While the use of e-cigarettes is increasing, vaping is less likely to lead to a long-term habit than smoking, according to a group of 10 interrelated papers prepared for the ongoing Population Assessment of Tobacco and Health (PATH) study.
“The most surprising finding was that while we know cigarette smoking is persistent, and we see use of electronic cigarettes, or e-cigarettes, increasing, especially among young people, what we are not seeing is that e-cigarette use is anywhere near as persistent as cigarette smoking,” says Andrew Hyland, chair of health behavior at Roswell Park and scientific lead on the PATH study.
“Cigarette smokers tend to stay cigarette smokers over time, but e-cigarette users are more likely to discontinue their use over time compared with cigarette smokers. We don’t know why that is.”
Hyland speculates that cigarettes deliver nicotine more effectively than e-cigarettes. Studies have shown that the types of e-cigarettes used during the data-collection period from 2013 to 2016 didn’t deliver nicotine as efficiently as cigarettes.
The study also found that e-cigarette use is associated with attempting to quit smoking. E-cigarette users were 20 percent more likely to try quitting cigarette smoking than adult smokers who did not use e-cigarettes.
The South African vaping industry is demanding to be allowed to sell its products online and for delivery during lockdown level3. They also want to be disassociated from the tobacco sector.
Vapour Products Association of South Africa (VPASA) chief executive Asanda Gcoyi told The Star that the narrative that vapour products, cigarettes and tobacco products were the same was problematic, according to a story posted on iol.co.za. “Vaping is not smoking, those are two different things. Both vaping and cigarettes contain nicotine, but nicotine is not what kills people in smoking, people die because of the tar,” she said.
Gcoyi added that categorising them together caused serious problems, because of the global agenda of harm reduction. “There are world associations that are pushing for tobacco harm reduction and South Africa is one of those countries, so it baffles us that we know what we know, yet we’re choosing to pretend that we don’t know the science and that vaping is less harmful,” she said.
The VPASA is calling for the government to allow vapour products to be purchased online and for delivery during lockdown level 3, according to the story.
The chief executive said the lockdown had been very bad for the vapour products industry, because the sector largely consisted of small businesses. She added that most of the business owners were former smokers who found a safe alternative and then opened shops.
“We’ve got about 5000 direct jobs that are at risk and we’ve about 400-500 small businesses across South Africa, and a lot are on the brink of bankruptcy because they can’t sell,” she said.
Gcoyi said the VPASA was worried that customers would go back to smoking. “My other concern is the illicit market. People are buying vape juice from shops we know nothing about, we hear it’s available at spaza shops, stories that people are mixing juices at home, which is extremely dangerous, because they are just mixing things and the environment is not right.”
Over the weekend, there were reports that Co-operative Governance Minister Nkosazana Dlamini Zuma had tabled draft level 3 regulations that proposed lifting the ban on alcohol sales, but extending the prohibition of cigarette sales.
Gcoyi said this caused frustration to the association as the government had not responded to the association’s communication. “We just saw now that there is a possibility of us only coming back during level 1, which is completely unacceptable. We aren’t tobacco.” Gcoyi said the industry was worried that by level 1, there wouldn’t be any business left to reopen.
She added that the association understood that there were studies on the relationship between cigarette smoking and Covid-19, however according to her there was no data that linked the coronavirus with vaping.
The World Health Organization (WHO) has published three reports to inform countries on the current state of scientific knowledge and policy options available for novel tobacco products such as electronic nicotine delivery systems (ENDS), electronic non-nicotine delivery systems (ENNDS) and heated tobacco products (HTPs).
ENDS and ENNDS, commonly known as e-cigarettes, are available in more than 100 countries while HTPs can be bought in about 40 countries.
The WHO insists that many of the new products are harmful to health.
“HTPs expose users to toxic emissions similar to those found in cigarette smoke, many of which can cause cancer, while ENDS on their own are associated with increased risk of cardiovascular diseases and lung disorders and adverse effects on the development of the fetus during pregnancy,” the WHO stated in a press release.
Because of the damaging and addictive nature of these products, the WHO says regulation is crucial to protect populations, particularly youth.
The publication of the briefs coincides with World No Tobacco Day 2020 on May 31. This year’s theme is “protecting youth from industry manipulation and preventing them from nicotine and tobacco use.”
DS Technology Licensing, the owner of registered trademarks associated with the Puff Bar vapor device, and Puff Inc., an authorized US distributor, filed a lawsuit in Los Angeles County Superior Court against over 20 Chinese and American companies accused of distributing counterfeit vaping devices, according to a story on businesswire.com.
The companies included as defendants include international manufacturer and distributor CACUQ, US distributors, e-commerce companies, and brick and mortar retail stores. The lawsuit addresses both counterfeit “Puff Bar” vapor devices as well as knockoff products identified as “Puff Smart,” “Puff Mini,” “Puff Stig,” and “Airis Puff” and seeks $50 million in restitutionary and $25 million in punitive damages.
Defendants in the lawsuit have infringed on the famous “Puff” and “Puff Bar” marks by introducing competing devices which use the stylized “Puff” associated with Puff Bar Vapor Devices as well as by openly selling fake or counterfeit Puff Bar vapor devices. Defendants are believed to be only a small number of the violators, as the anti-counterfeit verification system at puffbar.com has identified thousands of retail stores at which consumers bought devices which failed the check.
A vaping advocacy group in New Zealand has asked the Ministry of Health to reject information peddled by the World Health Organization (WHO) which inaccurately and negatively reflects on smoke-free nicotine products.
The Aotearoa Vapers Community Advocacy (AVCA) has written to Associate Health Minister, Jenny Salesa, calling for New Zealand’s position to support current global scientific evidence instead, according to an article on scoop.co.nz.
New Zealand’s Ministry of Health is [was] preparing to present at the Ninth Session of the Conference of the Parties (COP9) to the World Health Organisation’s Framework Convention on Tobacco Control (WHO-FCTC) at The Hague, in the Netherlands, this November. However, the conference has now been cancelled due to Covid-19 concerns.
Director of AVCA, Nancy Loucas, says consumers have been effectively excluded by WHO-FCTC so it is entirely up to the Ministry of Health to represent the interests of the New Zealand public.
“We need you to represent our interests based on pragmatic decisions based on current scientific evidence and verified information on the benefits of the reduced risk products.
“There are numerous scientific studies and statistical evidence reports that prove the harms of these products are no more than five percent of the harms of combustible tobacco. Nicotine is no more addictive than caffeine, and hundreds of thousands of smokers worldwide have been successful switching off combustible tobacco using ENDS (electronic nicotine delivery systems), HTPs (heated tobacco products) as well as snus,” AVCA wrote.
Loucas says despite such evidence, the WHO-FCTC continues to issue information, reports and guidance that contains several inaccuracies regarding e-cigarettes. It insists that ENDS and smokeless alternatives do not help smokers quit smoking; are more harmful than combustible tobacco; and that nicotine is equivalent to heroin in terms of addictiveness.
She believes the WHO’s position is being influenced by vested interests that provide funds to the organisation. The ‘WHO Global Report on the Tobacco Epidemic 2019’ and the ‘WHO Q&A detail on E-cigarettes’ were written with and funded by individuals who have a vested financial interest in pharmaceutical nicotine replacement therapies in development, she says.
“This vested interest has coloured the information in order to serve the political and financial interests of Bloomberg Philanthropies and the Gates Foundation who provide nearly half of all the funding for the WHO-FCTC.
“The WHO is lying to you to protect their own financial interests and keep their private donors happy. They are not objective. They are not focused on their own mandate under FCTC to promote the health of the people and their right to have information to make informed choices regarding their health,” AVCA wrote in its letter to Minister Salesa.
AVCA continues to call for New Zealand’s confirmed position on smoke-free nicotine products to be publicly released ahead of the Ministry of Health’s presentation at the WHO’s Framework Convention on Tobacco Control at The Hague later this year.
The European Tobacco Harm Reduction Advocates (ETHRA) is calling on policymakers to recognize the benefits of tobacco harm reduction in advance of World No Tobacco Day on May 31.
According to ETHRA, reduced-risk products such as e-cigarettes and snus are providing a gateway out of smoking for millions of Europeans, yet across the continent, consumer access to these products is being denied or is under threat.
Today, the organization launched a manifesto to promote appropriate regulation of innovative solutions for people who wish to continue using nicotine in far safer forms than smoking tobacco, as well as on behalf of the many smokers who may be able to quit through switching to these products in the future.
Among other things, the manifesto calls for access to harm reduction, including tobacco harm reduction, to be recognized as a human right; for consumers of safer nicotine products to be recognized as essential stakeholders in discussions of policy; and for the regulation for safer nicotine products to reflect the risks relative to the risks from smoking.
What’s more, regulators must recognize that having a wide choice of products and flavors is key to the success of safer nicotine products in enabling people to stop smoking, according to the manifesto. Regulation must consider the harm to adults when considering bans intended to protect youth, and tax policy must consider that high taxation of safer nicotine products increases rates of smoking.
Comprising 21 consumer associations in 16 European countries, the ETHRA was created to increase understanding about the benefits of “new” risk-reduced nicotine products and to promote recognition of long-term recreational use of nicotine as an incentive for smoking cessation.
Millions of e-cigarette users, or vapers, across the globe are celebrating World Vape Day on May 30, 2020, a day before World No Tobacco Day.
World Vape Day aims to raise awareness on e-cigarettes or vapes and encourage smokers who are unable to quit on their own or with currently available smoking cessation tools to switch to safer nicotine products.
“Safer nicotine products, such as e-cigarettes and heated tobacco products, are the most disruptive influence on smoking in decades.These are the innovations that have the potential to save millions of lives in the Asia Pacific region as well as globally,” said Nancy Loucas, executive director of the Coalition of Asia-Pacific Tobacco Harm Reduction Advocates, or CAPHRA, one of the lead organizers of World Vape Day 2020, according to an article in the Manilla Standard.
“These products have disrupted the standard of harm reduction in tobacco by giving the power back to the smokers to choose the option that works for them and allows them to have agency over their own and their loved one’s health and wellbeing,” she said. The number of vapers globally has been increasing rapidly from about seven million in 2011 to 41 million in 2018, according to Euromonitor International. The market research group estimates that the number of adult vapers worldwide will reach almost 55 million by 2021.
In its 2018 independent evidence review, Public Health England concluded that “e-cigarettes are around 95% safer than combustible cigarettes.”
Published in March 2020, the agency’s latest report said “Despite reductions in smoking prevalence, smoking remains the biggest single cause of preventable death and disease and a leading cause of health inequalities. So, alternative nicotine delivery devices that are less harmful could play a crucial role in reducing this health burden.”
Recent warning letters demonstrate that the FDA is looking beyond devices when enforcing its rules against youth appeal.
By Bryan Haynes, Agustin E. Rodriguez and Dascher Pasco
On April 27, 2020, the U.S. Food and Drug Administration (FDA) sent warning letters to 10 retailers and manufacturers who “sell, manufacture and/or import unauthorized electronic nicotine delivery system (ENDS) products targeted to youth or likely to promote use by youth.”1 Nine of these warning letters targeted ENDS products such as flavored e-liquids and ENDS designed to look like handheld gaming systems, watches and fidget spinners.
However, one warning letter targeted products “such as a backpack and sweatshirt designed with stealth pockets to hold and conceal an e-cigarette.” In its warning letter to Vaprwear Gear, the FDA asserted authority over Vaprwear’s sweatshirts and backpacks because they were components and parts of tobacco products.
Pursuant to the “Deeming Rule,” published in May of 2016, the FDA has asserted authority over all tobacco products, including ENDS products and their “components and parts.” However, the FDA does not have authority over tobacco products’ “accessories.”2 The practical consequence of the Deeming Rule is that ENDS, and their components and parts, are subject to the tobacco control authorities set forth in the Tobacco Control Act (TCA). This includes premarket authorization requirements, which, when not met, result in deemed new tobacco products being considered adulterated.
Earlier this year, the FDA published guidance clarifying how it intended to prioritize enforcement resources regarding the marketing of certain deemed new tobacco products that do not have premarket authorization. Specifically, the FDA stated it would prioritize enforcement against flavored, cartridge-based ENDS products, as well as ENDS products that were targeted to minors or the marketing of which was likely to promote use of ENDS by minors. The guidance noted that the FDA is particularly concerned with ENDS products with flavors that youth find appealing as well as products with design features that make them more appealing to youth by allowing discreet use, or enabling youth to “use the product in circumstances where the use of tobacco products is prohibited.”3
Given the FDA’s stated priorities, much of what was seen in the April 27 warning letters did not come as a surprise. For example, some of the warning letters targeted e-liquids that the FDA claimed were labeled and/or advertised in a way that resulted in the product resembling “food products that are typically marketed toward and/or appealing to children.”4 Others targeted ENDS products that resembled smartwatches, identified by FDA as a product that is “commonly worn by children” allowing the ENDS product to “be carried and worn without revealing to parents, teachers, or other adults that the product is a tobacco product.”5 As e-liquids and ENDS products, the products targeted in those warning letters are well recognized as regulated products within the FDA’s authority as stated in the Deeming Rule.
Bryan Haynes (Credit: Troutman Sanders)
Less obvious is the basis of the FDA’s authority to regulate products such as sweatshirts and backpacks as “components and parts” of ENDS. For purposes of the Deeming Rule, components and parts are defined as “any software or assembly of materials intended or reasonably expected: (1) to alter or affect the tobacco product’s performance, composition, constituents or characteristics; or (2) to be used with or for the human consumption of a tobacco product.” In contrast, accessories do not contain tobacco, are not derived from tobacco and do not affect or alter the performance, composition, constituents, or characteristics of a tobacco product.6
The warning letter to Vaprwear states that the Vaprwear Weekend Pullover, Vape-Ready Hoodies and Vaprwear HydroVape, as well as the Vape-Ready Backpacks are all components or parts of tobacco products and, as such, are subject to FDA jurisdiction. While FDA’s regulation of these products initially seems like a startling overreach, upon closer inspection of the products and their marketing it becomes more apparent how FDA claims authority.
Each of these products contains a “hosing system” that can be connected to a pod system and used to deliver vapor to the wearer. For example, the Vape-Ready Hoodies contain a drawstring made from hosing and woven into the hood. One end of the drawstring connects to the device and the other end is used to inhale. The Vaprwear products are largely monochromatic with few or no graphics and contain pockets that allow for storage of the ENDS device while it is being used with the products’ vapor delivery system, allowing for discreet use of ENDS devices in a number of environments.
Agustin E. Rodriguez (Credit: Troutman Sanders)
The hosing system, which is an integral part of Vaprwear’s products, physically connects to the ENDS device and is used to deliver vapor directly to the consumer. This system is identified by Vaprwear as a “vapor delivery system” that “delivers compatibility with the hundreds of vape devices now on the market,”7 and allows the FDA to claim that the products are used for the consumption of a tobacco product and alter or affect the tobacco product’s performance, composition, constituents or characteristics.
There are a couple of takeaways from FDA’s warning letter to Vaprwear. First, the FDA’s decision to target Vaprwear’s sweatshirts and backpacks demonstrates FDA’s view that a product does not have to be a necessary element of an ENDS device, such as an e-liquid or an atomizer, to be considered a component or part within the FDA’s purview. Additionally, the FDA is not only focused on discreet ENDS devices, but on all products that may be appealing to youth because they facilitate discreet use.
Dascher Pasco (Credit: Troutman Sanders)
In conclusion, the April 27 warning letters highlight the FDA’s continued focus on ENDS marketing. The FDA appears to be keeping up with the ENDS market and its consumers, recognizing and regulating the new ways individuals can easily and discreetly vape. Much of this regulatory energy is focused on retailers.
For example, while some of the companies that received an April 27 warning letter were manufacturers, each of the 10 entities operates as a retailer. Further emphasizing this point, both Wizman Limited, a manufacturer and online retailer, and EighCIt, an online retailer, received warning letters regarding a product manufactured by Wizman Limited.
The bottom line is that the FDA expects retailers to undertake appropriate due diligence with regard to all marketed products. Retailers may ultimately be held responsible by the FDA, whether or not any action is taken against the manufacturer, as the agency continues to focus on the ENDS industry and the potential youth appeal of its products.
Bryan Haynes, a partner with Troutman Sanders, specializes in tobacco industry regulatory compliance and enforcement matters.
Augustin Rodriguez, counsel for Troutman Sanders, provides cross-functional, multidisciplinary counsel to advertising, marketing and consumer goods and services companies.
Dascher Pasco, an associate with Troutman Sanders, specializes in government and regulatory white collar and government investigations and enforcement actions and investigations.
1 FDA, news release, “FDA Warns Manufacturers and Retailers to Remove Certain E-cigarette Products Targeted to Youth from the Market,” April 27, 2020, available at https://bit.ly/2LIenHu.
2 21 CFR § 1100.1.
3 FDA, “Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and Other Deemed Products on the Market Without Premarket Authorization” (Revised), April 2020, available at https://bit.ly/3dYFkTu.
4 FDA, Warning Letter to VapeCentric, MARCS-CMS 607375, April 27, 2020, available at https://bit.ly/36dWGZO (finding the product appeared “very similar to Pocky Strawberry biscuit sticks”) and FDA, Warning Letter to Vape Royalty, MARCS-CMS 606271, April 27, 2020, available at https://bit.ly/3bHKDVX (finding the product appeared “very similar to Sour Patch Kids candy”).
5 FDA, Warning Letter to Vapewear, MARCS-CMS 605196, April 27, 2020, available at https://bit.ly/2XfBs9O and Warning Letter to Shenzhen Uwell Technology Co., Ltd. d/b/a DTD Distribution Inc., April 27, 2020, available at https://bit.ly/2yf7uu8.
6 81 FR 28973 at 28975. The Deeming Rule defines an accessory as “any product that is intended or reasonably expected to be used with or for the human consumption of a tobacco product; does not contain tobacco and is not made or derived from tobacco; and meets either of the following: (1) is not intended or reasonably expected to affect or alter the performance, composition, constituents, or characteristics of a tobacco product or (2) is intended or reasonably expected to affect or maintain the performance, composition, constituents, or characteristics of a tobacco product but (i) solely controls moisture and/or temperature of a stored product or (ii) solely provides an external heat source to initiate but not maintain combustion of a tobacco product.”
The governor of Oklahoma has signed a bill to raise the minimum age to purchase vapor, e-cigarettes and other tobacco products to 21 years old. Gov. Kevin Stitt signed it into law on Tuesday morning.
Because the bill contains an emergency clause, the increase went into effect immediately. The bill, S.B. 1423, was approved by the Senate 28-19 in early March, while the House approved it by a 79-20 vote on May 12.
Oklahoma’s laws now match that of the federal government, an increase that came on Dec. 21, 2019. However, due to enforcement largely happening at the local level, many states, counties and cities have had to pass bills or ordinances to change laws to better reflect the 21-year-old minimum.
Additionally, states are passing their own increases as it will allow them to remain eligible for $6.4 million in federal funds that go to the state’s Alcoholic Beverage Law Enforcement Commission, according to a story on Halfwheel.
FDA has stated that it is not yet enforcing the 21-years-old standard through its compliance checks program.
More smokers could turn to reduced-risk products like e-cigarettes after the U.K.’s menthol ban becomes enforceable today, new research suggests.
The study by TobaccoIntelligence shows that many retailers are planning to use the shelf space previously occupied by menthol cigarettes for alternatives such as vapour and heated tobacco products.
David Palacios, from TobaccoIntelligence, said: “The opportunities to convert menthol smokers to less risky alternatives are substantial.
“In the UK alone, for example, it is estimated that 1.3 million people currently using menthol cigarettes will need to find an alternative product.”
