Author: Staff Writer

UK Health Authorities Warn of High Nicotine Vapes

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The Health and Safety Executive (HSE), a UK health authority, has warned the public against the use of a number of e-cigarette products due to illegal levels of nicotine found in Ireland.
Irish retailers have been ordered to remove the two products from sale and to issue a recall to customers, reports the Irish Times.
The two products are both disposable MK Bar 7000s from the brand McKesse, with separate flavors, Blue & Razz Ice and Green Apple, subject to the warning.
The products contain more than the permitted amount of nicotine of two percent or 20mg/ml.
The HSE’s environmental health service, the national tobacco control office, has submitted an alert to the European Safety Gate, the EU rapid alert system for dangerous non-food products.
This is the second alert submitted by the environmental health service to the EU in recent weeks.
“I therefore must remind manufacturers and importers of electronic cigarettes and refill containers (e-liquids), it is their responsibility to ensure that they fully comply with all legislative requirements,” said Maurice Mulcahy, regional chief environmental health officer in the HSE.
Anyone who has purchased these products has been advised to avoid their use return them to the shop from which they were bought.
Retailers have been instructed to issue a recall notice on their premises and online, both on retail websites and social media. Shops have also been asked to supply the HSE with supplier traceability details of the relevant products.
July 16, 2023
Monday Deadline for Utah Nicotine Increase Comments

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The proposed settlement between the Utah Department of Health and the Utah Vapor Business Association, which represents vaping manufacturers and wholesalers, would allow Utah retailers to sell vape pens with a higher nicotine concentration than is currently legal.
Current regulations were designed to safeguard the health of Utah’s youth and reduce the risk of nicotine addiction, KPCW reports.
Two years ago, Utah set a limit of 3 percent nicotine by weight per container. If the proposed settlement goes through, that could increase to 5 percent by weight.
Newspaper reports state the U.S. Food and Drug Administration limits the amount of nicotine to 5 percent by weight. The FDA has not set a maximum nicotine level, according to the FDA.
But opponents want to prevent the increase. Gayle Ruzika, who serves as president of the Eagle Forum, a conservative lobbying organization, as well as Drug Safe Utah, says this is a non-partisan issue.
If the state doesn’t settle, Ruzika says the issue would go back to court, which she believes would be worth it.
The Department of Health and Human Services is accepting public comment on the proposed settlement. The deadline to submit comments is Monday, July 17, the day of the public hearing. Concerned individuals can email the Utah Department of Health and Human Services at comments@utah.gov.
The virtual public hearing agenda has been posted on the Utah Public Notice Website. The hearing starts at 10 a.m. July 17.
July 16, 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
Doctors Decry Tobacco’s Pharma Investments

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Pulmonologists are concerned about the tobacco industry’s investments in the pharmaceutical business, according to a Nieuwsuur report relayed by the NL Times.
Confronted with declining sales in their traditional line of business, cigarette manufacturers have been exploring adjacent activities, including in the medical sector. For example, Philip Morris International in 2021 acquired the Vectura Group, a British manufacturer of inhaled treatments, and Fertin Pharma, a Danish developer and manufacturer of pharmaceutical and well-being products based on oral and intra-oral delivery systems.
British American Tobacco and Japan Tobacco, too, have medical interests.
Nieuwsuur journalists looked at 87 pharmaceutical products and medicines the tobacco industry is investing in. They found that half of the products are intended to treat diseases linked to smoking, including lung diseases, heart disease and diabetes.
Frits Franssen, pulmonologist and professor of COPD at the University Medical Center in Maastricht in the Netherlands, worries about tobacco companies’ growing presence in the pharmaceutical business. He called their investments into medicines that treat smoke-related illnesses “uncomfortable,” pointing out that they’re earning twice from the smoker—once from the packet of cigarettes, then from treating the diseases caused by smoking.
Tobacco companies insist that their diversification efforts fit with their strategy to reduce the health toll of tobacco use. By investing in noncombustible products, for example, they are offering smokers a less harmful way to consume nicotine.
July 14, 2023
FDA Grants $3.9 Million to Study Effects of Flavors

Image: Tobacco Reporter archive
The U.S. Food and Drug Administration has given the Center for Tobacco Research at The Ohio State University Comprehensive Cancer Center a $3.9 million grant to evaluate the effects of e-cigarette flavors on smoking behaviors of current adult smokers, according to News Medical Lifesciences.
The study will be co-led by Theodore Wagener, director of Ohio State’s Center for Tobacco Research, and Tracy Smith from the Medical University of South Carolina Hollings Cancer Center.
Wagener says, “the FDA must decide how to balance its goals of protecting young people and offering harm-reduction options to adults. This new trial will generate critical data to help make more informed public health decisions that have a lasting impact.”
“The FDA is currently making regulatory decisions about e-cigarette flavors with incomplete scientific data,” Wagener said. “Existing data show that smokers also prefer flavored e-cigarettes, and while there are a few survey studies suggesting that flavored e-cigarettes may be more helpful for switching to vaping, these studies are not rigorous enough for the FDA to base its regulatory decisions on. Our study will be the first to provide the FDA with definitive information as to the benefit, if any, of e-cigarette flavors to adult smokers.”
The national, randomized, controlled trial will recruit up to 1,500 cigarette users from across the country, and researchers will measure e-cigarette flavor impact on product uptake and appeal, cigarette craving, symptoms, dependence and smoking behavior. Combination nicotine-replacement therapy will be used as a comparator to determine potential increased benefit of e-cigarettes versus nicotine-replacement therapy.
“If our study demonstrates no significant improvements in switching with flavored e-cigarette use, then the continued sale of these products is likely indefensible; however, if improvements are significant, these findings will provide a critical counterweight to the current FDA regulations and will aid future decision-making,” Wagener said.
July 13, 2023
Kentucky School District to Criminally Charge Vaping Youth

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A western Kentucky school system will issue criminal citations to kids vaping on school grounds. The zero-tolerance policy will begin during the next school year.
Vaping on school grounds in Christian County will now be a criminal offense, according to media reports.
Under a new policy adopted on Monday by Christian County Public Schools, any student in possession of a vape will be cited by law enforcement for drug paraphernalia.
If the vape contains a controlled substance, the student will also be charged with drug use, possession, or distribution.
“In middle and high school, students go through critical changes in their developing brains,” said Kim Stevenson, Director of Alternative Programs for the district. “Nicotine and other controlled substances impairs the growth of neurons and directly harms the portion of the brain responsible for learning, memory, and attention.”
Sometimes, vapes are laced with fentanyl, which is deadly in the smallest amounts, media reports stated.
July 13, 2023
Chemular Adds Carignan as Chief Commercial Officer

Jason Carignan
Jason Carignan has joined Chemular, an FDA regulatory consultancy group, as its chief commercial officer.
Carignan will lead the company’s revenue generation initiatives, strategic partnerships, and intellectual property monetization strategies across its diverse portfolio of business units, according to a press release.
“Carignan brings a wealth of experience and expertise to Chemular, having held various leadership positions in the tobacco and nicotine industry. He most recently served as president of Phillips & King and the Total Product Expo (TPE), both part of the Kretek International Inc. family of companies,” the release states. “Prior to that, he served as president of DRYFT Sciences, overseeing the successful development of the DRYFT line of nicotine pouches before selling the company to British American Tobacco in late-2020.”
With an impressive track record of driving growth and creating strategic alliances, Carignan is well-positioned to play a pivotal role in expanding Chemular’s market presence and further establishing the company as a leader in FDA regulatory matters.
Kevin Burd, CEO of Chemular. said he is thrilled to welcome Carignan to the Chemular team. “His deep industry knowledge and proven leadership in revenue generation and partnership strategies will be instrumental in driving our growth and expanding our client base,” said Burd. “We believe Jason’s appointment will advance our mission of providing comprehensive regulatory solutions to our clients and partners.”
Carignan will work closely with Chemular’s executive team to develop and execute business development strategies, identify new revenue opportunities, and forge strategic partnerships that enhance the company’s market position, according to the release.
Carignan said he was excited to join the Chemular team.
“Chemular has established itself as a trusted and innovative partner for clients navigating the complex landscape of FDA regulations,” Carignan said. “I look forward to leveraging my experience and expertise to drive revenue growth, establish impactful partnerships, and contribute to Chemular’s continued success.”
July 12, 2023
Korean Ministry Urges Group to Cancel Vape Show

Photo: Taco Tuinstra
South Korea’s Ministry of Health and Welfare (MOHW) has urged events organizer The Fairs to cancel its Korea Vape Show 2023, reports Korea Biomedical Review.
The exhibition is scheduled to take place July 21-23 in Goyang, Gyeonggi Province.
“We sent a letter asking for the event to be canceled because we had concerns from a health promotion perspective,” a MOHW official was quoted by Yonhap News as saying. “We are also concerned that adolescents may visit the show if access to the convention is not properly controlled.”
The ministry also expressed worries about advertised vaping contests that it said would violate indoor smoking restrictions. South Korea allows indoor smoking only in separate, fully enclosed areas.
The MOHW said it plans to inspect the venue on the day of the event and impose penalties if the organizers fail to create a fully enclosed smoking room inside the venue.
The organizers said they had submitted plans to resolve the issues raised by critics and said it would not cancel the convention.
The official also stressed that previous conventions had been held without problems. “During the past three conventions, officials from the local public health center visited the convention and found no wrongdoings,” she said.
July 12, 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
Broughton Grows into Extractables and Leachables

Photo courtesy of Broughton
Broughton has launched a new extractables and leachables (E&L) testing service for the reduced-risk nicotine industry. The new service will offer tailored E&L studies for products aimed at the premarket tobacco product application (PMTA) and the marketing authorization application (MAA) pathways.
According to Broughton, regulatory bodies increasingly focus on the interactions between manufacturing components, nicotine delivery devices and container-closure systems, and the final product formulation. Producers must identify and assess any toxicological risks that could arise via such interactions via E&L studies.
Aimed at supporting reduced-risk nicotine product categories such as electronic nicotine delivery systems, Modern Oral nicotine pouches and nicotine replacement therapy, the service is available across all stages of the product development lifecycle.
The new testing service includes study design, extractables studies, extractables toxicology assessments, leachables method development and validation, leachables shelf-life studies and leachable toxicology evaluation.
“Extractable and leachable studies are essential to the PMTA and MAA regulatory pathways for reduced-risk nicotine products to ensure their safety and demonstrate evidence of mitigating risk. Even in emerging categories, where regulations may not exist, such as nicotine pouches, they should be adopted as a best practice approach to product understanding and stewardship,” said Chris Allen, CEO of Broughton.
“Our scientific experts and toxicologists have years of combined experience conducting E&L studies across a range of reduced-risk nicotine product and device categories. By offering a one-stop solution for E&L studies, we can ensure a fully integrated approach across study design, extractables study delivery, leachables method development and toxicology assessment with our specialized consultants available to troubleshoot, problem-solve and develop analytical solutions to issues that may arise.”
July 11, 2023