Tag: e-cigarettes

Elf Bar Maker Wants U.S. FDA to Reverse Red List Addition

Imiracle, the manufacturer of Elf Bar, Lost Mary and EB Design vaping products, is calling on the U.S. Food and Drug Administration to reverse the agency’s recent addition of Imiracle products to its import red list and “for coherent, clear and depoliticized regulation of the U.S. vaping market.
IMiracle Shenzhen Technology Co. Ltd. issued a statement regarding the placement of its products on the FDA’s Import Alert # 98-06. The company said it is disappointed by the FDA’s decision to “abruptly and arbitrarily” add the company’s products to the FDA import red list.
The company stated that it was given no notice regarding the decision and was provided no opportunity to address any FDA concerns before action was taken.
“It is the job of the FDA to provide consistent and coherent regulatory clarity to the U.S. marketplace. This red list announcement fails to meet this responsibility and provides yet another example of FDA’s politicized decision-making,” a spokesperson for Imiracle stated. “The FDA is singling out IMiracle’s products, despite the fact that the company was working in good faith through the FDA’s PMTA process. At the same time, the FDA is failing to address the flood of products from manufacturers that have ignored and never attempted to comply with FDA regulations.
“This decision also ignores the latest science on e-cigarette use and continues to prevent U.S. adults from accessing an entire category of nicotine products that FDA knows are significantly safer than cigarettes. Further, no IMiracle brands have ever been identified in the National Youth Tobacco Survey as top brands used by youth.
“The FDA’s capricious action is not surprising given the agency’s history of regulating vaping products out of existence. It is appropriate for the industry and its more than 10 million adult consumers to demand a clear and thoughtful regulatory regime from the federal government, and they have done so. The FDA has failed to respond.
“IMiracle calls on the FDA to reverse its decision to place IMiracle products on the import red list. We welcome the engagement and the conversation needed to create a proper and fair regulatory regime around the e-cigarette marketplace that works for all stakeholders.”
The FDA last week issued “Import Alert 98-06” that states the regulatory agency will detain new tobacco products such as e-cigarettes without marketing authorization at the border.
The companies impacted would include all importers, manufacturers and transporters of vaping product brands such as Elf Bar, EB Design, Eonsmoke, Esco Bars and Stik that are on the agency’s “Red List.”
May 25, 2023
U.S. FDA Warns Vape Makers Esco Bars, Breeze Smoke

Credit: Pastel Cartel
Two warning letters to firms that manufacture popular flavored, disposable e-cigarette products have received warning letters from the U.S. Food and Drug Administration.
Shenzen Innokin Technology Co. Ltd., the producer of Esco Bars products, and Breeze Smoke, LLC who import and distribute Breeze products for manufacturing, distributing, and/or importing unauthorized tobacco products in the United States, according to the FDA.
Esco Bars and Breeze are presently among the most commonly sold brands of disposable products in the United States.
“Today’s actions underscore FDA’s commitment to protecting youth against illegal flavored, disposable e-cigarette products. On May 12, FDA also issued an import alert for Esco Bars products,” according to an FDA statement. “The import alert places these tobacco products on the red list, which allows FDA to refuse or detain the product at the time of entry and to prevent illegal products from being distributed in the U.S.”
Credit: Breeze
Brian King, the director of the FDA’s Center for Tobacco Products, said the science clearly shows that a majority of youth who use e-cigarettes report that the products they are using are disposable and flavored products. “Given their appeal to youth, these products are a priority for FDA compliance and enforcement action,” King said.
FDA generally sends warning letters the first time an investigation or inspection reveals a violation. A majority of recipients of warning letters correct the stated violation.
However, failure to promptly correct the violations can result in additional FDA actions such as an injunction, seizure and/or civil money penalties.
May 25, 2023
Derek Yach: The Promise of Synthetic Nicotine

As consumer demand for healthier and more environmentally friendly alternatives to combustible cigarettes increases, we should expect greater focus on the benefits of this man-made alternative.
By Derek Yach
Tobacco-derived nicotine has been the sole source of nicotine used by pharmaceutical and tobacco companies until recently. The naming of the sector (tobacco sector), the naming of companies (British American Tobacco for example) and the framing of public health policies as tobacco control all show how pervasive and deeply embedded the word tobacco has become despite its scientific name being Nicotiana.
The dominance of tobacco plants started to wane when pharmaceutical companies developed nicotine-replacement therapies (NRTs) as cessation products. That highlighted the fact that while nicotine is addictive, it is not the source of death and disease caused by the products of combustion. The advent of a wide range of consumer-facing products that also use nicotine (especially e-cigarettes and nicotine pouches) to help smokers switch and/or quit has further increased the focus on nicotine.
Initially, there was no debate about the source of nicotine since it was assumed to come from the plant. In recent years, several companies have started using patented laboratory processes to develop nicotine from scratch. Many, like Zanoprima, use green chemistry to convert plant-based molecules into synthetic nicotine. Other companies, such as Contraf-Nicotex-Tobacco (CNT), begin with plant-based molecules used in cosmetics and derived from vitamin B.
Nicotine, like many molecules, exists in two orientations: S-nicotine and R-nicotine; however, nicotine that occurs naturally in the tobacco plant is entirely S-nicotine. Prior to the popularization of synthetic nicotine, this distinction had not been of great practical importance due to its naturally occurring form. Pharmaceutical-grade synthetic nicotine manufacturers such as CNT and Njoy therefore treat R-nicotine as a byproduct of the S-nicotine manufacturing process while Zanoprima’s patented process does not produce R-nicotine at all. Other manufacturers may use methods that may well not meet the high-quality standards of the pharmaceutical industry.
What Benefits Does It Bring to Consumers and the Environment?
Consumers increasingly demand information about the supply chain of end products. Leading food companies have led in being transparent about the source of all ingredients in their products with a shift toward those where labor conditions on the farm are known, addition of chemicals are reported, water and greenhouse gas use associated with products are made public and the traceability of food product ingredients is independently audited. Investors are more likely to invest in companies with sound records on these issues.
So it will be for all future nicotine products.
For many combustible users, the incentive to switch to a reduced-risk product usually starts with a desire to lower health risks. But for a considerable number, environmental issues are fast becoming reasons to switch, often independent of their health concerns. Again, this has its analogy in the food sector, where companies like Whole Foods have built their main value proposition on an environmental benefit, with health credentials being dubious.
The tobacco industry emits 84 million metric tons of carbon dioxide (CO2) a year, which is equivalent to 0.2 percent of global CO2 emissions, according to researchers at Imperial College London. Of the total, 20.87 million tons of CO2 come from cultivation, and 44.65 million tons of CO2 come from curing, together amounting to 78 percent of all tobacco industry emissions. Synthetic nicotine has the potential to virtually eliminate these.
Synthetic nicotine brings tangible benefits to consumers: A better sensorial experience, assurances about the absence of contaminants and a stamp of quality good enough for pharmaceutical companies, to name a few.
The recent World Health Organization report Tobacco: Poisoning Our Planet paints a vivid picture of the harms of tobacco farming, curing and processing for the environment. More recently, the Foundation for a Smoke-Free World provided a qualitative summary of the potential sources of environmental harm associated with reduced-risk products. Both the WHO and the foundation advocate for the reduction in global tobacco farming, outlining the harms caused by tobacco growth and cultivation on arable land, workers’ rights and malnutrition. It is likely that products created with synthetic nicotine can mitigate many concerns in the product lifecycle. And as companies selling clean nicotine push harder to ensure their products are recyclable and/or reusable, the overall negative environmental footprint will decline further.
Where Is It Likely to Grow Fastest?
Today, synthetic nicotine is used in next-generation nicotine products by emerging nicotine pouch companies like NIIN and by mainstream vape companies like Njoy. This trend is set to continue and will gain traction as e-cigarettes and nicotine pouch companies seek medical licensing using synthetic nicotine.
One example is SMOOD, an up-and-coming next-generation e-cigarette and NRT company based in New York City. SMOOD creates its products as a comprehensive approach to address both health and environmental issues simultaneously. Synthetic nicotine, recyclable hardware and design features to support smokers to quit may well be a signal of what is to come. “We always used nontobacco nicotine due to the absence of minor tobacco alkaloids and metals, both of which are inherent in agricultural production,” says Martin Steinbauer, chief engineer of SMOOD. “Together with repeatable pharmaceutical production processes, nontobacco nicotine improves the toxicological safety of our devices and eliminates carbon emissions, water use and deforestation from tobacco growing. Most importantly, it offers a clean break of nicotine from tobacco finally.”
Snus and heated-tobacco products are unlikely to shift away from tobacco in the medium term but are lowering the health risks of the tobacco they use through processing changes in the case of snus and by eliminating combustion in the case of heated-tobacco products. For decades to come, tobacco plants will be used in these products as well as in combustibles like cigarettes and cigars where a significant demand from consumers is likely to remain even as overall demand declines.
Most major tobacco companies already support farmers to diversify. It will be interesting to watch the dynamic within companies with large and growing reduced-risk portfolios who will continue to sell combustibles even as they shift to reduced-risk products to a greater extent in later numbers for several decades. Altria’s purchase of Njoy, Philip Morris International’s acquisition of Swedish Match and BAT’s dominance in the U.S. vape space all signal that these companies will take a twin track approach to nicotine sourcing.
Who Makes It and How Do They See the Future?
CNT has stated that synthetic nicotine is currently a niche product with enormous potential. “We see enormous demand there and the capacity for the synthesis of chemical is unlimited.”
Zanoprima, the only company to use myosmine as the starting material believe that in time synthetic nicotine will become the main source of nicotine in pharmaceutical products as well as in products likely to be sold as both medically approved cessation products, and as recreational products for ex-smokers to use.
Isn’t It Expensive To Use?
No—prices have been dropping recently and will continue to do so as demand increases.
Conclusion
Health and environmental consumer demand combined with benefits in terms of quality and safety, suggest that synthetic nicotine is set to meet its potential in the coming years.
A global health expert and anti-smoking advocate for more than 30 years, Derek Yach is the owner of Global Health Strategies. Previously, Yach was the director of the Foundation for a Smoke-Free World and a World Health Organization cabinet director and executive director for noncommunicable diseases and mental health. He was deeply involved with the development of the Framework Convention on Tobacco Control.

May 25, 2023
Latvian Vapers Petition to Keep Flavored Vapes

Credit: Butenkov
More than 10,000 citizens have signed a petition to keep e-cigarette flavors legal in Latvia, reports the Baltic News Network. Because the initiative has received the legally required number of signatures, it is entitled to a review by Latvia’s parliament, the Saeima.
Rather than banning flavors, the petition urges Latvia’s government to crack down on illegal vape sales and educate society about healthy choices.
According to the Tobacco-Free Products Association, the vaping industry targets smokers aiming to quit cigarettes, which are believed to be far more harmful than e-cigarettes.
According to Toms Lusis, the author of the initiative, Latvian legislators’ attitudes toward vapor products are based on outdated beliefs and studies.
“The latest scientific data shows that e-cigarettes are up to 95 percent less dangerous for human health than regular cigarettes,” he said. “The use of e-cigarettes [is] supported as a way out of sorts for residents to stop using tobacco products as well as radically combat the widely spread smoking-related diseases like lung cancer.”
Lusis cautioned that by denying adults the freedom of choice when it comes to e-cigarette flavors, the state could also lose considerable revenue from excise tax on flavored e-cigarette liquids.
May 24, 2023
Misconceptions About E-Cigarettes Persist: Study

Photo: pavelkant
About half of cigarette smokers and young adult nonsmokers think that nicotine-based electronic cigarettes have the same amount or even more harmful chemicals than regular tobacco-based cigarettes, according to a Rutgers study.
Published in Addiction, the study measured perceived levels of harmful chemicals in e-cigarettes compared with cigarettes using national samples of more than 1,000 adults ages 18 and older who smoke cigarettes and 1,000-plus adults ages 18 to 29 who are nonsmokers. The study also measured associations with e-cigarette/cigarette relative harm perceptions, e-cigarette use and interest. About 20 percent of all participants believed e-cigarettes contain fewer harmful chemicals than cigarettes while about 30 percent responded that they did not know how the levels compared.
“Our results were interesting to see given that previous review reports suggest e-cigarettes expose users to fewer types and lower levels of harmful and potentially harmful chemicals than cigarettes,” said Olivia Wackowski of Rutgers Center for Tobacco Studies, an associate professor at the Rutgers School of Public Health and lead researcher of the study, in a statement. “It was also interesting to find that only about half of adult smokers who thought e-cigarettes have fewer harmful chemicals also thought e-cigarettes are less harmful to health.”
E-cigarette harm perception relative to typical cigarettes is a common question included on major national health and tobacco surveys in the United States. However, surveys of e-cigarettes typically haven’t included a question about the perceived exposure to or level of harmful chemicals in e-cigarettes relative to cigarettes.
According to the study researchers, measuring perceptions of e-cigarette and cigarette chemical exposure is important because e-cigarette communications often directly refer to chemicals in some way, which may impact perceptions about chemicals and harms from using e-cigarettes compared to cigarettes.
May 24, 2023
Innovator to Harness Artificial Intelligence for Tobacco

Ryan Selby | Photo: Poda Holdings
Generative AI Solutions Corp. intends to build a large language model (LLM) dedicated to harnessing the power of artificial intelligence for the tobacco industry. For this purpose, it has incorporated a new subsidiary called GenAI Tobacco. The company intends to launch the LLM tobacco product under the brand name Tobacco Titan.
Tobacco Titan aims to provide AI-powered information about products, marketing and regulations, along with health and safety insights. The product could also make customized recommendations, such as new flavors, brands or smoking accessories that align with the adult user’s tastes and preferences.
“I have seen the need for innovation and data collection firsthand in the tobacco industry,” said GenAI Chairman and CEO Ryan Selby, who previously was co-founder and CEO of Poda Holdings, in a statement.
“Through my various contacts at some of the largest tobacco companies in the world, along with various other industry leaders, I believe we can build Tobacco Titan into an extremely valuable global enterprise system, providing utility to individuals and businesses alike.
“Our goal is to partner with certain companies in the tobacco industry that have access to various proprietary datasets which will give Tobacco Titan a competitive advantage based on the uniqueness of the data that is not generally available on the internet. We plan on working with our partners Metachain Technologies. to facilitate the development of Tobacco Titan and will finalize our arrangement with them in the coming weeks.”
May 24, 2023
India Health Ministry Wants Crack Down on Vape Sales

Credit: Dovidovich Mikhail
The Union Health Ministry in New Delhi, India on Monday issued a public notice for stricter implementation of ‘The Prohibition of Electronic Cigarettes Act, 2019’, which prohibits the production, manufacturing, import, export, transport, sale, distribution, storage and advertisement of e-cigarettes.
“The Prohibition of Electronic Cigarettes (Production, Manufacture, Import, Export, Transport, Sale, Distribution, Storage and Advertisement) Act, 2019 on December 5, 2019, prohibits the production, manufacture, import, export, transport, sale, distribution, storage and advertisement of electronic cigarettes and the like devices in the interest of public health,” the Ministry’s public notice said, according to The Print.
The Ministry’s public notice comes after finding that the norms allegedly being flouted by the producers, manufacturers, importers, sellers and distributors in selling and advertising electronic cigarettes.
“It is hereby informed to all Producers, Manufacturers, Importers, Exporters, Distributors, Advertisers, Transporters including Couriers, Social Media Websites, e-Commerce Websites, Online shopping websites, Shopkeepers/ retailers etc. not to directly or indirectly, produce or manufacture or import or export or transport or sell or distribute or store electronic cigarettes, whether as a complete product or any part thereof; and if advertise electronic cigarettes or take part in any advertisement (in print, electronic media, internet or website or social media etc.) that directly or indirectly promotes the use of electronic cigarettes.”
A 2022 survey showed that 94 percent of Indian vapers have given up e-cigarettes and other electronic nicotine-delivery systems (ENDS) following their ban in 2019.
The survey, designed by the Campaign for Tobacco-Free Kids and conducted in collaboration with the National Law School of India University, Bengaluru, was disseminated online and targeted those aged 18 to 34. Most respondents were from Karnataka.
The survey also showed that over 56 percent of respondents believed there was a health risk in using ENDS products while 24 percent were unaware of any risks.
May 23, 2023
U.S. FDA Envisions Harm Reduction Approach to CBD

Credit: Sofia
The U.S. Food and Drug Administration envisions a harm reduction framework for CBD (cannabidiol, an active ingredient in cannabis that doesn’t make you high) through which consumers could make informed choices.
That’s the pathway described last week by Patrick Cournoyer, who heads the FDA’s Cannabis Product Committee, at the annual Food and Drug Law Institute (FDLI) conference.
In January, the FDA announced that it would not issue long-awaited guidelines for the inclusion of CBD in food and beverages, because the agency’s existing regulatory framework was not appropriate.
The FDA’s decision came nearly five years after the federal government legalized hemp-derived CBD containing less than 0.3 percent of the psychoactive compound Delta-9 THC via the 2018 Farm Act.
Concerns over the ingestion of CBD derive from the 2018 approval of the prescription drug Epidiolex, which contains CBD for the treatment of seizures associated with two forms of epilepsy.
Studies at the time showed a significant potential risk of liver disorder and other side effects from ingesting CBD.
Cournoyer shed more light on the FDA’s January decision by calling safety concerns regarding CBD in food and beverages “important toxicological red flags that are not typical for food ingredients,” as reported by Cannabis Wire.
“What’s envisioned here is really a harm reduction framework. The existing pathways that we have for foods and supplements don’t really allow for risk or harm. If it’s shown to be harmful or we can’t really show that it won’t be harmful, then it’s not allowed to be there,” Cournoyer said.
“What we’re proposing here is a more permissive category where it is acknowledged that there’s a risk here. We can’t eliminate it, but we would view that people can make an informed choice.”
He did not provide a timeline for the development of a harm reduction framework the FDA could develop in collaboration with the U.S. Congress.
Congressional lawmakers in the U.S. have refiled a pair of bills meant to provide a pathway for the regulation of hemp derivatives like CBD as dietary supplements and food and beverage additives.
Earlier versions of the bills were filed last Congress and ultimately did not advance, but advocates and industry stakeholders feel that the U.S. Food and Drug Administration’s recent announcement that it wouldn’t be taking steps to regulate CBD will put pressure on lawmakers to act this time around.
May 23, 2023
Malaysia Ready to Table New Tobacco Endgame Bill

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Malaysia’s Ministry of Health is ready to table the Control of Smoking Product for Public Health Bill, which includes the Generational Endgame (GEG) policy, reports the New Straits Times.
If enacted, the legislation would prohibit anyone born in 2007 or later from buying and using cigarettes or vaping products in Malaysia. A provision to ban possession of those products has been dropped from the bill on the recommendation of the Parliamentary Special Select Committee.
The bill also governs registration, advertising, promotion and sponsorship, packaging and sales of smoking products.
“Any violation, including selling of cigarettes to children in the GEG group will be an offence when the bill is passed,” said the health minister’s special adviser, Helmy Haja Mydin.
People in the targeted age group caught buying or using tobacco or vaper product risk fines of MYR500 and community service. The fines had been reduced from a previous proposal to avoid unduly burdening the GEG group.
According to Mydin, the order is meant to educate and show that the policy is not purely punitive.
After its enactment, the bill requires periodic reports to measure the legislation’s effectiveness in combating underage smoking.
May 23, 2023
Alaska Senate Again Sends Tobacco 21 Bill to House

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Last week, the Alaska Senate voted 14-6 in favor of S.B. 89, a bill that would change the state’s minimum age to purchase and possess vaping and other tobacco products from 19 to 21 years old.
If approved, the bill would align Alaska’s state law with the federal standard.
The bill also would impose a statewide tax of 25 percent on e-cigarettes. A similar bill was vetoed by Gov. Dun Mike Dunleavy last fall.
The 25 percent statewide tax would add to Alaska municipal nicotine taxes already in place, such as Juneau, which currently taxes 45 percent, or $3 a pack, on the wholesale price of tobacco products, according to City and Borough of Juneau Finance Director Jeff Rogers.
The action would also allow local law enforcement to enforce the federal Tobacco 21 standard and ensure the state doesn’t lose out on grants and other funds it can receive for having its tobacco laws in line with the federal standard, reports Charlie Minato with Halfwheel.
S.B. 89 would make it illegal for anyone to sell or give tobacco or vaping products to anyone under the age of 21 years old. Those caught selling or giving tobacco or vaping products to someone under the age of 21 would be subject to a fine of at least $300.
The bill would also introduce fines for those under the age of 21 years old caught possessing tobacco or vaping products. They would be subject to a fine of no more than $150 and could be subject to a tobacco education program.
In December 2019, President Donald Trump signed a large federal spending bill that also included a provision increasing the minimum age to purchase tobacco products from 18 to 21 years old at the federal level.
While the federal law already exists, its enforcement is restricted to those who sell tobacco products and not the consumers. The vast majority of U.S. states have updated their laws to make them consistent with the federal standard.
S.B. 89 now moves onto the Alaska House of Representatives.
Last year, Alaska’s governor vetoed a Tobacco 21 bill because it included a 35 percent tax increase on vaping products.
May 23, 2023