The chairmen of five key Senate committees on Thursday warned the chief executives of major convenience stores and wholesalers to stop selling illicit flavored vaping products, which they called “widespread violations of federal law.”
The senators voiced their concerns in letters to the companies, amplifying the frustration among some lawmakers in Congress over the continued availability of disposable e-cigarettes. They say the vivid colors and candy flavors only attract kids. The unchecked sales, they wrote, “pose a tremendous public health threat.”
“F.D.A. and the industry must do more to address the youth vaping epidemic and remove unauthorized vaping products from their shelves immediately,” Senator Dick Durbin said, according to media reports.
The letters were addressed to retailers including 7-Eleven, Circle K, bp America, Pilot, Kwik Trip and others. The U.S. Food and Drug Administration had earlier issued warnings about sales of unauthorized brands like Elf Bar, E.B. Design and Funky Republic.
“Today, millions of children use unauthorized e-cigarettes, risking nicotine addiction, respiratory illness, exacerbation of depression and anxiety, and many other harms,” read the letter to Joseph DePinto, the chief executive of 7-Eleven.
The other senators who signed the letter were Ron Wyden, Bernie Sanders, Sherrod Brown, and Richard Blumenthal.
The U.S. Food and Drug Administration has again issued warning letters to several small business owners for selling flavored disposable vaping products.
The regulatory agency issued letters to 14 online businesses for selling unauthorized e-cigarette products. The warning letters cite the sale of disposable e-cigarette products marketed under brand names, including Elf Bar/EB Design, Lava Plus, Funky Republic/Funky Lands, Lost Mary, Cali Bars, Cali Plus, and Kangvape.
“These warning letters were informed by FDA’s ongoing monitoring of multiple surveillance systems to identify products that are popular among youth or have youth appeal, an agency press release states. “Findings from the 2023 National Youth Tobacco Survey found that more than 50 percent of youth who use e-cigarettes reported using the disposable e-cigarette brand Elf Bar; in 2023, the manufacturer of Elf Bar began marketing the product under the name EB Design.”
In addition, the brands Lava Plus, Funky Republic/Funky Lands, Kangvape, Cali, and Breeze were identified as popular or youth-appealing by the agency following a review of retail sales data and emerging internal data from a survey among youth, according to the agency.
Retailers receiving warning letters sold or distributed e-cigarette products in the United States that lack marketing authorization from the FDA violate the Federal Food, Drug, and Cosmetic Act.
Warning letter recipients are given 15 working days to respond with the steps they will take to correct the violation and to prevent future violations. Failure to promptly correct the violations can result in additional FDA actions such as an injunction, seizure, and/or civil money penalties.
As of Jan. 30, 2024, FDA issued more than 440 warning letters and 88 CMPs to retailers for the sale of illegal e-cigarettes, including through a series of nationwide inspection efforts of brick-and-mortar retailers, according to the release.
In a press release, the agency stated that it had previously issued each retailer a warning letter for their sale of unauthorized tobacco products. However, follow-up inspections revealed that the retailers had failed to correct the violations.
The agency now seeks the maximum penalty of $20,678 from each retailer.
The U.S. Food and Drug Administration has issued complaints for civil money penalties (CMPs) against 21 brick-and-mortar retailers for selling unauthorized Esco Bars e-cigarettes.
In a press release, the agency stated that it had previously issued each retailer a warning letter for their sale of unauthorized tobacco products. However, follow-up inspections revealed that the retailers had failed to correct the violations.
The agency now seeks the maximum penalty of $20,678 from each retailer.
The complaints announced today represent the first set of CMPs FDA has filed for the sale of unauthorized Esco Bars e-cigarettes. “These retailers were duly warned of what could happen if they continued selling these unauthorized e-cigarettes,” said Brian King, director of the FDA’s Center for Tobacco Products (CTP). “They should have acted responsibly to correct the violations, but they chose not to do so and now must face the consequences of that decision. FDA won’t sit back and tolerate inaction to comply with the law.”
Currently, $20,678 is the maximum civil money penalty amount FDA can seek for a single violation from each retailer, consistent with similar CMPs sought against retailers for the sale of unauthorized Elf Bar products in Sept., Nov., and Dec. of 2023.
The retailers can pay the penalty, enter into a settlement agreement based on mitigation factors, request an extension of time to file an answer to the complaint, or file an answer and request a hearing. Retailers that do not take action within 30 days after receiving a complaint risk a default order imposing the full penalty amount, according to the release.
“Today’s CMP actions are just the latest in the continued, comprehensive push by FDA to take action across the supply chain to remove unauthorized e-cigarettes, particularly those that are popular among youth, from the marketplace,” the release states. “As of Jan. 30, 2024, FDA has issued more than 440 warning letters and 88 CMPs to retailers, including brick and mortar and online retailers, for selling unauthorized tobacco products.
“In addition to actions involving retailers, FDA has issued more than 660 warning letters to firms for illegally manufacturing and/or distributing unauthorized new tobacco products, including e-cigarettes.
“The agency has also filed civil money penalty complaints against 48 e-cigarette firms for manufacturing unauthorized products and sought injunctions in coordination with the U.S. Department of Justice against seven manufacturers of unauthorized e-cigarette products.”
The number of vape shops in the United Kingdom increased significantly last year, according to a reports in The Independent citing a survey by the Local Data Co. (LDC).
The country currently has 3,573 specialist vape shops, 233 more than at the start of 2023. This compares with an increase of 61 shops in 2022 and a decline of 23 in 2020.
The LCD figures exclude the numerous convenience stores, post office shops and news agents that also stock e-cigarettes and related products.
Sales of vape products grew by £897.4 million ($1.14 billion) in 2023, according to data published by NIQ and trade The Grocer.
The fastest growing vape brand in the U.K. was Lost Mary, which saw its sales grow by £310 million over 2022.
The market for traditional tobacco products contracted in 2023. Sales of cigarettes and loose tobacco declined £849.1 million and £393.1 million, respectively.
Keen to crack down on youth vaping, the government recently announced a consultation on how to protect children while encouraging adults to use e-cigarettes to quit.
Its suggestions include restricting flavors and product descriptions that may be appealing to underage consumers, along with rules on how products are presented in stores.
Jonne Dunne, director general of the U.K. Vaping Industry Association, said the rise in the number of specialist vape shops reflects the growing demand from smokers wanting to quit their cigarette habit.
“Vapes are proven to be the most effective way for smokers to quit,” he was quoted as saying, adding that e-cigarettes are helping around 50,000 more smokers beat their habit every year.
U.S. House lawmakers are demanding information from federal officials on what they are doing to stop the recent influx of kid-appealing electronic cigarettes from China.
Members of a new congressional committee on U.S.-China relations sent the request last week to U.S. Justice Department and Food and Drug Administration leaders, calling attention to “the extreme proliferation of illicit vaping products.”
The letter cites the Associated Press reporting on how thousands of new disposable e-cigarettes have hit the market in recent years, mostly manufactured in China and sold in flavors like watermelon and gummy bear.
In May, the agency called on customs officials to block imports of Elf Bar, a small, colorful vaping device that is the No. 1 choice among teenagers.
The media has reported that the company behind Elf Bar has been able to evade the ban by simply renaming its products, which remain widely available in convenience stores and vape shops.
“We ask you to work with the Customs and Border Protection to address this urgent problem with all due speed,” states the bipartisan letter from 12 members of the committee, including Chairman Rep. Mike Gallagher, and Rep. Raja Krishnamoorthi.
The special committee was established early this year to counter Chinese policies that can damage the U.S. economy. Tensions between the two countries have been rising for years, with both China and the U.S. enacting retaliatory measures on imports.
The U.S. Food & Drug Administration (FDA) announced that it has increased the penalties that nicotine companies and retailers pay if found in violation of the various federal laws regarding nicotine products.
The changes are part of the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, which requires the penalties to adjust with inflation.
2 within a 12-month period — $345 (Previously $320)
3 within a 24-month period — $687 (Previously $638)
4 within a 24-month period — $2,757 (Previously $2,559)
5 within a 36-month period — $6,892 (Previously $6,397)
6 within a 48-month period — $13,785 (Previously $12,794)
The civil monetary penalties are handed out to vaping and other tobacco companies or retailers that are found to violate FDA’s rules regarding vaping and other tobacco products.
Examples could range from an e-cigarette company failing to use a proper warning label to a retailer caught selling any nicotine product without checking the I.D. of an undercover buyer.
A Louisiana state court has put the brakes on the state’s release of its official vaping and e-cigarette registry. However, Alabama’s registry, which has been active since spring 2022, may offer some insight into what products Louisiana will allow on the market.
Passed earlier this year, Louisiana’s new law bans retailers from selling vape products not listed on a state-approved registry, known as the V.A.P.E. Directory. To receive authorization, products need a marketing order from the U.S. Food and Drug Administration or must meet one of several narrow exceptions, which favor products that have been on the market since at least 2016.
It’s still unclear which products will be listed in the directory, but Louisiana’s new law mirrors one that’s already in effect in Alabama, which has been keeping a similar list of pre-approved vaping and e-cigarette products, called the Electronic Nicotine Delivery Systems Products Directory, for over a year.
There are 1,602 vaping, e-cigarette, and alternative nicotine products listed in Alabama’s directory, meaning that many products can still be legally sold in the state, according to NOLA.com. On it are several kinds of JUUL products, various flavors of ZYN nicotine Pouches, Vuse, NJOY and BIDI Stick products.
Missing from the list are several massively popular disposable vapes, including Elf Bars, Puff Bars and EscoBars.
Click the green box at the top right corner of the homepage that says “MyAlabamaTaxes.”
Scroll to the “Businesses” section, and click “View or upload a report.”
Under “Tobacco Reports,” click “ENDS Product Directory.”
Click the green “Search” button for every product in Alabama’s directory. Or toggle the “Manufacturer” or “Product” buttons and then search for the products you’re interested in.
If the product you search for does not appear on the list, it is not authorized for sale in Alabama and likely will not be authorized for sale in Louisiana, according to sources.
“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 Scottish Grocers’ Federation (SGF) trade association has written to Scotland’s public health minister Jenni Minto MSP, following the Programme for Government announcement, which said restrictions on vaping in Scotland will be considered.
The SGF outlined a number of measures which it believes can reduce vaping among children, while also ensuring adult smokers looking to quit have access to alternative forms of nicotine, according to media reports.
It said packaging and naming of vape brands should be changed to make them less appealing to children, but said it opposes restrictions on flavor.
The SGF said flavor is shown to be the key factor which helps people switch from smoking to vaping – an alternative it argues is less harmful.
ALD has announced the market availability of FRESOR B8000 X1, a disposable vape that boasts a smart screen, 8000-puff capacity and customization options, according to an e-mailed press release.
The device is an extension of the company’s popular FRESOR disposable series, “setting new industry standards with its innovative digital display,” the release states.
“No more guessing about e-liquid levels. The smart screen provides real-time updates, preventing dry hits,” it states. “The smart screen provides instant access to battery status and recharging progress … The interface is designed for both seasoned vapers and newcomers, offering simplicity without sacrificing sophistication.”
Key features of the new device include:
Digital display screen that keeps track of e-liquid and battery levels;
Unique CMF design that offers a blend of elegance and innovation;
Smart dual mesh coil that provides consistent flavor throughout the devices lifespan;
OEM/ODM is also available that includes custom flavors, nicotine levels (0/1/2/5%), and branded packaging.
“The FRESOR B8000 X1 promises an elevated vaping experience. Its digital display, unique design, FRESOR MAX technology, and customization options cater to vapers worldwide,” the release states.
