts and figures about their process of trying to make their products “legal.” Legal, in the eyes of the FDA, has caused his company to squander over $5 million in the past few years trying to get authorization.
Mike Larsen is a detailed and focused vape guy who has been in the industry for over a decade and is with Lotus Vaping Technology, which started in 2011. As a partner and director of sales, he is on the front line of everything the company does to stay legal and compliant and is riding the roller coaster ride on a daily basis.
“Disposables have really changed the game,” he said, “and they have reduced the role of vape shops where people used to come for education and guidance. Consolidations and closures have also reduced the shop numbers by 30 to 40 percent, and now you have larger conglomerates doing the work of the multitude of shops.”
We spoke about a possible flavor ban nationally, and he said he was skeptical.
“The PMTA process has already reduced or eliminated flavors, so it may not be necessary to go to that length. There have been between six and seven million submissions by thousands of companies, and so far, just 23 have been approved. I know of a few companies that submitted over a million applications themselves. And here’s the irony: everyone approved has been a Big Tobacco company, and they make up just a fraction of the total vaping market.”
The second irony on top of that, is that those so-called approved products are ones that no one wants.
We talked about whether those approvals were fair or were the result of favoritism and bias, and he smiled since we both knew the answer.
“When you look at the PMTA process and the rigid requirements, it seems pretty obvious that they were written to the advantage of the larger, established companies, and the “small guy” had very little chance in this skewed game. You can’t even budget for something like this,” he continued. “The original filing costs over a million dollars, and I know several companies that have put another ten million in, only to get denied. Who has deep pockets like that? In 2016 I could have named over 150 liquid companies doing good business; today I can name about three dozen.”
And that is why the number of companies manufacturing tobacco and vape products is half what it was and is getting smaller every year. The FDA changes the rules of the game continually.
“There’s something happening here, but what it is ain’t exactly clear,” is the beginning line of a song that speaks to changes going on in society. That song by Buffalo Springfield may have nothing to do with vape, but the message says the same thing: there is something happening here although it may be clearer than we realize. We all knew this would happen; it was predicted a decade ago.
In the vape space, the more things change…the more things change.
Norm Bour is the founder of VapeMentors and works with vape businesses worldwide. He can be reached at norm@VapeMentors.com.
The retailers selling illegal flavored disposable vapes are under scrutiny. The U.S. Food and Drug Administration issued complaints for civil money penalties (CMPs) against 22 retailers for the illegal sale of Elf Bar/EB Design.
The FDA previously warned each retailer in the form of a warning letter to stop selling unauthorized tobacco products, according to the agency. During follow-up inspections, the FDA observed the retailers had not corrected the violations, which resulted in the civil money penalty actions.
“The FDA has been abundantly clear that we are committed to using the full scope of our authorities, as appropriate, to hold those who break the law accountable,” said Brian King, director of the FDA’s Center for Tobacco Products (CTP). “These retailers were duly warned of what could happen if they failed to correct their violations. They chose inaction and will now face the consequences.”
The complaints seek the maximum civil money penalty of $19,192 for a single violation from each retailer. While the FDA has issued civil money penalty complaints to retailers for selling unauthorized tobacco products in the past, this is the first time the agency is seeking CMPs for the maximum amount against retailers for selling illegal flavored disposable vapes.
The retailers can pay the penalty, enter into a settlement agreement, request an extension of time to file an answer to the complaint or file an answer and request a hearing. Those that do not take action within 30 days after receiving the complaint risk a default order imposing the full penalty amount.
Courtesy: US FDA
In addition to the CMP complaints, today the FDA announced an additional 168 warning letters to brick-and-mortar retailers for illegally selling Elf Bar/EB Design products. These warning letters were the result of a coordinated nationwide retailer inspection effort conducted throughout the month of August, according to the agency.
Warning letter recipients have 15 working days to respond with the steps they have taken to correct the violation and ensure compliance with the law. Failure to promptly correct the violations can result in additional FDA actions such as injunction, seizure or civil money penalties.
“We continue to monitor closely all those in the supply chain, including retailers, for compliance with federal law,” said Ann Simoneau, director of the Office of Compliance and Enforcement in the CTP. “This includes follow-up inspections and surveillance of those who have received a warning letter, and taking additional action, as appropriate, to enforce the law.”
Vaping product sales in Oklahoma are set to get more complicated. On Oct. 1, the state will publish a list of vaping products allowed for sale within its borders.
Oklahoma’s new rules prohibit sales of products that have not received a marketing granted order (MGO) by the U.S. Food and Drug Administartion or are still under review in the regulatory agency’s premarket tobacco product application (PMTA) process.
Vaping product manufacturers were required to submit documentation by July 1 to the Oklahoma Alcoholic Beverage Laws Enforcement (ABLE) Commission that attested under penalty of perjury that the products listed were available for sale before Aug. 1, 2016 (the effective date of the FDA’s Deeming Rule), and that a PMTA had been submitted for each product on or before the agency’s Sept. 9, 2020 PMTA submission deadline.
The bill creating the Oklahoma law passed the state legislature in 2021, but vaping advocates were able last year to get implementation postponed until 2023. Attempts this year to repeal the law or delay it again until 2024 were unsuccessful.
The law will make vape shop owners criminals if they are found to be selling bottled e-liquid or disposable vaping products not named on Oklahoma’s list. Giving false information about the authorization status of any product submitted to the list is also a crime.
Manufacturers are required to notify the state of Oklahoma within 30 days of a change to the product’s authorization status with the FDA.
Biometric measures for age verification are gaining ground in Canada and Washington state, as retailers and regulators try to prevent youth from accessing vapes and other restricted products.
Imperial Tobacco Canada (ITCAN), which produces most of Canada’s major cigarette brands as well as the VUSE brand of vapes, has announced the expansion of a pilot for a biometric pass to access its VUSE retail stores, according to media reports.
According to a release, customers who sign up for the VUSE Pass through a one-time age verification process will be able to verify their age at VUSE outlets with a biometric palm scan.
The nationwide rollout follows a successful pilot program in Toronto.
“We say we are committed to preventing youth vaping, and we mean it,” says Frank Silva, the president and CEO of ITCAN. “A root cause of the problem is that kids unfortunately have access to vaping products. We’ve taken an important first step by making sure that we do more to control access to our own stores.”
Silva says there is a lack of government leadership around ensuring proper age verification procedures for restricted products. “Governments have all the tools necessary to stop retailers from selling to minors. They are simply not being enforced.”
Lawmakers in Washington State are deciding whether or not regulators will be able to add fingerprint scans for biometric age verification to their ID toolkit. The State Liquor and Cannabis Board has been considering a pilot project for biometric age verification. But, as the Center Square reports, doubts and questions about equity, security and oversight continue to arise.
Doughnut chain Dunkin’ sued an e-cigarette maker in New York federal court on Friday, claiming its “Vapin’ Donuts” products violate the chain’s trademark rights.
The lawsuit said Singh Handicraft Corp uses branding that is “nearly identical” to Dunkin’s on disposable vaporizers shaped like an iced coffee cup and a glazed doughnut, with a logo in the same “distinctive orange and pink color scheme and rounded font,” Reuters reports.
Massachusetts-based Dunkin’ also said that Singh sells the vaporizers in identical flavors to some of the chain’s drinks, including White Mocha and Iced Cappuccino. It accused Farmingdale, New York-based Singh of intentionally associating its products with Dunkin’ in a way that is likely to cause consumer confusion.
Representatives for Dunkin’ and Singh did not immediately respond to requests for comment on the lawsuit.
The complaint said that Singh’s products are sold through several online and brick-and-mortar vaping outlets. It said buyers of the e-cigarettes have “expressed that the only reason they purchased Defendants’ products is out of an affection for Dunkin’,” citing internet comments.
Dunkin’ also accused Singh of targeting underaged buyers and said that such “morally reprehensible and illegal conduct” hurts the chain’s reputation.
Dunkin’ asked the court for an order to stop Singh’s alleged trademark infringement and an unspecified amount of money damages.
Singh applied for a federal trademark covering “Vapin’ Donuts” in March. Its application is still pending.
Healthier Choices Management Corp. sued RJ Reynolds Vapor Co. seeking royalties from sales of its Vuse Alto vape pens, chargers, and pre-filled liquid pods, alleging the products infringe a patent for vaping products.
Hollywood, Fla.-based HCMC said the British American Tobacco Plc’s subsidiary and its Vuse Alto products infringe US Patent No. 9,538,788, according to a complaint filed in the US District Court for the Middle District of North Carolina, according to Bloomberg.
The patent, which Bloomberg Law estimates will expire in July 2034, is among 16 HCMC owns that are related to its Q-Unit, Qwik-T, and Qwik-G heating devices, mouthpieces, and related vape hardware.
