The U.S. Food and Drug Administration has defeated Logic Technology Development after the e-cigarette manufacturer asked the courts to block the regulatory agency’s market ban on Logic’s menthol-flavored e-cigarette products, according to media reports.
Logic filed a petition for review in the U.S. Court of Appeals for the Third Circuit, alleging the FDA violated the Administrative Procedure Act when it denied Logic’s premarket tobacco product application to market its menthol-flavored vaping products. The court denied that petition Thursday after concluding the FDA “based decisions on scientific judgments.”
Logic alleged it was arbitrary and capricious for the FDA to apply the same regulatory framework to menthol that it used to remove fruit- and dessert-flavored e-cigarettes from commerce. The Third Circuit Court entered a stay on the FDA’s marketing denial orders (MDOs) in December 2022. The MDOs were the FDA’s first-ever MDOs directed at menthol e-cigarette products.
Altria Group today said that its e-cigarette subsidiary NJOY, LLC has filed lawsuits against 34 foreign and domestic manufacturers, distributors and online retailers of illicit disposable vaping products. If successful, the lawsuit could potentially decimate the flavored disposable vaping market.
Altria joins its largest U.S. competitor, BAT-owned RJ Reynolds, in using the courts to remove unauthorized vaping products (and their competition) from the U.S. market.
On Oct.13, Reynolds filed a U.S. International Trade Commission (ITC) complaint charging multiple manufacturers, distributors, and retailers of several popular disposable vaping devices with unfair importation. It is one of several recent actions Reynolds has made to remove its competitor’s vaping products from store shelves. Several legal scholars have told Vapor Voice that if the ITC agrees with Reynolds, all flavored disposable vaping devices without an FDA marketing authorization could be stopped at the border and prevented from entering the U.S. market.
The NJOY suit alleges that the disposable products are unlawfully marketed and sold in the State of California and other U.S. states in violation of California’s flavor ban law and federal marketing rules.
The products are illegal under federal law and subject to action by the U.S. Food and Drug Administration and illegally compete against companies that comply with state and federal laws, according to an Altria press release.
The suit seeks a nationwide injunction against the import, marketing and sale of these illicit products and significant compensatory and punitive damages. If successful the lawsuit could lead to the removal of all disposable flavored vaping products without an FDA marketing order from the market.
“These companies knowingly violate federal and state laws and need to be held accountable,” said Murray Garnick, Altria’s Executive Vice President and General Counsel. “Today there are two markets – one for those who play by the rules and one for those who flagrantly ignore them. We are taking this action because the current state of the illicit e-vapor market is intolerable, and we must see more action from FDA and others.”
The litigation, filed in the United States District Court for the Central District of California, is brought under four claims: unfair competition, false advertising, false advertising in violation of the Lanham Act and violation of the Prevent All Cigarette Trafficking Act of 2009.
Named Defendants in the suit manufacture and distribute illicit disposable e-vapor products which include, but are not limited to, brands including Breeze, Elf Bar, EB, EB Create, Esco Bar, Flum, Juice Box, Lava Plus, Loon, Lost Mary, Mr. Fog and Puff Bar (many of these companies were also named in the Reynolds suit). Domestic Defendants include companies doing business in Arizona, California, Delaware, Florida, Michigan, Minnesota, New Jersey, New York and Texas. Foreign Defendants are all based in China.
None of the Defendants has received premarket tobacco product authorization (PMTA) approval from the FDA. In many instances, Defendants also have not filed PMTA applications. Several of these Defendants have already received warning letters from the FDA stating that their products are adulterated and misbranded and cannot be sold without marketing authorization.
Additionally, some of these Defendants are subject to an FDA-ordered import alert authorizing U.S. Customs and Border agents to seize their products. NJOY may add additional manufacturers, distributors and retailers to this complaint and will consider further litigation activity, the release states.
Despite a ban on the sale of flavored tobacco products that went into effect in December 2022, flavored vapor products make up more than 97 percent of the California market according to a recent study commissioned by Altria. Conducted by an independent research firm WSPM Group, “the study collected 15,000 empty discarded cigarette packs and 4,529 e-vapor product packages” from May 1st through June 28th in 10 California cities.
The implications could be far-reaching. R.J. Reynolds has filed a U.S. International Trade Commission (ITC) complaint charging multiple manufacturers, distributors, and retailers of several popular disposable vaping devices with unfair importation. It is one of several recent actions Reynolds has made to remove its competitor’s vaping products from store shelves.
Reynolds is asking the ITC to investigate and issue an exclusion order preventing further U.S. imports of disposable vaping products. Several legal scholars have told Vapor Voice that if the ITC agrees with Reynolds, all flavored disposable vaping devices without a U.S. Food and Drug Administration marketing authorization could be stopped at the border and prevented from entering the U.S. market.
Reynolds wants the ITC to issue a permanent “cease and desist order” prohibiting any businesses from selling illegal vaping products. The move would push nearly the entire vaping industry underground, with the exception of products owned by major tobacco companies such as Reynolds that have received marketing orders from the FDA.
Several businesses were named specifically as “peddlers of illegal disposable vapes” in the Reynolds complaint, including the manufacturers, importers, distributors and retailers of Breeze, Elf Bar, Esco Bar, Hyde, Puff Bar, and R&M disposable vapes.
Also named are several well-known U.S. wholesale and retailers of disposable vapes, including Element Vape, Flawless Vape, Magellan Technology, Mi-One Brands, Price Point Distributors, and Vape Sourcing.
The ITC complaint accuses what amounts to the manufacturers of all unauthorized vaping products of importing “illegal disposable vapes” in violation of Section 337 of the Tariff Act of 1930. Specifically, Reynolds claims the named businesses either falsely advertised that their products are authorized for sale by the U.S. government, failed to comply with federal laws imposing registration and reporting requirements and limitations on sales, or violated customs laws and regulations.
Reynolds owns the Vuse vaping brand, including the Vuse Alto. Last week, the FDA issued a marketing denial order (MDO), ordering Alto menthol refill pods off the market. The Alto device and tobacco-flavored pods are still under review by the agency. Two older Vuse vapes, the Solo and Vibe models (and their tobacco-flavored refills) are among the 23 products currently authorized by the FDA.
Reynolds also states it has the capacity to fill any void in the market if the illegal products were removed. “Reynolds has the capacity to replace any increase in demand if the Accused Products were excluded from importation,” the complaint states. “Reynolds is willing to meet any increased demand and can do so in a commercially reasonable time, given that it already supplies the industry with significant quantities of ENDS products, as well as oral tobacco and nicotine products.”
The ITC has not yet made a decision on the complaint that was filed on Oct. 13.
The company is now importing its disposable vaping devices under a different name, EBCreate, EBDesign and brands such as Airo Max. The rebranded products also list different Chinese manufacturers than those targeted by the FDA, such as iMiracle.
Convenience stores in Washington D.C., Philadelphia, New York and other cities remain fully stocked with the brightly colored vapes, sold in fruity flavors like strawberry melon and claiming to contain 5,000 “puffs” per device, according to the AP.
The makeover underscores the FDA’s inability to stanch the flow of unauthorized e-cigarettes into the U.S., mainly through large shipping hubs like Los Angeles and Houston.
“E-cigarette manufacturers have proven themselves to not operate in good faith,” said Desmond Jenson, an attorney at the Public Health Law Center. “Until there’s something global that’s a deterrent to selling illegal products this is going to be the status quo.”
Elf Bar generated U.S. sales of over $271 million in the past year, according to retail data tracker Nielsen. Separate data previously obtained by the AP shows the brand hit U.S. stores in November 2021, racking up hundreds of millions in sales over 18 months before being targeted by FDA regulators.
Two weeks after the FDA notified Elf Bar of the import ban, a request to trademark EBCreate was filed with the U.S. Patent and Trademark Office. The filing was made by the same patent attorney who submitted Elf Bar’s previous applications. But unlike those filings, the paperwork doesn’t mention Elf Bar’s parent company, iMiracle Shenzhen Technology. Instead the application lists a Hong Kong company, Nevera HK Limited, the same company listed on new EBCreate e-cigarette packages.
The Latvian government has amended its Excise Tax Law to include a gradual increase in excise taxes on e-liquids and other next-generation tobacco products.
E-liquids other vaping products will see their excise tax rates increase by an average of 21 percent every year in 2024, 2025 and 2026. Other tobacco “substitute products” which include nicotine pouches, will rise by 10 percent.
The amendments will negatively impact Latvia’s efforts to curb smoking by making options to switch less attractive, according to Alberto Gómez Hernández, Community Manager of the World Vapers’ Alliance.
“Increasing the taxation of safer nicotine products will discourage smokers from switching and push users back to smoking,” Gómez Hernández said in a press release. “The international evidence has shown that increasing taxation of e-cigarettes and e-liquids has always led to an increase in smoking, particularly among young adults and low-income groups.
“Latvia should follow the steps of countries that are successfully reducing smoking rates by encouraging smokers to switch, such as the United Kingdom and Sweden, instead of making it more costly for them.”
The bill will also increase the excise tax rates of heated tobacco products and combustible cigarettes by 5 percent and 5.6 percent every year, respectively.
The U.S. Supreme Court declined Tuesday to hear arguments against the Food and Drug Administration’s regulatory authorization process.
The denial order comes in one of several cases questioning the FDA’s oversight of the vaping industry.
The US Court of Appeals for the Fourth Circuit sided with the FDA, finding that Avail hadn’t shown that its products had benefits for adults that offset the risk to youth.
The case is connected to the FDA’s 2021 determination to deny all of Avail Vapor’s requests to approve fruit and dessert-flavored e-cigarettes. The company claimed that the agency made the application process intentionally difficult, which led to mass denials of new product submissions.
In a Supreme Court brief filed Aug. 3, the company claimed the FDA failed to inform companies of a change in policy that would only allow for approval if the applications included data from studies conducted over time comparing the effectiveness of the multi-flavored products to that of tobacco flavored ones as an aid in adult smoking cessation.
Avail Vapor had asked the U.S. Supreme Court to examine a lower court’s refusal to review a marketing denial order issued by the FDA to Avail products.
In its petition, known as a Writ of Certiorari, Avail asked the Supreme Court to consider the lower court’s legal reasoning and decision.
Among other things, Avail argues in its petition that the FDA’s decision making was arbitrary and capricious; that another court sided with a different petitioner against the FDA on the same basic arguments; and that the case is significant not only for Avail but for the entire industry and its customers.
The Netflix documentary Big Vape: The Rise and Fall of Juul will premiere on Oct. 11. Netflix states the docuseries is “a scrappy electronic cigarette startup becomes a multibillion-dollar company until an epidemic causes its success to go up in smoke.”
Helen Redmond of Filter wrote that she was prepared to hate-watch the docuseries, directed by R.J. Cutler, in her review of the show.
“The name alone pissed me off because of its implied conflation of Juul, which is not a tobacco company, with ‘Big Tobacco.’ The trailer is a feverish montage of talking heads and voiceover accusing the company of being ‘wildly irresponsible,’ photos of hospitalized patients with bloody chest tubes, and a clip of James Monsees, one of Juul’s founders, being called ‘a marketer of poison to young people’ at a congressional hearing,” she wrote.
She also states that she “was happily shocked” when the series presented a alternate viewpoint.
The docuseries is based on TIME journalist Jaime Ducharme’s book, Big Vape: The Incendiary Rise of Juul.
The Center for Black Equity (CBE) called on the U.S. Food and Drug Administration and the Center for Tobacco Products to grant broad approval to a full range of nicotine e-cigarettes, also known as vapes, in a major step toward closing the significant harm reduction and health equity gaps perpetuated by current FDA tobacco policies, according to a press release. The approval of vaping products would benefit Black and LGBTQ+ populations disproportionately impacted by the negative health effects of smoking, including cancer, according to the CBE.
The CBE’s call for expansive regulatory approval of e-cigarettes, including flavored vaping products, comes as the CBE released an econometric report that, for the first time, quantifies the benefits of switching from smoking to vaping in terms of lives saved, GDP benefit and healthcare savings.
The report was authored by Robert J. Shapiro, former undersecretary of commerce for economic affairs and advisor to former President Clinton, former President Obama and President Biden. Shapiro’s report found that between 2010 and 2022, shifting from smoking to vaping saved 113,000 lives, preserved $137 billion in GDP and saved $39 billion in healthcare costs—and that the availability of e-cigarettes reduced the number of smokers in the U.S. by 6.1 million during that same period.
“Championing meaningful harm reduction initiatives for Black and LGBTQ+ communities has been an elusive but essential aspect of effective public health advocacy for decades,” said Earl Fowlkes, president and CEO of the CBE. “If the Biden administration and the FDA are serious about health equity and harm reduction, especially when it comes to the president’s Cancer Moonshot initiative, the science is clear: Broad approval of flavored vaping products will save Black and LGBTQ+ lives, reduce smoking and drive meaningful progress in lowering preventable cancer rates in the U.S., especially among the most vulnerable populations.”
The report also reviewed existing academic and medical literature on vaping versus smoking to examine and verify the substantial scientific evidence that e-cigarettes have a drastically lower risk profile than cigarettes and can help individuals successfully reduce smoking or quit altogether.
“The single most effective way to help people stop smoking, which kills 480,000 people per year, is to encourage them to switch to vaping, which kills no people per year,” said Shapiro.
“The Center for Tobacco Products needs to be honest with American smokers—especially those in Black and LGBTQ+ communities who smoke at disproportionately higher rates—and proactively convey the substantial health benefits of shifting from smoking to vaping,” Shapiro said. “Future FDA policy on tobacco and nicotine products should draw on the well-established scientific evidence regarding the relative risks of e-cigarettes versus cigarettes and the utility of people using vaping to stop or reduce their smoking.”
The report also squarely examined the primary concern of critics of e-cigarettes, the supposed “youth vaping epidemic,” to which formal FDA approval of vaping products would allegedly contribute. “The supposed ‘youth vaping crisis’ narrative that has existed for some time in the media and, curiously, in public health conversations at the FDA is unfounded,” Shapiro continued. “The U.S. Centers for Disease Control and Prevention’s own data show that adolescent vaping has declined substantially in recent years—receding to 2014 levels, well below the 2019 peak—and that most young people who vape do so on an irregular or occasional basis without becoming dependent on nicotine.”
“The FDA and the Center for Tobacco Products have an obligation to follow the science, support harm reduction and health equity, and advance—rather than stall—President Biden’s Cancer Moonshot,” concluded Fowlkes. “The FDA must acknowledge the evidence-based benefits of switching from smoking to vaping and aggressively educate Black, LGBTQ+ and other smokers about those benefits. Failure to approve a wide range of vaping products is an abdication by the FDA of its public health responsibility to Black and LGBTQ+ individuals across the country who desperately want to access a way to quit smoking that actually works.”
“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.”
The Netflix documentary Big Vape: The Rise and Fall of Juul will premiere on Oct. 11. Netflix states the docuseries is “a scrappy electronic cigarette startup becomes a multibillion-dollar company until an epidemic causes its success to go up in smoke.”
