22nd Century says that it could supply within one growing season enough low-nicotine-tobacco seed to satisfy the needs of the US tobacco industry.
The company’s claim is contained in a press note outlining its response to the US Food and Drug Administration’s proposed rule that would require all cigarettes sold in the US to contain minimally or non-addictive levels of nicotine.
‘In preparation for the prompt implementation of the new FDA rule, 22nd Century is already growing increased amounts of the company’s VLN™ tobacco in order to be able to supply a sufficient quantity of the company’s proprietary VLN™ tobacco seeds to grow enough VLN™ tobacco for the entire US tobacco industry in just one growing season,’ the press note said.
22nd contrasted its position with that of Reynolds American, which, 22nd said, believed the industry was 20 years away from being able to comply with the FDA’s proposed rule.
22nd Century said in the press note that it was willing to license the use of its VLN™ technology and VLN™ tobacco seeds/plants to all interested companies.
‘The availability of this licensing opportunity from 22nd Century negates any argument by other tobacco companies that contend it is somehow not possible to comply with the planned FDA nicotine reduction mandate,’ the note added.
“Big tobacco companies now have a choice: Combat, obfuscate and attempt to delay the most important public health initiative of the last 100 years… or demonstrate a genuine commitment to improving the health of their customers,” said Henry Sicignano, III, president and CEO of the 22nd Century Group. “Now that 22nd Century’s VLN™ technology is proven and readily available for licensing, it will be interesting to see which big tobacco companies genuinely care about smokers… and which are determined to keep their customers addicted to the deadliest consumer product available on the market.”
Category: Regulation
Century's best initiative
Nicotine down, job losses up
Altria says that making it mandatory that all cigarettes sold in the US deliver very low levels of nicotine could cost up to 951,000 jobs, according to a story by Uliana Pavlova for Bloomberg News.
A rule proposed by the US Food and Drug Administration would require all cigarettes sold in the US to contain minimally or non-addictive levels of nicotine.
The proposal has been the subject of an FDA Advanced Notice of Proposed Rulemaking, to which comments have been sought.
Altria reportedly said that, if implemented, the proposal would cause a net loss, directly or indirectly, of up to 951,000 jobs, and that the nation’s unemployment rate could rise from 3.9 percent to 4.5 percent.
The company, which employed 8,300 employees at the end of 2017, estimates that tobacco growers, manufacturers, wholesalers, retailers and distributors would all feel the impact.
ITG Brands said that the proposed changes would create a robust black market.New purulent warnings
India’s Supreme Court yesterday declined to stay the central Government’s new tobacco-packaging rules that require an increase in the size of pictorial health warnings from 40 percent to 85 percent from September 1, according to a story by Bhadra Sinha for the Hindustan Times.
The Cigarettes and other Tobacco Products (Packaging and Labelling) Second Amendment Rules, 2018, require the rotation of graphics and the replacement of current images. The image of a person’s throat with a hole in it, for instance, is to be replaced with more “gruesome pictures of a person’s lips with diseased and purulent growth”.
And in line with this change, the written warning, ‘Smoking causes throat cancer’ is to be replaced with ‘Smoking causes painful death’ and Tobacco causes cancer’, in white upper-case letters against a red background.
The rules require also that packs carry a quit number through which tobacco-product users can connect with online assistance.Vapor pressure building
Hong Kong’s Legislative Council has begun to debate a proposal to regulate vaping and heat-not-burn (HNB) products because of a push by pro-liberalization members including Helena Wong, according to a story by Alex Frew McMillan for Nikkei Inc.
Vaping and HNB products occupy a gray regulatory region in Hong Kong, which means that they are not readily available to people without access to overseas sources.
Despite this, they seem to have a big following.
As Council discussions began in June on the proposal, supporters presented Wong with a petition bearing 10,000 signatures. And Peter Shiu, who represents the retail and wholesale trade in the legislature, was quoted as saying that 10 percent of Hong Kong’s 600,000 smokers had switched to alternatives.
The government however is guarded about the legalization proposal. The secretary for Food and Health Sophia Chan said in June that her department was “very concerned about the existence of e-cigarettes … [because] there are many unknown constituents or components,” some of which had been shown to be harmful. There had been little to no third-party research in Asia on their health effects.
McMillan reported that in much of Asia-Pacific, the sale of vaping and/or HNB devices was either illegal or, as in Hong Kong, occupied a regulatory gray area that kept them off store shelves. Now with users on the rise, consumers were joining together to pressure the authorities for explicit legalization on what they felt were healthier alternatives to traditional cigarettes. And they were starting to have some political impact.
In the past three years, consumers had formed vape-advocacy organizations in Australia, India, Malaysia, New Zealand, the Philippines and Thailand. And the International Network of Nicotine Consumer Organisations, an umbrella group, was lobbying for change in places including Hong Kong, Indonesia, Singapore and Taiwan. Its Asian members had gathered last December in Bangkok to plan a concerted lobbying effort.
“There was an unprecedented feeling among delegates that they are no longer alone, that they are part of a regional and even global movement for change,” said Nancy Sutthoff, the president of INNCO’s board.
And help might come from an unlikely place – Australia, where laws differ from state to state but where, in effect, the sale of e-liquids containing nicotine is either banned or heavily restricted.
This is because Australian lawmakers are themselves under pressure now that New Zealand and Canada have both legalized vaping. “These are countries we compare ourselves with,” said Colin Mendelsohn, associate professor of public health and community medicine at the University of New South Wales and chairman of the Australian Tobacco Harm Reduction Association. “If Australia does make progress in this area, it will be very influential to other Asian countries. Drug policy in Australia has been very instrumental in Asia.”
Mendelsohn went on to say that allowing smoking and banning vaping was costing lives. “The government just needs to get out of the way and let people get on with leading their lives, as long as they are not harming anyone else,” he said.E-cig information requested
The European Commission has been asked to provide information on the implementation within EU member states of the Tobacco Products Directive in respect of electronic cigarettes.
Roberta Metsola, a Maltese member of the European Parliament said in a preamble to her request that a top Greek court had decided that the advertising of e-cigarettes and their use in public places should be covered by the same laws as applied to traditional cigarettes and smoking.
Metsola said that, in its reply to a previous question, the Commission had stated that ‘Article 20 of the Tobacco Products Directive contained requirements relating to safety, quality and consumer protection of electronic cigarettes’.
The Commission had stated also that it was monitoring regulatory developments relating to electronic cigarettes. In this respect, it remained in close contact with member states to enable the exchange of available information and experience, by means of different forums, including the Expert Group on Tobacco Policy, its Subgroup on Electronic Cigarettes and the upcoming Joint Action on Tobacco Control.
Metsola asked whether the Commission could already provide information on the implementation within EU member states of the Tobacco Products Directive in respect of e-cigarettes.
The Commission is due to reply in writing.Missing even a no-brainer
The debate about whether to legalize electronic cigarettes in Australia is unfolding all over again, according to a story by Luke Grant for 4bc.com.au.
Grant said that a recent report suggested the push for e-cigarettes was coming from tobacco companies that were eager to lure another demographic into their market. ‘On this reasoning, vaping is presented as being a “gateway” activity,’ Grant said. ‘It supposedly leads or prompts consumers towards conventional smoking products.’
But Dr. Attila Danko, the medical director of Nicovape and the former president of the New Nicotine Alliance, Australia, was quoted as saying this was not the case.
“If it was true that e-cigarettes were a massive gateway to children becoming addicted, I wouldn’t be on the side of legalizing it,” Danko said.
“But the truth is, the use among young people is mostly experimental. They have found that teenagers who tried e-cigarettes also tried smoking. They’ve said that because they tried e-cigarettes and then they tried smoking, the e-cigarettes must have led to the smoking. But it’s just not the case.”
Danko said he could not understand the resistance around legalizing e-cigarettes, given that, comparatively, vaping was far less dangerous [than was smoking].
“The Royal College of Physicians, which has to be one of the most authoritative medical bodies in the world; they did one of the most extensive studies on the whole field, looking at all the research,” Danko said.
“They concluded that vaping almost certainly represents less than five percent of the risk of smoking.
“It’s just a no-brainer. Why would you allow the most harmful product to be freely sold everywhere and ban the far safer product?”Nicotine focus flawed
Three US health activists have told the Food and Drug Administration that while nicotine in cigarettes should be lowered to non-addictive levels, the agency should not expect that this reduction alone will solve the smoking problem.
Jesse Elias, MA, Yogi Hale Hendlin, PhD, and Pamela M. Ling, MD, MPH, of the University of California, San Francisco, recently submitted a public comment to the FDA on its proposed Nicotine Product Standard.
‘The FDA is considering its proposed nicotine product standard as part of its “comprehensive nicotine policy”,’ the comment said. ‘The FDA’s description of this proposal to date appears to focus narrowly on the pharmacological properties of nicotine. By reducing nicotine delivery in cigarettes, this standard would encourage smokers to switch to other nicotine delivery systems, including those made by tobacco companies, so as to reduce the harm caused by tobacco products. In the best-case scenario, reduced-nicotine cigarettes will prompt smokers to quit smoking altogether, and cease use of all tobacco products. Second best, smokers will switch to non-combustible tobacco products yet maintain their nicotine addiction.’
The comment, of more than 800 words, ended by saying that to improve addiction outcomes and public health, the FDA should both reduce the nicotine levels permitted in cigarettes and other combustible tobacco products, while also expanding and strengthening social and environmental restrictions on cigarette smoking.Restrictions spreading
The Chiba Municipal Government is following the lead of Tokyo by seeking to make the majority of eating and drinking establishments in Chiba smoke-free, according to a story by Hiromi Kumai for Asahi Shimbun.
Chiba officials have drafted regulations that would prohibit smoking inside eateries where at least one employee is working, regardless of the dimensions of the premises – regulations that are similar to those of Tokyo’s ordinance.
The Government estimates that about 70 percent of the approximately 3,200 dining establishments in the city will be subject to the new regulation, though the percentage will drop to 66 percent if bars or taverns are excluded.
Chiba officials, who sought opinions from the public, aim to have the anti-smoking law in place no later than the 2020 Tokyo Olympics and Paralympics are due to take place.
By comparison, under a central government bill, smoking is prohibited in principle at eateries, offices and hotels. But such facilities may set up special rooms for the exclusive use of smokers – albeit rooms where no food or drink will be served. Existing eateries with customer seating areas of up to 100 square meters and capital of up to ¥50 million are exempted from the smoking ban and are not required to set up separate smoking areas if they display a sign in front of their buildings indicating that they allow smoking.
The central-government bill restricts also the use of heat-not-burn products by requiring eateries to set up special smoking rooms if they want to allow their customers to use such devices while they dine.
The Tokyo measure will cover an estimated 84 percent of restaurants and bars across the capital, whereas 45 percent are likely to be regulated by the national law.
The new Tokyo ordinance is said to seek to protect the well-being of those deemed vulnerable, particularly children and employees, with a ban on tobacco smoking on public-facility premises, such as kindergartens, schools and day care centers.
Although tougher than the national legislation, the Tokyo ordinance stops short of banning smoking in all facilities.
A less stringent measure, for example, will apply to the premises of institutions such as universities, hospitals and government offices, where smoking can be allowed in designated areas outside buildings.
Among those subject to the most relaxed regulation are gyms, hotels and some eateries, where only indoor smoking will be outlawed. And even inside, people will be able to smoke tobacco in segregated rooms specially equipped to prevent smoke from leaking out.
Tokyo’s ordinance is set to take effect from April 2020, just a few months before the start of the Olympics.
Chiba’s proposed ordinance will regulate all restaurants and eateries with at least one employee, though smoking will be permitted in smoking areas.
Under the Chiba ordinance, however, bars or taverns that are subject to the law regulating adult entertainment businesses will be required only to make reasonable efforts to comply. They will not merit punishment for the time being based on the belief that smoking at such drinking establishments is socially accepted.
However, the regulation will be strengthened for such alcohol-related establishments after the prohibition against lighting up becomes customary at restaurants and eateries.Big brother is watching
Smoking in non-smoking areas without getting caught is about to get a lot harder in Singapore, according to a story in The Straits Times.
The National Environmental Agency (NEA) intends to deploy surveillance cameras around the island with high definition thermal sensors to help detect smoking in prohibited areas. The cameras will be aimed also at capturing what the story described as ‘other unhygienic acts’ such as spitting and littering.
Singapore prohibits smoking in an estimated 32,000 premises and locations, such as entertainment outlets, shopping malls, office premises, hospitals, schools, cinemas, bus-stops, covered walkways, lift lobbies, stairwells and entrances to buildings.
Cameras deployed in areas where smoking is prevalent but barred will record images of the person as well as the date and time.
The tamper-proof thermal cameras, which can detect a person holding a lighted cigarette during the day or night, will be placed discreetly on rooftops, in common corridors and staircases of residential buildings, multi-storey carparks and other locations.
But the thermal cameras will focus only on the common corridors, lift lobbies or staircase landings where smoking is prohibited.
NEA said it would be mindful of the privacy of members of the public, though it is aiming to deploy 140 cameras a year.
The NEA said there were strict protocols governing the viewing of the footage from cameras and that only authorized NEA staff and the vendor would be authorized to handle and view the video footage, and then only for official purposes.
The NEA issued about 22,000 tickets last year to people smoking in prohibited areas, up from 19,000 in 2016, but this rise was only to be expected given the exponential rise in the number of places where people cannot smoke.
People caught smoking in prohibited areas are liable to fines of S$200-S$1,000 if convicted in court.
Members of the public can report infringements via the NEA website or MyENV app.Blind faith in warnings
Reports in Australia based on a study published in the Medical Journal of Australia (MJA) raise some interesting questions about smokers’ thinking; or perhaps about the way that anti-tobacco operatives think that smokers think.
According to a story by Tegan Taylor for the Australian Broadcasting Corporation, the MJA study asked 1,800 Australians about whether they thought smoking increased the risk of 23 conditions shown to be associated with tobacco use, such as lung cancer, stroke and diabetes.
While more than eight in 10 participants knew lung, throat and mouth cancers, heart disease and emphysema were linked to smoking, a much smaller proportion were aware it was associated with erectile dysfunction, female infertility, diabetes and liver cancer.
Dr. Michelle Scollo of Cancer Council Victoria, which ran the study, was quoted as saying the results of the study showed the current warning labels were doing their job, and that it might be time to expand them.
“It was predictable and pleasing that smokers knew about the health effects that have been highlighted in the current sets of warnings and media campaigns,” Scollo said.
But this seemed not to be the case entirely. According to the story, which was illustrated – perhaps ironically – with a huge picture apparently of a Department of Health and Ageing mock-up of a cigarette pack showing a current graphic health warning in which somebody’s eye was being held open with a metal instrument and that bore above the picture the legend: SMOKING CAUSES BLINDNESS, blindness was one of conditions people were least likely to associate with an increased risk caused by smoking.
Scollo went on to say that fewer than half of the people who responded to the study realised smoking could reduce fertility, something that could have a major impact on the course of people’s lives. “There’s a lot that people need to appreciate,” she was quoted as saying.
The current set of graphic warning labels have been in place since 2012 and Scollo hopes the results of the study will lead to an expanded campaign including new graphic warning labels, showing more of smoking’s health risks.
“People need continuous reminders of these sort of things if they’re going to remember them but I don’t see why we need to be limited to just 14 warnings,” she said.
“I think we need as many warnings as we need to adequately warn people about the risks they face.”