Legislation was introduced in the US’ House of Representatives on Thursday that, if adopted, might prevent the electronic cigarette business from falling into a state of de facto prohibition, according to a story by Guy Bentley for the Washington Examiner.
The bipartisan legislation would alter Food and Drug Administration rules requiring products deemed to be tobacco products that came on the market after February 15, 2007 (the ‘grandfather’ date), to undergo a prohibitively expensive and complex approval process.
The grandfather date is especially damaging for electronic cigarette businesses because almost all vapor products were launched after February 2007.
There have been various and varying estimates of the cost of the premarket tobacco application process but all those estimates suggest that the small- and medium-sized companies that have pioneered the electronic cigarette revolution would not be able to afford it.
The only players that would be left in the electronic cigarette space would be major tobacco companies that could afford to comply with the FDA regulations, Bentley wrote.
Not only would a change in the grandfather date keep different product options open for those trying to quit smoking, it would save tens of thousands of jobs and thousands of small- and medium-sized businesses from closing.
But while the proposed legislation would give vital breathing space to the electronic cigarette industry, the two congressmen who introduced the legislation were eager to stress consumer safety and reducing tobacco-related harms as the primary objectives of their reforms.
Macau’s Health Bureau announced yesterday a proposal to retain smoking lounges in the city’s casinos and therefore drop a previous plan to implement a zero-smoking regime inside these venues, according to a GGRAsia story.
The bureau’s deputy director, Cheang Seng Ip, said, however, that the new proposal would include higher technical requirements for smoking lounges.
Additionally, smoking at VIP gambling tables would be banned under the proposed new regime. And VIP smoking lounges could not be established as a right of the casino operators, who would need to apply to the government for permission, just as they currently do for smoking lounges on the main floors of casinos.
A number of investment analysts have said that in markets where casino smoking has been banned completely, casino revenues subsequently dipped.
The bureau’s announcement came two days after the public release of results from a survey commissioned from the University of Macau by the city’s six casino operators. The survey indicated more than half of respondents supported the retention of smoking lounges on the main floors of casinos.
The new technical requirements for smoking lounges now proposed by the bureau echo those included in a proposal on that topic by the six operators, who suggested that the lounge specifications were publicly disclosed on Monday along with the results of the opinion survey.
Smoking on the main floors of casinos in Macau is currently only allowed in airport-style enclosed smoking lounges that do not contain any gaming tables or slot machines, but having a cigarette while gambling is allowed in VIP rooms.
A story by Jacob Grier in the online magazine Slate asks whether public-places tobacco smoking bans have gone too far given new evidence that the health risks associated with second-hand tobacco smoke have been overstated.
Grier starts his long piece in Helena, Montana, US, which in 2002 implemented a comprehensive smoking ban in its workplaces, bars, restaurants, and casinos.
In the first six months of the ban, the rate of heart attacks in the city plummeted by nearly 60 percent, Grier wrote. Just as remarkably, when a judge struck down the smoking ban in November 2003, the rate of heart attacks shot back up to its previous level.
For three anti-smoking advocates this sudden drop in heart attacks had been proof that smoking bans ushered in extraordinary benefits for public health.
Newspapers ran with the story, he wrote, credulously assuming that the correlation had been truly caused by the smoking ban.
In the early 2000s, as jurisdictions across the country fought over expanding smoking bans to bars and restaurants, anti-smoking advocates seized on the Helena study and related research showing that second-hand smoke exposure could affect coronary functions to promote fear of second-hand smoke. The message they put out was that even the briefest exposure to second-hand smoke could kill you.
‘A decade later, comprehensive smoking bans have proliferated globally,’ wrote Grier. ‘And now that the evidence has had time to accumulate, it’s also become clear that the extravagant promises made by anti-smoking groups – that implementing bans would bring about extraordinary improvements in cardiac health – never materialized.
‘Newer, better studies with much larger sample sizes have found little to no correlation between smoking bans and short-term incidence of heart attacks, and certainly nothing remotely close to the 60 percent reduction that was claimed in Helena.
‘The updated science debunks the alarmist fantasies that were used to sell smoking bans to the public, allowing for a more sober analysis suggesting that current restrictions on smoking are extreme from a risk-reduction standpoint.’
Jacob Grier is a freelance writer based in Portland, Oregon, and the author of Cocktails on Tap: The Art of Mixing Spirits and Beer and the weblog Liquidity Preference.
Heat not burn (HNB) products, which heat tobacco rather than incinerating it at temperatures that cause many harmful chemicals to form, represent a potentially promising public-health tool to reduce the harm of cigarette smoking, according to a new policy study by Edward Anselm, a senior fellow of the R Street Institute, a, public policy research organization headquartered in Washington, D.C., USA.
“Heating tobacco at lower temperatures than combustible cigarettes allows nicotine to be delivered in ways that retain much of the ritual and experience of smoking,” writes Anselm. “Comprehensive scientific programs have demonstrated these products present significantly reduced risk when compared to traditional cigarettes. Collectively, they represent a new set of tools to reduce the harm of combustible tobacco.”
HNB products are available in several markets. Anselm believes that their success in the United States may be dictated by how the Food and Drug Administration chooses to regulate them.
“While it appears the research programs to support HNB products are well on their way toward meeting the requirements for new and modified risk products, it is not yet clear how stringently the FDA will interpret the guidelines,” Anselm writes.
Even as it suffers setbacks, Swedish Match’s MRTP application offers a path for other tobacco companies to follow.
By Timothy S. Donahue
Developing less risky alternatives to cigarettes is all the rage nowadays. Nearly every tobacco company has an alternative tobacco product that aims to be safer than smoking. However, only one company can be first in gaining approval from the U.S. Food and Drug Administration (FDA) to make the claim publicly.
Despite recent setbacks, Swedish Match (SM) remains far ahead of the pack. In June 2014, the firm filed a modified-risk tobacco product (MRTP) application for its General snus brand. It was the first such application to ever be accepted for review by the FDA. Snus is a moist tobacco product placed under the upper lip that does not involve spitting or chewing. In mid-December 2016, the FDA finally responded to the 135,000-page document. The regulatory agency decided to defer any decisions on whether to allow the company to claim the products cause less harm than cigarettes or whether to allow removal of a warning that the products may cause mouth cancer.
In another first, the FDA stated that it believed the SM application “could be amended to support issuance of modified risk orders.” However, it also informed the company that it would not be able to remove a warning that the products may cause gum disease and tooth loss. SM intends to meet with the FDA (a 45-day response deadline places a possible meeting in mid-February, although no date could be confirmed as of this writing), according to Jim Solyst, vice president for federal regulatory affairs for SM. The FDA requires SM fully address all remaining concerns within two years.
“What we will do is certainly have a conversation with the FDA, but the exact nature of those discussions have yet to be determined. We are more than willing to keep this process going, to respond to the letters we’ve received and the document they put out,” said Solyst. “We would need some additional information, some clarification as to what would be the path forward. Yes, we will have discussions. We believe it’s in all parties’ best interests that we keep this dialogue going.”
One challenge facing SM is that the FDA’s “conversations” with tobacco companies are not necessarily of the type that most people associate with that word. They are more like a dialogue through documents. When a tobacco company meets with the FDA’s Center for Tobacco Products (CTP), it’s a listening session where a company presents, the FDA listens, and at some point later the FDA makes a decision that is often unclear and more often without explanation. “The burden has always been on us, the applicant, to propose something,” says Solyst. “Then they comment on it.”
Risk reduction quantified
Jim Solyst
The actions on the MRTP applications have no impact on SM’s premarket tobacco product application (PMTA) authorizations issued for eight of its General snus products in November 2015. SM was the first—and, so far, only—tobacco company to receive product approvals under the PMTA process. In its PMTA, SM proposed that General snus should be considered to be protective of the public health, and the FDA agreed. In its response, the agency determined that the General snus products are protective of the public health and contain significantly lower levels of harmful constituents compared with over 97 percent of the smokeless products on the U.S. market.
“They even went further than we did,” says Solyst. “They quantified the risk reduction.” The MRTP response, however, was different. “The FDA stated that ‘No, this is not quite what we need. We’re not willing to remove the warning labels, and we want you to do your consumer perception in a different way.’ Going forward, part of our conversation with them would be, well, ‘Which way is that?’ Yes, it’s been a difficult process. They aren’t very clear on their expectations.”
Understanding the industry interest and complexity of its decision, the FDA did attempt to explain its scientific review process and what was considered in the actions taken against SM in its MRTP application. In a note on its website, the FDA states that to pursue an MRTP order, a company, among other things, is required to establish that submitted modified-risk data for a product is supported by scientific evidence that shows “the product (as actually used by consumers) can significantly reduce the harm and risk of tobacco-related disease to individual tobacco users, as well as benefit the health of the population.”
In its MRTP applications, SM proposed to remove two warning statements required of smokeless tobacco products by the FDA: one stating that the product can cause gum disease and tooth loss, and the other stating the product can cause mouth cancer. In reviewing these requests, the FDA determined that “removing the warning statement about gum disease and tooth loss would imply that using these snus products cannot cause gum disease and tooth loss, as compared to other smokeless tobacco products,” according to its statement. Similarly, the FDA determined that removing the warning statement about mouth cancer would imply that using these snus products cannot cause mouth cancer. “Based on the available scientific evidence, we determined that the applicant’s proposal to remove this warning should be denied,” wrote the FDA. “There is sufficient evidence that the use of these products increases the risk of mouth cancer in users compared to nonusers.”
However, the FDA did state that evidence provided by SM may support other claims, such as a claim about the “reduced risk of mouth cancer provided on the product labeling, in advertising, or otherwise outside of a health warning. That claim would need to be carefully worded and adequately tested with consumers to ensure satisfaction of the MRTP requirements, including consumer comprehension.”
The FDA’s use of the word “imply,” however, is confusing. Is the agency attempting to determine how the general public may or may not interpret a statement without doing any reasonable research? Is the research of the wording a responsibility of the applicant? Solyst says he’s not sure. It’s hard to guess as to the FDA’s intent. “We believe that what they’re basically saying is that because there are the existing warning labels, they’re not going to remove them. They don’t address this specifically, but if you look back at the 2015 decision, the inference would be that had there not been a warning label at all, that’d be a different story,” says Solyst. “Because there is already a warning label, they’re not inclined to remove it no matter how much evidence we present.”
Public interpretation
Further muddying the waters, SM also asked to revise a third warning statement to say that General snus products present “substantially lower risks to health than cigarettes.” This seemed fair considering the FDA’s PMTA response that General snus products were 97 percent safer than similar products. Even the FDA’s review of the submitted scientific evidence for the MRTP concluded that “General snus products, as used by consumers in Sweden and Norway, may pose substantially lower health risks to individual smokers who switch completely to these products for some health outcomes, such as lung cancer or chronic obstructive pulmonary disease.”
Conversely, the FDA again claims that there is insufficient scientific evidence to support the claim, as would be implied by a generalized statement about health risks as compared to smoking. “However, as with the evidence related to mouth cancer, the evidence on relative health risks provided by Swedish Match may support a different explicit claim, such as one outside of a health warning providing information concerning the differences in specific health risks, if the claim is carefully constructed, and adequately tested,” wrote the FDA.
Why the FDA is trying to speculate at public interpretation is anyone’s guess. The agency may be losing sight of the bigger picture by being so vague and secretive. “We think that telling smokers that these products are 97 percent safer than similar products is the key message; this message is getting lost,” says Solyst, adding that maybe the FDA wants SM to take more of a relative risk approach. “Should our claims be that this product is significantly less risky than other products? That very well could be what they’re saying. The main message is, to us, that they’re not going to remove the current labels, but that doesn’t mean they wouldn’t consider other marketing claims. They seem to want us to continue this process. They gave us options, and one of those options was to present different claims. That’s why we need more information from them. What exactly do they mean by that; what evidence would be necessary to go that route?”
Spread the word
Looking back at its PMTA approval, Solyst says another frustration with the FDA is that the CTP didn’t really attempt to get the word out to the industry surrounding the significance of the first PMTA issued. The CTP decision was of global, and possibly even historical, significance. It was the first time any public health regulatory agency had made such a decision (allowing a new, safer tobacco product on the market). “We would have liked to have seen the FDA make more of it. Maybe they will, in the future, but that has been the frustration, which is: We agree with the decision; we just wish it was better known among tobacco users,” Solyst says. “We understand that this is an ongoing process, and we’re not discouraged. We think we have a harm reduction product that has already received one very positive decision from the FDA [in the PMTA], and we expect to continue this process and secure the first MRTP.”
While continuing and completing the MRTP is important to SM and its vision of a “world without cigarettes,” Solyst says the story is much bigger. As a leader in tobacco harm reduction and the only company to successfully navigate the PMTA course, SM has an obligation to the industry to establish the process of navigating the MRTP minefield. “We’re the only company who’s gotten this far. We feel we have to try to understand what exactly it is that they want. We’re not just acting as a company or as a product, but as a leader in the industry,” he says. “We feel this obligation to demonstrate how this [MRTP] can be done, and that it should be able to be done in an efficient manner. We felt the same way about the PMTA process. Now that we’re the only one with a PMTA, and we think we will do future PMTAs, we have that obligation to set a standard and continue the fight.”
Political advisers in Shanghai, China, have proposed that the city learn from other cities about publicizing a tobacco smoking ban that will take effect in five weeks, according to an Ecns.cn story.
From March 1, all public indoor venues and work areas, as well as some outdoor areas, such as those at art performance and sporting venues, those at maternity hospitals, infant hospitals and kindergartens, and those around bus stops, will become non-smoking zones.
But the current anti-smoking notifications in the city are far from enough, said some local political advisers during their annual gathering last week.
“In Singapore, smoking bans with pictures, such as broken cigarette butts and children covering their mouths and noses surrounded by smoke, are very commonly seen in the streets to gain people’s attention,” said Wang Xinmei, a member of the Shanghai Municipal Committee of the Chinese People’s Political Consultative Conference, Shanghai’s political advisory body.
“Beijing also did a good job informing the public of its smoking ban, which became effective in June 2015. On all the flights and trains bound for Beijing there are repeat broadcasts of the smoking ban, which seems powerful, and Shanghai can learn from that,” said Wang, who is also chairwoman of the Jinshan district branch of the city’s political advisory body.
Gwan Tat-cheong, another political adviser in Shanghai, said Shanghai might look to Hong Kong where smoking in indoor public places has been prohibited since 2007. Publicity surrounding the smoking ban was ubiquitous in public venues and on different communication channels throughout the city, and the notifications highlighted also the cost that violators faced. “It always states clearly that errant smokers can be slapped with fines of HK$1,500 ($193),” said Gwan, who is also a senior adviser at the Bank of East Asia (China) Ltd.
And, apparently, Shanghai does intend to crack down from the start. Individuals caught smoking tobacco in places forbidden to smokers will be fined from 50 to 200 yuan, and organizations that fail to stop smokers will be fined up to 30,000 yuan, according to the new regulations.
“Any new regulation, such as the citywide fireworks and firecrackers ban since the beginning of last year, faces challenges when it first comes into being, but it’ll become easier when a consensus is formed in the whole society,” said Wu Fan, director of the Shanghai Center for Disease Control.
Indonesia’s House of Representatives (DPR) is planning to bring in a ban on the advertising of tobacco products on television and radio, according to an Indonesia Investments story.
Currently, radio and television advertisements for tobacco products are the subject of restrictions, including those governing when such advertisements may be aired.
Indonesia Investments said that Indonesia’s tobacco industry, which it described as ‘massive’, objected to the plan for a full ban on radio and television advertising.
It said that such a ban would have a big effect on government revenue since cigarette excise duties were a key source of government revenue, and on the revenue generated by media organizations since tobacco companies comprised the fifth-largest advertiser in Indonesia.
Based on data from the research firm AdsTensity, Indonesia’s tobacco industry spent IDR6.3 trillion (US$474 million) on television advertising last year, with the biggest industry spenders being Djarum (IDR 1.91 trillion), Gudang Garam (IDR1.32 trillion), and HM Sampoerna (IDR1.25 trillion).
Elvira Lianita, head of fiscal affairs and communication at HM Sampoerna, said the government needed to re-think whether a full ban would be appropriate because there already existed a law that limited tobacco-related advertisements in the Indonesian media.
Lianita said the ban would have far-reaching effects because not only would the earnings of the tobacco industry decline, but so would those of the government and the media. And it would affect the welfare of many small Indonesian tobacco farmers as well as workers in the country’s cigarette plants.
Budi Darmawan, corporate communications manager at Djarum, said the ban would have a big impact on the tobacco industry of Indonesia because among all forms of advertisement, television advertisements were the most effective.
The industry’s views, as expressed by the story, seem to undermine the claim that advertising affects brand shares rather than overall volumes.
Meanwhile, the Indonesian Consumers Foundation (YLKI) has urged the government to ban tobacco-related advertisements on television. Tulus Abadi, chairman of the YLKI, said Indonesia was the only country worldwide that still allowed cigarette producers to advertise on television.
The Indonesia Investments story said the DPR’s proposal showed that the Indonesian government was in favor of tobacco control and the protection of public.
The European Commission is in favor of a cautious approach to heat-not-burn products because it believes that there is a lack of evidence relating to the short- and long-term health effects of using such devices.
This was part of the answer given by the Commission to questions raised by the Belgian MEP, Frédérique Ries.
In a preamble to her questions, Ries said that Philip Morris International had said that it intended to market its new ‘device for smoking’ in the UK, following its initial launch in Japan, Italy and Switzerland.
‘The distinctive feature of this new product, which has been named iQOS, is that it stands on the borderline between traditional cigarettes and electronic cigarettes,’ she said.
‘The major difference between iQOS and electronic cigarettes is that while the latter use a liquid transformed into vapor, IQOS heats the tobacco and keeps it burning [iQOS has been designed so as not to burn the tobacco it contains, only to heat it, as is implied in part of the Commission’s reply], which is very harmful to health.’
Ries asked whether the Commission concurred with health experts who claimed that marketing a hybrid tobacco product of this kind was a ploy to circumvent legislation in force and, in particular, all the requirements laid down in Article 19 of Directive 2014/40/EU concerning novel tobacco products.
‘What steps will the Commission take to thwart the strategies employed by cigarette manufacturers to sell alternative products that are still just as harmful to people’s health?’ she asked.
‘Will the Commission take this opportunity to alter its negative views on electronic cigarettes, which, as a growing number of cancer experts in the EU are now pointing out, do not contain any tobacco or tar and are helping many people to stop smoking?’
In reply, the Commission said it was closely monitoring the developments related to new tobacco products, including “heated not burned” tobacco products.
‘Currently, there is lack of evidence relating to short-term and long-term health effects and use patterns of these products,’ it said. ‘Therefore the Commission is in favour of a cautious approach.
‘At the same time, the Commission would like to underline that with regard to the sale, presentation and manufacturing of these products within the European Union, the relevant provisions of the Tobacco Products Directive apply and should be enforced. This includes the ban on misleading elements foreseen by Article 13 and notably any suggestions that a particular tobacco product is less harmful than others. The Commission oversees whether member states fully and correctly apply the provisions of the directive.
‘With regard to e-cigarettes, given the lack of conclusive evidence relating to the long-term health effects, use patterns and potential to facilitate smoking cessation, Article 20 of the directive contains their regulation with an emphasis on safety, quality and consumer protection.
‘The rules for e-cigarettes nevertheless allow these products to remain widely available to consumers. A recent Commission report COM (2016) 269 underlines a number of potential risks to public health relating to the use of e-cigarettes, at the same time highlighting the need for further research.’
As tobacco and vaping companies focus on new nicotine products that are potentially less harmful than are cigarettes, industry players see an opening under the Trump administration for rolling back rules governing these new products, writes Jilian Mincer in a story for Reuters.
Trump’s surprise election victory in November and his pledges to reduce federal regulations on business have led tobacco lobby groups to draft a new plan of action, according to company executives, lobbyists and consultants interviewed by Reuters.
The immediate goal was to delay implementation of new regulations on the latest generation of electronic cigarettes and other vaping devices.
Longer-term, they were setting their sights on repealing the 2016 law that treats these devices as if they were tobacco products.
Lobbyists, writes Mincer, describe a cautious optimism as they approach lawmakers with their plans for products that they say can help smokers quit and avoid the known dangers of tobacco.
‘With U.S. sales of conventional cigarettes shrinking, big tobacco has made a major bet in recent years to dominate the e-cigarette industry,’ she said.
Although Beijing residents accustomed to smoky restaurants and bars doubted that the city’s latest ban on tobacco smoking would have any effect, it’s been a slow but steady success, according to a story by Kyle Mullin for The Beijinger.
No doubt the residents were influenced by the many commentators who, after the announcement of the public-places smoking ban, predicted non-compliance on a grand scale.
However, if they had looked around the world, they would have seen that smokers are generally law abiding – much more so than are drivers, for instance – and that smoking bans, where properly enforced, have been complied with – unlike speed limits.
And this has been the case in Beijing where most food and beverage venues have reported good compliance with the rules.
Not only that; state media recently reported that 200,000 fewer Beijingers are lighting up these days than used to be the case. Based on findings jointly released at the end of 2016 by the Beijing Patriotic Health Campaign Committee and the Beijing Municipal Health Commission, the percentage of local adult smokers has gone down from 23.4 percent in 2014 to 22.3 percent this year.
Stricter smoking restrictions were announced in 2014, and put into effect citywide in 2015, barring anyone from smoking at eateries and workplaces, on public transport and at other public places.
Legislation was introduced in the US’ House of Representatives on Thursday that, if adopted, might prevent the electronic cigarette business from falling into a state of de facto prohibition, according to a story by Guy Bentley for the Washington Examiner.
Macau’s Health Bureau announced yesterday a proposal to retain smoking lounges in the city’s casinos and therefore drop a previous plan to implement a zero-smoking regime inside these venues, according to a GGRAsia story.
