Category: Regulation

FDA Warns 61 Small Businesses for Selling Elf Bar

The U.S. Food and Drug Administartion has again issued warning letters to several small businesses for selling illegal vaping products.
The warning letters handed to 61 brick-and-mortar retailers cite the sale of disposable e-cigarette products marketed under the brand names Elf Bar/EB Design and Lava.
“These warning letters were a result of FDA’s ongoing monitoring of multiple surveillance systems to identify products that are popular among youth or have youth appeal,” the agency wrote in a release. “Findings from the 2023 National Youth Tobacco Survey found that more than 50 percent of youth who use e-cigarettes reported using the brand Elf Bar.
“In 2023, the manufacturer of Elf Bar began marketing the product under the name “EB Design.” In addition, the brand Lava was identified as popular or youth-appealing by the agency following review of retail sales data and emerging internal data from a survey among youth.”
According to the agency, the retailers receiving these warning letters sold or distributed e-cigarette products in the United States that lacked authorization from the FDA, in violation of the Federal Food, Drug, and Cosmetic Act.
Warning letter recipients are given 15 working days to respond with the steps they will take to correct the violation and to prevent future violations. Failure to promptly correct the violations can result in additional FDA actions such as an injunction, seizure, and/or civil money penalties.
To date, the FDA has issued more than 550 warning letters and more than 100 civil money penalty actions to retailers for the sale of unauthorized e-cigarettes. However, few retailers respond to the FDA’s actions.
March 26, 2024
Belgium to Ban Sale of Disposable Vape Devices

Photo: Bennphoto
Belgium will ban the sale of disposable e-cigarettes effective Jan. 1, 2025, making it the first EU country to do so, reports The Brussels Times, citing Federal Health Minister Frank Vandenbroucke. The country has received approval from the European Commission for the ban.
“The disposable e-cigarette causes a lot of damage to society and the environment,” said Vandenbroucke. “This harmful product mainly targets our young people. I am therefore pleased that we can remove this from the market.”
Vandenbroucke said that marketing for vapes is “very savvy” and “youth-oriented” despite sales of vapes to minors being banned in Belgium. Youth use is widespread, and in 2023, about three in four points of sale sold disposables to minors, according to an inspection.
“Belgium is playing a pioneering role in Europe to break the power of the tobacco lobby,” Vandenbroucke said upon receiving approval for the ban from the European Commission. “This is another milestone in our fight against tobacco.”
“We strive for a smoke-free generation and want people, especially young people, to be better protected and to come into less contact with tobacco or alternative smoking methods,” Vandenbroucke said. “With this measure, we ensure that we remove an extremely harmful product from the market, which is also cheap and therefore attractive to young people.”
Nondisposable e-cigarettes will still be allowed as many use them to quit smoking combustible cigarettes. “Still, we have been able to agree that they can no longer be offered with lights and other things to make them attractive,” Vandenbroucke said. “It should not be a product to start smoking but to stop smoking.”
March 25, 2024
Solicitor General Asks SCOTUS for Review of Ruling

The Office of the Solicitor General filed a petition for certiorari in the case of the U.S. Food and Drug Administration v. Wages & White Lion Investments LLC, asking the Supreme Court to review the U.S. Court of Appeals for the Fifth Circuit’s en banc decision concluding that the FDA’s denial of some premarket tobacco product applications (PMTAs) was arbitrary and capricious.
According to the SG, a Supreme Court review of the Fifth Circuit’s decision is warranted because the court relied upon “legal theories that have been rejected by other courts of appeals that have reviewed materially similar FDA denial orders.”
At one level, the federal government’s decision to seek Supreme Court review is what one might expect, according to Reason. However, there is a circuit split on whether the FDA acted in an arbitrary and capricious fashion when it refused to consider certain materials submitted with PMTAs and departed from previous guidance it had given the industry. Most circuits to hear such claims turned them away.
The Fifth Circuit (along with the Eleventh Circuit) did not. Certiorari would thus be warranted to resolve the circuit split and remove any cloud over the FDA’s continuing ability to review (and deny) PMTAs for vaping products. Without Supreme Court review, vaping product manufacturers would be incentivized to seek review of any PMTA denials in the Fifth and Eleventh Circuits, which could undermine the FDA’s regulatory authority.
March 23, 2024
Louisiana to Begin Enforcing Vaping Bans Monday

Credit: Gustavo Frazao
The Louisiana Office of Alcohol and Tobacco Control (ATC) announced that it will resume enforcing state laws affecting the marketing and sale of vaping and e-cigarette products on March 18, 2024.
Beginning that day, all vapes not authorized or under review by the U.S. Food and Drug Administration cannot be legally sold in Louisiana. The ATC will provide the V.A.P.E. Directory on their website, a list of all approved vapor or alternative nicotine products and electronic cigarettes.
Businesses must remove all products not listed on the directory from their inventory and display.
The enforcement of this law was put on hold when the Louisiana Convenience Store and Vape Association filed a lawsuit, saying the law was unconstitutional. A judge granted a preliminary injunction in January, temporarily halting the enforcement of the new law.
After a permanent injunction hearing on Feb. 21, the ATC said the injunction was rendered moot, and that the vape law was now enforceable, according to media reports.
Initially, the ATC passed a law in June 2023 to triple vape taxes in Louisiana and ban the sale of vapes not authorized by the FDA. The extra revenue was to be allocated to entities like state police. The increase is due to Act 414 HB635, which was signed into law by former Gov. John Bel Edwards.
March 12, 2024
Massachusetts High Court Upholds First Generational Ban

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The highest court in Massachusetts ignored objections from vape shop owners and tobacco retailers and upheld the legality of a novel bylaw that bars cigarette sales to anyone born after January 1, 2000, in the town of Brookline. The restriction, the first of its kind in the United States, is designed to prevent future generations from using not only tobacco but also nicotine.
Retailers argued that the 2021 Brookline bylaw was pre-empted by a state law approved in 2018 that raised the minimum age for purchasing a tobacco product from 18 to 21, according to media reports. The retailers pointed out that the Brookline bylaw effectively means someone born after January 1, 2000, will not be able to purchase a nicotine product regardless of their age.
Over time, as the population ages, the bylaw will effectively ban the sale of tobacco products in the town.
In the Supreme Judicial Court’s unanimous opinion, written by Justice Dalila Wendlandt, the court acknowledged the Brookline bylaw is more restrictive than the state’s minimum age standard, but the justices had no issues with that. They said the bylaw “augments the state statute” by further limiting access to tobacco products to persons under the age of 21.
The court rejected claims by the tobacco retailers that the state law was designed to clarify what had become a muddled regulatory environment as municipality after municipality raised the minimum age for buying tobacco products.
“The retailers claim that the purpose of the Tobacco Act was ‘actually to benefit tobacco retailers . . . by eliminating the confusion that arises when the minimum age for purchasing tobacco varies from town to town and city to city across the Commonwealth,’” the opinion said. “To the contrary, the act reflects the legislative intent to protect young persons and other vulnerable populations from the deleterious health effects of tobacco product use.”
The case drew attention in Massachusetts and around the nation and the world and the outcome is likely to prompt more communities to follow Brookline’s lead, creating a patchwork quilt of regulation of tobacco products.
March 9, 2024
Senators Ask Retailers to End Flavored Vape Sales

Credit: Roland Magnusson
The chairmen of five key Senate committees on Thursday warned the chief executives of major convenience stores and wholesalers to stop selling illicit flavored vaping products, which they called “widespread violations of federal law.”
The senators voiced their concerns in letters to the companies, amplifying the frustration among some lawmakers in Congress over the continued availability of disposable e-cigarettes. They say the vivid colors and candy flavors only attract kids. The unchecked sales, they wrote, “pose a tremendous public health threat.”
“F.D.A. and the industry must do more to address the youth vaping epidemic and remove unauthorized vaping products from their shelves immediately,” Senator Dick Durbin said, according to media reports.
The letters were addressed to retailers including 7-Eleven, Circle K, bp America, Pilot, Kwik Trip and others. The U.S. Food and Drug Administration had earlier issued warnings about sales of unauthorized brands like Elf Bar, E.B. Design and Funky Republic.
“Today, millions of children use unauthorized e-cigarettes, risking nicotine addiction, respiratory illness, exacerbation of depression and anxiety, and many other harms,” read the letter to Joseph DePinto, the chief executive of 7-Eleven.
The other senators who signed the letter were Ron Wyden, Bernie Sanders, Sherrod Brown, and Richard Blumenthal.
March 7, 2024
New Virginia Vape Rules, Tax Likely to Become Law

Credit: TS Donahue
Virginia’s 2024 legislative session is likely going to send two bills regulating vaping and a new vaping tax to the governor’s desk.
Among the bills with a presumably higher impact is one that would create a new state registry that would limit sales to only FDA-approved products.
“It’s an important step to address childhood vape use,” said Rodney Willet, a cosponsor of the registry effort, according to media reports. The Henrico-based delegate says it would still open the door to sell plenty of vape products for consumers, but Midgette said the trendiness of the industry makes it hard for any one brand to stay popular.
“It’s an evolving business. There’s one brand everyone wants, then a few months later people want a different one,” Midgette said.
Midgette also pushed back on the FDA approval requirement, suggesting the products the federal government had approved represent a small and low-quality collection of brands.
Another bill would block any new shops from opening within 1000 feet of a school or daycare center.
But the business owner also noted a carve out made in Lopez’s bill for convenience stores and gas stations.
Last on the list is a new six-cent-per-mil of nicotine tax on vape products currently in the Senate budget.
“Six cents? That’s nothing,” Midgette joked, noting North Carolina added a five-cent tax already, and it’s handled by his distributors before being passed down to consumers.
March 4, 2024
Colorado Senate Approves County-Wide Flavor Bans

Credit: Marek Photo Design
Last week, the Colorado Senate voted 21-14 in favor of S.B. 24-022, a bill that allows counties in the state to pass bans on the sales of flavored tobacco products and regulate the distribution of tobacco products.
While the bill itself wouldn’t ban the sale of flavored tobacco products, it would open the door to local bans, which are currently forbidden.
This is the second time in recent years that the Colorado General Assembly has moved towards allowing local control over tobacco regulation. In March 2019, H.B. 1033 was enacted, allowing Colorado cities, towns, and counties to increase the minimum age to purchase tobacco products to 21 and increase taxes and retailer licenses, according to Halfwheel. Previously, those actions were prevented via a preemption clause.
That law was signed by Gov. Jared Polis, who remains governor today. Two years ago, Polis, a Democrat, indicated that he opposed efforts to ban the sale of flavored tobacco products statewide, saying that he instead supported giving local communities the option to enact their own bans.
S.B. 24-022 now moves on to the House of Representatives.
February 26, 2024
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
Singapore to Strengthen Vaping Enforcement

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Singapore plans to intensify its crackdown on vaping, reports The Straits Times.
In a joint statement in December 2023, the Health Sciences Authority (HSA) and the Ministry of Health said enforcement and education efforts would be stepped up to prevent vaping from gaining a foothold in Singapore.
The city state banned vaping in 2018. Buying, owning or using a vaporizer in Singapore can result in fines of up to SGS2,000 ($1,484.69). First-time offenders who import, distribute, sell or offer for sale vaporizers and their components can be fined up to SGD10,000, jailed for up to six months, or both.
Authorities encourage citizens with information on the illegal possession, use, purchase, import, distribution, sale or offer for sale of vaporizers to the Tobacco Regulation Branch.
Despite the risks, vaping has been steadily gaining ground in Singapore, with consumers buying vapes online and from overseas suppliers. In 2022, 4,916 people were violating Singapore’s vaping ban, compared with 1,266 in 2020 and 4,697 in 2021. In December 2023 alone, authorities reported 1,656 vaping -related cases.
February 18, 2024