Category: Regulation

Brazil Maintains E-cigarette Ban

Photo: Brenda Blossom
Brazil’s national health surveillance agency, Anvisa, decided on July 6 to maintain its ban on the import, advertising and sale of electronic cigarettes in Brazil, according to News Bulletin 24/7. The restriction began in 2009, but marketing continues illegally in the country, so Anvisa also called for increased inspections and educational campaigns to curb the illicit trade in e-cigarettes.
The decision was taken unanimously during a meeting of the body’s collegiate board. According to Anvisa Director Cristiane Rose Jourdan, scientific studies show that the use of electronic smoking devices increases the risk of smoking in young people, the potential for dependence and the likelihood of lung, cardiovascular and neurological health problems.
The Brazilian Medical Association (AMB) applauded Anvisa’s position. ”This is a wise decision, as there is increasing scientific evidence that the use of electronic smoking devices, the DEFs, is not harmless, does not support smoking cessation or is a form of harm reduction, but a product that causes dependence and can cause several diseases, especially cardiovascular, respiratory and cancer,” said Ricardo Meirelles, coordinator of the Commission to Combat Tobacco at AMB.
A survey carried out in the first quarter of 2022 by the Vital Strategies organization and the Federal University of Pelotas, revealed that 19.7 percent of Brazilians aged between 18 and 24 have tried electronic cigarettes.
BAT Brasil (formerly Souza Cruz) said it will assess the regulatory impact analysis of Anvisa’s decision when it is published.
“Dozens of countries have already understood the importance of risk reduction as part of their tobacco control policies and, given this reality, have advanced in the regulation of these devices,” the company said in a statement, citing the examples of United States, the European Union and the United Kingdom, among others.
Japan Tobacco International regretted Anvisa’s decision. “The use of electronic devices in the country is current and supplied exclusively by illicit trade. Legalized companies do not sell the product and the growth in consumption that affects the population comes from the illegal acquisition of devices,” the company said.
July 8, 2022
Panama Bans Vaping Imports and Sales

Photo: searagen
Panamanian President Laurentino Cortizo has signed legislation banning the sale of vapor products, reports Vaping360. The country had already prohibited e-cigarette sales in 2014 by executive decree.
The new law prohibits not only sales and imports of e-cigarettes, but also bans consumption in any place where smoking is not allowed. The ban includes internet purchases and authorizes customs officials to inspect and seize shipments. Resellers are still allowed to import vapor products intended for export to third countries.
Consumer vaping advocates have warned that restrictions on vaping products will push vapers to illegal products of questionable quality.
Panama joins more than a dozen Latin American and Caribbean countries with vape bans. On May 31, Mexican President Andrés Manuel López Obrador signed a decree outlawing the sale of e-cigarettes.
Panama will host the 1oth Conference of the Parties to the Framework Convention on Tobacco Control in 2023.
July 2, 2022
Pathways To Acceptance

Photo: Artinun
Scientists, regulators and industry must work together to help change perceptions of nicotine.
By Phil Saunders
A recent story in Tobacco Reporter highlighted that more than 60 percent of U.S. doctors are confused about the tobacco harm reduction risk continuum. Many incorrectly believe that all nicotine products are equally harmful, making them unlikely to recommend e-cigarettes to people trying to quit smoking.
Elsewhere, the picture isn’t that different. For example, a survey released earlier this year showed that in England, one of the most pro-vaping countries in the world, only 40 percent of local authorities actively offer e-cigarettes as part of stop-smoking services. This might seem more positive, but it still leaves the remaining 60 percent unconvinced.
There are some positive developments in Australia, which recently scrapped its earlier plans to ban e-cigarette imports. Hollie Hughes, chair of a committee established to examine vaping, recently stated that she believes vaping to be “an incredibly powerful cessation tool” that is part of the discussion on reducing smoking rates in the country. But there are still many countries with extremely high smoking rates where e-cigarettes are completely illegal, including India, Mexico, Brazil and Singapore.
There is obviously still a long way to go to get a unified acceptance of the role reduced-risk nicotine products can play in tobacco harm reduction.
Perception is Key
Fundamentally, the issue is that nicotine is perceived as the bad guy. That is why 60 percent of doctors in the U.S. don’t understand e-cigarettes. For years, the popular discourse has equated tobacco and nicotine as completely interchangeable in terms of smokers’ health and the damage it does to society. Widespread misperceptions around nicotine remain the industry’s biggest challenge and are the No. 1 issue that public health bodies and regulators will need to address to change the status quo.
Recently, U.K. Secretary of State for Health and Social Care Sajid Javid announced that anyone born after 2008 in the U.K. will not be allowed to purchase tobacco products and that the minimum age will raise every year. A similar approach is also being considered in Denmark. But Javid is not considering including e-cigarettes in this approach, which may be an acknowledgment that he at least doesn’t see nicotine as the biggest issue impacting smokers’ health.
What is obvious is that the scientific community, regulators and the wider electronic nicotine-delivery system (ENDS) industry must work together to help change perceptions about nicotine and educate people about the difference between tobacco and nicotine.
A Supportive Regulatory Environment
Taking England as an example of an environment supportive of vaping, the Tobacco and Related Products regulatory framework for e-cigarettes as consumer products is a light touch compared with the premarket tobacco product application (PMTA) in the U.S. As a result, the U.K. offers one of the world’s fastest consumer routes to market for new vape products and has a thriving vape retail sector and a falling adult smoker rate.
The U.K.’s Medicines and Healthcare products Regulatory Agency is now also actively encouraging the use of e-cigarettes to support smoking cessation. The Department of Health and Social Care 2017 Tobacco Control Plan states that the scientific evidence is clear that e-cigarettes are less harmful to health than smoking cigarettes. The U.K. has now set a target to be “smoke-free” by 2030 with vaping and next-generation alternatives seen as a key enabler in reaching that goal. A review commissioned by the government recommends that the National Health Service increases efforts to encourage smokers, particularly pregnant women, to switch to vaping and e-cigarettes.
Scientific Substantiation
Undoubtedly, we need to be led by science. Regulatory submissions, conference presentations, scientific posters and papers must continue to add to the body of evidence demonstrating the role of noncombustible next-generation nicotine-delivery products in tobacco harm reduction.
“Real world” evidence and behavioral studies are also invaluable, particularly to convince regulators and medical professionals of smokers’ switching habits and that these products don’t encourage “on-ramping” of nonsmokers, particularly youth. Peer groups and professional bodies also have their role to play in supporting this aim to be driven by science rather than opinion and media headlines.
In the U.S., the huge amount of data now available due to the rigor of the PMTA process is also invaluable. Companies have spent millions of dollars on scientific studies to demonstrate to the Food and Drug Administration that their products are appropriate for the protection of the public health.
However, there is still the issue of a lack of independent scientific research into vaping as most universities shun research into tobacco-related products. The FDA’s first PMTA marketing orders for consumer vape products in the U.S. are the closest the ENDS industry has to independently verified in-depth scientific evidence that vape products can be evaluated as less harmful than smoking cigarettes.
Industry Opportunities
The next step in product acceptance is to see companies start to further develop consumer products for a medicinal regulatory pathway. Acceptance as a medicinal device to help smokers quit would further legitimize vaping as reduced harm. Achieving this could also lead the way for nicotine strengths to be prescribed at higher dosage levels to support smokers to give up more effectively through a medically monitored offramping process.
Looking to the Future
There are still significant global differences in the acceptance and understanding of the role of e-cigarettes in supporting tobacco harm reduction. The confusion between the different roles tobacco and nicotine play in causing smoking-related diseases, however, remains a common limitation.
Robust regulatory frameworks for both consumer and medical ENDS will help build legitimacy for the sector with both regulators and consumers. In this way, regulation is an important tool to help build confidence in the sector.
Whichever market is chosen for a product, an in-depth understanding of that country’s regulatory frameworks and ongoing investment in gathering scientific evidence is essential. The start of manufacturers looking to gain regulatory approval for their ENDS as medical devices will be an important next step in the industry’s journey to acceptance.
Phil Saunders is the strategic partnership manager at Broughton.

July 1, 2022
Juul: FDA ‘Overlooked’ Aerosol Data

The U.S. Food and Drug Administration overlooked a key part of Juul’s premarket tobacco product application (PMTA) when the agency ordered Juul Labs’ products off the U.S. market, according to court documents.
In court filings Tuesday, Juul said the agency overlooked more than 6,000 pages of data that the company had submitted to the FDA on the aerosols that users inhale, according to the Wall Street Journal.
Juul also said the agency failed to consider the totality of Juul’s evidence, which the company said established that the public-health benefits of Juul products significantly outweighed the potential risks.
“FDA’s order acknowledged that ‘exposure to carcinogens and other toxicants present in cigarette smoke were greatly reduced with exclusive use’ of Juul products compared with combustible cigarettes,” Juul Labs stated in court documents.
A federal appeals court last week granted Juul Labs a temporary stay of the FDA’s marketing denial order that requires the vaping company to pull its e-cigarettes off the U.S. market.
“The purpose of this administrative stay is to give the court sufficient opportunity to consider petitioner’s forthcoming emergency motion for stay pending court review and should not be construed in any way as a ruling on the merits of that motion,” the court wrote.
The FDA has until July 7 to respond to Juul’s motion and Juul Labs has until July 12 to reply to the FDA response if submitted.
June 28, 2022
Bangladesh Mulls Ban on E-Cigs and Pouches

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Bangladesh’ Ministry of Health and Family Welfare wants to amend the country’s tobacco act to ban e-cigarettes and oral nicotine pouches, reports The Business Standard. The proposal also includes new restrictions on combustible tobacco products.
Health activists have been calling for prohibition of e-cigarettes, which are not mentioned in the current legislation. The proposal would prohibit not only the consumption of vapor products, but also the production, import, export, storage, sale and transportation of e-cigarettes or their parts.
People caught vaping would face maximum fine of BDT5,000 ($53.80) under the plan, while producers and traders would risk imprisonment for a maximum of six months or a fine not exceeding BDT200,000 or both for the first time. The punishment would double each time the offence is repeated.
E-cigarettes started arriving informally in Bangladesh a few years ago and quickly became popular. As demand increased, British American Tobacco started producing and selling e-cigarettes in the market. Japan Tobacco is also reportedly preparing to market e-cigarettes in Bangladesh.
The health ministry’s proposal would also tighten restrictions on traditional tobacco products. Among other provisions, it includes a ban on flavors and an increase in the size of graphic health warnings to 90 percent of the packaging’s surface from the 50 percent required under current legislation. The draft also foresees new retail licensing requirements and limitation on where tobacco can be sold.
The health ministry has recently sent copies of the draft to stakeholders. The Directorate General of Health Services is accepting opinions on the draft until July 14.
June 28, 2022
It’s Official: FDA Denies Juul Market Access

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Today, the U.S. Food and Drug Administration confirmed what many had already been anticipating: Juul Labs must remove all currently marketed Juul products from the U.S. market.
“Today’s action is further progress on the FDA’s commitment to ensuring that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public health standards,” said FDA Commissioner Robert M. Califf. “The agency has dedicated significant resources to review products from the companies that account for most of the U.S. market. We recognize these make up a significant part of the available products and many have played a disproportionate role in the rise in youth vaping.”
These marketing denial orders (MDO) pertain only to the commercial distribution, importation and retail sales of these products, and do not restrict individual consumer possession or use—the FDA cannot and will not enforce against individual consumer possession or use of Juul products or any other tobacco products.
After reviewing the company’s premarket tobacco product applications, the FDA determined that the applications lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health. In particular, some of the company’s study findings raised concerns due to insufficient and conflicting data—including regarding genotoxicity and potentially harmful chemicals leaching from the company’s proprietary e-liquid pods—that have not been adequately addressed and precluded the FDA from completing a full toxicological risk assessment of the products named in the company’s applications.
The FDA says that, to date, it has not received clinical information to suggest an immediate hazard associated with the use of the Juul device or Juul pods. However, the MDOs issued today reflect FDA’s determination that there is insufficient evidence to assess the potential toxicological risks of using the Juul products.
“There is also no way to know the potential harms from using other authorized or unauthorized third-party e-liquid pods with the Juul device or using Juul pods with a non-Juul device,” the agency wrote in a statement.
“The FDA is tasked with ensuring that tobacco products sold in this country meet the standard set by the law, but the responsibility to demonstrate that a product meets those standards ultimately falls on the shoulders of the company,” said Michele Mital, acting director of the FDA’s Center for Tobacco Products. “As with all manufacturers, Juul had the opportunity to provide evidence demonstrating that the marketing of their products meets these standards. However, the company did not provide that evidence and instead left us with significant questions. Without the data needed to determine relevant health risks, the FDA is issuing these marketing denial orders.”
June 23, 2022
Sweden: Lawmakers Reject Vape Flavor Ban

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Sweden’s Parliament, the Riksdag, rejected a ban on sales of flavored vaping products, with 177 lawmakers voting against the proposal and 126 lawmakers voting in favor, reports Vaping360.
Introduced by the government’s Ministry of Social Affairs in late February, the new rules would have taken effect next January, and would have prohibited flavors other than tobacco in all e-liquid, including zero-nicotine vape juice.
In rejecting the proposal, lawmakers heeded the advice of the Riksdag’s social affairs committee, which had recommended adopting proposed regulations for nicotine pouches and synthetic nicotine but eliminating the flavor ban.
Seven other European countries have banned non-tobacco vape flavors. In Denmark, Estonia, Finland, Hungary and Ukraine, flavored vape restrictions are currently in place. Lithuania’s flavor ban will take effect July 1. In the Netherlands, the flavor prohibition scheduled to begin in July has been postponed until January 2023.
No European country has banned vaping products outright.
June 22, 2022
EU to Review Feedback on Tobacco Framework

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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.”
The IEVA’s full contribution can be viewed here.
The European Commission will hold a public consultation in the fourth quarter of 2022 and anticipates adoption in the second quarter of 2023.
June 21, 2022
Canada Proposes New Vapor Disclosure Requirements

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The Canadian government wants vapor product manufacturers to disclose information about their sales and the ingredients used in their products.
On June 17, Minister of Mental Health and Addictions and Associate Minister of Health Carolyn Bennett announced the launch of a 45-day public consultation period on the proposed rules.
“Canada’s vaping market is evolving rapidly,” Health Canada wrote in a press release. “A large number of vaping substances are available across the country and new formulations are frequently introduced with new flavors. Health Canada is restricted in its capacity to properly track market trends due to limited access to information on vaping products sales and composition.”
According to Health Canada, the proposed regulations are the first step of a gradual approach to introducing vaping product reporting requirements. Health Canada is considering additional reporting requirements for implementation in the future similar to those already in place for tobacco products. This could include reporting on information related to research and development as well as promotional activities. It could also include disclosing some information to the public which would increase industry transparency.
“As the vaping market continues to evolve rapidly and entice Canadians, including young people, to use vaping products, we are taking action to better protect everyone in Canada by more fully understanding the impact of these products on their health,” said Bennett. “The proposed regulations will help us educate Canadians about the health harms while furthering research aimed at reducing the amount of people impacted by harms related to tobacco and vaping product use across the country.”
The proposed regulations have been published in the Canada Gazette. Stakeholders can submit comments to mailto:mpregs@hc-sc.gc.ca until Aug. 2.
June 21, 2022
Marketing Approvals for NJOY ‘Daily’ Vapes
Photo: NJOY
The U.S. Food and Drug Administration has approved the premarket tobacco product applications (PMTA) for NJOY’s Daily Rich Tobacco 4.5% and NJOY Daily Extra Rich Tobacco 6%.
“It should be noted that our determination that the marketing of these products is APPH [appropriate for the protection of public health] is based in part on the submitted microbial stability data,” the agency wrote in its marketing granted order (MGO).
The designation does not mean the products are safe and they are not “FDA approved,” the agency said, but the MGOs allows the NJOY to legally market the authorized products in the United States.
While approving NJOY’s Daily Rich Tobacco 4.5% and NJOY Daily Extra Rich Tobacco 6%, the FDA denied authorization for multiple other Daily e-cigarette products. These are presumed for products with nontobacco flavors. Any of those products that remain on the market must be removed or risk FDA enforcement, the agency said. Applications for two menthol-flavored Daily products remain under FDA review.
Additionally, the authorization imposes marketing restrictions on the company to greatly reduce the potential for youth exposure to advertising for these products. The FDA said it will closely monitor how these products are marketed and will act as necessary if the company fails to comply with any applicable statutory or regulatory requirements, or if there is a notable increase in the number of non-smokers—including youth—using these products.
On April 26, the FDA authorized four NJOY Ace products through the PMTA pathway.
June 10, 2022