Tag: regulation

FDA Denies Blu Marketing of 5 Flavored Products
Credit: Fontem US
The U.S. Food and Drug Administration continued its de-facto flavor ban and issued marketing denial orders (MDOs) to Fontem US LLC for four Blu disposables and one Myblu brand e-cigarette product.
The currently marketed products that received an MDO are:

Blu Disposable Menthol 2.4%
Blu Disposable Vanilla 2.4%
Blu Disposable Polar Mint 2.4%
Blu Disposable Cherry 2.4%
Myblu Menthol 1.2%
After reviewing the company’s premarket tobacco product applications (PMTAs), the regulatory agency determined that the applications lacked sufficient evidence to demonstrate that permitting marketing of the products would be appropriate for the protection of the public health, which is the standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act, according to a press note.
“The application lacked sufficient evidence regarding harmful and potentially harmful ingredients in the aerosol for one product and battery safety for several products,” the release states. “Additionally, the applicant did not present sufficient data demonstrating that the new products have a potential to benefit adult smokers, in terms of complete switching or significant cigarette use reduction, that would outweigh the risk to youth.”
While the FDA has approved 23 vaping products, none have been a flavored product. Last month, the agency also issued Fontem US, LLC MDOs for its Blu PLUS+ brand e-cigarette products. Fontem is expected to appeal the FDA decision.
February 5, 2024
Vermont Moving Closer to Flavored Nicotine Ban

Credit: Belyay
It’s likely going to become law. The Vermont House Committee on Human Services advanced a bill last week that would ban selling flavored vaping and other tobacco products, but made changes to address disagreements on whether to include menthol cigarettes.
If passed, the ban would go into effect on Jan. 1, 2025. However, the ban on menthol cigarettes would be delayed until July 1, 2025, and the Health Equity Advisory Committee would produce a report on whether the ban is discriminatory and present it to the assembly in the 2025 legislative session, according to media reports.
The bill proposes a ban on selling flavored tobacco products and substitutes, including cigarettes, vapes, cigars, snuff, and chewing tobacco. The bill’s most recent draft defines flavors as any taste or aroma other than that of tobacco, including “fruit, chocolate, vanilla, honey, maple, candy, cocoa, dessert, alcoholic beverage, mint, menthol, wintergreen, herb or spice, or other food or drink.”
There were disagreements over whether the ban supports people of color, who are disproportionately targeted by the marketing of menthol cigarettes, leading to them being more likely to die of tobacco-related diseases. Or, the ban would discriminate against people of color and the LGBTQ community by banning their preferred cigarettes and other menthol tobacco products.
February 5, 2024
North Carolina Launches Juul Document Depository

Credit: Andreykr
The attorney general for the U.S. state of North Carolina announced the launch of an online, searchable public depository that will contain nearly four million documents from the state’s lawsuit against e-cigarette manufacturer Juul Labs.
The depository was created and is being housed by the University of North Carolina at Chapel Hill’s University Libraries (UNC) and the University of California, San Francisco (UCSF). The first 50,000 documents are now available online in the UCSF Industry Documents Library, and additional documents will be added monthly, according to Attorney General Josh Stein.
“We insisted on a publicly accessible database of JUUL’s documents to ensure transparency,” said Stein. “We want people to understand what JUUL did so this never happens again. I’m grateful for the partnership with UNC and UCSF and appreciate their teams’ hard work to bring this document library to life.”
Attorney General Stein sued Juul Labs in 2019 for unlawfully designing, marketing, and selling its e-cigarettes to teenagers. In 2021, he reached a first-in-the-nation settlement with the pod vaping system manufacturer, winning $47.8 million and requiring the company to make significant business changes and publicize many of the documents it had produced during the lawsuit.
The documents include information about Juul Labs’ business practices, research, advertisement, marketing, and sales data, and “they shine a light” on how the company marketed its products to youth. Stein negotiated the release of the documents to help the public and regulators better understand JUUL’s “unlawful business practices” and prevent other companies from being able to follow the same path, the press release states.
“Libraries have deep expertise in managing complex information, along with a strong professional ethos of collaboration,” said María Estorino, vice provost for University Libraries and University Librarian at UNC-Chapel Hill. “This partnership between UNC-Chapel Hill and UCSF is a perfect example of libraries working together to bring vitally important information directly to the public.”
The Juul Labs documents will be cross-searchable with more than 18 million other documents in the UCSF library’s tobacco, opioid, chemical, drug, food, and fossil fuel industry archives.
Stein is also investigating Puff Bar and other e-cigarette manufacturers, distributors, and retailers due to ongoing concerns about flavors, age verification, and marketing.
February 5, 2024
Columbus, Ohio Vows to Sue State Over Flavor Ban

Ohio State House in Columbus (Credit: Mandritoiu)
The City of Columbus is drafting a lawsuit against Ohio for the legislature’s recent decision to ban cities from regulating tobacco sales, continuing a long battle between state and city government officials.
Last week, the Ohio Senate followed the House’s lead and voted to override Gov. Mike DeWine’s veto on a provision prohibiting local governments from enacting regulations on the sale of tobacco, including banning flavored tobacco products, according to media reports.
Starting on April 24, when the law goes into effect, cities with flavored tobacco bans will no longer be able to enforce the legislation. Columbus, Grandview Heights, Worthington and Bexley will be among the cities barred from enforcing their flavored tobacco bans.
Columbus City Attorney Zach Klein is now looking to file a lawsuit in response to the veto override.
“The governor was right to veto legislation undermining local efforts to reduce tobacco use and long-term adverse health effects, especially among young people,” Klein said. “Now that Republican lawmakers have chosen to override the governor’s veto, the City is weighing all options, which certainly includes filing a lawsuit challenging this legislative overreach.”
Klein said his office must defend the Ohio Constitution’s home rule authority, which has existed for more than 110 years. Municipal home rule grants cities the constitutional right to establish laws; as long as a rule or regulation doesn’t interfere with the laws in the Ohio Revised Code, cities have the right to make their own policies.
Republican state lawmakers have tried multiple times to prohibit local governments from restricting the sale of tobacco, only to be thwarted by DeWine’s vetoes.
In 2022, he struck down such a proposal. Last July, he struck the provision from the rest of the state budget, saying that local bans were “essential” to curb nicotine use, especially among children, without a statewide ban in place.
February 4, 2024
Ban Forces Chill Brands to Pivot From Disposables

Callum Sommerton, CEO of Chill Brands Group, told media outlets that his company is already pivoting towards a post-disposable product landscape after the UK government announced its plans to ban disposable vaping products.
Sommerton highlighted the company’s focus on compliance and innovation, emphasizing its development of a fully compliant, reusable pod system, which is being accelerated in response to the proposed regulations.
Sommerton also raised concerns about the potential unintended consequences of the ban, such as the growth of a black market for disposable vapes and a possible resurgence in tobacco use, in media reports. Citing studies and opinions from health and industry organizations, he argued for regulation over outright prohibition.
“The government’s ban, or proposed ban, I should say, is frustrating but not entirely surprising. We have prepared ourselves. At this stage, we don’t exactly know what the ban will specifically include or not include,” Sommerton said. “We can take a good guess at that, but this is, at the moment, policy and PR as opposed to draft legislation.
“So, we will have to wait and see. But that being said, regardless, we are already starting to, if we hadn’t already, pivot ourselves and position ourselves within the market for a post-disposables landscape, which we’re now sort of careering towards.”
The new rules are expected to provide retailers with a six-month moratorium once any prohibition occurs. Sommerton said there is a clear opportunity to bring to market a product that is compliant, reusable, rechargeable, and contains a degree of novelty.
“That novelty for us focuses on actually helping people quit nicotine and tobacco rather than just keeping them hooked in a cycle of addiction. We’ll be revealing much more about the products that we intend to place on the market in due course,” he said. “But beyond that, I do think this is a sort of watershed moment for the industry, albeit the government’s measures are likely to have the unintended consequence of supporting a black market in disposable vapes.
“In the legitimate market, I fully anticipate that we will see certain brands that are perhaps only interested in turning a quick buck and moving on, leaving the market, while those that are interested in longevity, building a business, and building a brand will stay in place.”
February 4, 2024
UK Flavored Vape Ban Likely to Become Law

Credit: Mapix
Proposals to ban disposable vapes and gradually phase out the sale of tobacco to people of all ages in the UK are likely to become law soon. Only a few Conservative MPs have objected to the plans, so they are expected to pass with little opposition.
Both measures will be voted on in parliament, Downing Street confirmed. While Conservative MPs will be given a non-whipped free vote on the smoking ban, it remains to be decided whether this will also happen for vaping products.
The ban on disposable vapes, along with action to combat the sale of some child-friendly, fruit-flavored varieties and restrictions on packaging and in-shop displays, would come into force late this year or in early 2025 via a mixture of a bill and secondary legislation, according to media reports.
The already announced ban on selling tobacco products to anyone born on or after Jan. 1, 2009 will also be introduced as a law, potentially in the same bill as that connected to vaping.
Although Labour is likely to back both measures, meaning they are guaranteed to pass, Sunak might have expected a significant pushback from libertarian-minded Tory MPs. However, only Liz Truss publicly denounced the plans, calling the date-based tobacco ban “profoundly unconservative” and an extension of the “nanny state.”
February 4, 2024
Quebec Urged to Crack Down on Flavored Vapes

Eric Gagnon, Vice-President of Corporate and Regulatory Affairs at Imperial Tobacco Canada, urges the government to buckle down on enforcing its law during the press conference. (Photo: Imperial Tobacco Canada)
Imperial Tobacco Canada is urging the government of Quebec to crack down on illegal flavored vaping products.
Three months after the law banning flavors in vaping products came into force, flavored e-cigarettes remain available at a large number of retail outlets that either infringe on the law or are using a variety of tactics to circumvent the law, according to Imperial Tobacco Canada, which is part of British American Tobacco.
“We are aware of the growing concern with the proliferation of products that circumvent the regulations, resulting in the creation of an illicit market,” said Imperial Vice-President of Corporate and Regulatory Affairs Eric Gagnon in a statement.
“We recently identified over 200 sales outlets that sell non-compliant vaping products. These stores have not adjusted to the new regulations and continue to offer a wide range of flavored products, including those that exceed the maximum permitted quantity of 2 ml.”
According to Imperial, these stores now also sell flavor enhancers as a way to circumvent the new regulation. “Given that these enhancers are not intended to be vaped, they can pose serious risks to consumers who use them,” the company wrote in a press note. “It is also because of a similar illegal market that a wave of lung diseases spread between 2019 and 2020 in the U.S., claiming 68 lives.”
Imperial says that instead of meeting its objective of tackling vaping among young people, the government has created a thriving illicit market.
During a Jan. 21 appearance on the talk show Tout le monde en parle Health Minister Christian Dubé blamed tobacco companies for the situation.
Imperial Tobacco Canada said it strongly refutes the allegations. “As a responsible company that fully complies with the regulations in place, we denounce these abuses and reiterate our call for stronger enforcement of the law,” said. Gagnon. “We warned the minister’s office several months ago about the inevitable collateral damage that would result from such a regulation being implemented. Unfortunately, nothing was done, and the situation persists as a result.”
February 2, 2024
U.S. FDA Warns 14 More Sellers of Flavored Vapes

Credit: Chris Titze Imaging
The U.S. Food and Drug Administration has again issued warning letters to several small business owners for selling flavored disposable vaping products.
The regulatory agency issued letters to 14 online businesses for selling unauthorized e-cigarette products. The warning letters cite the sale of disposable e-cigarette products marketed under brand names, including Elf Bar/EB Design, Lava Plus, Funky Republic/Funky Lands, Lost Mary, Cali Bars, Cali Plus, and Kangvape.
“These warning letters were informed by FDA’s ongoing monitoring of multiple surveillance systems to identify products that are popular among youth or have youth appeal, an agency press release states. “Findings from the 2023 National Youth Tobacco Survey found that more than 50 percent of youth who use e-cigarettes reported using the disposable e-cigarette brand Elf Bar; in 2023, the manufacturer of Elf Bar began marketing the product under the name EB Design.”
In addition, the brands Lava Plus, Funky Republic/Funky Lands, Kangvape, Cali, and Breeze were identified as popular or youth-appealing by the agency following a review of retail sales data and emerging internal data from a survey among youth, according to the agency.
Retailers receiving warning letters sold or distributed e-cigarette products in the United States that lack marketing authorization from the FDA violate 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.
As of Jan. 30, 2024, FDA issued more than 440 warning letters and 88 CMPs to retailers for the sale of illegal e-cigarettes, including through a series of nationwide inspection efforts of brick-and-mortar retailers, according to the release.
Earlier this week, the FDA issued complaints for civil money penalties (CMPs) against 21 brick-and-mortar retailers for selling unauthorized Esco Bars e-cigarettes.
In a press release, the agency stated that it had previously issued each retailer a warning letter for their sale of unauthorized tobacco products. However, follow-up inspections revealed that the retailers had failed to correct the violations.
The agency now seeks the maximum penalty of $20,678 from each retailer.
February 1, 2024
E-cigarette Smuggling Ring Uncovered in Finland

Photo: Kekyalyaynen
Finnish Customs uncovered a substantial e-cigarette smuggling operation in Helsinki, according to The Helsinki Times. The operation involved illicit imports from China.
Customs officers discovered a shipment of about 1,000 nicotine e-cigarettes during routine inspections at a courier terminal in Helsinki. The suspect had ordered about 1,600 e-cigarettes from China in 2023.
Finland prohibits importation of vapes through “distant communication methods” like online orders. Penalties can range from fines to imprisonment plus paying back evaded taxes and illicit gains.
Some people are unaware of the rules, however. “Not all those persons always know that it is illegal to order and distribute e-cigarettes,” said Marko Laitinen, investigation leader, referring to young people ordering e-cigarettes. “Once you get caught doing that, it always entails criminal liability.”
January 31, 2024
Sunak Asked to Reconsider UK Disposables Ban

Photo: Lumos sp
The U.K. Vaping Industry Association sent a letter to U.K. Prime Minister Rishi Sunak to “express profound dismay and disappointment” that the government decided to proceed with a disposable vape ban.
“This decision jeopardizes the significant progress made in reducing smoking rates in the U.K. and poses a threat to the well-being of millions of adults who have successfully quit smoking with the help of vaping,” the letter reads.
“We urge the government to reconsider the ban on disposable vapes and adopt a more balanced approach that prioritizes effective enforcement over draconian bans,” the letter says. “A distributor and retailer licensing scheme, as proposed to government repeatedly by the UKVIA, would achieve such an outcome without any cost to the taxpayer.”
January 30, 2024