Category: Disposables

Kaival Brands Amends Agreement With Philip Morris

Photo: Kaival Brands Innovations Group
Kaival Brands Innovations Group, announced that its wholly-owned subsidiary, Kaival Brands International (KBI), has amended its agreement with Philip Morris Products, a wholly owned affiliate of Philip Morris International (PMI), for the development and distribution ENDS products in markets outside of the U.S.
Eric Mosser, CEO of Kaival Brands, the exclusive distributor of all products manufactured by Bidi Vapor, including the BIDI Stick electronic nicotine delivery system (ENDS), said in a press note that with more than a year of operational history for KBI and given the recent changes to regulations in international markets, it became clear that there were a number of opportunities to improve the terms of the original licensing agreement with PMI and reduce the burden of administering it.
“We are extremely pleased to reach an agreement that shall enable us to achieve our objectives. The revised licensing agreement simplifies the payment structure resulting in cost savings of approximately $2.7 million for the Company over the lifetime of the license agreement,” said Mosser. “It also enables better predictability and forecasting for KBI and streamlines data reporting. Finally, we anticipate that the acceleration of royalty payments will be a net positive to our financial performance over the duration of the agreement.”
Under the terms of the amended agreement, the parties agreed to revise certain terms, which provide for, among other things, a fixed pricing structure with volume-driven increases and a recapture of non-recurring engineering costs by KBI.
Accordingly, Kaival Brands expects a reconciliation payment of approximately $135,000. It projects approximately $300,000 in additional royalties to be earned through the end of 2023.
August 20, 2023
FDA Warns 3 Major Flavored Disposable Distributors

The U.S. Food and Drug Administration today issued warning letters to three distributors for selling and/or distributing multiple brands of unauthorized e-cigarette products.
The illegal products listed in the warning letters sent to ABS Distribution Inc., EC Supply, Inc. and Easy Wholesale, LLC include the popular and youth-appealing e-cigarette products Elf Bar/EB Design, Esco Bars, and Puff Max (Puff Bars).
“FDA is committed to keeping a finger on the pulse of the rapidly evolving e-cigarette landscape, including through a variety of scientific assets equipped to quickly identify products with high youth appeal,” said Brian King, director of FDA’s Center for Tobacco Products (CTP). “We will continue to use this data-driven approach to inform actions across the entire supply chain, including against those who distribute illegal products between manufacturers and the point of sale.”
The distributors receiving warning letters sell and/or distribute e-cigarettes in the United States that lack authorization from FDA, which is a prohibited act under the Federal Food, Drug, and Cosmetic Act, according to an FDA release.
All of the brands cited in these warning letters have been identified as being among the most popular e-cigarettes among U.S. youth.
“Warning letters are generally the first step once an inspection reveals a violation of the law,” said Ann Simoneau, director of the Office of Compliance and Enforcement within CTP. “We will monitor to ensure these violations are corrected, and if they are not, the recipient is at risk of further actions such as civil money penalties, seizures, and injunctions.”
The FDA has stepped up enforcement of flavored disposable products after several lawmakers complained the agency wasn’t fulfilling its duties.

Credit: Pastel Cartel
July 27, 2023
UK Councils Call for Disposable Vape Ban by 2024

Credit: Iama Sing
Councils in England and Wales have called on the UK government to ban the sale of single-use vapes by 2024 on both environmental and health grounds.
The Local Government Association (LGA), which represents councils in England and Wales, said it was crucial a ban came into effect rapidly, as with the European Union proposing a ban in 2026 and France rolling out a ban in December this year, there was a risk that as markets close disposable vapes could flood into the UK, according to Reuters.
“Disposable vapes are fundamentally flawed in their design and inherently unsustainable products, meaning an outright ban will prove more effective than attempts to recycle more vapes,” David Fothergill, chairman of the LGA’s Community Wellbeing Board, said.
The UK Vaping Industry Association defended disposable vapes.
“Disposables have been around for well over a decade and provide a low-priced accessible product that helps smokers to quit smoking tobacco,” John Dunne, the association’s director general told BBC radio on Saturday.
The LGA said 1.3 million disposable vapes were thrown away every week. They were a hazard for waste and litter collection and caused fires in bin lorries.
It said single-use vapes were designed as one unit so batteries cannot be separated from the plastic, making them almost impossible to recycle without going through special treatment.
The LGA said councils were also concerned about the impact vaping was having on children and young people.
July 16, 2023
New Report Urges Ban on Disposable Vape Products

Credit: Iama Sing
The only solution to curb the plastic and battery waste created by disposable vaping products is to ban the products entirely, according to a report released Tuesday from the U.S. Public Interest Research Group (PIRG) Education Fund.
“It doesn’t make any sense to manufacture electronics with rechargeable batteries, ship them across the world, and throw them out within a few days,” the report states.
The report explores the environmental impacts of disposable products and found that the devices are difficult to recycle properly due to a lack of infrastructure and regulation around e-waste recycling.
Disposable vaping devices also contain lithium-ion batteries as well as small plastic parts. They also contain nicotine, which is considered a toxic chemical.
“According to CDC Foundation sales estimates, lining up the disposable vapes sold in a year would stretch for 7,000 miles—long enough to span the continental U.S. twice,” a PIRG report states. “This vape waste is becoming more common while cigarette butts become less common as the trash that litters our beaches and waterways.”
The report advocates for federal and state legislation banning or restricting disposable vapes to keep them out of landfills and waterways and prevent fires.
It also calls for the U.S. Food and Drug Administration to make enforcement of vape marketing restrictions a priority, particularly for disposable products.
July 12, 2023
UK’s Leading Vape Shops Support Disposables Ban

Credit: VPZ
The head of one of the leading retailers and manufacturers of vaping products in the United Kingdom says he would support a ban on disposable vapes as long as it did not create a black market.
Doug Mutter, company director of VPZ, said a ban in Australia had led to unsafe products being sold there illegally.
He insists the industry recognizes that the environmental impact of single-use products needs to be addressed.
An urgent review of disposable products was ordered by the Scottish government and is due to be released within days, reports Yahoo! News.
It was commissioned after a campaign by climate activist Laura Young who had been collecting dozens of disposable vapes each day while walking her dog Cooper in Dundee.
The review is likely to quantify the scale of the problem and lay out the options available to ministers.
Disposable vapes are a problem because they contain lithium batteries which should be taken to a recycling facility for disposal.
But millions are either discarded or thrown into bins each year where they can cause a fire at processing facilities.
Refillable vapes are available which are much cheaper to use in the long term and have less of an environmental impact.
VPZ has 150 stores throughout the UK.
Mutter – who is also the director of the UK Vaping Industry Association (UKVIA) – said disposables have a place for smokers who would like to try vaping but do not want to invest in reusable systems.
He acknowledges the environmental impact of them and their attractiveness to young people who do not already smoke.
“For me, there should be a ban on disposables that we would support if there were proper punishments and policing put in place to enforce the ban and ensure that a black market doesn’t bubble up,” said Mutter.
Enforcement should be funded by a licensing scheme, he said, which retailers would have to be a part of to sell vaping products.
June 26, 2023
ANDS Develops 99 Percent Recyclable Vape Device

Fadi Maayta | Image: Tobacco Reporter archive
ANDS has created a disposable vape that is 99.29 percent recyclable, according to Waste Experts, reports UKVIA.
Slix is constructed of an outer casing made of 100 percent recyclable high-grade cardboard with a biodegradable silicone mouthpiece and end piece.
“While the analysis carried out by Waste Experts suggests that our single-use vape is highly recyclable, we will continue to work toward zero waste,” said Marina Murphy, senior director of scientific and medical affairs at ANDS. “We aim to build a high rate of recyclability into all our products by using high-quality recyclable materials and simple construction that allows for highly efficient dismantling. This contributes to a fast, efficient overall recycling process, which reduces waste management costs. This in turn helps to keep product prices competitive, creating a win-win for the environment and adult consumers who value our products.”
“We’re very much on a journey, and by the end of this year, we hope to launch a 100 percent recyclable and recoverable version of Slix, which will reduce the tonnage of waste going to landfill even further,” said Fadi Maayta, president of ANDS. “If these single-use vapes are restricted or banned over environmental fears as is being talked about in some circles—smokers could lose what many believe to be a very convenient, accessible and compelling alternative to conventional cigarettes.”
ANDS is partnering with Waste Experts to create a recycling program.
June 13, 2023
UK Pediatricians Call for Ban on Disposable Vapes

The Royal College of Paediatrics and Child Health (RCPCH) in the UK has called for a ban on disposable e-cigarettes, stating that vapor products can be just as addictive as traditional cigarettes, according to Metro.
“Since e-cigarettes have only been on sale in the UK since 2007, long-term studies don’t yet exist,” the RCPCH said. “We have even less evidence on the long-term impacts of these products on young lungs, hearts and brains.
“It took experts decades to fully understand the impact of traditional cigarettes; we cannot risk our children’s health in waiting this long again for longer-term studies.”
Action on Smoking and Health data found that there has been a 50 percent increase in UK kids trying vaping over the last year and a rise in experimental vaping among 11-year-olds to 17-year-olds.
“Without a doubt, disposable e-cigarettes should be banned,” said Mike McKean. “There is absolutely no reason that these cheap, readily available, brightly colored, recreational products should be single use.
“Westminster’s approach to this problem is out of step with even our closest neighbors, with countries such as Scotland, France, Germany and Ireland all seriously considering a ban.”
In response to the RCPCH’s call, the U.K. Vaping Industry Association (UKVIA) stated that while youth vaping needs to be addressed, banning disposables is not the answer.
“There is no doubt that strong, targeted action directed at those illegally selling vape products to children is the way forward,” said John Dunne, director general of the UKVIA, in a statement. “Vitally, any youth prevention measures cannot be to the detriment of adult smokers looking to quit through vaping and vapers who want to avoid a return to smoking.”
June 7, 2023
U.S. FDA Sends Warnings to Sellers of Puff Bar, Hyde

Credit: Hyde
Warning letters have been issued to 30 retailers, including one distributor, for illegally selling unauthorized disposable vaping products. The FDA typically sends warning letters to manufacturers, however, now retailers are facing stiffer scrutiny.
The U.S. Food and Drug Administration stated today that the unauthorized products were various types of Puff and Hyde brand disposable e-cigarettes, which were two of the most commonly reported brands used by youth e-cigarette users in 2022, according to the FDA.
The “action underscores the agency’s unwavering commitment to addressing the role retailers and distributors of unauthorized tobacco products play in this concerning public health issue facing America’s youth.,” according to the release.
FDA Commissioner Robert Califf said cracking down on disposable products most used by youth is a priority for the regulatory agency. “We’re committed to holding all players in the supply chain – not just manufacturers but also retailers and distributors – accountable to the law,” he said.
The warning letters are a result of a nationwide blitz to crack down on the sale of unauthorized e-cigarettes that are popular with youth – specifically Puff and Hyde products. The blitz included investigations of hundreds of retailers and distributors across the country. All products cited in the warning letters are disposable e-cigarettes.
“Since becoming director of CTP, I’ve been crystal clear that FDA will not stand by while retailers and distributors seek to profit off illegally selling products that are well-known to appeal to youth,” said Brian King, director of the FDA’s Center for Tobacco Products. “Retailers and distributors play a key role in keeping unauthorized tobacco products off the shelves, and if they fail to do so, we’re committed to taking appropriate action.”
The FDA generally sends warning letters the first time an inspection or investigation reveals a violation of the law, and recipients are given 15 working days to respond with the steps they’ll take to correct the violation and to prevent future violations. A majority of recipients of warning letters voluntarily correct the stated violation.
Failure to promptly correct the violations can result in additional FDA actions such as an injunction, seizure and/or civil money penalties. In addition to today’s actions among retailers, the FDA issued a warning letter to an importer of Puff Bar in October 2022; that investigation remains ongoing.
In February, FDA filed the agency’s first civil money penalty complaints against four e-cigarette manufacturers; to date, FDA has filed civil money penalty complaints against ten e-cigarette manufacturers.
And in October 2022, the first complaints for permanent injunctions were filed against six e-cigarette manufacturers. From January 2021 through May 2023, FDA issued more than 560 warning letters. All of these actions are part of FDA’s standing compliance and enforcement portfolio, and the latest counts of these actions will continue to be reported on a routine basis.
“FDA will continue to take action against anyone making, distributing, importing, or selling unauthorized e-cigarette products, especially those most used by youth,” the release states.
May 31, 2023
UK Lawmakers Under Fire to Ban Disposable Vapes

Credit: Arie Studio
Pressure is mounting against UK lawmakers to impose an outright ban on single-use vapes, amid concern about their rising popularity among youth and doubts over regulators’ ability to control the fast-moving sector.
A government call for evidence on vaping and young people in England is due to end on 6 June, with action expected on measures to clamp down on illegal vape sales, as well as the marketing and placement of relatively cheap single-use vapes.
One government official said the latter was a particular worry. They said: “Some of the marketing and branding is pretty appalling – it can look like a sweet shop.”
Some health groups have wider concerns about the approach of the government, set out by the junior health minister Neil O’Brien in a speech last month, to encourage vape use as a substitute for traditional tobacco products, with a planned “swap to stop” scheme offering a million smokers in England a free vaping starter kit.
They argue that the relatively short history of e-cigarettes means there is minimal knowledge about long-term health effects, and that evidence about their efficacy as methods to stop smoking is similarly limited, pointing to countries such as Australia, which permit them only on prescription, according to The Guardian.
The most immediate battle is likely to be fought over single-use vapes, now the chosen product for more than half of young people who use e-cigarettes.
May 28, 2023
Elf Bar Maker Wants U.S. FDA to Reverse Red List Addition

Imiracle, the manufacturer of Elf Bar, Lost Mary and EB Design vaping products, is calling on the U.S. Food and Drug Administration to reverse the agency’s recent addition of Imiracle products to its import red list and “for coherent, clear and depoliticized regulation of the U.S. vaping market.
IMiracle Shenzhen Technology Co. Ltd. issued a statement regarding the placement of its products on the FDA’s Import Alert # 98-06. The company said it is disappointed by the FDA’s decision to “abruptly and arbitrarily” add the company’s products to the FDA import red list.
The company stated that it was given no notice regarding the decision and was provided no opportunity to address any FDA concerns before action was taken.
“It is the job of the FDA to provide consistent and coherent regulatory clarity to the U.S. marketplace. This red list announcement fails to meet this responsibility and provides yet another example of FDA’s politicized decision-making,” a spokesperson for Imiracle stated. “The FDA is singling out IMiracle’s products, despite the fact that the company was working in good faith through the FDA’s PMTA process. At the same time, the FDA is failing to address the flood of products from manufacturers that have ignored and never attempted to comply with FDA regulations.
“This decision also ignores the latest science on e-cigarette use and continues to prevent U.S. adults from accessing an entire category of nicotine products that FDA knows are significantly safer than cigarettes. Further, no IMiracle brands have ever been identified in the National Youth Tobacco Survey as top brands used by youth.
“The FDA’s capricious action is not surprising given the agency’s history of regulating vaping products out of existence. It is appropriate for the industry and its more than 10 million adult consumers to demand a clear and thoughtful regulatory regime from the federal government, and they have done so. The FDA has failed to respond.
“IMiracle calls on the FDA to reverse its decision to place IMiracle products on the import red list. We welcome the engagement and the conversation needed to create a proper and fair regulatory regime around the e-cigarette marketplace that works for all stakeholders.”
The FDA last week issued “Import Alert 98-06” that states the regulatory agency will detain new tobacco products such as e-cigarettes without marketing authorization at the border.
The companies impacted would include all importers, manufacturers and transporters of vaping product brands such as Elf Bar, EB Design, Eonsmoke, Esco Bars and Stik that are on the agency’s “Red List.”
May 25, 2023