LATEST ALERTSUS - general: Juul Labs has announced that it has reached settlements covering more than 5,000 lawsuits brought by around 10,000 plaintiffs. The settlements cover personal injury allegations, consumer class action, and cases brought by government bodies and Native American tribal groups. Financial terms of the settlements were not disclosed, but Juul said it had secured an equity investment to fund them.
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From February 2022, subscribers can view and filter individual regulatory alerts per region. If you want to get our monthly compilations, visit our alerts round-up section.
US - Maine: South Portland City Council is considering a ban on the sale of flavoured tobacco products, including e-cigarettes. Councillors voted 5-2 yesterday in favour of the ban, which will include menthol products, press reports. South Portland, which has a population of 27,000, could become the fourth Maine community to ban flavoured tobacco, a previous attempt having failed in 2019.
US - Oregon: The Multnomah County Board of Commissioners has approved the first reading of an ordinance banning the sale of flavoured tobacco and nicotine products. A final reading and vote on the ordinance will be held on 15th December. Multnomah County has a population of around 800,000.
US - General: New warning letters have been sent out by the Food and Drug Administration (FDA) to e-liquid manufacturers for manufacturing/selling/distributing e-liquid products without a marketing authorisation order. In two of the warning letters, the FDA pointed out that products containing nicotine from any source are now under the FDA's jurisdiction as per this year's federal legislation modifying the definition of tobacco product.
US - New York: Westchester County legislators have voted to ban the sale of flavoured tobacco products, including menthol-flavoured products. The county-wide ban will come into effect in six months. Local media reports differing opinions in the community. Supporters said the ban would be a victory for “young people and the Black community”, citing data from the US Centers for Disease Control and Prevention (CDC). On the other hand, critics said the ban could lead to a black market in flavoured products, especially menthol cigarettes. Others said it may harm local businesses, especially those near other areas where there is no such ban. Westchester County, north of New York City, has a population of almost 1m.
US - California: RJ Reynolds and other tobacco companies have filed a motion in the US Supreme Court asking for an emergency order to prevent California from enforcing the flavour ban approved in the November ballot, press reports.
US - Oregon: The Multnomah County Board of Commissioners hosted a public hearing yesterday on proposed rules which would ban the sale of flavoured tobacco and nicotine products in the county. The board is scheduled to hear a first reading of the ordinance on Thursday, with a possible second reading on 15th December. Part of the Portland-Vancouver metropolitan area, Multnomah County has a population of just over 800,000 and includes Portland, the largest city in Oregon.
US - California: Attorney general Rob Bonta announced $18.6m in state grant funding to 41 local government agencies to tackle the illegal sale of tobacco products, especially to minors, as part of the Department of Justice’s annual Tobacco Grant Program. The grant programme hopes to not only curb retailers disregarding federal tobacco laws, but to ultimately prevent the next generation from being addicted to tobacco.
US - Ohio: Columbus City Council is debating a ban on flavoured tobacco products, which would include e-cigarettes and menthol tobacco products, news reports. The ordinance provides civil penalties and makes it a violation for any tobacco retailer to sell e-cigarettes and flavoured tobacco products. Columbus is the capital of Ohio, with a population of around 900,000.
US - general: A medical study published in the Journal of the American Dental Association (JADA) suggests that patients who used e-cigarettes were at a higher risk than non-vapers of developing dental cavities. This is treated as preliminary data, and the researchers say: “evidence on the potential oral health effects of vaping is scarce and there are limited data on possible links to both caries and periodontal disease”.
US - Louisiana: The Department of Revenue has published a rule amending the Louisiana Administrative Code (LAC 61.III.1533 and 1534) to mandate electronic filing of tobacco tax returns and reports by retailers of vapour products and electronic payment of the tax. The proposed rule was published on 20th August and heard on 27th September.
US - Oklahoma: The Oklahoma County Board of Commissioners has voted to join the litigation against the biggest e-cigarette manufacturers, alleging that companies such as Juul Labs knew about the risks involved and their marketing to youth, local media reports. District commissioner Brian Maughan said: “Oklahoma statistically has an exorbitantly high number of young people before they’re even 18, participating in doing e-cigarette forms of tobacco usage.” Oklahoma County, which includes the state capital Oklahoma City, has a population of around 800,000.
US - Montana: Bill LC 1111 – a draft request to classify e-cigarettes as tobacco – has been introduced. The text for the bill has not been produced yet.
US - Nevada: Assembly Bill 53 has been prefiled in Nevada, which would modify the penalty for selling certain tobacco products, including e-cigarettes, to persons under 21. This bill would establish that for a second violation within a 24-month period the civil penalty would be decreased from $1,250 to $1,000. Additionally, the licence would be suspended for up to 180 days.
US - Federal: The US Food and Drug Administration (FDA) has released a statement about warning letters it sent yesterday (16th November) on why exactly they were issued. The reasons given were that (1) each product is packaged to look like toys, food, or cartoon characters and is likely to promote use by youth and (2) no premarket application had been submitted by any of the manufacturers. The e-cigarettes in question were designed to look like toys (such as a Nintendo Game Boy or a walkie-talkie); feature TV or video game characters that appeal to youth (such as The Simpsons or Minions); or imitate food (for example, popsicles). Brian King, director of the FDA’s Center for Tobacco Products (CTP) said: "The designs of these products are an utterly flagrant attempt to target kids.”
US - federal: New warning letters have been sent out by the FDA to e-liquid manufacturers for manufacturing, selling or distributing e-liquid products without a marketing authorisation order.
US - general: According to a new study by the US Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA), more than 3m middle and high school students reported using a “tobacco product” in 2022. The study assessed eight commercial products and concluded that for the ninth consecutive year e-cigarettes were the most commonly used tobacco product, followed by cigars, cigarettes and smokeless tobacco.
US - California: Tobacco companies are suing California over the flavour ban that passed via the ballot on Tuesday 8th November. They state that although the state and localities have broad authority to regulate tobacco products under federal law, "one thing they cannot do is completely prohibit their sale because they do not meet the state or locality’s preferred 'tobacco product standards'." Thus, the flavour ban would be pre-empted by federal law. The plaintiffs are RJ Reynolds Tobacco Company, RJ Reynolds Vapor Company, American Snuff Company, LLC, Santa Fe Natural Tobacco Company, Inc., Modoral Brands Inc., Neighborhood Market Association Inc., and MORIJA LLC dba Vapin' The 619.
US - General: New warning letters have been sent out by the Food and Drug Administration (FDA) to e-liquid manufacturers it accuses of manufacturing, selling or distributing e-liquid products without a marketing authorisation order.
US - California: As expected, voters in California yesterday passed Proposition 31 to uphold the 2020 legislation banning the sale of flavoured e-cigarette and tobacco products. Senate Bill 793 was delayed due to a referendum call by the industry, which gave the voters the final say. Many local jurisdictions in the state have already passed some sort of restriction on flavoured products, the sale of which will now be forbidden state-wide.
US - California: Proposition 31, which aims to uphold Senate Bill 793, is on the state ballot today. A “yes” vote would ban the sale of flavoured tobacco and vaping products in California.
US - General: RJ Reynolds is requesting a new federal court trial after a North Carolina federal jury declared that RJ Reynolds owes Altria $95m in damages due to an e-cigarette patent-infringement complaint, media reports. We have previously reported on this case, and more details can be found in Altria's statement.
US - Ohio: Last week, the Columbus City Council met with business owners to discuss a potential ban on flavoured tobacco, which would also include flavoured e-cigarettes and menthol products, according to local news. The idea came out of a Columbus Public Health study, which signalled that minority communities are being targeted by tobacco shops, especially regarding menthol flavoured products. In the meeting, many spoke out against the proposed ban, especially vape shop owners, though it was also supported by several others, among them doctors and a middle school teacher. Columbus is the capital of Ohio, with a population of around 900,000.
Massachusetts: The Massachusetts Superior Court has dismissed a challenge to the town of Brookline’s Tobacco-Free Generation bylaw, which will remain in effect, town administrator Chas Carey has announced. The bylaw prohibits anyone born after 1st January 2000 from purchasing tobacco products, including e-cigarettes, in the town. “The dismissal of this challenge is a positive outcome, validating decades of tobacco control work in local government to reduce access to tobacco and nicotine products and prevent disease for future generations,” the town’s public health commissioner Sigalle Reiss said. “Brookline has laid the path that other communities may now follow as they seek to keep harmful tobacco products out of the hands of generations to come.” Brookline, which lies in the Boston metropolitan area, has a population of around 60,000.
US - Federal: The US Food and Drug Administration (FDA) has received numerous comments from a variety of industry members about certain aspects of its Tobacco Program. Many of the comments claim that the regulatory agency has not convened its own group of scientific advisors in nearly four years and makes decisions based on political agenda and not the science surrounding nicotine products. Another comment states that the Tobacco Control Act (TCA) favours combustible tobacco products by allowing new combustible products to take easier pathways to market, such as being considered pre-existing tobacco products. The comment period will remain open until 7th November 2022.
US - Federal: The Food and Drug Administration (FDA) has sent out a new batch of warning letters to e-liquid manufacturers for manufacturing/selling/
US - federal: The US Food and Drug Administration (FDA) has issued marketing denial orders (MDOs) for several e-cigarette products currently marketed by Logic Technology Development, including the Logic Pro Menthol e-Liquid Package and Logic Power Menthol e-Liquid Package. These are the first menthol e-cigarette products to receive a marketing decision based on a full scientific review from the FDA.
US - general: A new study from the University of Louisville has found that exposure to specific e-cigarette ingredients can cause heart arrhythmias and cardiac electrical dysfunction. According to lead researcher Alex Carll, inhaling “certain flavors or solvent vehicles” could increase the risk of atrial or ventricular fibrillation and sudden cardiac arrest. He also stressed the “urgent need” for more research into the cardiac effects of these components on animals and humans.
US - general: Juul Labs has posted its 129-page administrative appeal against the marketing denial order (MDO) issued by the Food and Drug Administration (FDA), explaining the company’s position and describing the MDO as “substantively and procedurally flawed”. Juul has presented data to counter the four main deficiencies listed in the MDO, highlighting the lack of an iterative review, saying a different standard was applied to Juul’s premarket tobacco product application (PMTA) than to other PMTAs that have been accepted, and referring to the political pressure the FDA has been under to remove Juul products from the market. Links to all documents of the ongoing suit have been made available on Juul’s website.
US - Oregon: The Multnomah County Public Health Division has recommended that a ban on flavoured tobacco and nicotine products be passed in the county, local news report. The aim behind it is to reduce youth access to these products. Multnomah County has a population of around 815,000, making it the state's most populous county.
US - California: A flavoured tobacco products ban referendum is on the 8th November ballot in California. Some health organisations are advocating to vote yes, so as to uphold Senate Bill 793, which would ban the sale of flavoured tobacco products. San Luis Obispo County health officer, Penny Borenstein, is among them, encouraging the community to vote yes, stating: "We stand with commendable health organizations such as the American Heart Association, the American Lung Association, the Cancer Action Network of the American Cancer Society, the California Medical Association, and the American Academy of Pediatrics." San Luis Obispo County has a population of around 280,000.
US - federal: The US Department of Justice (DOJ) has filed complaints in federal district courts seeking permanent injunctions to stop six e-cigarette manufacturers making and selling unauthorised vaping products. The DOJ alleges infractions that include failing to submit premarket tobacco product applications (PMTAs) and repeatedly illegally manufacturing, selling and distributing their products, despite receiving warning letters from the Food and Drug Administration (FDA) that they were breaking the law. This is the first time the FDA has used injunction proceeding to enforce the Federal Food, Drug and Cosmetic (FD&C) Act’s premarket review requirements for tobacco products.
US - Massachusetts: The Massachusetts Superior Court has dismissed a lawsuit challenging a local by-law banning the sale of tobacco products in the town of Brookline to anyone born after 1st January 2000. The court saw no conflict between the town law and state law, which specifically allows cities and towns to restrict the sale of tobacco products.
US - Federal: The Food and Drug Administration (FDA) has published a press release reviewing its activities in the last months, stating: "FDA Completes Initial Review of 95% of Non-Tobacco Nicotine Product Applications; Agency Has Issued Over 60 Warning Letters to Manufacturers, Including for Products with a Submitted Application and Negative Action."
US - California: The Santa Rosa County District Schools has joined the lawsuit against the e-cigarette company Juul, which seeks damages for school districts nationwide impacted by student vaping. Santa Rosa is home to 180,000 people and 36% of the county's high schoolers have tried vaping, media reports. As of now, over 1,400 school districts have joined the lawsuit, but that number could grow as more districts make their decisions this month.
US - general: In a letter to the Senate Select Committee on Ethics, the American Vapor Manufacturers Association (AVM) has requested an investigation into “potential unethical misconduct” by Illinois senator Richard Durbin. They believe Durbin’s repeated demands that the Food and Drug Administration (FDA) ban all vaping products, before the agency could finish its assessment of them, violated a Senate ban on intervention in the decision-making of federal agencies.
Americas: The Pan American Health Organization, the regional office of the World Health Organization (WHO), has published a paper on “Taxation of novel and emerging nicotine and tobacco products (HTPs, ENDS, and ENNDS) globally and in Latin America”, analysing “the evolution and market structure” of heated tobacco and e-cigarettes, with and without nicotine, and proposes “possible elements of a good tax policy approach for countries to consider”. The paper makes extensive use of ECigIntelligence data.
US - general: A study published in the Journal of the American Medical Association (JAMA) has tested the impact of vaping prevention advertisements on US adolescents. The randomised clinical trial found that vaping prevention advertisements focused on health harms and nicotine addiction led to lower susceptibility to vaping among youth in the US, while also discouraging cigarette smoking. It thus concluded that the Food and Drug Administration (FDA) and other health authorities should try to strengthen their efforts in communicating with youth about the adverse effects of vaping.
US - general: Tim Andrews, director of consumer issues for the think tank Americans for Tax Reform, has said the “vaping vote” possesses immense influence, which could affect the upcoming 2022 midterm elections. He bases that claim on a survey of votes which found “two in three vapers are likely to vote for a candidate aligned with them on vaping policy”. He added: “There are 20 million adult vapers in the United States. That amounts to at least 45,000 in each Congressional district, easily enough to make the difference in a close election.”
US - General: Amanda Wheeler and Greg Conley from the American Vapor Manufacturers Association have joined RegulatorWatch to discuss the Food and Drug Administration (FDA)'s actions towards vape products. Conley stated that the FDA will often do what will be easiest politically for it, which drives it towards banning more things – which is why court challenges have been so important and will be more important moving forward. Wheeler also stated that while the FDA may be issuing warning letters to small businesses whenever the pressure is on, they have not seen the FDA go after companies that have made no effort whatsoever to comply with regulations. They also tackled the “big misinformation” that continues to this day about the vaping-associated lung injury – or Evali – breakout, which they say was not due to nicotine vaping products.
US - Michigan: The University of Michigan announced it “will prohibit the use of all tobacco products on all of its campuses effective Nov. 17, in conjunction with the Great American Smokeout”. The update will ban e-cigarettes and smokeless tobacco products, which are not included in the current policy.
US - General: The US Food and Drug Administration (FDA), in coordination with the Centers for Disease Control and Prevention (CDC), released federal data from the 2022 National Youth Tobacco Survey (NYTS) on e-cigarette use among US youth. The findings show that use of e-cigarettes among young people remains high, with 2.5 m (9.4%) of the nation’s middle and high school students reporting current e-cig use. FDA commissioner Robert Califf said: “The FDA remains deeply concerned about e-cigarette use among our nation’s youth. It’s clear that we still have a serious public health problem that threatens the years of progress we have made combatting youth tobacco product use. We cannot and will not let our guard down on this issue. The FDA remains steadfast in its commitment to using the full range of our authorities to address youth e-cigarette use head-on.”
US - Oregon: Portland Public Schools district is suing Juul, accusing the e-cigarette maker of intentionally targeting youth, enticing them with kid-friendly flavours, and employing deceitful advertising practices, local media reports. “PPS is committed to the health and well-being of our students,” the district said. “We’re proud to demonstrate this commitment by becoming the first school district in Oregon to join the Juul lawsuit. The defendants’ predatory practices have victimized students – our students – and we have a responsibility to hold them accountable for the harm they have caused our community.”
US - general: Juul Labs is beginning talks for funding a potential Chapter 11 bankruptcy filing, Bloomberg reports. Anonymous sources have reported that the company has engaged in informal talks, with formal discussions expected to progress in the coming days. The preparations are not final, as a spokesperson for Juul stated they are also considering other avenues. “We will continue the preparation process for both a restructuring and other strategic options as we determine what path is best for our company,” the spokesperson said.
US - Federal: The Food and Drug Administration (FDA) has issued new warning letters to manufacturers and distributors of e-liquid products that are "new tobacco products" without the required FDA marketing authorisation to remain in the market.
US - general: Altria Group has disclosed in a filing to the Securities and Exchange Commission that it plans to end the non-compete agreement with Juul, press reports. Altria stated: "We believe the decision to terminate our noncompete maximizes our flexibility to compete in the e-vapor space while maintaining our economic interest in JUUL." More information can be found in our news briefing.
Canada: On 1st October, the federal excise duty on vaping products will start applying. The rate of CAD1 (USD0.73) per 2 ml, or fraction thereof, is charged for the first 10 ml. For e-liquids exceeding 10 ml, a rate of CAD1 (USD0.73) per 10 ml, or fraction thereof, is charged.
US - general: Juul's chief regulatory officer, Joe Murillo, has criticised the Food and Drug Administration (FDA)'s approach towards vaping regulation during a tobacco conference, press report. “Fly-by-night companies have flooded the market with illegally marketed products,” Murillo said. “These products flout laws and regulations and present a public health danger. While we’ve seen progress, regulators need to improve and prioritize effective enforcement.”
US - Portland Oregon metropolitan area: Washington County’s Ordinance 878 – which passed last November, has been on hold since January, was ratified by voters in May, but kept on hold by a preliminary injunction in July – has now been struck down by a circuit court judge, who decided the county had no authority to enact a local ban on the sale of flavoured tobacco products. The county has issued a statement disagreeing with the ruling and saying it will consider options for an appeal.
US - California: The city of Chula Vista has unanimously voted to ban the sale of flavoured tobacco and vaping products from 1st January 2023, local media reports. With a population of over 275,000, Chula Vista is the second-largest city in the San Diego metropolitan area.
