Global Regulation - Tobacco Reporter

Many Comments on EU Tobacco Changes

An overwhelming majority of EU citizens who responded to a European Commission initiative say they support tobacco harm reduction products.

The Commission’s “Call for Evidence” on the legislative framework for tobacco control received an unprecedented level of feedback, with consumers of alternatives to tobacco products – vaping, heated tobacco and oral nicotine pouches – making their voices heard in huge numbers, according to EU Political Report.

More than 24,000 EU citizens responded to the call, launched by the Commission as part of its ongoing evaluation of what future EU tobacco laws will look like through revision of the Tobacco Products Directive.

The massive interest in the issue may surprise some and may put the European Commission on the back foot as has been seen by some as having previously failed to support ‘tobacco harm reduction’.

The 4-week public consultation, from May 20 May to June 17, had one of the biggest ever responses to a consultation. On average, calls of this length receive around 354 submissions. In recent years, only the “call for evidence” for a digital euro for Europe received a similar scale of a response, but still fell short of the 20,000 submission mark despite taking place over a longer period of time (10 weeks).

Of the 24.000 submissions, more than 90 percent came from individual EU citizens, suggesting the extent to which this issue is a priority for the European public at large. Many submissions came from citizens in Germany, Italy and Romania.

It showed that the biggest issue for citizens across all member states is the regulation of reduced-risk products such as e-cigarettes. On this, it has been argued that the Commission it out of sync with public opinion.

The Commission has favored the introduction of new restrictions on reduced risk products, including flavor bans and sale restrictions but some in the industry hope the public response could now force it to reconsider these plans.

In June, the Commission announced plans to prohibit the sale of flavored heated tobacco products in the EU. The proposal came, it said, in response to the “significant increase” in the volumes of heated tobacco products sold across the EU.

A Commission report showed a 10 percent pick up in the sales volumes of heated tobacco products in more than five Member States and overall in the EU, heated tobacco products exceeded 2.5 % of total sales of tobacco products.

An overwhelming majority of submissions supported tobacco harm reduction products, including vaping and nicotine pouches, as “critical tools” that have helped smokers to quit. Respondents were nearly unanimous in opposing any plans to restrict access to such products for adults over the age of 18.

July 22, 2022

Joytech Parent Submits PMTA to FDA

China-based JWEI has announced today that they have successfully submitted a premarket tobacco product application (PMTA) to the U.S. Food and Drug Administration for a device created with “new innovative technology” that focuses on safety, harm reduction and is designed to curb underage use.

“JWEI has been a leader in this industry from the start and this milestone again reiterates our commitment to the industry and public health: ensuring our adult customers continued access to less harmful alternatives to traditional tobacco products, while setting a new standard preventing underage youth access.” said VP of JWEI Group Jason Yao.

JWEI is the parent to the brands Joytech, Eleaf, Wismec and Joyevita. The company did not offer additional information on the specific device submitted for the PMTA.

JWEI developed a set of principles to guide through every step of its new product development, led by safety and effectiveness studies in early 2019. “The design philosophy is the foundation and guide rails for designing, manufacturing, verifying, validating, and continuously improving innovative, responsible, reliable, and high-quality products,” the release states.

The limited product debut in the UK has received overwhelming recognition from users and commercial partners after a few months’ actual use, according to JWEI

“As one of the world-leading device manufacturers and innovators of e-cigarette and vaping products, JWEI has over 3,600 granted patents and multiple internationally recognized manufacturing and quality certifications (GMP, HACCP, ISO9001, ISO13485, EHS, and ERP),” according to a press release.

July 21, 2022

FDA Reviewing Oversight Rules After Botched Juul PMTA

The head of the U.S. Food and Drug Administration Tuesday said he has commissioned an independent review of the agency’s food and tobacco programs following months of criticism over its handling of the baby formula shortage and e-cigarette reviews, according to AP.

The announcement comes as FDA Commissioner Robert Califf attempts to push past several controversies that have dominated his second stint running the agency, including his issuing of a marketing denial order (MDO) to e-cigarette maker Juul Labs and later having to rescind that order and placing Juul’s premarket tobacco product application (PMTA) back under review.

“Fundamental questions about the structure, function, funding and leadership need to be addressed” in the agency’s programs, Califf said in a statement. The agency’s Center for Tobacco Products (CTP) is facing challenges navigating policy and enforcement issues from “an increasing number of novel products that could potentially have significant consequences for public health … CTP will continue its important work during the evaluation, including review pending applications and take enforcement actions as needed.”

Califf said the non-profit Reagan-Udall Foundation — a non-governmental research group created by Congress to support FDA’s work — would convene experts to deliver evaluations within 60 business days of both the food and tobacco operations.

“It may take some time to implement any recommended changes, but I am committed to addressing them and communicating them to the public in a timely manner,” Califf stated. “It is my belief that this effort will continue strengthening the FDA and better position the agency to deal with the many immediate public health issues we are facing, while preparing for the many scientific challenges and fascinating opportunities of the future.”

July 19, 2022

Malaysia’s Generational Tobacco Ban Clears Cabinet

Malaysia’s Cabinet has approved the Tobacco and Smoking Control Bill, reports The Star.

“I will be sending [the Bill] to Parliament for this session,” Health Minister Khairy Jamaluddin told reporters during the presentation of a new drug perception study report on July 14.

Among other provisions, the bill calls for a ban on sales of cigarettes, tobacco and vapor products to those born after 2005.

The proposed law is modeled on legislation in New Zealand, which in December 2021 revealed a plan to phase out smoking by gradually raising the smoking age until it covers the entire population.

Presently, some 40.5 percent of men and 20 percent of women smoke in Malaysia.

July 17, 2022

Malaysia: Cabinet to Consider Generational Smoking Ban

Malaysia’s Cabinet will review a bill this week that would ban smoking for those born after 2005, reports The Edge.

According to Health Minister Khairy Jamaluddin, the bill’s “implementation of the generational endgame” provision aims to prevent Malaysia’s younger generations from picking up the smoking habit and getting addicted to tobacco products when they grow older, as well as to reduce the number of smokers in Malaysia to less than 5 percent by 2040.

“This will be able to reduce the risk of premature deaths, chronic diseases and treatment costs that have to be borne by the government due to smoking complications among the community,” Jamaluddin said.

Presently, some 40.5 percent of men and 20 percent of women smoke in Malaysia.

Anticipating resistance to the bill from cabinet members worried about tax revenues and tourist spending, Khairy said that without the legislation, the government would have to bear treatment costs of about MYR8 billion ($1.81 billion) to treat health problems linked to smoking.

Malaysia’s bill, which would also regulate vapor products, is modeled on legislation in New Zealand, which in December 2021 revealed a plan to phase out smoking by gradually raising the smoking age until it covers the entire population.

July 11, 2022

Brazil Maintains E-cigarette Ban

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

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

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

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.