Vapor products remain widely available in India eight months after the country banned them.
In September 2019, India prohibited the sale of vapor products to promote public health and prevent youth use (also see “Nipped in the Bud,” Tobacco Reporter, May 2020). “We immediately took a decision so that the health of our citizens, our young is not thrown at risk,” India’s finance minister, Nirmala Sitharaman, said at the time.
While leading players such as Juul have left the country, vapor products remain widely available today. People can still buy e-cigarettes on the internet or from any paan shop, according to press reports.
Most products on the market today originate in China and retail for less than the offerings of the banished Western companies did.
Samrat Chowdhery
“The only thing that the ban has changed is branded products are out of the market,” a seller who has been in the business for three years was quoted as saying.
“It is difficult to enforce regulations as nicotine is available in all other forms,” Samrat Chowdhery, founder and director of the Association of Vapers India, told Business Insider. “Formal players making e-cigarettes are exiting the market. Once black market industry gains a footover, it will be impossible to get control over it. The government missed a golden opportunity to tax these products.”
In a first for China, a store owner in Shenzhen has been fined 2,000 yuan ($280) for failing to display required warnings against smoking, according to local news outlet Yangcheng Evening News.
The report said the shop had flouted Shenzhen’s recently updated regulations banning vaping indoors and selling e-cigarettes on WeChat, China’s most widely used social app. In addition, two people who had been vaping inside the store were fined 50 yuan each, according to a story posted on sixthtone.com.
Xiong Jingfan, the manager of Shenzhen’s “smoke-free city” campaign, told Yangcheng Evening News that selling e-cigarettes on social platforms — despite being prevalent across the country — had become illegal under the recent ban.
In 2019, Shenzhen authorities amended the definition of a “cigarette” in the city’s smoking regulation to include e-cigarettes. Under the law’s new interpretation, shops selling such products were required to post two warning signs at visible locations: one stipulating that smoking is harmful to one’s health, and another noting that cigarettes cannot be sold to minors.
The regulation also forbids vaping indoors and in public places.
Despite the city’s stringent ban, Shenzhen is the world’s largest e-cigarette producer, accounting for around 90 percent of the global market share.
This is not the first time China has attempted to crack down on the domestic e-cigarette industry. Last November, the country’s state tobacco monopoly issued a nationwide e-cigarette ban, suspending the online sale and advertisement of such products. The ban, dubbed the “winter of e-cigarette merchants,” was aimed at keeping e-cigarettes out of the hands of minors. In 2018, China Tobacco had prohibited merchants from selling e-cigarettes — collectively referred to as Electronic Nicotine Delivery Systems, or ENDS — to minors.
Shenzhen’s restrictions on e-cigarettes attracted controversy online, however, after many netizens pointed out the authorities’ apparent double standard when it comes to smoking — namely, that regulations on cigarettes, which are sold by the government, are still relatively lax.
Taiwan’s Health Promotion Administration (HPA) wants to ban the sale of novel tobacco products such as e-cigarettes and heated tobacco products reports The Taipei Times.
On May 29, the agency announced draft amendments to the Tobacco Hazards Prevention Act (THPA) to cover products currently not covered by the act.
One amendment would raise the legal age for smoking and the minimum age for buying tobacco products from 18 to 20.
A recent survey found that smoking and vaping rates among young Taiwanese increased last year.
The smoking of cigarettes and e-cigarettes by junior high and high school students last year increased for the first time since the THPA took effect in 2009, HPA Tobacco Control Division Director Chen Miao-hsin said.
Physician Chen Mu-jung said that teenagers are less cautious when it comes to addictive substances and that flavors added to cigarettes could overpower the pungent taste of tobacco, making teenagers more curious and even leading some to believe that flavored cigarettes are somehow healthier.
Youth smoking is up for the first time in a decade, according to government figures. Photo: Taco Tuinstra
The number of young Taiwanese people smoking rose for the first time in a decade in 2019, reports Taiwan News, citing a report by the Ministry of Health and Welfare’s Health Promotion Administration.
Remarkably, considering that e-cigarettes are illegal in Taiwan, the popularity of vaping rose by half.
An estimated 81,000 young Taiwanese smoked combustible cigarettes last year, while 57,000 youths vaped, Central News Agency (CAN) reported.
The survey found that the proportion of junior high school students with a smoking habit rose from 2.8 percent in 2018 to 3 percent in 2019, and the proportion of senior high school students from 8 percent to 8.4 percent.
Four out of every 10 young smokers smoke flavored cigarettes, which are more popular with women, the study discovered. The most popular motivator to start smoking cited was curiosity, followed by “seeing other people smoke,” parents smoking and the desire to relieve pressure.
The popularity of vaping among young people surged from 2.7 percent in 2018 to 4.2 percent last year, with male senior high school students the most likely category to use e-cigarettes.
The UAE’s Federal Tax Authority (FTA) has announced the postponement of the implementation of the ban on supplying, transferring, storing, and possessing electronic cigarettes without digital tax stamps until to January 1, 2021.
The ban was previously scheduled to come into effect from June 1, 2020, in line with phase two of the ‘Marking Tobacco and Tobacco Products Scheme’, the FTA said in a statement on Tuesday, according to the official news agency WAM. The ban also includes water pipe tobacco.
“This extension on the timeline provides them with seven additional months to prepare for the mandatory implementation of the ban,” said FTA director-general Khaled Ali Al Bustani, according to a story in gulfbusiness.com.
“It also comes in response to the concerns expressed by stakeholders in the tobacco sector, and their requests for such an extension that would allow them to sort out any issues resulting from the current difficult circumstances and the necessary precautionary measures that were enforced to prevent the spread of the novel coronavirus. The decision provides them enough time to sell off any remaining tobacco products that do not carry the digital tax stamps.”
As part of the Covid-19 pandemic, restaurants and cafes across the country were temporarily closed and hence there is an existing stockpile of water pipe tobacco and electrically heated cigarettes in the UAE.
“The FTA has consulted all relevant business sectors, as well as the operator of the Scheme’s electronic system, and reassured all stakeholders that it fully understands the difficulties brought on by the current crisis, asserting its commitment to minimising the impact of the ban on businesses, and encouraging them to comply with tax procedures and legislation,” added Al Bustani.
The UAE banned the import of electric cigarettes and water pipe tobacco without ‘digital tax stamps’ from March 1.
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.”
Although it may have eclipsed our memories, COVID-19 is not the first disease outbreak that the Centers for Disease Control and Prevention has faced in the last three months.
It was as late as Feb. 25 — well after the first novel coronavirus case in the United States was reported — that CDC updated its numbers on what it called the EVALI (e-cigarette, or vaping-associated lung illness) outbreak. On that day, while COVID-19 was silently spreading throughout the country, CDC announced that this “e-cigarette”-related disease had caused 2,807 hospitalizations and claimed 68 lives. Little did we know at the time that these two events were profoundly connected.
Throughout its investigation of the first outbreak, CDC created public hysteria over the dangers of electronic cigarettes by attributing the outbreak to all vaping products, whether they contained nicotine or THC and whether they were purchased at a highly regulated vape shop or from a drug dealer on the street. The very name that CDC attached to the outbreak directly implicated electronic cigarettes, which are nicotine-delivery devices that are effective in helping adult smokers to quit smoking.
Following CDC’s lead, state health departments spread the word that using an e-cigarette to quit smoking could be life-threatening — so much so that seven states issued emergency bans on the sale of most or all electronic cigarettes.
Regulate, keep e-cigs away from youth
What the CDC failed to tell the public until nearly the end of the outbreak, and what many state health departments have still not publicly revealed, is that the lung illness outbreak was not caused by electronic cigarettes at all. Instead, it was caused by THC-containing vaping cartridges that were laden with a viscous oil — vitamin E acetate oil — that had begun to be used as a thickening agent in many black market THC vaping products shortly before the outbreak started.
Experts in the cannabis industry had the cause of the outbreak pretty much figured out by Aug. 30 and had definitively figured out the cause by Sept. 11. David Downs — the California bureau chief of Leafly.com — was almost single-handedly responsible for getting wholesale THC vape cartridge manufacturers (both licit and illicit) to stop using vitamin E acetate oil as a thickening agent. This not only led to the “eradication” of EVALI, but it has proven that e-cigarettes were never involved since the outbreak has ended but e-cigarettes continue to be sold in high volume and without any changes in their ingredients or manufacturing process.
Nevertheless, as late as Dec. 11, the Massachusetts Department of Public Health was still warning the public that: “We don’t understand what is causing these illnesses. From a public health point of view, we cannot recommend that anybody use vaping or e-cigarette products at this time.”
Sales data reported by PiperJaffray for the four weeks that ended Oct. 20 (when the Massachusetts emergency ban was in effect for 25 of the 28 days) and the four previous weeks (mostly before the ban went into effect) revealed that there was a substantial shift from vaping to smoking in the state. Nationally, there was very little difference in the rate of decline in cigarette sales between these two time periods from 2018 to 2019. The rate of decline decelerated by just 0.3 percentage points (from -7.8% to -7.5%). However, in Massachusetts, the rate of decline decelerated by a massive 5.7 percentage points (from -9.8 percent to -4.1 percent). This suggests that that many ex-smokers in Massachusetts who were reliant on e-cigarettes to stay smoke-free returned to smoking.
National data reported by Bloomberg News revealed the same pattern: the rate of decline in cigarette consumption slowed significantly because of the e-cigarette scare.
And the nation’s largest cigarette manufacturer — Altria — acknowledged in its 2019 annual report that: “Growth of the e-vapor product category and other innovative tobacco products has further contributed to reductions in cigarette consumption levels and cigarette industry sales volume and has adversely affected the growth rates of other tobacco products. Continued growth in these categories could have a material adverse impact on the business, results of operations, cash flows or financial position of Altria and its tobacco subsidiaries.”
What does this have to do with COVID-19?
It means that due to the zeal of CDC and other health agencies to condemn electronic cigarettes, cigarette smoking in the United States got a significant boost just before one of the most devastating respiratory disease outbreaks in our nation’s history. And there is strong evidence that smoking makes COVID-19 significantly worse.
Thus, the e-cigarette scare significantly worsened the health consequences of COVID-19, potentially resulting in more deaths than would have occurred if the CDC and state health agencies had simply told us the truth.
Dr. Michael Siegel is a professor in the Department of Community Health Sciences, Boston University School of Public Health, where he has conducted research on tobacco for 25 years. He wrote this for InsideSources.com.
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.
