Chill Brands Group PLC said Wednesday that it will end future development and U.S. sales of its tobacco-free nicotine product line in response to additional U.S. regulatory restrictions for synthetic nicotine products.
The London-listed cannabidiol-products company said the additional restrictions for the products would incur substantial costs to manufacturers and retailers, and that it is working with international partners to transfer remaining synthetic nicotine inventory for sale, according to Market Watch.
All of Chill’s other products are unaffected.
The company said a federal funding bill amending the definition of a tobacco product was passed by U.S. Congress in March, giving the U.S. Food and Drug Administration authority over synthetic nicotine–including Chill’s “tobacco-free nicotine” chew pouch products, launched in December.
As a result, Chill would have been required to submit premarket tobacco product applications for its products to legally remain on sale, a process that could exceed a full-cost of $400,000 per flavor and which it views as commercially unviable.
“Naturally this is disappointing, but this decision will at least allow us to avoid expending further capital which will be better allocated to developing other products and potential revenue streams,” Chief Executive Callum Sommerton said.
Under new legislation proposed in New York’s state Assembly, children caught vaping in school may be required to attend a state-created smoking cessation program.
Assemblyman Keith Brown introduced A.10547 to amend the state Public Health Law to require those caught using electronic cigarettes or vapor products in schools to attend an Electronic Cigarette or Vapor Product Prevention, Control or Awareness Program, according to news reports.
Attendance in the program would be part of a bigger state effort to create an educational program used in schools throughout the state to discourage electronic cigarette use.
Children under the age of 21 who are found using or in possession of an electronic cigarette or vapor product will also have their parents or guardians notified, according to the bill text.
“Electronic cigarettes are a relatively recent product and manufacturers had previously geared marketing toward non-smoking youth, with a large assortment of sweet flavors of e-liquid and ad campaigns,” Brown wrote in his legislative justification. “Additionally, certain youth-targeting e-cigarettes were designed to be small and sleek, and refillable with user-friendly pre-filled pods of liquid-making the device easy to conceal from authority figures.”
Altria Group reduced the value of its investment in Juul Labs by nearly 70 percent, to $1.3 billion, following the Food and Drug Administration’s decision to order the e-cigarette company off the U.S. market.
The stake for which Altria paid $12.8 billion in 2018 is now valued at $450 million–below a level that allows Altria to exit a noncompete agreement and launch its own e-cigarettes. During a July 28 call with analysts and reporters, Altria said it had opted not to be released from that agreement because the arrangement was still beneficial to Altria.
On June 23, the FDA ordered Juul Labs to pull its e-cigarettes from U.S. store shelves, saying the e-cigarette manufacturer had submitted insufficient evidence that they were “appropriate for the protection of the public health.”
A federal appeals court then granted Juul Labs a emergency stay of the order to give the judges time to evaluate the merits of Juul’s appeal. The e-cigarette company separately asked the FDA to stay its own order pending the appeal, and the agency complied.
In court filings last month, Juul said the FDA overlooked more than 6,000 pages of data the company had submitted on the aerosols that users inhale.
On July 5, the FDA temporarily halted its ban on Juul Labs products, saying there were scientific issues unique to the Juul application that warrant additional review.
The agency stressed that the stay suspends but does not rescind it the marketing denial order while the e-cigarette maker appeals the agency’s decision.
Altria’s revenue fell 4.1 percent to $12.44 billion in the first half of 2022, as consumers facing high inflation bought fewer cigarettes or switched from premium to discount brands.
Despite the challenges, Altria CEO Billy Gifford, was pleased with the results.
“Our tobacco businesses performed well in a challenging macroeconomic environment for the first half of the year,” he said in a statement. “The smokeable products segment delivered solid operating companies income growth behind the resilience of Marlboro, and our moist smokeless tobacco brands continued to drive profitability.
“Our financial plans for the year remain on track, and we reaffirm our guidance to deliver 2022 full-year adjusted diluted EPS in a range of $4.79 to $4.93.”
Smoore has opened China’s first non-clinical full-scale testing laboratory for U.S. premarket tobacco product applications (PMTA).
Operated by Smoore’s Analysis, Testing and Safety Assessment Center, the laboratory provides all non-clinical evidence required to bring a new nicotine product to market, including material safety, hazardous components and potentially hazardous components (HPHC’s), and toxicology testing.
This is the first PMTA testing laboratory to open in China, and will allow Smoore to further improve the safety of its products, and help the brands they work with to successfully pass PMTA certification.
Prior to Smoore opening its new laboratory, vaping companies wanting to enter the U.S. would need to use third-party partners to complete their PMTA testing, which can be a costly and time-consuming process. With the new China facility, Smoore’s brand partners can more easily complete their PMTA certification and improve their accessibility to the US market.
“The FDA is very concerned about HPHCs and has set out a list of 33 substances which must be tested for,” said Dr Long, the director of Smoore’s new Safety Assessment Center, in a statement. “Our new laboratory can do all this and more, and has the capacity to test for 37 substances; we are the only facility in China whose testing capabilities covers the full range of HPHCs substances.”
According to Smoore, the laboratory tests against a world-leading new database of HPHCs, developed by Smoore and derived from international toxicity databases including those maintained by the U.S. Environmental Protection Agency (EPA).
Advanced computational toxicology software is also used to predict for unknown and potentially hazardous ingredients not included in these databases, further increasing Smoore’s safety assessments.
Since establishing its first research institute in 2017, Smoore has continued to lead the industry in evidence-based research. Its Safety Assessment Center has raised safety standards to medical grade, and works to constantly review product safety.
A total of eight products have been approved for marketing by the FDA, many of which are manufactured by Smoore.
Thailand’s National Tobacco Products Control Committee has moved to ban sales of vaping products products containing cannabis extracts, along with traditional cannabis cigarettes and cigars.
The meeting was chaired by Deputy Prime Minister and Public Health Minister Anutin Charnvirakul. Following the decision, a new guideline will be introduced in the form of ministerial regulations, while rules for e-cigarettes fall under the responsibility of the police and the Ministry of Digital Economy and Society, according to Thai News..
Concerning the reported sales and consumption of cannabis by a primary school student in Lampang, the minister said the consumption of cannabis products among people under the age of 20 is strictly prohibited.
Charnvirakul reiterated the health ministry’s stance against recreational cannabis use, saying the draft cannabis and hemp bill proposed in Thailand’s National Assembly does not contain any clauses that explicitly permit recreational use.
Thailand decriminalized the growing, sale, possession, and use of cannabis last month with very few rules or regulations in place to manage the newly legalized drug. Politicians soon announced that they had thought the legalization would be used mainly for medical purposes, and never intended for it to be a legal recreational drug.
Regulation of e-cigarettes, vaping devices and other heated tobacco products (HTPs) must remain with the Food and Drug Administration (FDA) and not be transferred to the Department of Trade and Industry (DTI) in the Philippines because these products concern public health, according to the FDA.
The FDA made its position clear in a statement it released in support of the Department of Health (DOH)’s request for a presidential veto of the Vape Bill (Senate Bill No. 2239 and House Bill No. 9007), which transfers regulatory jurisdiction of the products to the DTI, according toPhilStar Global.
“It is the DOH, through the FDA, which bears the constitutional mandate to protect every Filipino’s right to health, through establishing effective regulatory systems,” the FDA statement read.
Contrary to the proposed measure, the FDA said vape products and HTPs must be considered as health products instead of consumer products.
“This is especially as such products are being marketed by the industry as an alternative to conventional cigarettes, with some even claiming or implying that these products as being safer or less harmful,” the FDA said.
An overwhelming majority of EU citizens who responded to a European Commission initiative say they support tobacco harm reduction products.
The Commission’s “Call for Evidence” on the legislative framework for tobacco control received an unprecedented level of feedback, with consumers of alternatives to tobacco products – vaping, heated tobacco and oral nicotine pouches – making their voices heard in huge numbers, according to EU Political Report.
More than 24,000 EU citizens responded to the call, launched by the Commission as part of its ongoing evaluation of what future EU tobacco laws will look like through revision of the Tobacco Products Directive.
The massive interest in the issue may surprise some and may put the European Commission on the back foot as has been seen by some as having previously failed to support ‘tobacco harm reduction’.
The 4-week public consultation, from May 20 May to June 17, had one of the biggest ever responses to a consultation. On average, calls of this length receive around 354 submissions. In recent years, only the “call for evidence” for a digital euro for Europe received a similar scale of a response, but still fell short of the 20,000 submission mark despite taking place over a longer period of time (10 weeks).
Of the 24.000 submissions, more than 90 percent came from individual EU citizens, suggesting the extent to which this issue is a priority for the European public at large. Many submissions came from citizens in Germany, Italy and Romania.
It showed that the biggest issue for citizens across all member states is the regulation of reduced-risk products such as e-cigarettes. On this, it has been argued that the Commission it out of sync with public opinion.
The Commission has favored the introduction of new restrictions on reduced risk products, including flavor bans and sale restrictions but some in the industry hope the public response could now force it to reconsider these plans.
In June, the Commission announced plans to prohibit the sale of flavored heated tobacco products in the EU. The proposal came, it said, in response to the “significant increase” in the volumes of heated tobacco products sold across the EU.
A Commission report showed a 10 percent pick up in the sales volumes of heated tobacco products in more than five Member States and overall in the EU, heated tobacco products exceeded 2.5 % of total sales of tobacco products.
An overwhelming majority of submissions supported tobacco harm reduction products, including vaping and nicotine pouches, as “critical tools” that have helped smokers to quit. Respondents were nearly unanimous in opposing any plans to restrict access to such products for adults over the age of 18.
China-based JWEI has announced today that they have successfully submitted a premarket tobacco product application (PMTA) to the U.S. Food and Drug Administration for a device created with “new innovative technology” that focuses on safety, harm reduction and is designed to curb underage use.
“JWEI has been a leader in this industry from the start and this milestone again reiterates our commitment to the industry and public health: ensuring our adult customers continued access to less harmful alternatives to traditional tobacco products, while setting a new standard preventing underage youth access.” said VP of JWEI Group Jason Yao.
JWEI is the parent to the brands Joytech, Eleaf, Wismec and Joyevita. The company did not offer additional information on the specific device submitted for the PMTA.
JWEI developed a set of principles to guide through every step of its new product development, led by safety and effectiveness studies in early 2019. “The design philosophy is the foundation and guide rails for designing, manufacturing, verifying, validating, and continuously improving innovative, responsible, reliable, and high-quality products,” the release states.
The limited product debut in the UK has received overwhelming recognition from users and commercial partners after a few months’ actual use, according to JWEI
“As one of the world-leading device manufacturers and innovators of e-cigarette and vaping products, JWEI has over 3,600 granted patents and multiple internationally recognized manufacturing and quality certifications (GMP, HACCP, ISO9001, ISO13485, EHS, and ERP),” according to a press release.
The head of the U.S. Food and Drug Administration Tuesday said he has commissioned an independent review of the agency’s food and tobacco programs following months of criticism over its handling of the baby formula shortage and e-cigarette reviews, according to AP.
The announcement comes as FDA Commissioner Robert Califf attempts to push past several controversies that have dominated his second stint running the agency, including his issuing of a marketing denial order (MDO) to e-cigarette maker Juul Labs and later having to rescind that order.
“Fundamental questions about the structure, function, funding and leadership need to be addressed” in the agency’s programs, Califf said in a statement. The agency’s Center for Tobacco Products (CTP) is facing challenges navigating policy and enforcement issues from “an increasing number of novel products that could potentially have significant consequences for public health.”
Califf said the non-profit Reagan-Udall Foundation — a non-governmental research group created by Congress to support FDA’s work — would convene experts to deliver evaluations within 60 business days of both the food and tobacco operations.
An FDA-funded study falsely claims that e-cigarette use negatively impacts health and increases utilization and cost.
By VV staff
Misinformation is incorrect or misleading information. It is different from disinformation, which is deliberately deceptive. Both are rampant in the vaping industry; however, it is difficult to distinguish between them.
Complicating the issue, it’s impossible to tell if researchers of disproven or flawed anti-vaping studies conducted defective studies intentionally or if they were just bad at their jobs. Many vapor industry advocates claim researchers are intentionally coming to conclusions that fit the U.S. Food and Drug Administration’s “supposed goal” of eventually banning all nicotine products, especially when the studies are being funded by the FDA.
In one recent study, researchers found that the use of electronic cigarettes costs the United States $15 billion annually in healthcare expenditures—more than $2,000 per person a year. The study, published on May 23 in Tobacco Control, is the first to look at the healthcare costs of e-cigarette use among adults aged 18 and older, according to researchers at the University of California San Francisco School of Nursing.
“Our finding indicates that healthcare expenditures for a person who uses e-cigarettes are $2,024 more per year than for a person who doesn’t use any tobacco products,” said lead author Yingning Wang of the University of California San Francisco Institute for Health and Aging.
According to the U.S. Centers for Disease Control and Prevention, combustible cigarette smoking-related illness in the United States costs more than $300 billion each year, including more than $225 billion for direct medical care for adults. With an estimated 30 million smokers, that is $10,000 a year more than for a person a who doesn’t use tobacco products.
The researchers based their estimates of healthcare costs and utilization on data from the 2015–2018 National Health Interview Survey. Healthcare utilization included nights in the hospital, emergency room visits, doctor visits and home visits. “Healthcare costs attributable to e-cigarette use are already greater than our estimates of healthcare costs attributable to cigar and smokeless tobacco use,” said Wang. “This is a concerning finding given that e-cigarettes are a relatively new product whose impact is likely to increase over time.”
The results of the study appear to be based on two key assumptions, according to Jamie Brown, professor of behavioral science and health and director of the Tobacco and Alcohol Research Group at University College London.
“First, that the identified associations between e-cigarette use and poor health status are caused by e-cigarettes. The majority of people who use e-cigarettes are also former or current cigarette smokers. Despite the attempts at adjustment, it is likely that at least some of the association is actually caused by cigarettes,” said Brown. “The second assumption appears to be that the alternative is simply that these people would not be using e-cigarettes. However, we know that e-cigarettes help people to quit smoking cigarettes and that cigarette smoking causes enormous healthcare expenditure. Therefore, the key question is: What is the net impact on healthcare utilization when trying to account for how e-cigarettes affect how many people smoke cigarettes? These types of models have tended to suggest net benefits are likely.”
Credit: Adrian_ilie825
Peter Hajek, director of the Tobacco Dependence Research Unit at Queen Mary University of London, called the study a “baffling” piece of work. “The authors report that people who use e-cigarettes have poorer health and incur higher health costs than nonsmokers, but it is not clear why they assume that the excess health expenditure incurred by smokers who are trying to limit their smoking by using e-cigarettes—often because of acute health problems—is caused by their recent vaping rather than by their lifetime smoking,” said Hajek. “This is like claiming that the extra health expenditure incurred by people with broken legs is caused by using crutches.”
Researchers for the study sought to put a price tag on the health costs of e-cigarette use, certainly a reasonable component in the policy trade-offs over the use of e-cigarettes, according to Chuck Dinerstein, director of medicine at the American Council on Science and Health (ACSH), who has over 25 years of experience as a vascular surgeon.
He stated that in order to get their data, researchers developed a model using the National Health Interview Survey (NHIS), a household survey of the general population in the U.S. that includes detailed questions on health and use of tobacco products. “The researchers point to a study using NHIS data that per smoker—meaning combustible—attributable healthcare expenditures are $5,602,” explained Dinerstein. “The finding of this study, for both those exclusively using e-cigarettes and the dual users, is roughly a third as much. E-cigarettes reduce healthcare utilization and costs.
“The researchers point out that exclusive e-cigarette users had ‘higher odds of reporting poor health status than never tobacco users.’ That would be no surprise; no one is claiming e-cigarettes do no harm; they are less harmful than the alternative. Just like the prescription of buprenorphine is less harmful than the free-market acquisition of fentanyl … E-cigarettes have been marketed for 15 years and have been the tobacco product of choice for young adults for eight years. I find the assumption that e-cigarettes alone have manifested increased health costs at this point debatable.”
Cameron English, director of bio-sciences at ACSH, believes that the study had several critical flaws, with the most serious being the assumption that e-cigarette use would negatively impact an individual’s health and that this negative impact would increase utilization and cost. “The authors assumed what they should have demonstrated,” stated English. “That’s especially troublesome because existing evidence suggests that vaping is far less harmful than smoking. Instead of boosting healthcare expenditures, e-cigarette use probably reduces the amount of money spent to treat sick smokers. In sum, the Tobacco Control paper is terrible.”
While the research itself is scientifically suspect, two other troubling details should also be highlighted, according to English. “First, FDA paid for this low-quality study—then publicly denied any involvement until the paper was published. Second, the agency’s actions appear to reflect a broader effort to shape the peer-reviewed vaping literature then use it to justify excessive e-cigarette regulations.”
It should also be noted that while the FDA’s primary concern is saving youth from the dangers of vaping, researchers in the FDA-funded study’s opening cite concerns about the increased use of e-cigarettes by youth, especially those aged 15 to 24. “The Truth Initiative, an anti-smoking group funded by money from the Tobacco Settlement, reports that those [aged] 15 to 17 are ‘16 times more likely to vape than people aged 25 to 34,’” explains English. “Among the limitations of the study, the researchers indicate that the young, those we should be most concerned about, were not included in the study. ‘We did not include youth in the analysis due to their low healthcare utilization,’ [the researchers said].”
EVALI caused chaos
Whether it’s misinformation or disinformation, it’s costing lives. It’s keeping combustible cigarette smokers from switching to less harmful products. Another recent study led by researchers at the American Cancer Society shows that perceptions of e-cigarettes as being “more harmful” than cigarettes by adults in the United States more than doubled between 2019 and 2020, and perceptions of e-cigarettes as “less harmful” declined between 2018 and 2020.
Credit: andriano_cz.
The study also found that an increase in cigarette smoking prevalence (2019–2020) was restricted to those who perceived e-cigarettes as “more harmful” than cigarettes while increases in prevalence of e-cigarette use were restricted to those who perceived e-cigarettes as “less harmful” than cigarettes, according to a press release.
Prevalence of dual use of both products increased only among those who perceived these products “as harmful.” The results coincide with the e-cigarette or vaping use-associated lung injury outbreak (EVALI) and the Covid-19 pandemic. The data was published in the American Journal of Preventive Medicine.
“While all tobacco products, including e-cigarettes, pose a risk to the health of the user, major health events, such as the EVALI epidemic in late 2019 and the Covid-19 pandemic in 2020, paved the way to new smoking/e-cigarette health risks,” the release states. “During this time, the quality and type of information individuals were exposed to may have shaped how they compare the potential harms of tobacco products, which, in turn, may have altered tobacco use behaviors.”
How individuals perceive the harm of e-cigarettes versus traditional cigarettes can predict their individual decision to use tobacco products, but according to the study authors, this is the first study to provide evidence that this relationship translates to population-based prevalence changes.
“While this study showed sharp changes in public perceptions of e-cigarette versus cigarette harms during EVALI and Covid-19, the more relevant finding for public health is that increases in cigarette smoking and e-cigarette use prevalence occurred primarily in individuals who perceived their preferred product as relatively less harmful,” said Priti Bandi, principal scientist of risk factors and screening surveillance research at the American Cancer Society and lead author of the study. “This suggests that public perceptions of e-cigarette versus cigarette harms influence population tobacco use patterns.”
In this study, researchers analyzed data from the National Cancer Institute-sponsored Health Information National Trends Survey collected from more than 10,000 U.S. adults from 2018 to 2020. The results showed that perceptions of e-cigarettes as “more harmful” than cigarettes doubled each year, increasing most between 2019 and 2020 (2018: 6.8 percent; 2019: 12.8 percent; 2020: 28.3 percent) while uncertainty (responses of “don’t know”) in relative harm declined (2018: 38.2 percent; 2019: 34.2 percent; 2020: 24.7 percent).
“Less harmful” relative perceptions declined (2018: 17.6 percent; 2019: 15.3 percent; 2020: 11.4 percent) while “as harmful” perceptions remained steady (2018: 37.4 percent; 2019: 37.7 percent; 2020: 35.6 percent). Exclusive cigarette smoking increased between 2019 and 2020 among those who perceived e-cigarettes as relatively “more harmful”(2018: 18.5 percent; 2019: 8.4 percent; 2020: 16.3 percent), exclusive e-cigarette use increased linearly among those who perceived them as relatively “less harmful” (2018: 7.9 percent; 2019: 15.3 percent; 2020: 26.7 percent), and dual use increased linearly in those who perceived them “as harmful”(2018: 0.1 percent; 2019: 1.4 percent; 2020: 2.9 percent).
“It is challenging for individuals to make conclusions about the short[-term] and long-term health effects of tobacco products without clear, effective and ongoing communication from public health authorities, especially when new contextual events that change health harms happen,” said Bandi in a statement. “There is a need for behavioral interventions to encourage individuals to be informed consumers of available scientific findings and appreciate that while no tobacco product is safe, there are inherent differences between relative and absolute harms between tobacco products that can influence behavior. In turn, public health education campaigns must facilitate informed decision-making by translating emerging scientific evidence accurately to appropriate audiences.”
Many people also mistakenly believe that the most dangerous thing about smoking is nicotine. Many falsely believe that nicotine causes cancer. “When people who smoke perceive nicotine-replacement therapy or nicotine vapor products to be as harmful or more harmful than smoking, they are less likely to use less harmful products when attempting to quit smoking,” says Kim Murray, a research fellow with the Taxpayers Protection Alliance.
Murray believes that the widespread misperception about nicotine is due to misinformation. The misinformation is rampant in media and government messaging. This can have damaging impacts on public health.
Credit: Wachiwit
“Unfortunately, the number of people believing the misinformation about nicotine vapor products is rising,” she wrote in an opinion piece. “One of the biggest sources of misinformation is fake news shared on social media. There is a real need for informative and accurate information about smoking and nicotine, but most people don’t know where to find the information,” states Murray. “A logical resource should be their healthcare provider. However, most of the time, that would be the wrong choice because 60 percent of nurses incorrectly perceive nicotine as carcinogenic, and 72 percent believe that nicotine patches could cause heart attacks.”
In April, researchers concluded that more than 60 percent of all doctors incorrectly believe all tobacco products are equally harmful, making them less likely to recommend e-cigarettes for people trying to quit smoking, according to a study published in JAMA Network Open.
The authors of the study, led by Rutgers University, asked more than 2,000 doctors in the U.S. in 2018 and 2019 how they would advise patients on using e-cigarettes as a method of combustible smoking cessation. One in four physicians discouraged all use of e-cigarettes and were more likely to advise against e-cigarettes if the hypothetical smoker they were counseling were a younger, light smoker compared to an older, heavy smoker.
Although no associations were found between harm reduction beliefs and being asked about e-cigarettes by patients, the association between physicians’ harm reduction beliefs and their e-cigarette recommendation practices was significant.
“It will take a lot to change minds and dispel the now entrenched, and largely mistaken, mistrust of nicotine. As in many areas of public life, urban myths and half-truths, which are ingrained over time, are often easier to believe than the truth for many in society. It is difficult to persuade people that the beliefs that they hold are wrong,” states Murray. “Consumers deserve accurate information to enable them to make informed choices. The country won’t achieve health equity and social justice if we continue to misinform those who choose to use nicotine in a safe manner.”
This article first appeared in Vapor Voice 3, 2022.
“JWEI has been a leader in this industry from the start and this milestone again reiterates our commitment to the industry and public health: ensuring our adult customers continued access to less harmful alternatives to traditional tobacco products, while setting a new standard preventing underage youth access.” said VP of JWEI Group Jason Yao.
