Tag: e-cigarettes

China Rules Make Shops Close, Black Market Growing

Before China’s national standards were implemented, vape shops were growing rapidly throughout the country. (Photo: Timothy S. Donahue)
China’s National Standard for Electronic Cigarettes have begun, however, a reporter from Beijing Youth Daily claims many businesses still secretly sell the “fruit flavor” that has been banned from sale, a Chinese news outlet claims.
The report also states that after the implementation of the national standard several vape shops have closed. A reporter from Beijing Daily visited some e-cigarette sales stores or brand counters on October 2 and found that a small number of stores had been closed, and the words “transfer” were also posted.
In stores that are still in operation, only an estimated six brands of vaping products are on display, and there only two or three varieties of products. Some stores have seen the increased sale of combustible tobacco products.
China’s ban on flavored vapor products went into effect on Oct. 1 along with other new vaping product standards that were decided on earlier this year.
In November 2021, Chinese law was amended to bring the vapor industry under control of the State Tobacco Monopoly Administration, which regulates China’s tobacco products.
Products meant for export will not have to meet Chinese standards unless the destination country does not have its own specific standards.
October 5, 2022
Colorado: State Cannot Sue Juul Labs Executives

Credit: Wirestock
The Colorado Supreme Court ruled last week that the Colorado Attorney General Office’s lawsuit against electronic cigarette manufacturer Juul Labs cannot include four of the company’s executives.
The AG’s Office hoped to hold both the company and the four executives liable for alleged deceptive marketing practices which targeted adolescents and teens.
Colorado filed its lawsuit against the company in 2020 after a yearlong investigation into the company’s advertising downplaying its products’ nicotine concentration and claims that the product was a healthy alternative to traditional cigarette smoking, according to CBS News.
In the ruling, Justice Richard L. Gabriel wrote that the AG’s Office’s prosecutors provided “no facts supporting a conclusion that any of the defendants expressly aimed their conduct at Colorado.”
Six of the seven state justices were in agreement with the ruling. The seventh did not participate in the decision.
“Had the record shown that these defendants individually targeted Colorado, among other states, then our conclusion might have been different,” Gabriel wrote.
The ruling reversed a district court decision which rejected a request for dismissal by the executives’ attorneys.
October 5, 2022
Qnovia Gets $17 million for RespiRx NRT Nebulizer

Photo: Qnovia
Qnovia has raised $17 million to continue development of its RespiRx nicotine replacement product, reports Richmond Business Sense.
RespiRx is a portable, hand-held nebulizer, a powered medical device that delivers medicine as an inhaled mist and is similar to an inhaler. The device is designed to deliver a nicotine hit more quickly than existing therapies, thus enabling users to better manage withdrawals and, therefore, increase the likelihood of smoking cessation.
Qnovia was founded in 2018 in Los Angeles by Mario Danek as Respira Technologies and rebranded in September. In May, the company appointed former Altria executive Brian Quigley as CEO and Danek as chief technology officer.
The company also moved to Richmond, Virginia, in part because that state offers a more business friendly environment, according to Quigley, whose tobacco career included a six-year stint as CEO of Altria’s U.S. Smokeless Tobacco Co. subsidiary.
In addition, many of the partners the company works with are on the East Coast. Qnovia contracts with a Boston manufacturer to make its device and a firm in Pennsylvania to create the medicine administered through the device.
Qnovia will use the newly raised funds to develop a proof of concept for RespiRx as a nicotine replacement therapy product and move it through an FDA approval process before the anticipated start of human clinical trials in 2023.
The product is expected to hit the market as a prescription treatment. Qnovia is also interested in exploring how RespiRx can be used for asthma, pain management, vaccines and other uses.
October 5, 2022
Scotland Urged to Rethink Vape Ad Restrictions

Photo: jazrotorman
The U.K. Vaping Industry Association (UKVIA) has called on the Scottish government to reconsider its proposal to tighten advertising restrictions on vaping.
The call follows the publication of the outcomes of the government’s consultation on the plan. According to the UKVIA, the feedback from the consultation, which involved the input of individuals, local authorities, public health organizations and the vaping community, clearly shows that there is no majority of support for the recommendations put forward by the government, instead dividing opinions and leaving more questions than answers on the future of vaping regulations.
At the time the consultation went live, the UKVIA warned that the Scottish government’s proposals could derail the country’s 2034 smoke-free ambitions and that its stance is “in denial of the facts,” creating a significant risk to the health of people of Scotland looking to quit smoking as well as more uncertainty around vaping caused by misinformation.”

The proposals that were put forward only sought to further conflate vaping with combustible tobacco products by aligning advertising and promotion rules to existing restrictions on tobacco products.
John Dunne, director general, UKVIA
The UKVIA’s position was echoed by the Scottish Grocer’s Federation, which stated that the Scottish government’s move was unjustified and failed to appreciate the potential benefits of vaping products.
Many proposals put forward by the government generated 50-50 responses, and a number resulted in more respondents disagreeing than agreeing with them. These included proposals to ban in-store promotional displays, to make free distribution and nominal pricing of vaping products an offense and to make sponsorship agreements in respect to vaping products an offense. A higher proportion of respondents indicated that the proposed policy would have a negative impact on individuals (50.5 percent who felt it would versus 36.9 percent who didn’t) and on those with socioeconomic disadvantages (48.6 percent versus 25.5 percent).
“The proposals that were put forward only sought to further conflate vaping with combustible tobacco products by aligning advertising and promotion rules to existing restrictions on tobacco products,” said John Dunne, director general of the UKVIA, in a statment.
“Only by working with others, following the evidence and listening to people’s testimonies can we succeed in the goal of tobacco harm reduction.
October 5, 2022
European Vape Alliance Opposes Dutch Flavor Ban

Photo: Wirestock
The Independent European Vape Alliance (IEVA) has expressed concerns about the Draft Amendment of the Tobacco and Smoking Products Order for regulation of e-cigarette flavors presented by the Dutch Ministry of Public Health, Welfare and Sports.
According to the statement submitted by the Dutch authorities, the draft amendment intends to ban flavors other than tobacco in e-liquids in order to “reduce the temptation for young people and former smokers to purchase e-cigarettes.” The measure, authorities note, is “justified by the need to protect public health.”
The proposal also suggest that the Netherlands will be more likely to achieve its objective of a smoke-free generation by 2040 if e-cigarettes are rendered less attractive.
According to the IEVA, the proposed flavor ban is neither proportional nor necessary, as it is too strong a measure for the objective it seeks to achieve and fails the EU requirement that member states choose the means that least restricts the free movement of goods.
The IEVA insists that the ban will boost black market activity and jeopardize tens of thousands of jobs, while leading to a reduction in government revenues by reducing tax collection.
October 4, 2022
PMI Argues IQOS Ban Hurts Smokers Trying to Quit

Photo: librakv
The U.S. International Trade Commission (ITC) should have consulted more with the Food and Drug Administration before banning IQOS imports, lawyers for Philip Morris International argued before an appeals court panel on Oct. 3, according to Reuters.
In September 2021, the ITC upheld an initial determination from May 2021 that PMI’s IQOS device infringes on two patents owned by BAT subsidiary Reynolds American Inc. (RAI). The agency then instituted an import ban and a cease-and-desist order preventing IQOS consumables and devices from being sold in the U.S.
PMI has challenged the import ban in court, arguing among other things that the ban deprives American smokers of nicotine products that are less unhealthy than cigarettes.
The case is part of a global patent dispute between RAI’s parent company British American Tobacco and tobacco giant Altria Group, which separated from PMI in 2008 and is the exclusive distributor of IQOS in the United States.
A North Carolina jury awarded Altria won $95 million last month on claims that RAI’s Vuse e-cigarettes infringed its patents. In a separate case over RAI’s Vuse line, PMI won more than $10 million from a Virginia jury.
RAI sued Philip Morris at the ITC in 2020. Its related patent case against PMI in Virginia is on hold.
In July 2020, the FDA granted IQOS modified-risk orders, allowing Altria and PMI to tell consumers that the product generates lower levels of harmful chemicals than traditional cigarettes, among other claims.
October 4, 2022
South Africa: Stricter Tobacco, Vape Rules Ahead

Photo: michaeljung
The South African Parliament accepted submission of the Tobacco Products and Electronic Delivery Systems Control Bill, which will replace the Tobacco Products Control Act of 1993, reports Business Insider.
The bill, which was tabled in 2018, aims “to deter people, especially children and youth, from using tobacco products, encourage existing users to quit and protect nonsmokers from tobacco smoke exposure.” Regulation will cover sale, advertising, packaging and labeling of tobacco products as well as where smoking and vaping are allowed.
Under the bill, smoking and vaping in enclosed public spaces will be prohibited. Smoking too close to “an operable window or ventilation inlet of an entrance or exit” of “an enclosed public place, enclosed workplace or in or on a public conveyance” is also prohibited.
The health minister can also prohibit smoking in certain outdoor areas to “reduce or prevent the public’s exposure to smoking.” Smoking in vehicles or enclosed private spaces while in the presence of a child or nonsmoker will be prohibited. Smoking in an enclosed common area of a multi-unit residence will be banned as well.
The bill will also mandate generic packaging for tobacco products; the packaging “must have a uniform plain color and texture” and be of the same “size, type and shape.” The health minister will be responsible for setting standardized packaging and labeling requirements.
The only branding allowed on packaging will be brand name and product name in a standard color and typeface. Packages will be dominated by graphic health warnings.
Additionally, stores will only be allowed to display “a single prescribed notice informing consumers that a list of relevant or related products for sale, along with their prices and quantities, may be requested at the sales counter.” Retailers and wholesalers will no longer be allowed to display tobacco products. They “may make the product available to consumers upon request, provided that the requestor is not a child.”
This bill could also affect flavored vapor products. The health minister can prohibit “any substance or ingredient that creates a specified color, characterized flavor, smell or effect on the consumer.”
“The industry wants to be regulated,” said Asanda Gcoyi, CEO of the Vapour Products Association of South Africa. “We have to be regulated.”
“But we propose that government use [vapes and e-cigarettes] as a tobacco harm reduction product [and] this bill does not actually go that far.”
October 4, 2022
McKeganey on the Mystery of the PMTA Process

Photo: Olivier Le Moal
How effective must a product be in helping adult smokers quit to overcome the theorized level of harm to youth?
By Neil McKeganey
If there is one thing that you can say about the U.S. Food and Drug Administration’s premarket tobacco product application (PMTA) process, it is that it is exceedingly data heavy. E-cigarette manufacturers’ submissions under the PMTA process can run to the thousands of pages, reporting the results of research costing millions of dollars. To receive a marketing authorization, e-cigarette manufacturers have to be able to show that their product is “appropriate for the protection of the public health” (APPH).
The APPH standard has become something of a modern-day mantra in the world of tobacco regulation, but what exactly does it mean? While nobody would accuse the FDA of excessive clarity in its communications with industry, this much is clear—in the simplest of terms, manufacturers need to be able to show that their product is helping adult smokers to quit, or at least to substantially reduce their smoking, and that their products are not being used by nonsmokers. This, in a nutshell, is what the FDA means when it talks about the importance of assessing the net public health impact of new tobacco products—the capacity to assess the likely overall impact of a new tobacco product on the nation’s health.
The kind of evidence that manufacturers are required to present under the PMTA process ranges from longitudinal customer studies collecting data from consumers of their products over weeks or months to assess how those products are impacting on the individual’s smoking behavior. Alongside such customer studies are the randomized control trials that monitor changes in smokers’ behavior when they are using the new tobacco product under control conditions. The randomized trials are probably the sort of things most manufacturers have heard of before even if they have not carried them out. These studies are often presented as the gold standard in research evaluating the impact of a new drug. The shortcoming with the control trial design, though, is that it tells you about the impact of your product under controlled conditions; it does not tell you how people will use your product in their real life.
The results of these studies can be presented to the FDA along with studies showing which population groups are currently using the new tobacco product and which ones are likely to start using the new tobacco product if it were approved. This is where the PMTA process starts to get more mysterious. One of the key groups that the FDA wants to know about is young people. With recent studies showing that more than one in 10 young people in the U.S. are using e-cigarettes, the FDA has repeatedly stressed that in deciding whether a manufacturer’s product is going to be judged as APPH, it needs to balance the impact of the product on adult smokers and young people. When the former FDA commissioner stated in 2018 that the “offramp” to adult smoking must not be achieved at the cost of the on-ramp to youth vaping, he was making it clear that the FDA would be prepared to deny approval to a new tobacco product that might be helping adult smokers to quit if at the same time it was being used by youth or likely to be used by youth.
In a scenario where youth use of a new tobacco product can become a deal breaker for a company seeking regulatory approval for their new tobacco product, it is clear that the FDA is placing greater weight on youth vaping prevention than on adult smoking cessation. For many people, the greater value placed on youth vaping prevention may seem entirely fair—but the question at the heart of all this is by how much is the FDA valuing youth vaping prevention over adult smoking cessation? The answer to that question, or more accurately, the failure of the FDA to answer that question, is the mystery at the heart of the PMTA process. An e-cigarette manufacturer may be able to present stellar data to the FDA showing the benefit of their product in helping adult smokers to quit and still receive a marketing denial order on the basis that in the view of the FDA, the product poses too great a risk to youth.
In interpreting the results of the empirical studies that manufacturers may have carried out, the FDA is trying to model the likely impact of the product on the total population—adults and youth. Modeling, though, is a mysterious process in which you try to anticipate what you think might happen in the future under various assumed conditions in the present. Some years ago, the National Academies of Science Engineering and Medicine carried out a modeling exercise to try to quantify the impact of e-cigarettes on population health in the U.S. This was a limited exercise carried out under precisely stated assumptions about how effective e-cigarettes might be in helping smokers to quit and how harmful they may be compared to combustible cigarettes. In contrast to such transparency, the FDA has never specified how it is weighing youth harm prevention against adult smoking cessation. As a result, e-cigarette manufacturers will never know how effective their product needs to be in helping adult smokers quit to overcome the theorized level of harm to youth to be judged APPH.
Neil McKeganey is the director of the Center for Substance Use Research in Glasgow, Scotland.

October 3, 2022
States Urged to Use Juul Settlement for Prevention

Photo: gawriloff
Medical groups are urging the U.S. states that recently won a case against Juul Labs to use the money for tobacco prevention and cessation programs, according to Pew. The court case ended in a $438.5 million settlement.
The deal, which resolved an investigation by 33 states into Juul Labs’ marketing practices, requires Juul to pay states over six years to 10 years, prohibits Juul from further marketing to young people, limits where Juul products can be sold and advertised, bans flavors that haven’t been approved by the U.S. Food and Drug Administration and prohibits free samples and brand-name merchandise marketing.
Groups, including the Campaign for Tobacco-Free Kids (CTFK), the American Cancer Society Cancer Action Network, the American Heart Association, the American Lung Association, Americans for Nonsmokers’ Rights and the Truth Initiative, called on the states involved in the settlement “to both build on the successes of the historic 1998 Master Settlement Agreement with the tobacco industry and avoid some of the mistakes that were made.”
The groups cited a CTFK report showing that of the $27 billion that states collected from tobacco settlements and taxes in fiscal 2022, only 2.7 percent was spent on programs to prevent kids from smoking and help smokers quit.
Several attorneys general have expressed intent to use the Juul settlement money for smoking prevention and cessation programs. The health groups urged the officials to “translate that admirable intention into a firm commitment expressed in the text of the final agreement.”
October 3, 2022
Mendelsohn: Prescription-Only Vaping Policy Has Failed

Photo: makistock
Australia’s prescription-only model for nicotine vaping has failed, according to Colin Mendelsohn, founding chairman of the Australian Tobacco Harm Reduction Association. Writing in Filter, he urges the country to adopt a more realistic regulatory model for nicotine products.
In October 2021, the Australian government introduced a policy that requires nicotine vapers get a doctor’s prescription and purchase supplies exclusively from pharmacies or international online vendors.
The regulations were intended to prevent youth vaping and to allow access for adults as a smoking-cessation aid. One year on, the policy has achieved neither of those goals, according to a report prepared by Mendelsohn.
Instead, the rules have created a thriving illicit market for unregulated vaping products that do not comply with Australian standards. Meanwhile, vaping by adolescents has reportedly increased in Australia. With no age controls in an unregulated market, vaping products are easily accessible by teens from stores and through social media.

Nicotine liquid should be an adult consumer product, sold from licensed retail outlets such as vape shops, convenience stores, tobacconists and general stores as it is in other countries.
Colin Mendelsohn, founding chairman of the Australian Tobacco Harm Reduction Association
While the prescription model has made it harder for adults legally access nicotine vapes, combustible cigarettes remain widely available.
According to two recent surveys, between 88 to 97 percent of vapers do not have a prescription and only 2 percent of purchases are made from a pharmacy. Exposed to frequent negative messaging by Australia’s medicines regulator, the Therapeutic Goods Administration, general practitioners have been reluctant to prescribe nicotine.
The only way forward, according to Mendelsohn, is to replace the prescription-only model with a legal and regulated retail market. “Nicotine liquid should be an adult consumer product, sold from licensed retail outlets such as vape shops, convenience stores, tobacconists and general stores as it is in other countries,” he writes. “There should be strict age verification and penalties up to loss of license for underage sales.”
October 3, 2022