The U.S Food and Drug Administration (FDA) alongside the Department of Health and Human Services announced deeming regulations for the vapor industry today.
The FDA will stick to its position that all tobacco products not currently regulated that hit stores after February 2007 would have to be approved by the FDA. The e-cigarette industry was virtually non-existent before then.
The Tobacco Control Act of 2009 sets February 15, 2007, as the latest date by which all tobacco products would have to have to be grandfathered in. Mitch Zeller, head of the FDA’s Center for Tobacco Products, has said publicly that he couldn’t choose a later date, it can only be changed by an
act of the U.S. Congress.
An amendment to appropriations legislation working its way through the U.S. House would change the date so more e-cigarettes would be grandfathered in.
The legislation would prevent the FDA from requiring retroactive safety reviews of e-cigarettes that are already on the market and exempt some premium and large cigars from those same regulations. E-cigarette products introduced in the future would still undergo the safety reviews.
Republicans have said the pre-market review would be a lengthy and expensive process. Gregory Conley, president of the American Vaping Association, says each review could cost more than a million dollars.
“There are thousands of small businesses and tens of thousands of jobs on the line,” Conley said.
Author: GTNF Trust Staff
FDA unveils US vapor regulations
EU court upholds new vapor laws
The European Union’s top court approved sweeping new rules that will require plain cigarette packs, ban menthol cigarettes and regulate the growing electronic cigarette market.
The Independent British Vape Trade Association said in a statement that it is disappointed by the ruling and argued it could push some e-cigarette smokers back to tobacco.
Tobacco companies had protested a 2014 EU directive on the new rules, calling it disproportionate. But the European Court of Justice on Wednesday upheld the directive, arguing it’s in line with efforts to fight smoking and protect public health.
The rules will require warnings for e-cigarettes, limit their nicotine levels to 20 grams and restrict advertising and sponsorship by their makers.
The court said it is OK to ban menthol and other flavorings that make tobacco more appealing. The directive also requires standardized, plain labels that cover at least 65 percent of all cigarette packs with health warnings.
Study detects increase in vapers
The number of vapers more than doubled in key markets between 2013 and 2015, according to an Ernst & Young study.
The report, E-cigarettes: an emerging category, surveyed the vapor business in Italy, France, Germany, Poland, the U.K., Russia and South Korea
Ernst & Young found that the number of vapers in these countries rose from an estimated 2.8 million in 2013 to 5.1 million in 2015, with the U.K. and France registering the highest usage. According to the study, vapers represent 4 percent of the U.K. adult population and 3.5 percent of the French adult population.
In 2015, 37 percent of those who used the devices identified themselves as ex-smokers, compared with 31 percent in 2013.
The size of the vapor market was equivalent to 20 percent of the size of the combustible tobacco market in the U.K. and 12 percent of that in France;
The most common reason cited for using the devices in Germany, Italy and Russia was that they are “less harmful than regular cigarettes.”
Countries with higher cigarette prices reported greater penetration of vapor products.
RCP: Vapor 95% safer than smokes
A groundbreaking 200-page report that supports e-cigarettes as a tool to quit smoking and demolishes several vaping myths in the process has been released by one of the world’s most prestigious medical organizations.
The Royal College of Physicians (RCP), the most respected medical institution in the United Kingdom, concluded e-cigarettes are 95 percent safer than regular cigarettes and are likely to be hugely beneficial to public health.
Patricia Kovacevic, general counsel and chief compliance officer for U.S.-based Nicopure Labs, summarized the report’s key areas: “The Royal College of Physicians findings are clear: 1. E-cigarettes are not a gateway to smoking. 2. Their use does not result in normalization of smoking. 3. Among smokers, e-cigarette use is likely to lead to quit attempts and eventually successful smoking cessation. 4. Possibility of long term harm cannot be entirely dismissed but it is likely to be very small, and substantially smaller than that arising from smoking. These findings should weigh heavily here, in the U.S., against the (U.S. Food and Drug Administration) decision to issue a deeming rule that may decimate the vaping industry.”
Titled “Nicotine without smoke
: tobacco harm reduction,” the report is one of the most comprehensive ever published examining e-cigarettes and could be a game changer for health officials and politicians all over the world, according to an article published in The Daily Caller.The RCP’s seminal 1962 report, which demonstrated the link between smoking, lung disease and bronchitis spurred the U.S. Surgeon General to publish the historic 1964 “Smoking and Health: Report of the Advisory Committee to the Surgeon General of the United States.”
The RCP’s new report tears apart scare stories, including the ever-more popular idea that vaping is somehow a gateway to smoking. “To date, there is no evidence that any of these processes is occurring to any significant degree in the UK,” said the report’s authors.
Contrary to the claims of some public health activists in the U.S., the RCP is clear: e-cigarettes can help smokers kick their habit for good. “Among smokers, e-cigarette use is likely to lead to quit attempts that would not otherwise have happened, and in a proportion of these to successful cessation. In this way, e-cigarettes can act as a gateway from smoking.”
JTI launches Logic Pro across UK
JTI’s New Logic PRO tank e-cigarettes have been available at Sainsbury’s stores in the UK since January, but were launched nationwide this month. The release will be boosted with a TV and outdoor media campaign beginning May 1.
Tanks are the cartridges that hold the e-cigarette’s vaping liquid and can be replaced when empty, according to an article in City A.M.
The launch comes a year after JTI bought one of the United States’ leading independent e-cigarette makers, Logic, last April. Founded in 2010, Logic specialized in rechargeable, ready-to-use and disposable e-cigarettes, including the Logic Pro tank system.
Around 85 percent of vapers use tank e-cigarettes, equating to around two million regular users in the UK.
The Right to Be Heard
Censorship, publication bans and integrity in scientific research
By Marina Murphy
Industry scientists deserve a voice. In a recent commentary piece in the journal Addiction, professor Jim McCambridge from the University of York said that academic journals should not publish any e-cigarette research funded by the tobacco industry. But research and innovation—whether or not conducted or funded by industry—have the potential to immeasurably improve people’s lives. This is as true for the tobacco industry as any other industry and is particularly relevant given that with e-cigarettes, we now have potentially revolutionary products in tobacco harm reduction.
Many in the public health community believe that e-cigarettes represent a historic opportunity to save millions of lives and drastically reduce the public health burden of smoking-related diseases. We need to be able to trust the science and research that comes out of the industry driving this revolution, and the regulators that oversee it. Doesn’t this mean that we need to foster a culture of collaboration, cooperation and greater—not less— transparency? It therefore makes no sense to suggest that the science on which this innovation is based be censored or hidden from the scientific community, the public, consumers or regulators. It makes no sense that the science conducted by companies that research and manufacture e-cigarettes, or indeed any product we consume on a daily basis, be banned from publication. It is in everyone’s interest that scientific results are demonstrated to be based on research that is repeatable, traceable, and open for critique and comment by the scientific community. Censorship and publication bans are not the way to achieve this.
SCIENCE AND INDUSTRY
Industry plays a crucial role in the research process, which is not likely to change. Society in general expects that this research be tied to commercialism, and so much of the science supporting innovation, from green chemistry to new drugs, will happen in companies not universities. All of us depend on industry to put research results into practice—to feed us, clothe us, get us around and provide medicines when we are ill. Industry scientists outnumber academic research scientists, and industry funds more research than any government or noncommercial organization.
A common view is that industry scientists have conflicts of interest and that this conflict influences the integrity of the science—that these scientists are compromised and that the science should be viewed to some degree at least to be of suspect credibility or value. Regrettably, much of this debate mixes up bias and conflict; if all conflicts were banished forever, there would still be many sources of bias. But conflicts of interest are not, in themselves, determinants of bias.
You could argue that of course industry scientists are conflicted—of course they want the research to yield positive results, better products, advances in technology, etc. But it is not necessarily biased. If industry scientists were truly biased, how do we explain the marvelous innovations and advancements that have so successfully and so immeasurably enhanced all our daily lives?
BANS
Science students are more likely to end up working for an industrial organization than for a government or university. They can’t all be bad. That is not to say that mistakes have not been made in the past. But surely we can learn from these mistakes and work together to engender a culture of transparency and collaboration—to fulfill our duty of care and to ensure that society benefits from the immeasurable good possible through scientific and technical innovation and expertise.
In his commentary, McCambridge concedes that his proposal to ban the publishing of tobacco-funded e-cigarette research is not based on the evidence of any current misconduct on the part of the tobacco industry with regard to research it funds on e-cigarettes, but on evidence of decades-old misconduct. His proposal is based on his own belief that this misconduct occurs, and he suggests creating a register that does “not rely exclusively on self-disclosure,” a suggestion that one commentator called a “new McCarthyism in which allegation stands in place of evidence and where the appearance upon such a blacklist could destroy a researcher’s career.”
This commentator goes on to say, “Here is a real danger of creating an academic environment in which allegations have supplanted proof when it comes to scientific misconduct … suspicion has assumed primacy over evidence.”
It cannot be right to judge an industry based on incidents that happened many decades ago, in a different world, in a different century. Indeed, generations of scientists have passed through the doors of the research laboratories of the tobacco industry since then. The scientists in our laboratories believe in tobacco harm reduction and the potential of e-cigarettes and other next-generation products. We all accept that there is a huge public health benefit to be gained by reducing or eliminating the impact of tobacco-related disease. In our capacity as scientists, it is our role to create the science needed to develop products that are substantially reduced-risk compared to combustible cigarettes and that are acceptable to those who wish to continue to use nicotine.
INVESTMENT
In the past few years, hundreds of millions have been invested by the tobacco industry in e-cigarettes and other next-generation products. These products are now used by millions of consumers. Vaping represents a new subculture, with its own jargon and its own technology. High levels of investment means that this technology is evolving rapidly and is often the topic of conversation, controversy and debate. Almost every day, e-cigarettes appear in the mainstream media. Vaping is trending!
A clear advantage of this “trending” is that smoking cessation now enjoys a place on the news agenda like never before. Smoking cessation had not been covered in any depth until relatively recently. E-cigarettes may take the lead in much of the coverage, but smoking cessation and nicotine are both now routinely featured in mainstream science and health coverage. Another advantage to this is the fact that nicotine, once much maligned, is now widely understood not to be the cause of tobacco-related disease. This contrasts sharply with the situation just a few years ago, when a survey of general practitioners revealed that 40 percent of them thought that nicotine was the first or second riskiest component of tobacco smoke (see info box). It isn’t. It is the toxicants produced as a result of burning dried tobacco that are responsible for the development of tobacco-related diseases, from cardiovascular disease to cancer.
Research has shown e-cigarettes to be better than existing nicotine-replacement therapies or nothing at helping smokers quit smoking. That e-cigarettes are substantially less risky than conventional cigarettes is also a view endorsed by Public Health England, Cancer Research UK, Action on Smoking and Health and the British Heart Foundation.
There is much to be positive about when it comes to all this activity in e-cigarettes. The category is rapidly evolving. Smoking cessation is getting the attention it deserves, and nicotine is better understood than ever before. But this progress cannot and will not continue in a scientific vacuum, and much of that science does and will come from the industry. This science deserves to be reviewed, shared and debated. It is only in this way that the industry can show that it conducts research to the highest standard and demonstrate integrity and best practice. We need more transparency, not less.
There have been examples of scientific misconduct. The worse examples are plagiarism, double publishing of results and falsifying data. There have been a few cases (not in the tobacco industry) in the past decade, but in most cases the peer review system has successfully rooted out the small (though often potentially extremely high-impact cases) number of misconduct cases. Peer review is not perfect, but it is very effective. And if there are doubts about this effectiveness, that needs to be dealt with. It is, after all, an ancient system operating in a modern world.
Advances in science and technology over the last millennia have realized benefits in every facet of mankind’s existence, from shelter and food to health and mobility. No scientific bodies have driven this progress more so than industrial scientists as they apply fundamental science to deliver their products. It is imperative that industry science continues to be seen as a flagship for scientific integrity, and to this end, all science deserves the opportunity to be commented upon and critiqued objectively by the scientific community through continued engagement and peer review.
The potential that e-cigarettes and other products have to save millions of lives cannot be lost in a zeal that sees a desire to eliminate tobacco-related disease confused with a desire to eliminate an industry.
Nicotine misperceptions widespread
Marina Murphy is head of scientific media relations, research and development, at British American Tobacco. A 2013 survey of general practitioners (GPs) revealed that many then believed nicotine to be one of the most harmful components of cigarette smoke
A study of GPs in the U.K. and Sweden, published in Drugs and Alcohol Today, revealed that many hold the view that one of the greatest health risks from smoking is nicotine
The study participants (100 in the U.K., 120 in Sweden) were asked about the risks associated with tobacco and nicotine products, smoking cessation and tobacco harm reduction approaches, and influential sources of information.
The majority of survey respondents (96 percent in the U.K., 98 percent in Sweden) said that they regularly discussed smoking cessation with their patients, but less than half believe that long-term nicotine replacement therapy (NRT) is preferable to smoking (31 percent in the U.K., 48 percent in Sweden).
The survey findings show that a substantial proportion of GPs (40 percent) believe nicotine to be the first- or second-riskiest component of cigarettes, incorrectly identifying it as more harmful than smoke.
Many (44 percent in the U.K., 56 percent in Sweden) also wrongly believe that nicotine in tobacco products is associated with cancer, while 15 percent in the U.K. and 22 percent in Sweden believe the same for pharmaceutical nicotine.
Amendment to change 2007 predicate date passes US House committee
The U.S. House Appropriations Committee, on April 19, approved an amendment to the Agriculture Appropriations bill offered by Rep. Tom Cole (R-OK) and Rep. Sanford Bishop (D-GA), that would modify the predicate date for vapor products.
The vapor industry has been very concerned with one proposed U.S. Food and Drug Administration (FDA) regulation in particular – a rule that would require all e-cigarette and vapor products that came on the market since February 2007 to undergo a Pre-Market Tobacco Applications (PMTA) process that could cost each company/manufacturer millions of dollars.
“What happened today is a big boost of momentum for the industry,” said Arnaud Dumas de Rauly, treasurer of the Vapor Technology Association, which represents manufacturers and businesses. “We’re happy to have bipartisan co-sponsors because up until now we only had Republican buy-in. Now we have Democratic buy-in as well.”
The amendment to modify the “grandfather” date was approved 31-19.
The FDA is expected to issue a final rule (sometime this year, although there is no specific date) giving it authority for the first time to regulate e-cigarettes and vapor products (the White House has been reviewing the FDA deeming regulations for exactly six months on April 19),which generated $3.3 billion in U.S. sales last year.
The committee’s decision doesn’t mean the amendment is law. It will now have the chance to go forward as part of an appropriations bill and be voted on in the House of Representatives. If passed, it would then move on to the U.S. Senate.
Vapor industry representatives say this legislation is a strong step forward. However, future innovations may not be able to meet the substantially equivalent standard, even with a 2016 date, due to the lack of a substantially equivalent product being on the market.
India: man jailed for vapor sales
In the first conviction of its kind in the country, a shopkeeper in Mohali, Punjab, India has been sentenced to three years in jail for selling e-cigarettes under the Drugs and Cosmetics Act, 1940, according to a story in the Indian newspaper the Tribune Trust
.Sessions Judge Saru Mehta Kaushik also slapped a fine on 25-year-old Parvesh Kumar of Punjab Crockery. Out on bail, he’s been given a month to appeal. In 2013, the State Drugs Controller had issued a circular declaring e-cigarettes as an “unapproved drug”.
In the April 7 ruling, the judge noted, “E-cigarette contains nicotine in chemical form, which is highly addictive and potentially lethal. The youth take to such kind of addictive and potentially lethal products, and the offenders involved in promoting and selling such products should be dealt with sternly by law for the welfare of the society.”
He was sentenced to three years of rigorous imprisonment and required to pay fines.
“Having done well in the field of tobacco control in general, Punjab, with this conviction, has shown the way to the entire country to end the nicotine-delivery devices sold in the form of e-cigarettes,” Health Secretary Vini Mahajan reacted. Food and Drug Administration Commissioner Hussan Lal said, “E-cigarettes have ushered in a so-called ‘no-smoking revolution’, becoming a fad especially among the youth. They are marketed as a healthy substitute to cigarettes. There are a lot of misconceptions about their potential benefits but all this is farce. The most important ingredient of e-cigarettes is nicotine.”
Still hope for vapor in c-stores
Electronic cigarettes have been taking a hit lately, with many wondering what is happening in the segment. Some ar
e even questioning whether it is still a viable segment to be in — particularly considering the uncertainty surrounding the Food and Drug Administration’s (FDA) proposed deeming regulations, according to a story in Convenience Store News (CSN).What is known is this: In the grand scheme of things, e-cigarettes are still pretty new, and the segment continues to grow and evolve. Industry insiders still see plenty of opportunity — for both retailers and manufacturers.
Speaking during a CSN webcast entitled “E-Cigs: The Category of Evolution,” Miguel Martin, president of webcast sponsor Logic Technology Development Corp., pointed out it is important to understand that the consumer for electronic cigarettes is the adult smoker.
“The reality is, cigarettes have had a tremendous year, but regardless of the success of cigarettes, almost half of adult smokers are looking for an alternative,” said Martin, whose company is the maker of Logic Premium Electronic Cigarettes. “And whether that’s been snus or different items in the past, electronic cigarettes do appear to meet many of the core needs that adult smokers have.”
These core needs go beyond just nicotine to include societal cues, social cues and the hand-to-mouth experience. These attributes that attract adult smokers to electronic cigarettes are just as true today as they were in the past, he explained.
However, Martin acknowledged that it is not lost on Logic, nor anyone else in the industry, that e-cigarettes have slowed in sales.
“To be frank, that is true. That being said, it is a still a very large segment and companies like Logic that are focused primarily on brick-and-mortar see a very bright future,” he maintained.
“While electronic cigarettes may not be growing as they once were, they are still a very important category for retailers and wholesalers, and very importantly allow the trade to have much higher margins than traditional combustible products,” Martin said. The segment also has the potential to allow retailers and wholesalers the flexibility to customize their offerings, he noted.
While there is no syndicated data available on vape shops and online sales, Logic is aware these outlets exist and are an important part of the overall electronic cigarette business.
When you look at the market share of the e-cigarette segment, Martin explained the consumer is still figuring things out, so the brands are moving around very quickly.
Fontem sues RJR Vapor and NuMark over patents
Imperial Tobacco subsidiaries Fontem Ventures BV and Fontem Holdings BV filed complaints in federal court against R.J. Reynolds Vapor Co. and NuMark LLC on Monday, suing for what it is calling unlawful use of four pat
ented technologies.Previous lawsuits have been filed against Lorillard, which makes blu eCigs, as well as NJoy Inc., Ballantyne Brands LLC of Charlotte, maker of the Mistic brand, and Vapor Corp. The lawsuits are in U.S. District Court for the Central Circuit of California, according to a story in the Winston-Salem Journal.
Altogether, the Fontem companies are a party in 84 complaints, including 20 that are open. The filing began March 5, 2014, with undisclosed settlements reached in some lawsuits.
Reynolds Vapor manufacturers Vuse, the top-selling U.S. e-cig product, while NuMark, an affiliate of Philip Morris USA, makes MarkTen.
The Fontem companies again focus their claims of patents for rechargeable e-cigs, cartridge refill packs, batteries and disposable e-cigs. Fontem said it obtained patents on its technology in February 2013.
Both Reynolds and NuMark have developed internal e-cig technology.
Fontem accuses Reynolds Vapor of patent infringement in its Vuse solo rechargeable digital vapor cigarettes and its Connect power units.
For example, Fontem repeats the legal accusation it made against Lorillard in that Reynolds Vapor is in infringement with its cartridge technology, in particular when it says it does not allow another e-cig product to be used with Vuse products.
Fontem is suing for an undisclosed amount of damages because of “irreparable harm” done to the companies, including lost market share and lost profits on infringing sales.
Reynolds said it is its policy not to comment on pending litigation.
