Tag: regulation

Retailers: More Work Needed to Curb Black Market

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After New York City moved to ban flavored vape products three years ago, Sheriff Edgar Domenech says some distributors continue to sell illegal products.
“This is organized criminal activity at the forefront,” he said.
More needs to be done to address the sale of illegal flavored vape products in the state, according to retailers and former law enforcement officials.
Earlier this month, New York City Mayor Eric Adams moved to sue four vape distributors he alleges are illegally targeting minors by continuing to sell the now-banned products.
The suit against the four distributors was praised by Domench as a potential path forward for addressing the issue.
“It’s a model that other states should basically replicate to go after these distributors who are selling counterfeit vape products that are endangering the lives of our children,” Domenech said.
The proliferation of illegal vape products can be damaging to small businesses that are following the law, he added, according to Spectrum News.
“Mom-and-pop operators want to do it the right way,” he said. “They are paying the tax on the tobacco products. They’re only selling a legitimate product.”
New York Association of Convenience Stores President Kent Sopris says the lack of enforcement has hurt business owners.
“You don’t want folks to go to another store, but you especially don’t want folks going to another store because they’re selling the illegal products you can’t sell,” he said.
But more work is needed to address existing laws for flavored vape products in New York, Sopris said. The push comes as New York is working to crack down on the sale of unlicensed marijuana as the legal marketplace has struggled to get off the ground.
“What it takes is some coordination,” Sopris said. “The infrastructure is there. The will, the funding and the coordination have to be provided.”
July 18, 2023
Study: Support with Flavors Helps Smokers Quit

Image: Tobacco Reporter archive
A new study has found that smokers who get help picking flavored e-cigarettes and receive supportive text messages are more likely to quit smoking, reports The Guardian.
The study was led by London South Bank University (LSBU), and it explored in what settings vapes could help smokers quit. After three months, about 25 percent had quit and a further 13 percent reduced cigarette consumption by more than half.
Those who received help choosing a vape flavor and got supportive texts were 55 percent more likely to quit smoking in three months.
“Smoking kills approximately 8 million people worldwide every year, and even some of the often most effective treatments have little effect on reducing the number of smokers,” said Lynne Dawkins, professor of nicotine and tobacco studies at LSBU. “From this treatment, 24.5 percent were smoke-free after three months and a further 13 percent had reduced their cigarette consumption by more than 50 percent.
“The simplicity of tailored support through flavor advice and supportive messages could have a huge impact in helping people lead smoke-free lives.”
The research examined: tailored advice on which product, nicotine strength or flavor to buy; brief information on vaping harms relative to smoking; and text message support. Some people received all of these, others received none and some received some but not all.
July 18, 2023
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
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
FDA Grants $3.9 Million to Study Effects of Flavors

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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
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
Germany Readies to Ban Flavored Vape Products

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The German Bundesrat approved a third amendment to the Tobacco Products Act, which would ban flavored heated-tobacco products, according to Dokumentations und Informationssytem fur Parlamentsmaterialien.
The amendment includes “alignment of EU rules banning flavorings and distinctive flavors in heated-tobacco products; definition of the heated-tobacco product and its classification as a smoking tobacco product or smokeless tobacco product, extended labeling requirements in the form of combined text and image warnings and an information message, extension of the ban on placing cigarettes and roll-your-own tobacco with a characteristic flavor on heated-tobacco products; [and] amendment of various sections of the Tobacco Products Act,” according to the German Bundestag website.
July 11, 2023