The US Food and Drug Administration’s Center for Tobacco Products (CTP) is due to explain the processes it uses in the review of tobacco product applications. Vapor products are considered a tobacco product by the CTP.
In a press note, the FDA said it planned to hold a meeting of the Tobacco Products Scientific Advisory Committee (TPSAC) on April 6.
‘During this meeting, representatives from the FDA’s Center for Tobacco Products will present information to the Committee, which includes several new members, on the processes CTP uses in the review of tobacco product applications, including substantial equivalence (SE), modified risk tobacco product (MRTP) and premarket tobacco applications (PMTA),’ the note said. Vapor companies are expected to have to survive at least one of the regulatory pathways to keep products on the market.
‘Topics will include the statutory standards applicable to the different types of applications; the scientific basis for review decisions, with a focus on PMTA and MRTPA; and the role of the committee in the review process.
‘People interested in presenting data, information, or views, either in person or in writing, must send in their submissions by March 15 or March 23, respectively.’
Philip Morris International is unlikely to get permission to sell its iQOS heated tobacco device in Australia under current regulations, according to a story in the Sydney Morning Herald relayed by the TMA and quoting the assistant health minister, David Gillespie.
Gillespie said that the commercial supply of nicotine was effectively prohibited in Australia via state and territory poisons legislation, with some exceptions, such as for tobacco prepared and packed for smoking, and certain nicotine replacement therapies.
He was quoted as saying that these exemptions would be unlikely to apply to heat-not-burn products because ‘the nicotine in them would not be in the form of tobacco prepared and packed for smoking’.
The story said that the recent decision by Australia’s Therapeutic Goods Administration to retain nicotine on its poisons list, effectively banning eVapor products containing nicotine, also complicated PMI’s plans.
Despite the TGA having no direct role in making rules about heat-not burn products, Gillespie said that “further consideration of policy options to address heat-not-burn products may be considered in the context of a national response to e-cigarettes”.
Meanwhile, Tony Snyder, PMI’s vice president of communications, said that iQOS was for adult smokers “looking for product choices that offer the satisfying taste, ritual, and pleasure they get from cigarettes, but with far lower amounts of the harmful compounds found in smoke”.
A new survey has found that marketing for vapor products in the UK might be wide of the target.
The survey found, for instance, that two-thirds of vapers were over 40 years of age.
SmokShop.com, which describes itself as one of the largest retailers of electronic cigarettes in the UK, said it had recently carried out its first survey to determine what the average ‘vaper’ looked like. And it said the results were surprising.
The target audience for most vape-company marketing comprised mainly men aged somewhere between their mid-20s and early 30s. The emphasis seemed to be on hip, urban street culture.
Smokshop said that the data it collected ‘from a random group of 500 customers’ was expected to back up this consumer profile, but that had not been the case.
The survey found that:
15.5 per cent of vapers were under 30;
66.6 percent were over 40;
39.3 percent were over 50;
15.7 percent were over 60; and
1.6 percent were over 70.
The survey found too that 76 percent of vapers were men; that 83.5 percent of vapers had quit smoking altogether since starting to vape; and that 13.2 percent of vapers wanted to quit vaping.
Smokshop said that most vapers seemed to be older ex-smokers who ordered electronic cigarettes online and used vaping as a substitute for smoking.
Round two. The fight to ease FDA requirements over vapor products was halted last year when Congressmen Tom Cole (Oklahoma) and Sanford Bishop (Georgia) failed to get their Cole-Bishop Amendment into federal budget legislation. However, the two Republicans have regrouped in their effort to alter the FDA’s deeming regulations for new tobacco products and the fight is back on track.
Cole and Bishop reintroduced legislation, designated HR 1136, on Feb. 16 to amend the FDA’s rules. The proposal would change the current Feb. 2007 predicate date for new tobacco products, as well as introduce other vaping-related initiatives, according to a press release from Cole’s office.
Changing the predicate date will not alter the FDA’s approval authority over products introduced after the new predicate date. The legislation would allow all current products to remain on the market. Existing products will still have to comply with the FDA’s safety and marketing rules.
The Cole-Bishop Amendment has been a key player in the ongoing battle between the FDA and the vaping industry. What started as just a general disagreement against FDA regulations, quickly became an amendment sponsored by Rep. Tom Cole (R-OK) and Rep. Sanford Bishop (D-GA). Together, they have formed a movement to keep vaping products on the market for adult consumers.
“Before the amendment was created I didn’t know a lot about the vaping industry, but I was bothered by the idea of the FDA going back to 2007 for approval on vaping products,” said Rep. Tom Cole. “It’s like regulating through the review mirror and retroactively. To me, that did not seem fair to any business on any kind of regulation. I began to learn how many people the vaping industry had helped kick tobacco. I looked at the medical evidence, which was a considerable amount, and it’s much safer than smoking cigarettes or cigars. I began to wonder why the FDA was making it more difficult for these people.”
As Congressman Cole became involved with the legislation, he began to work closely with Congressman Bishop and made the amendment a bi-partisan effort. They spoke with vapers and vape shop owners and began to realize that the FDA’s regulations were not a productive way to move forward.
“The entire regulatory approach the FDA is taking toward both premium cigars and vaping has been punitive, and counterproductive. You don’t want to drive people out of business when they are selling a perfectly lawful product that helps people get out of the business of smoking,” said Congressman Cole. “There is a legitimate role for tobacco regulations, but vaping is not a tobacco product. The FDA is punishing an industry that does not need to be punished at all. They are creating barriers for customers and entrepreneurs with no evidence to justify. I think we have too many people that think they know what’s best, but in my experience, you allow individuals to make the choices they want to make. That’s their right. Regulations should be based on evidence and the FDA doesn’t have the evidence to say that vaping is a harmful product.”
The main purpose of the Cole-Bishop Amendment is to amend the February 15, 2007 grandfathered date set by the Tobacco Control Act for currently unregulated tobacco products, including nicotine containing electronic vaping devices and the e-liquid used in them. The Tobacco Control Act placed a requirement on these products to receive FDA marketing authorization – through either a Premarket Tobacco Application (PMTA) or Substantial Equivalence (SE) Report – before it can enter the market. The PMTA is a time consuming and expensive process, and unfortunately many vaping companies can’t afford that expense – especially when the process doesn’t guarantee approval.
“There is no scientific basis for forcing the vaping industry to jump through this many hoops, said Congressman Cole. “There is a legitimate role the FDA plays for tobacco regulations, but e-cigarettes are not a tobacco product. They don’t have the same consequences for your health. I think the FDA got caught up in the hysteria over the declining use of tobacco products. The alternative to tobacco products is found in the vaping industry, and that’s good, not bad.”
This is why the Cole-Bishop Amendment is so important to the vaping industry. The Cole-Bishop Amendment will switch the grandfathered date to Aug. 8, 2016 – the effective date of the Deeming Regulation. The amendment would allow vaping products to avoid the lengthy and expensive PMTA process.
So, what can you do to ensure the amendment is passed?
“The most powerful thing to do is to meet with members of Congress and educate them,” said Congressman Cole. “A lot of the propaganda surrounding the vaping industry is negative and inaccurate. The best people to educate political leaders are their constituents. Believe me, when someone comes in that I represent, and they discuss their point of view, I make a point of listening and so does my staff. Availing yourself of the right as an American citizen to petition your government is the number one thing to do.”
If you don’t know who your local Congress representative is, you can find out by clicking here.
“I encourage people to explain to their congressman why we don’t need this kind of federal regulation, and what the consequences will be in terms of the manufacturing, selling and using the product for people who are in many cases trying to kick the tobacco habit,” said Congressman Cole. “We should be working to encourage it, not discourage it.”
The Global Forum on Nicotine is organizing a series of public dialogues in the UK.
The organizers say that the format of the events is designed to stimulate discussion and debate, involving the audience, on the often-contentious issue of vaping in public and work places.
The dialogues are due to be held in Leicester on March 21, Liverpool on March 22 and Glasgow on March 23.
Each will start at 14:00 and end by 17:00.
The Leicester event, which is to be hosted by the Leicester City Council Stop Smoking Services, will see Professor Gerry Stimson, programme director of the Global Forum on Nicotine, in the chair, and will include panellists Dr. Konstantinos Farsalinos, of the Onassis Cardiac Surgery Center, Athens; Ruth Tennant, director of Public Health Leicester; Louise Ross, manager of Leicester’s Stop Smoking Services, and Alan Law, a vaper and vaping advocate.
The Liverpool event, which is to be hosted by HIT, will see Pat O’Hare, director of HIT, in the chair, and panellists Farsalinos; Sarah Jakes, secretary of the New Nicotine Alliance; and Dr. Russell Newcombe, research and evaluation manager, User Voice.
The Glasgow event, which is to be hosted by the Centre for Substance Use Research, will see Dr. Delon Human, of Health Diplomats, in the chair, and panellists Farsalinos; Andy Morrison, of the New Nicotine Alliance, Scotland; Dr. Joanna Miler, of the Centre for Substance Use Research; and Robbie Preece, NHSGG&C Health Improvement Lead – Tobacco.
Attendance at the dialogues is free, but those interested in participating are required to register.
The Australian Therapeutic Goods Administration’s (TGA) recent interim decision to effectively ban nicotine-containing electronic cigarettes has been described by Dr. Colin Mendelsohn, a tobacco treatment specialist who teaches at the University of Sydney, as a harsh blow to smokers.
Writing on theconversation.com, Mendelsohn said Australian smokers would be denied access to life-saving technology that was estimated to have helped millions of overseas smokers quit.
Those most affected would be from lower socio-economic and disadvantaged groups, which had the highest smoking rates and were hardest hit by the cost of smoking.
‘Currently, nicotine-containing e-cigarettes are effectively prohibited in Australia,’ Mendelsohn wrote. ‘If the TGA’s interim decision is made final in March 2017, e-cigarette users (or vapers) in Australia will still not be able to buy or import nicotine for vaping without a prescription. Their only legal option would be to ask their doctor for a prescription, which doctors are generally reluctant to provide.
‘If the current ban remains, vapers will still be forced to source nicotine solutions (e-liquids) from an unregulated and illegal black market, placing them at even greater risk. Without regulation, the contents of nicotine refill bottles are a mystery, labels are inaccurate, childproof bottles are not mandated and there is no quality control or manufacturing standard.
‘Other users will buy large quantities of highly concentrated nicotine online and mix their e-liquid at home, with the risk of exposure to children and dosage errors.
‘Meanwhile, vapers who try to quit smoking are branded criminals. The fine for possessing nicotine for vaping in Queensland is up to A$9,108 and the government encourages the public to report any offenders. This fear will lead some vapers to return to smoking.
‘The TGA’s decision also leaves Australia out of step with other similar countries. E-cigarettes with nicotine are legal and available, or are in the process of being legalised, in the United Kingdom, European Union, United States, Canada and New Zealand.
‘Their approach to smoking cessation products is in sharp contrast to policy in Australia, which has missed the opportunity to welcome e-cigarettes as a harm reduction tool, and a safer alternative, for smokers. Meanwhile, the most lethal nicotine products, cigarettes, are freely available in Australia and do not need TGA approval.’
After applying his forensic analysis to a recent study, a US public health expert has found that the study’s claim that vaping is ‘a one-way bridge to cigarette smoking among youth’ is based on the fact that four young, previously-non-smoking recent vapers had tried a cigarette.
‘This story illustrates why you have to be very careful in reading and interpreting the scientific literature,’ Dr. Michael Siegel, a professor in the Department of Community Health Sciences, Boston University School of Public Health, wrote on his blog, the Rest of the Story.
‘If you didn’t look at the supplemental material, which was not part of the article itself, you would never even be aware that the sweeping conclusions of this study were based on four kids.’
Not too many scientists are willing to divulge such information to the laity.
Vaping has been given an emphatic thumbs-up by UK health experts after what was described as the first long-term study of its effects on ex-smokers.
According to an Associated Press story published by the Daily Mail, after six months, people who switched from traditional tobacco cigarettes to electronic cigarettes – or to nicotine replacement therapies (NRT) such as nicotine patches – had far fewer toxins and cancer-causing substances in their bodies than those who continued to smoke.
The new findings showed also that to achieve such benefits smokers had to switch over completely to electronic cigarettes or NRT. Study participants who failed to make a clean break were found to have significant amounts of tobacco-related toxins in their saliva and urine.
Lead author, Dr. Lion Shahab, of University College London, said the results of the study had added to existing evidence showing that the use of electronic cigarettes and NRT products was far safer than was smoking. It suggested that there was a very low risk associated with the long-term use of these devices.
“We’ve shown that the levels of toxic chemicals in the body from e-cigarettes are considerably lower than suggested in previous studies using simulated experiments,” Shahab said. “This means some doubts about the safety of e-cigarettes may be wrong.”
He went on to say that while electronic cigarettes were not only safer than traditional cigarettes were, the amount of nicotine they provided was not noticeably different to the amount of nicotine delivered by conventional cigarettes. “This can help people to stop smoking altogether by dealing with their cravings in a safer way,” he added.
The Cancer Research UK-funded scientists studied a total of 181 individuals including smokers and ex-smokers who had used electronic cigarettes or NRT products for at least six months.
Alison Cox, director of cancer prevention at Cancer Research UK, was quoted as saying that about a third of tobacco-caused deaths were due to cancer, “so we want to see many more of the UK’s 10 million smokers break their addiction”.
“This study adds to growing evidence that e-cigarettes are a much safer alternative to tobacco, and suggests the long term effects of these products will be minimal,” she said.
“Understanding and communicating the benefits of nicotine replacements, such as e-cigarettes, is an important step towards reducing the number of tobacco-related deaths here in the UK.”
A study that compares human exposure to cigarette smoke, electronic-cigarette vapor and nicotine replacement therapies has been described as unique, and an important contribution to the debate on electronic-cigarette safety.
Dr. Ed Stephens, senior research Fellow at the University of St Andrews was commenting at sciencemediacentre.org.
He was one of four public health experts to comment on the study. The others were: Jamie Hartmann-Boyce, senior researcher in health behaviours at the University of Oxford and managing editor of the Cochrane Tobacco Addiction Group; Prof. Kevin Fenton, national director of health and wellbeing at Public Health England; and Prof. Peter Hajek, director of the Tobacco Dependence Research Unit at Queen Mary University of London.
Stephens said in part that one slightly unexpected finding was that combined smoking and vaping did not offer any long-term health benefit while smoking continued. But, he added, if initial dual use led to quitting altogether then the health gains could be significant.
“There may be additional hazards in vaping that have yet to be discovered, but the best evidence to date should encourage smokers who are thinking of taking up vaping for health reasons to progress to stopping smoking quickly and completely, then gradually wind down their vaping.”
The study, Nicotine, Carcinogen, and Toxin Exposure in Long-Term E-Cigarette and Nicotine Replacement Therapy Users, by Lion Shahab et al, was published in Annals of Internal Medicine on Monday.
