Virginia has long been the epicenter of the tobacco industry; now, two bills that would ban flavored vaping products have been filed with the state’s General Assembly.
Sponsors say Virginia should step in where Washington has been ineffective in blocking unregulated flavored e-cigarettes, such as Elf Bar disposables, off of store shelves.
The bills, House Bill 1069 and Senate Bill 550, call for a fine of $1,000 a day for each product sold that the U.S. Food and Drug Administration has not authorized to be marketed in the U.S.
The Attorney General would maintain a directory of legal products, much like Alabama and Louisiana. Products not listed in that directory could not be legally sold in Virginia.
The bill states any retailer and wholesaler that sells or distributes any liquid nicotine or nicotine vapor product in the state is subject to scheduled or unscheduled compliance checks carried out by the Attorney General’s Office for enforcement purposes.
Manufacturers must certify, in a filing with the Attorney General, that an FDA marketing authorization order covers their product or is exempt from that because it was sold in the U.S. before 2016 or subject to a premarket tobacco product application dating from before 2020.
“It’s a public health issue,” said Del. Rodney Willett, who sponsored the House of Delegates bill.
“They’re targeting kids with the flavors,” he said, according to media reports. “When I walk into a convenience store, I’m just stunned by the number of these products that are for sale.”
The Singapore government said that the potential loss in revenue from tobacco tax was not a factor in its decision to ban the use of e-cigarettes in 2018.
In his reply to a question by a Workers’ Party and Sengkang member of Parliament, Deputy Prime Minister Lawrence Wong, who is also the Minister for Finance, said, “The Government’s decision to ban the use of e-cigarettes in 2018 was based on public health considerations, to protect our population from the harms of these products. The potential loss in tobacco tax revenue from the reduced consumption of tobacco products was not a factor in this decision.”
… our priority is to protect the health of our population and prevent e-cigarettes from causing harm to our people, especially to younger Singaporeans.”
Lawrence Wong
Wong added that if the government were to legalize and tax e-cigarettes “the challenges would be similar to those we encounter for cigarettes and other tobacco products today,” according to a Yahoo news report.
“In any case, the government has no plans to change our current approach, as our priority is to protect the health of our population and prevent e-cigarettes from causing harm to our people, especially to younger Singaporeans,” he said.
U.S. Senate Majority Whip Dick Durbin has again decried the Food and Drug Administration on its unacceptable failure to “protect children from the dangers of vaping” as the agency continues to miss and delay critical deadlines.
In a press release, Durbin stated that he has repeatedly criticized theFDA for its long-overdue review of premarket tobacco product applications (PMTAs) from e-cigarette manufacturers, which originally had a federal court deadline of September 9, 2021.
FDA has missed that court-ordered deadline by 28 months as unauthorized e-cigarettes flood the market.
During his speech, Durbin also called on the Biden Administration to swiftly implement a proposed public health rule to prohibit the production and retail sale of menthol cigarettes and flavored cigars.
“I know this President cares deeply about the toll of cancer. It has touched his family personally, as it has mine,” the Senator said. “If we want to make a difference in the health of Americans—and set a legacy for future generations—then the Administration must finalize this public health measure to end Big Tobacco’s predatory promotion of menthol cigarettes. Lives hang in the balance.”
The FDA stated in prior status reports for PMTAs that the agency would complete a review of 100 percent of the applications by the end of 2023. The agency is now estimating that completion of the reviews may be delayed as the FDA considers the D.C. Circuit’s opinion in Fontem US v. FDA, affirming in part and vacating and remanding in part marketing denial orders for certain vaping products.
The chairman of the Consumer Protection Authority states that a fine of up to OMR2,000 ($5,196) for multiple violations will be imposed on anyone who trades in e-cigarettes, shisha, and their accessories in the Sultanate of Oman.
His Excellency Sulayem bin Ali Al-Hakmani issued Ministerial decision No. 756/2023 on Sunday, January 7, 2024, creating the ban, according to media reports.
Article One stipulates that the circulation of e-cigarettes, shisha, and their accessories is prohibited.
Article Two states that, “without prejudice to the penal penalties stipulated in the aforementioned Consumer Protection Law, an administrative fine not exceeding OMR1,000 shall be imposed on anyone who violates the provisions of this decision, and the fine shall be doubled in the event of a repeat violation.
Credit: Helga Bragina
“If this violation continues, an administrative fine of OMR 50 will be imposed for each day that the violation continues, provided that its total does not exceed OMR 2,000. The seized quantities of electronic cigarettes, shishas, and their accessories will be destroyed in accordance with the controls in force at the Consumer Protection Authority.”
The new bill also repealed an earlier Resolution (No. 698/2015), as well as any laws or rules that contravene the current resolution or conflict with its provisions.
It also stipulates that the decision “shall be published in the Official Gazette, and shall be effective from the day following the date of its publication.”
A new University of Louisville study shows the nicotine in certain types of electronic cigarettes can increase the risk for an irregular heartbeat, according to a press release.
Tests in mice showed that nicotine salts used in pod-based e-cigarettes led to heart arrhythmias and could trigger a fight-or-flight response in higher doses.
“This suggests the nicotine is harmful to the heart and counters popular claims that the nicotine itself is harmless,” Alex Carll, an assistant professor in UofL’s Department of Physiology who led the study, said in a news release Thursday. “Our findings provide new evidence that nicotine type and concentration modify the adverse cardiovascular effects of e-cigarette aerosols, which may have important regulatory implications.”
Researchers state that regulating nicotine salts could help mitigate the health risks of vaping.
The research also suggests choosing e-cigarettes with freebase nicotine instead of nicotine salts, or using e-cigarettes with a lower nicotine content could reduce the risk of harm.
A former Altria executive has been promoted to CEO and resident of Kaival Brands Innovations Group, Inc. The company announced that it has expanded the role of Executive Chairman Barry Hopkins to include the additional positions.
Former CEO and president, Eric Mosser, has been appointed CEO and president of Kaival Brands International, a Kaival Brands Innovations Group’s subsidiary with an international licensing relationship with Philip Morris Products.
Niraj Patel, founder and chief science officer of Kaival Brands, said that from the beginning he has envisioned a diverse platform that could “capture the tailwinds” generated by the company’s core offering, the BIDI Stick electronic nicotine delivery system (ENDS) product.
“Barry understands this vision, the importance of regulatory compliance and youth access prevention, and has done an exceptional job since joining Kaival Brands. He has eagerly taken on increasing levels of responsibility, leveraging his decades of experience in management in our industry,” said Patel in a press release. “His appointment as Interim CEO and president was a natural progression, and we look forward to potentially expanding our excellent management team further during 2024 with a permanent CEO and/or president as our needs dictate.
“Having Barry in this position now is particularly important since we are at a significant inflection point, as we remain hopeful that FDA will soon complete its review of the pending premarket tobacco product application (PMTA) for the tobacco-flavored BIDI Stick Classic. If we receive a marketing granted order for this product, we will have significant momentum in the new year with the ability to continue to transition adult cigarette smokers, drive revenue and grow our company.”
According to a recent U.S. Food and Drug Administration announcement, the agency’s next status report regarding its review of the still-pending PMTAs for major brands and market share leading ENDS products is due to be filed by January 22, 2024 with the U.S. District Court in Maryland.
Although FDA has not indicated publicly which PMTAs it is prioritizing for review, Kaival Brands is hopeful that the BIDI Stick Classic will be included in the January status report. The company also anticipates the PMTAs for the other 10 BIDI-branded SKUs will remain in scientific review, according to Patel.
Recently, the Kaival Brands has been encouraged by the coordinated efforts of the FDA, U.S. Customs and Border Protection, and other government agencies to increase their coordinated focus on enforcement. The company believes it has been hurt by illicit vaping products flooding the market, and it is now preparing to scale along with other legal products, assuming increased enforcement continues alongside the January announcement by the FDA.
“Hopkins will spearhead the company under the direction of the Board of Directors with a continued focus on accelerating revenue growth, improving operational efficiencies and executing Kaival Brands’ strategic growth and diversification initiatives, while remaining in compliance with applicable state and federal regulations.
“The company, alongside BIDI Vapor (the maker of the BIDI Stick), is also continuing to focus on working with Philip Morris to accelerate the international distribution of ENDS products using BIDI technology (which Philip Morris markets under the brand name ‘VEEV Now’), as part of Philip Morris’s plan to deliver a smoke-free future.”
BAT Germany has selected Arvato as its logistics and fulfillment partner for its e-commerce operations encompassing e-cigarettes and heated tobacco products.
Since the end of June, BAT Germany online orders have been processed centrally from the site in Marienfeld, Guetersloh district. At this site, Arvato, a leading supply chain and e-commerce service provider, operates a state-of-the-art distribution center spanning approximately 32,000 square meters, serving multiple clients in the technology sector, according to the American Journal of Transportation(AJOT).
The comprehensive logistics services provided for BAT Germany at the facility encompass goods receipt, storage, order picking, packing, and shipping, as well as returns management.
“BAT’s goal in awarding the e-commerce logistics contract was to guarantee the most efficient and fastest delivery service for its customers. Our customer-centric approach allowed us to accommodate BAT’s specific processes and requirements,” says Thomas Becker, executive vice president at Arvato.
The logistics service provider commits to delivering within a 48-hour timeframe. To optimize warehouse operations for efficiency and speed, Arvato heavily integrates automation technology. Automated carton setup and closure processes significantly enhance the speed of operation. Moreover, product information is automatically included with orders through flyer dispensers.
“With its experienced team, Arvato provided us with very flexible and reliable support in setting up our logistics and distribution concept,” confirms Robert Juhnke, distribution manager at BAT Germany. “Even throughout the offer and final negotiation phase, the collaboration has been exceptionally cooperative.”
Sustainability is a growing trend in the vaping industry. Arvato is dedicated to doing its part, according to the AJOT story. In an effort to reduce plastic waste, the company adopted wet adhesive tape made from recycled paper, resulting in the annual saving of approximately 16 tons of plastic, as an alternative to polypropylene adhesive tape. Arvato’s approach to optimizing shipment sizing and processing minimizes the consumption of packaging materials.
The implications could be far-reaching. Reynolds American Inc. (RAI) 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 Tobacco Reporter that if the ITC agrees with Reynolds, all flavored disposable vaping devices without 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.
“As a result of the relentless influx of illegal vapor products flowing through U.S. borders, Reynolds American Inc. subsidiaries R.J. Reynolds Tobacco Co. and R.J. Reynolds Vapor Co. have filed a complaint with the U.S. International Trade Commission against more than 30 companies involved in illegally importing unregulated, youth appealing flavored disposable vapor products,” RAI wrote in a statement. “Many of the manufacturers of these disposable vapor devices intentionally and systematically market to youth, selling products with dessert and candy flavors and featuring cartoon characters.
“These illegal disposable vapor devices, which have unknown ingredients and bypass regulations, are jeopardizing public health by refusing to adhere to the laws that regulate the sale of tobacco products. The complaint requests that the ITC institute an investigation into unfair acts in the importation and sale of these Chinese-manufactured, youth appealing flavored disposable vapor devices into the United States.”
Reynolds owns the Vuse vaping brand, including the Vuse Alto. Last week, the FDA issued a marketing denial order, 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. The marketing denial order was subsequently stayed by the Fifth Circuit Court of Appeals.
In its ITC complaint, Reynolds 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 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.”
