Juul Labs received an emergency stay of the Food and Drug Administration’s order for the vaping company to pull its e-cigarettes off the U.S. market.
The U.S. Court of Appeals for the D.C. Circuit on June 24 granted Juul’s request to delay the FDA’s ban. The temporary stay gives the court time to hear arguments and wasn’t a ruling on the merits of the case, the judges wrote.
In its court filing, Juul argued that the FDA’s order was extraordinary and unlawful and it would suffer significant irreparable harm without a stay, according to The Wall Street Journal.
Juul said that the requirement to immediately remove all Juul products from U.S. stores was a departure from the agency’s practices, which typically have a transitional period.
The e-cigarette maker also questioned the agency’s handling of the announcement, noting The Wall Street Journal reported on the ban a day before it was announced.
“Regulation through leaks and press releases is no way to handle agency action, much less to order a company to cease essentially all business operations,” Juul said in the court filing.
Former FDA Center for Products Director Mitch Zeller said that Juul’s e-cigarettes were judged solely on the strength of the company’s application. Political pressure to ban Juul didn’t influence the ruling, nor did Juul’s past actions, he said. “This was a scientific review conducted by subject-matter experts,” he said. “That’s the way the system is supposed to work.”
In a statement, Juul Labs it was exploring all its options under the FDA’s regulations and the law.
“We respectfully disagree with the FDA’s findings and decision and continue to believe we have provided sufficient information and data based on high-quality research to address all issues raised by the agency,” said Juul Labs Chief Regulatory Officer Joe Murillo.
“In our applications, which we submitted over two years ago, we believe that we appropriately characterized the toxicological profile of Juul products, including comparisons to combustible cigarettes and other vapor products, and believe this data, along with the totality of the evidence, meets the statutory standard of being “appropriate for the protection of the public health.”
“We remain committed to doing all in our power to continue serving the millions of American adult smokers who have successfully used our products to transition away from combustible cigarettes, which remain available on market shelves nationwide.”
Among other options, Juul is reportedly exploring a bankruptcy filing if the company is unable to get relief from the government’s ban, reports The Wall Street Journal, citing people familiar with the matter.
The Independent European Vaping Association (IEVA) has called on the Spanish government to reconsider a proposal to ban vape shops. According to the IEVA, the legislation under consideration would hand the entire electronic cigarette business to big tobacco companies.
“Against all principles of EU law (proportionality, good regulation, good administration, fair competition and harmonization), the Spanish government has proposed to ban and close all vape shops across Spain (transferring the sale of electronic cigarettes and e-liquids to the state monopoly of tobacco shops and to prohibit all online sales,” the IEVA wrote on its website.
According to the IEVA, these measures not only contravene EU rules on free competition and free movement of goods, but will also generate unemployment at a time or economic crisis. What’s more, the proposal will deprive vaper from personalized access to vaping products, forcing them to buy them at tobacco shops, which could temp them back to more risky combustible products, the group said.
As part of the legislative process, Spain submitted a so-called TRIS notification to the European Commission on June 21 The IEVA shared its views on the proposal and the full submission is available here.
Juul Labs today asked a federal appeals court to temporarily block the U.S. Food and Drug Administration’s marketing denial order until it can petition the court for an emergency review.
In its filing, Juul said the FDA’s order was extraordinary and unlawful and it would suffer significant irreparable harm without a stay.
On June 23, the regulatory agency ordered Juul Labs to remove its products from the market, saying the e-cigarette company had provided insufficient evidence in its premarket tobacco product application to demonstrate that its products are “appropriate for the protection of public health.”
In particular, the FDA noted that its concerns about genotoxicity and potentially harmful chemicals leaching from the Juul Labs’ proprietary e-liquid pods had not been adequately addressed.
“We respectfully disagree with the FDA’s findings and decision and continue to believe we have provided sufficient information and data based on high-quality research to address all issues raised by the agency,” said Joe Murillo, chief regulatory officer at Juul Labs, in a statement.
We respectfully disagree with the FDA’s findings and decision and continue to believe we have provided sufficient information and data based on high-quality research to address all issues raised by the agency.
“In our applications, which we submitted over two years ago, we believe that we appropriately characterized the toxicological profile of Juul products, including comparisons to combustible cigarettes and other vapor products, and believe this data, along with the totality of the evidence, meets the statutory standard of being “appropriate for the protection of the public health.”
In its court filing, Juul said the FDA’s decision followed “immense political pressure from Congress once it became politically convenient to blame [Juul] for youth vaping, even though several of its competitors now have a larger market share and much higher underage-use rates,” according to The Wall Street Journal.
Juul said that the FDA’s order to immediately remove all Juul products from U.S. stores was a departure from the agency’s practices, which typically have a transitional period. The e-cigarette maker also questioned the agency’s handling of the announcement, pointing to the fact that the order had reported in the press before it was officially announced.
“Regulation through leaks and press releases is no way to handle agency action, much less to order a company to cease essentially all business operations,” Juul said in the court filing.
In a press note, Juul Labs said it is exploring all of its options under the FDA’s regulations and the law. “We remain committed to doing all in our power to continue serving the millions of American adult smokers who have successfully used our products to transition away from combustible cigarettes, which remain available on market shelves nationwide,” the company wrote.
Meanwhile, the announcement that Juul products must come off the market triggered a run on stores, according to various news outlets, including Bloomberg. “Gonna clear the shelves and hoard ’em like our incandescent bulbs!” one user wrote on Twitter following the news.
The removal of Juul products from the U.S. market would boost the prospects of British American Tobacco, create opportunities for Philip Morris International but represent a problem for Altria Group, according to Morgan Stanley.
In a letter to investors, the financial institution evaluated the impact of the U.S. Food and Drug Administration’s leaked plans to deny Juul Labs’ premarket tobacco product application (PMTA). While the FDA has not issued a formal statement yet, shares in Altria Group were down more than 9 percent in the immediate wake of the news. Altria owns about a third of Juul Labs.
According to Morgan Stanley, Juul is Altria’s only exposure to the growing vapor category. While a Juul marketing denial order (MDO) would give Altria an opportunity to terminate its noncompete agreement with Philip Morris International, allowing it to step-up its vapor product research and development or acquire vapor technology, the company would not be coming from a position of negotiating leverage, according to the investment bank.
“In addition, there are few larger scale independent e-vapor assets on the market,” wrote Morgan Stanley.
The investment bank believes that removing market leader Juul from U.S. store shelves would create opportunities for other products, such as PMI’s IQOS heat-not-burn device, which has already received PMTA approval.
The key beneficiary of a Juul MDO, however, would be British American Tobacco, according to Morgan Stanley.
Several of the company’s products have already received PMTA authorizations, the investment bank points out. Though its Vuse brands, BAT recently overtook Juul as the leading U.S. e-cigarette player with a market share of more than 33 percent. The company has gained significant momentum in the category over the past 24 months and a Juul MDO could lead to further BAT market share gains, according to Morgan Stanley.
Zinwi Bio-Tech has secured a production license for electronic cigarettes (e-liquid category) in China, becoming one of the first manufacturers to do so under the country’s new regulatory framework.
In March, the State Tobacco Monopoly Administration passed the Electronic Cigarette Administration Measures, which took effect May 1. Under the new rules, a production license issued by the STMA is a precondition for the incorporation of a company involved in the manufacture of vapor hardware, e-liquids or e-cigarette nicotine.
Companies applying for the license must supply documents showing financial and manufacturing fitness, among other evidence.
Zinwi Bio-Tech was established in 2016 and is headquartered in Shenzhen’s Guangming District. A high-tech enterprise integrating the R&D, production and sales of e-liquid, the company ships more than 2,000 tons of e-liquid and approximately 1.3 billion pods per year. Products are exported to Europe, America and Canada, the Middle East, Russia and other destinations.
In a press note, the company said its commitment to quality is demonstrated by numerous accreditations, including the ISO9001 quality system, national CNAS laboratory and GMP certifications.
The European Commission has collected feedback from almost 25,000 organizations, experts and citizens about its legislative framework for tobacco control. Its initial call for evidence feedback period ended June 17.
The Commission will use the feedback to evaluate to what extent the legislative framework has fulfilled its goals and whether it is able to support a “tobacco-free generation” by 2040, as announced in Europe’s Beating Cancer Plan.
Participants included organization such as the Independent European Vaping Alliance (IEVA), which identified several opportunities for improvement.
“The European e-cigarette market is one of the most regulated and safest worldwide. IEVA supports the tobacco product directive which has allowed for safe products to be made available to EU consumers. These rules have prevented irresponsible business—as we unfortunately have witnessed in the U.S., where the vaping market was not regulated—and whose behaviors we most vehemently condemn,” the IEVA wrote in a statement.
“We would like to use this submission to present areas that merit further consideration through the process of evaluating the Tobacco Products Directive which we believe have not been addressed through the process thus far. We will focus on three core areas which we believe need to be further explored in any discussion about a legislative review: the impact on smokers, the impact on SMEs [small and medium-sized enterprises] and employment, and the impact on illicit trade.”
“By stirring up anti-vaping hysteria, New Zealand’s Asthma and Respiratory Foundation will only send more minors back to smoking and put the country’s decade long Smokefree 2025 ambition in jeopardy,” says Nancy Loucas, executive coordinator of the Coalition of Asia Pacific Tobacco Harm Reduction Advocates (CAPHRA).
Loucas’ comments follow the Asthma and Respiratory Foundation (ARFNZ) launching a video series titled, “Spotlight on Vaping.” The campaign claims New Zealand is experiencing an “epidemic” of youth vaping. Together with the Secondary Principals’ Association of NZ (SPANZ), it also claims over a quarter of students have vaped in the past week.
“What these sensationalized numbers don’t take into account is, if 26 percent of school students had in fact vaped in the past week, many would only be trying it, and secondly, almost all of them would’ve been smoking deadly cigarettes a generation ago,” says Loucas.
CAPHRA says while smoking-related illnesses kill around 5,000 New Zealanders every year, vaping has not reportedly caused one death in the country. In fact, vaping been widely attributed for positively contributing to New Zealand’s plummeting smoking rate. The overall adult daily smoking rate has fallen from 18 percent in 2006/07 to 9.4 percent in 2020-2021.
“What ARFNZ fails to mention is [that] the 2021 ASH Year 10 Snapshot survey that they selectively refer to confirms that vaping is not hooking nonsmokers. In that survey, just 3 percent of those who vape daily have never smoked. What’s more, while many may try it, very few ever become regular vapers, particularly non-smoking students,” she says.
Loucas says while ARFNZ attract headlines by alleging a “youth vaping epidemic,” University of Auckland researchers in 2020 came to a different conclusion: “Our findings do not support the notion of a so-called vaping epidemic in New Zealand or a large youth population dependent on vaping,” the researchers wrote
“While no one wants youth vaping, we are not seeing an ‘epidemic’ as ARFNZ would have the public believe.
E-cigarettes may become legal in Brazil later this year as ANVISA, the federal health sanitary agency, plans to revisit its regulations regarding the products. Proponents of vaping have been pushing the government to legalize the products to help smokers quit combustibles, but critics are concerned about youth usage as well as potential higher rates of vaping that could follow legalization.
Electronic tobacco products have been banned in Brazil since 2009, but there are currently shops that sell the products anyway, often with statements that the products are safe, according to The World.
“Once the product is legally allowed to be commercialized, it gets into the distribution network of the tobacco companies, which have one of the best distribution systems around,” said Stella Bialous, a Brazilian expert on tobacco issues and a professor from the University of California, San Francisco. She fears that more people would likely take up vaping if the products are allowed to be commercialized. In 2019, less than 1 percent of Brazilians used e-cigarettes. However, if the products are commercialized, they would become more easily available, and that percentage could quickly rise.
“Considering that these products are attractive to youth and that we can’t affirm that they really work for tobacco cessation, we believe that we must prioritize the public policies to prevent smoke initiation and also to promote health for the Brazilian population,” said Monica Andreis, the executive director from ACT Promocao da Saude, a nongovernmental organization that focuses on tobacco control policies.
“Brazil has a leadership role in Latin America and also around the world related to tobacco control policies. I believe that the decision from ANVISA has the potential to influence other countries in Latin America,” Andreis said.
ANVISA has not commented on the situation, stating that it is still analyzing data. “Up to this point, there are still uncertainties and controversies related to the risks attributed to these devices,” the agency stated in February.
Taat Global Alternatives has signed a letter of intent with a U.S. subsidiary of Shanghai Shunho New Materials Technology Co. to undertake development work for a white-labelled heat-not-burn device as well as heatable sticks containing Taat’s proprietary tobacco-free and nicotine-free Beyond Tobacco material in all three flavors (original, smooth, and menthol).
As heat-not-burn has proven to retain users exceptionally well compared to other tobacco cigarette alternatives, Taat has identified the opportunity to build upon its existing international market share in the tobacco industry by planning an expansion into the heat-not-burn category with a tobacco-free and nicotine-free offering that would be among the first of its kind in the United States.
In addition to procuring heatable Taat sticks made using the company’s Beyond Tobacco material, Shunho’s U.S. subsidiary is to supply a proprietary heat-not-burn device on a “white-label” basis, which is to be commercialized in the United States under the Taat brand name. Uniquely, this device will offer reverse compatibility with heated tobacco sticks offered by the company’s competitors, as well as the Taat original, smooth, and menthol heatable sticks.
Headquartered in Shanghai, Shunho is a renowned tobacco ancillary service company that has worked closely with international tobacco companies. Under Shunho, there is a portfolio of firms that are currently developing next-generation electronic cigarette and vaporizing products. Taat will be the first foreign third-party with whom a Shunho subsidiary has partnered for white-label production of heat-not-burn products. Additionally, distribution services will be provided for the Taat heat-not-burn offerings through various in-house and third-party e-commerce channels in the United States.
“The reason we chose to pursue the heat-not-burn segment is because it is the most ‘sticky’ option out of all commercially available alternatives to cigarettes,” said Taat CEO Setti Coscarella in a statement. “The tobacco industry has invested heavily in cultivating a user base for heat-not-burn to the point that it may even replace major brands of tobacco cigarettes altogether in certain markets.
“We are excited to be leveraging innovative technologies to create a unique nicotine-free and tobacco-free experience using heat-not-burn for consumers who currently use and prefer this method. Because the Taat heat-not-burn device will work with Taat sticks as well as certain competitors’ heatable tobacco sticks, we believe this strategy authentically embodies our values as a company by providing consumers the choice and flexibility they deserve to have.”
Many countries continue to limit access or have outright banned vaping and e-cigarette products.
By Norm Bour
As much as we would like to think that vaping and the sale of vape products is universally accepted, that is not the case. The world has changed a lot over the past 10 years, and the medical community’s support has carried some weight, but old customs and rituals die hard. Here is an overview of where the status of vape remains iffy.
Turkey
You can use vape products where tobacco is permitted, but the Turkish government is vehemently anti-vape—regardless of the medical documentation that shows the advantages of vaping over combustible cigarettes. Since 2009, President Recep Tayyip Erdogan has led the campaign against all tobacco products, including cigarettes, regardless of their popularity.
Turkey banned the import of e-cigarettes and related products on Feb. 25, 2020. The ban covers e-cigarettes, accessories, spare parts and solutions (e-liquids) as well as e-cigarette products that use heating or incineration, like electronic hookahs. The country had already banned the sale of electronic cigarettes.
Erdogan’s aggressive posture has resulted in the seizure of almost 18 million packs of cigarettes in 2020 and 140,000 e-cigarettes. The government offers a hotline for people to call and blow the whistle on illegal products, and 1,500 teams scour the country doing random inspections. For vapers, the online channel remains open, and there are many foreigners who vape in the street without concern.
India
With a population of 1.38 billion, India has banned vaping products since 2019. With an estimated 120 million people lighting up, India has the dubious honor of having 12 percent of the world’s cigarette smokers. The country loses about 1 million people per year to tobacco-related illnesses.
India’s aggressive anti-smoking posture has proven successful as the number of smokers has dropped significantly over the past 20 years. In 2000, it was estimated that one-third of the male population smoked, with 5.7 percent of the female population smoking. A decade later, those numbers had dropped to 23 percent for men and 2.5 percent for women. Currently, an estimated 14 percent of the country’s population smokes.
With a 28 percent luxury tax on tobacco, there are huge incentives to quitting smoking in India. The bad news is that vaping products are lumped into the tobacco pile, but evidence for the relative safety of e-cigarettes is gaining ground. The anti-vape campaign was geared toward the young smokers, but there may be light at the end of this tunnel.
Under the guise of preventing potential health risks to the country’s youth, India banned the “import, manufacture, sale, advertisement, storage and distribution” of e-cigarettes in September 2019. However, according to Research and Markets, the Indian e-cigarette market reached a value of $7.8 million in 2018, and it is further predicted to witness a CAGR of 26.4 percent during the forecast period (2019-2024) even with the ban in place.
There is very little regulatory enforcement for vaping products in India. Vaping products are even being displayed on some store shelves. A few of the biggest paanwalas in the cosmopolitan cities reportedly sell Juul and other high-end hardware. It’s not plainly obvious everywhere, and the specialist “vape only” vendors are all clandestine, according to several sources. Most of the specialists are discerning and do not entertain new customers without a reference from a known customer.
Australia and New Zealand
Australia has been a teeter-totter in terms of vapor regulations. In October of 2021, it declared all nicotine products illegal without a doctor’s prescription. The prescription is intended only for the patient and may not be shared or sold. The sole light at the end of this this tunnel is that nicotine- free products are excluded from this heavy-handed ban.
Devices and liquids can be sold in all eight territories, though advertising and promotion is legal in some but illegal in others. Spotty monitoring and enforcement have resulted in a lively online trade in vapor products.
Compared to many countries, the perceived “problems” of youth smoking are modest with percentages of vapers and smokers under 20 percent among different age groups. According to 2021 research from the Australian National University, about 16 percent of current e-cigarette users in Australia are non-smokers who have never inhaled tobacco, while the remaining third are ex-smokers. There are about 400,000 e-cigarette users in Australia.
While often lumped in with Australia by outsiders, New Zealand has followed its own, more reasonable, path in vapor regulation. The small island country of just 5 million people estimates that 11.6 percent of its population smokes. Its priority is on reducing underage vaping and smoking.
The Middle East
Excluding the North African countries sometimes included in the Middle East, this part of the world is home to almost 0.5 billion people and encompasses about 20 percent of the Muslim world. While Islam frowns on tobacco use, many Muslim countries have high smoking rates. While tobacco use has been grudgingly tolerated, vaping was initially disdained, with some countries banning the practice. That is changing, as was evidenced in September 2021 when the World Vape Show was held in Dubai, which has now legalized vaping.
Tim Phillips, managing director of ECigIntelligence, says the United Arab Emirates is leading the Middle East in vape product sales and access, but considering it started from scratch, the numbers are still small. As tobacco-oriented as this part of the world is, buyers prefer flavored liquids with three out of four sales being sweeter fruit flavors followed by menthol flavors.
Across the Middle East, the rules are in constant flux. Currently, Kuwait, Jordan, Egypt, Saudi Arabia and Bahrain offer legalized vape, but Qatar and Oman do not. Market intelligence company Mordor Intelligence projects a growth rate of almost 10 percent through 2025 in the regional vapor market.
In late 2020, a Euromonitor International study found only a very small minority of smokers used e-cigarettes to quit smoking in the Middle East region. Analysts found just 1.8 percent of smokers in the region took up alternatives to conventional cigarettes in 2020. The figure is up from 1.4 percent in 2017 but it remains significantly low when compared to other parts of the world.
South America/Latin America
On the other side of the globe, South America’s 433 million people also face an ever-changing landscape of vaping laws. The largest country, Brazil, allows vaping, with some restrictions in enclosed areas. Sales are highly regulated by the Health Surveillance Agency, which closely monitors underage sales, though enforcement of sales and production is weak.
No. 2 by population, Argentina has banned vaping for a decade and shows no sign of changing its policy. The ban extends to nicotine-free products, and there are virtually no sales, production or importation of e-cigarettes. Ironically, Argentina reportedly accounts for as much as 15 percent of total tobacco consumption in South America.
Contrary to some of its neighbors, Peru has been open-minded about vaping—to the point where the government appears to turn a blind eye to the practice. With an estimated 2.3 million smokers—just under 10 percent of the population—Peru has no official numbers on the vapers and vape products. It seems the country has higher priorities and has decided to leave vapers alone.
According to Mordor Intelligence, as enforcement of e-cigarette laws are often open to local authorities, vape shops are often found in places where they are technically illegal in the region. In the entire region only five countries allow the legal sale of e-cigarettes: Chile, Ecuador, Honduras, Paraguay, and Costa Rica.
Following the recent enactment of smoke-free laws in Paraguay, every South American country has now banned vaping and smoking in most public places. Under Decree No. 4624, approved by Paraguay’s presidency on Dec. 29, consuming lit, heated, or electronic tobacco products is permitted only in uncrowded open air public spaces that are not transit areas for nonsmokers.
Norm Bour is the founder of VapeMentors and works with vape businesses worldwide. He can be reached at norm@VapeMentors.com
“By stirring up anti-vaping hysteria, New Zealand’s Asthma and Respiratory Foundation will only send more minors back to smoking and put the country’s decade long Smokefree 2025 ambition in jeopardy,” says Nancy Loucas, executive coordinator of the Coalition of Asia Pacific Tobacco Harm Reduction Advocates (CAPHRA).
Excluding the North African countries sometimes included in the Middle East, this part of the world is home to almost 0.5 billion people and encompasses about 20 percent of the Muslim world. While Islam frowns on tobacco use, many Muslim countries have high smoking rates. While tobacco use has been grudgingly tolerated, vaping was initially disdained, with some countries banning the practice. That is changing, as was evidenced in September 2021 when the World Vape Show was held in Dubai, which has now legalized vaping.
On the other side of the globe, South America’s 433 million people also face an ever-changing landscape of vaping laws. The largest country, Brazil, allows vaping, with some restrictions in enclosed areas. Sales are highly regulated by the Health Surveillance Agency, which closely monitors underage sales, though enforcement of sales and production is weak.