Tag: regulation

Altria set to Submit PMTA for Flavored Njoy Products

It seems U.S. regulators are prepared to accept premarket tobacco product applications (PMTAs) for some flavored vaping products other than tobacco from a brand that already has a marketing authorization for its tobacco-flavored products.
A marketing authorization for a fruit flavor would be unexpected from U.S. regulators. And giving a flavored-product authorization to a major tobacco company would likely cause an uproar from a majority of the vaping industry.
According to media reports, Altria Group is finalizing its submissions to the U.S. Food and Drug Administration to sell Njoy vape products in blueberry and watermelon flavors, CEO Billy Gifford said Wednesday at the Consumer Analyst Group of New York (CAGNY) conference in Florida.
Altria is already waiting for action from the FDA on a menthol version, he said. The company said it hopes its plans to employ Bluetooth technology to prevent underage use in a way it hasn’t yet detailed will be enough to sway the regulatory agency that has yet to approve a flavored e-liquid vaping product in a flavor other than tobacco.
“We’ve demonstrated the age-gating restrictions are effective at preventing underage access in virtually all cases,” Gifford said, according to a transcript of the company’s webcast.
Altria plans to get its regular tobacco-flavored Njoy vape products into 100,000 stores in 2024, up from around 75,000 last year, with new packaging, Gifford said. He estimated that the international opportunity to sell heated tobacco and vape products is worth $35 billion to $50 billion.
After encouraging results from the launch of its larger-sized oral nicotine pouches, On! Plus, in Sweden, Altria plans to expand distribution there, and launch the On! Plus products in the U.K. this year, according to CFO Salvatore Mancuso.
February 22, 2024
Ispire Technology Adds Partners for Joint Venture
Credit: Kamiphotos
Ispire Technology has partnered with Touchpoint World Wide, parent to Berify, a platform that links physical products to the digital world, digital engagement, and brand protection, and Chemular International, a multi-disciplinary regulatory consulting firm to form a joint venture.
The group hopes to expedite innovation in the e-cigarette technology space, including developing secure, user-friendly solutions for age verification and age-gating nicotine vapor devices.
“The U.S. market is ripe for technological disruption that addresses age-verification, safety, and counterfeit issues,” said Berify Founder and CEO Dan Kang. “Our mission is also to create smart products that generate a new level of consumer satisfaction. We plan to achieve this by leveraging our blockchain authentication, tokenized rewards, and creating true decentralization while keeping companies in control of their products and data.”
Leveraging Berify’s multi-patented technology, Chemular’s regulatory consulting and PMTA expertise, and Ispire’s hardware capabilities, the joint venture’s goals are to introduce an industry-standard age-verification solution for vapor devices as well as the submission of PMTA applications that incorporate new technologies across the U.S. e-cigarette market.
“Our commitment is not only to create next-gen vapor devices but also to elevate market education. This venture includes additional partnerships that will bring together biometric identity and access control, ensure the solution is embedded into vapor devices during manufacturing, and provide safety, security, and privacy for consumers,” Kevin Burd, CEO of Chemular, added. “It is also a testament to our dedication to positively shaping the future of vape hardware innovation.”
Some of the possible solutions include:

Next-generation e-cigarette hardware with a user-friendly point-of-use age-verification and geo-fencing capability that eliminates the use of hardware in certain designated areas such as schools and sensitive areas;
E-cigarettes with end-to-end a range of dynamic features such as authentication, direct-to-consumer engagements, and exclusive offerings all built on the foundations of blockchain technology;
A real-time biometric identity platform for user access controls, creating added security and reliability that deters counterfeiting.
“By combining our collective expertise in hardware, blockchain and regulatory consulting, we aim to set a new standard for age verification, security and overall quality in the e-cigarette space,” said Ispire Technology Co-CEO Michael Wang. “Our hope is that this JV will be a large step forward in innovative device control, safety, counterfeit prevention and enhanced user experiences that increase overall market and consumer satisfaction.”
February 22, 2024
Florida Vape Registry Bill Moving Closer to Reality

Credit: Aleksandr Kondratov
Legislation to clear Florida shelves of all but 23 vaping products — including all flavors but tobacco — is advancing despite complaints from retailers that it will crush the industry and send consumers back to cigarettes.
The bill (SB 1006) would limit sales in Florida only to vape products approved by the U.S. Food and Drug Administration (FDA), all of which are made and sold by major tobacco companies. Scores of other products now sold throughout the state would, in turn, be banned.
More than a dozen Floridians in the vape industry spoke out against the bill before the Senate Appropriations Committee on Agriculture, Environment and General Government unanimously approved it, according to media reports.
However, according to Sen. Keith Perry, the measure’s sponsor, the limits are necessary to protect children and consumers from unsafe products and counteract a $363 million illegal vape market.
If approved, SB 1006 would create a directory under DBPR for manufacturers of nicotine dispensing devices, e-cigarettes, and vape cartridges to register the products they sell that have received FDA approval. DBPR would then publish that list online for retailers and wholesalers to review and ensure they comply.
The bill would also require wholesalers to receive a permit to do business in Florida and prohibit manufacturers from destroying certain records, including information identifying their customers, for three years.
Companies or people that provide false information to DBPR would face third-degree felony charges, punishable by up to five years in prison and $5,000 in fines. Manufacturers that knowingly ship or receive unapproved or unregistered vape and e-cig products would face up to $1,000 in fines per violation.
Any person who knowingly ships or receives unapproved or unregistered products would face a second-degree misdemeanor charge, punishable by up to $500 in fines and 60 days in jail.
DBPR estimates it will cost an additional $562,500 to cover nine new positions and create an online system necessary to facilitate and enforce the proposed law, a Senate staff analysis of the bill said.
Nick Orlando, a shop owner in Clearwater and President of the Florida Smoke-Free Association, said the bill would have a staggering impact on the growing industry here while doing nothing to improve public health.
He recommended that lawmakers toss the measure and instead draft another that will allow the market to thrive while still boosting safety. Such a bill, he said, should include the creation of a registry under DBPR that uses a federal list of manufacturers, create a permitting fee to fund enforcement, and limit the sale of vape products to 21-and-over specialty stores.
“This addresses the registry, youth access, and enforcement,” he said. “I believe Florida can do better.”
SB 1006 will next go to the Senate Fiscal Policy Committee, after which it could receive a floor vote. A similar House companion (HB 1007) by Rep. Toby Overdorf also pends one more committee hearing before being eligible for a full vote by the chamber.
February 22, 2024
Louisiana Hearing on Vape Product Registry Today
Credit: Pabrady63
A big decision is expected today regarding the sale of vapes in Louisiana.
In 2023, a law was passed to triple taxes on vape products in Louisiana. The extra revenue was to be allocated to entities like state police and the State Fire Marshal’s Office.
Part of the law banned the sale of products not approved by the FDA.
“All of the products we have here? Like 90 percent of them are not on there. So due to that, we were supposed to take a bunch of things off the shelves,” Ayub Kahn with Lit Vapes said, according to media reports.
Vape shop owners were supposed to register any approved products with Alcohol and Tobacco Control by November 2023, but that registry never came to fruition after the Louisiana Convenience Store and Vape Association filed a lawsuit.
They argue the law is unconstitutional and works against itself – it increased taxes on products, the majority of which it banned.
A judge granted a preliminary injunction in January temporarily halting the law from being enforced, and the permanent injunction hearing is taking place today.
February 21, 2024
U.K. Vape Industry Proposes New Licensing Scheme

Photo: VPZ
The vaping industry was poised to present a proposal for a retailer and distributor licensing scheme to U.K. lawmakers today.
In addition to a self-sustaining fee structure, the proposed scheme includes governance and oversight mechanisms along with criteria that businesses would need to meet before qualifying for a license. It also outlines a fine and penalty system for those who breach the terms of the license and the conditions under which a license can and should be revoked.
To qualify for a license, retailers will need to show they have put measures in place to prevent the sale of vapes to minors; do not sell nicotine-free vapes to minors; only stock and sell compliant products; operate legally across all areas of the business; promote products within the advertising regulations; and meet their environmental obligations.
Vape retailers and distributors may be blocked from obtaining a license under a number of circumstances, including if they’ve previously been caught selling vapes without the appropriate certifications or if they are attempting to reapply within two years of having their license revoked.
Under the plans, retail licensees would also have to undergo test purchasing exercises at least every six months to ensure they are following youth access prevention procedures as well as having their stock inspected to ensure the products they sell are registered on the Medicines and Healthcare products Regulatory Agency-notified products list.
They would also be checked on a regular basis to ensure they are complying with advertising and environmental regulations. Licensed distributors would be subject to regular inspections to ensure they are meeting compliance requirements across the board.
“It doesn’t matter what legislation the government introduces, whether the newly announced ban on disposables or any future restrictions, a robust and balanced licensing system is critical to ensuring the law can actually be enforced and for ushering in a new era of responsibility, accountability and best practice,” said Dan Marchant, co-founder of the U.K. Vaping Industry Association and managing director of Vape Club, which led the development of the proposed scheme, in a statement.
The presentation of the plan comes just days after a new investigation revealed a near twentyfold increase in the number of illicit vapes seized by councils across the U.K. since 2020.
February 21, 2024
Georgia Lawmaker Introduces Vaping Registry Bill

Credit: VFHNB12
A Georgia lawmaker is seeking for the state to create a registry of vape products approved by the U.S. Food and Drug Administration.
The goal is to let retailers and consumers know what’s legal and what’s not. The bill was introduced in committee.
Lawmaker Houston Gaines showed several examples of vape products that are illegal. Media reports also state that if you check on the back, they say, “Made in China.” Nearly all vaping hardware products, legal or otherwise, are produced in China.
The FDA does not approve them, so Gaines said Georgia shouldn’t either. The FDA does not approve vaping products for sale; it only authorizes them.
The state agriculture department would maintain and publish the list. Any product not on that list could not be sold legally in the state of Georgia.
At a Monday afternoon committee hearing, there were so many people that the committee chairman agreed to hold a second one so everyone could have their say, and some pushed back hard.
One of those who got their say Monday was vape store owner Dillon Gilbert, who insists this bill will destroy their industry.
“I own vape stores in Savannah and Columbus,” Gilbert said. “We want common sense regulation, but unfortunately, this bill is a death blow to our industry.”
But Gaines insists the bill will help keep vape products laced with fentanyl or THC off the shelves. No nicotine vaping product has ever been found to be laced with fentanyl. The GFDA does not regulate THC products.
Under the bill, any store caught selling these unapproved vape products could face serious fines and possible suspension of their licenses.
Louisiana’s passed a law that bans retailers from selling vape products not listed on a state-approved registry, known as the V.A.P.E. Directory. Alabama and Florida use the same list. Nebraska is also seeking to pass a bill to create a vape registry in the state.
February 20, 2024
SWT Global Asks 8th Circuit to Stay PMTA Denials

A Missouri-based maker of menthol-flavored e-liquids urged a federal appeals court to revive its application with the U.S. Food and Drug Administration to continue selling its products, saying the agency had not given it fair notice of what approval would require.
The appeal by SWT Global Supply Inc. is one of a slew of similar cases by e-cigarette companies in the wake of the FDA’s rule deeming e-cigarette products to be subject to the same law as combustible cigarettes and the agency’s subsequent denial of millions of premarket tobacco product applications (PMTAs) by manufacturers to sell their products, according to media reports. The question of whether the FDA acted fairly has already created a split among federal appeals courts.
Jerad Najvar, a lawyer for SWT, told a three-judge panel of the 8th U.S. Circuit Court of Appeals that the FDA had denied SWT’s applications because the company had not presented a controlled trial or study showing that the menthol liquids can help adult smokers quit smoking as compared to tobacco-flavored liquids. He said the agency’s guidance gave no hint that it would require such a study for approval.
The question of whether the FDA acted fairly has already created a split among federal appeals courts. Most other appeals courts that have considered similar appeals by manufacturers over denied applications – including the D.C., 2nd, 3rd, 4th, 7th and 9th Circuits – have sided with the FDA. However, the 5th Circuit last month ordered the agency to reconsider the denial of two companies’ applications in a case also involving menthol-flavored products.
Jerad Najvar, a lawyer for SWT, told a three-judge panel of the 8th U.S. Circuit Court of Appeals that the FDA had denied SWT’s applications because the company had not presented a controlled trial or study showing that the menthol liquids can help adult smokers quit smoking as compared to tobacco-flavored liquids. He said the agency’s guidance gave no hint that it would require such a study for approval.
Navjar said the lack of fair notice was particularly hard on small companies like SWT with limited resources. “A client like mine doesn’t have a lot of arrows in its quiver when it’s trying to fight a decision by a federal agency,” he said.
Catherine Padhi, a lawyer for the FDA, said that comparing products’ effectiveness to tobacco-flavored products was “a natural part of the risk-benefit analysis,” given that tobacco-flavored products have a “much-reduced risk of enticing children.” She also said that SWT could submit additional information to support its application.
February 16, 2024
Utah Moves Forward With Flavor Ban Legislation
Credit: Christopher Boswell
After this legislative session, the sale of flavored nicotine products may be banned in Utah.
SB61, the Electronic Cigarette Amendments, sponsored by Senate Minority Assistant Whip Jen Plumb, forbids the sale of flavored electronic cigarette products and “electronic cigarette products that have not received market authorization from the federal Food and Drug Administration.”
The Senate voted 20-3 to pass the bill, which now goes to the House for consideration, according to media reports.
The ban would exclude the flavors of tobacco, mint, and menthol for e-cigarettes.
States like California, Massachusetts, New Jersey and New York have also approved flavor sales bans.
February 15, 2024
Study Finds Vaping may be Altering Some Senses

Photo: fotofabrika
Research from the University of Otago shows that a side effect of vaping may be a distaste for “sweet” smells, reports the Otago Daily Times.
The study had more than 200 participants who vaped regularly, occasionally or never. It aimed to assess potential impacts of vaping on taste and smell.
The results showed that nonvapers found “sweet” smells more pleasant than vapers, according to Jessica McCormack, researcher from the university’s Department of Food Science.
The distaste may be a result of vapers’ overexposure to sweet vape flavors, according to McCormack.
Study participants rated pleasantness and intensity of smell and taste samples and did a sensory detection test where they guessed between plain water and the taste or smell at a very low concentration.
Results showing a smell dysfunction and taste changes in vapers were consistent with studies looking at smokers, McCormack said.
“We still have more we need to know about what the mechanisms might be here—is it related to the use of flavors or nicotine or a combination?”
The study was conducted in collaboration with the National Institute for Health Innovation and published in the journal Appetite.
February 14, 2024
Hallowell is 7th Maine City to Ban Flavored Nicotine

Credit: Lukasz Kochanek
There are now seven cities in the state of Maine that ban flavored nicotine products.
There is also legislation is due to be taken up in the Maine House for a statewide flavor ban in the coming weeks. The Senate passed it last year.
Monday night, the Hallowell City Council voted to end the sale of flavored nicotine products in the city.
The ordinance was passed after a 3-3 tie was resolved by the presiding officer.
Hallowell is now the seventh community in Maine to ban the products, joining the towns Falmouth, Portland, South Portland, Brunswick, Bangor and Bar Harbor in passing similar bans on selling flavored nicotine products.
Those who voted against the motion said prohibition isn’t effective and enforcing existing laws regarding underage sales should be a priority.
February 14, 2024