Electronic cigarettes are starting to garner support even in 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.
According to a story by Sian Powell for The Australian, in Australia e-cigarettes are ‘winning major support from official and political organisations’, including the Liberal Party of Western Australia and the CSIRO’ [the Commonwealth Scientific and Industrial Research Organisation, an independent Australian federal government agency responsible for scientific research].
Elsewhere, the UK’s House of Commons Science and Technology Committee on e-cigarettes on Friday endorsed their use as a quit-smoking aid.
‘E-cigarettes present an opportunity to significantly accelerate already declining smoking rates, and thereby tackle one of the largest causes of death in the UK today,’ Powell said in quoting the report. ‘They are substantially less harmful – by around 95 percent – than conventional cigarettes.’
The UK report had recommended relaxing e-cigarette licensing and advertising regulations and potentially relaxing e-cigarette taxes and rules on their use in public places.
The smokers’ group Forest has issued a qualified welcome to a report by the House of Commons Science and Technology Committee on electronic cigarettes.
Forest welcomed a call by MPs on the Committee to relax e-cigarette advertising regulations and to review the current limit on the strength of refills and the restriction on the size of tanks.
But it warned against medical licensing of e-cigarettes.
“We welcome the Committee’s open-minded approach to e-cigarettes,” said the director of Forest, Simon Clark.
“We agree that, post-Brexit, manufacturers should be allowed to inform smokers of the potential health benefits of switching to e-cigarettes.
“We agree too that the limit on the strength of refills and the restriction on tank size should be reviewed.”
But on the subject of medicinal licensing, Clark warned that such a move could damage the appeal of vaping for millions of smokers.
“The success of e-cigarettes to date has been based on the fact that they allow smokers who want to quit to switch to a product that, for many people, is as pleasurable as the cigarettes they are giving up,” he said.
“Aligning e-cigarettes with products such as nicotine patches and gum could be counter-productive.”
Members of parliament have warned the UK Government that misconceptions about electronic cigarettes mean that it is missing an opportunity to tackle a major cause of death.
In a press note issued today alongside its report, E-cigarettes, the House of Commons Science and Technology Committee said that these products, estimated to be 95 percent less harmful than conventional cigarettes, were too often being overlooked as a stop-smoking tool by the National Health Service (NHS).
‘Regulations should be relaxed relating to e-cigarettes’ licensing, prescribing and advertising of their health benefits,’ the note said. ‘Their level of taxation and use in public places must be reconsidered.’
In what will be seen by many as one of its most important interventions, the Committee said that it believed the risk for smokers of continuing to use conventional cigarettes was greater than the uncertainty over the long-term use of e-cigarettes. ‘To gather independent health-related evidence on e-cigarettes and heat-not-burn products, the Committee is calling on the Government to support a long-term research programme overseen by Public Health England and the Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment,’ the note said. ‘The Government should make its research available to the public and to health professionals.’
The chair of the Committee, Norman Lamb MP (pictured in 2017), said smoking remained a national health crisis and the Government should be considering innovative ways of reducing the smoking rate. “E-cigarettes are less harmful than conventional cigarettes, but current policy and regulations do not sufficiently reflect this and businesses, transport providers and public places should stop viewing conventional and e-cigarettes as one and the same,” he said. “There is no public health rationale for doing so.
“Concerns that e-cigarettes could be a gateway to conventional smoking, including for young non-smokers, have not materialised. If used correctly, e-cigarettes could be a key weapon in the NHS’s stop smoking arsenal.”
The Committee is recommending that:
‘The Government, the MHRA (Medicines and Healthcare products Regulatory Agency) and the e-cigarette industry should review how approval systems for stop smoking therapies could be streamlined should e-cigarette manufacturers put forward a product for medical licensing.
‘There should be a wider debate on how e-cigarettes are to be dealt with in our public places, to help arrive at a solution which at least starts from the evidence rather than misconceptions about their health impacts.
‘The Government should continue to annually review the evidence on the health effects of e-cigarettes and extend that review to heat-not-burn products. Further it should support a long-term research programme overseen by Public Health England and the Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment with an online hub making evidence available to the public and health professionals.
‘The limit on the strength of refills should be reviewed as heavy smokers may be put off persisting with them — and the restriction on tank size does not appear to be founded on scientific evidence and should therefore urgently be reviewed.
‘The prohibition on making claims for the relative health benefits of stopping smoking and using e-cigarettes instead has prevented manufacturers informing smokers of the potential benefits and should be reviewed to identify scope for change post-Brexit.
‘There should be a shift to a more risk-proportionate regulatory environment; where regulations, advertising rules and tax duties reflect the evidence of the relative harms of the various e-cigarettes, heat-not-burn and tobacco products available.
‘NHS England should set a policy of mental health facilities allowing e-cigarette use by patients unless trusts can demonstrate evidence-based reasons for not doing so.
‘The Government should review the evidence supporting the current ban on snus as part of a wider move towards a more risk aware regulatory framework for tobacco and nicotine products.’
In welcoming the report, the UK’s New Nicotine Alliance (NNA) said that it contained several evidence-based policy proposals that would positively transform the way vaping was viewed by businesses, institutions and the public alike.
It said that it ‘warmly welcomes this report for its clear and unequivocal message that e-cigarettes and other alternative nicotine products are far safer than combustible tobacco and should be treated as such’.
“E-cigarettes are a proven safer alternative to smoking and the UK boasts 1.5 million former smokers who have converted from combustible tobacco to exclusively vaping instead,” said Sarah Jakes, the NNA chair. “The Science and Technology Committee has wisely recognised that misconceptions about e-cigarettes are threatening further progress in encouraging their use by smokers who choose to quit.
“We welcome the Committee’s call for a root and branch review of how risk-reduced products are treated by businesses, institutions and government itself. The report is a beacon of enlightenment in an area of public health which is often burdened by dogma and outdated thinking towards the use of nicotine…”
Jakes said also that there was a lot of confusion about e-cigarettes among the public, health institutions and businesses; so the report was timely and could have hugely positive implications for public health if its recommendations were implemented in full.
“Sir Norman’s Committee has done an excellent job of peering through the mist of misunderstanding surrounding e-cigarettes and its policy proposals can go a long way to dispel the – often deliberately fabricated – misconceptions that are deterring many thousands of smokers from switching,” she said. “We would urge the government to read the Committee’s findings carefully and act on them without delay”
Commenting on the report, the Vaping Industry Association (UKVIA) said that, following an extensive inquiry into e-cigarettes, the Committee had concluded that the government was missing significant opportunities to tackle UK smoking rates.
The UKVIA highlighted that the Committee had urged the government to consider tax breaks for vaping products; to allow wider use of vaping in public places; and to create a streamlined route to medically licenced vaping products.
It pointed out too that the report called on the government to reconsider the regulations around e-cigarette packaging and advertising. ‘Advertising rules currently prevent the industry from making health claims comparing vaping to smoking,’ said the UKVIA. ‘The Committee believes this is stopping UK smokers (almost seven million), from making informed decisions about switching to vaping …’
The report said also that restrictions on nicotine strength, tank size and bottles was not founded on scientific evidence and should be urgently reviewed.
“The Science and Technology Committee report is a ringing endorsement of vaping’s public health potential,” said John Dunne, who appeared before the Committee on behalf of the UKVIA.
“They are absolutely right that advertising restrictions are preventing smokers from hearing the truth. More and more people wrongly believe vaping to be more harmful or as harmful as smoking. This is a direct consequence of advertising restrictions that prevent the industry from telling smokers that vaping is 95 percent less harmful. If health bodies can say it, why can’t we?
“The industry is pleased to see the Committee recognise the nonsensical packaging and nicotine strength regulations, that only hamper vaping’s potential appeal to smokers looking for an alternative.”
It’s getting worse. The vapor industry’s flavor fight has evolved into becoming the centerpiece in its battle for overall survival. From flavor’s role in youth access to how flavors keep smokers from going back to combustible cigarettes to when products entered the market, it seems every aspect of the vapor industry is under fire. Unfortunately, misinformation is becoming the weapon of choice for many anti-vapor advocates.
Sometimes, it’s a small mistake. For example, Education Week, a U.S.-based non-profit publication focused on precollegiate education, in July published an article suggesting that Juul flavor cartridges come in kid-friendly varieties such as mango, crème brulee and gummi bear. Juul does not and has never marketed a gummi bear flavor, according to Juul Labs spokesperson Victoria Davis.
Other times, it’s much larger. In April, the Campaign for Tobacco Free Kids (CTFK) stated that six leading public health and medical organizations sent a letter urging the U.S. Food and Drug Administration (FDA) “to take action to address Juul’s popularity among youth, including removing from the market Juul flavors such as mango and cool cucumber that appear to have been introduced after Aug. 8, 2016, the FDA’s deeming deadline, without FDA review.”
However, in an email to Vapor Voice, Davis wrote that “those flavors were commercially marketed consistent with FDA regulations.”
Then, again, in early August, the same six organizations sent another letter urging the FDA “to stop the sale of new electronic cigarette products that have been illegally introduced in recent months without the agency’s prior review and authorization,” according to a statement posted on the CTFK’s, one of the signatories, website. News of the letter was picked up by several major media organizations, including the Associated Press, USA Today and Good Morning America. The problem, however, is that at least some of the products mentioned in the letter were already on the market when the regulatory agency’s deeming deadline passed.
For example, Altria’s MarkTen Elite, R.J. Reynolds’ Vuse Alto and ITG Brands, Imperial Tobacco’s U.S. arm, Myblu devices were all on the market prior to Aug. 8, 2016, according to several sources who asked not to be named since they didn’t have permission to discuss the products because manufacturing and marketing data is confidential.
The public health groups did correctly interpret the law in that it prohibits any product changes, however slight, to any SKU that was on the market as of Aug. 8, 2016. However, there are some other rules that apply. Firstly, a product could have been on the market with the same, or with another name, as of the deeming deadline even in a very small quantity. While the Tobacco Control Act (TCA) suggests that selling a product in a “test market” may not be the same as placing a product into interstate commerce, the FDA has taken the position that all product sales, including online sales, qualify as interstate commerce and there is no minimum requirement for market size or quantities sold.
To meet the deadline, the manufacturer could have either rebranded or renamed that same exact product or began marketing the product more visibly so as to appear to consumers that it is a “new” product, when in fact the product could have existed on the market prior to the deadline. Altria’s MarkTen Elite, for example, was on the market prior to the deeming deadline under a different brand, according to industry sources.
Passing judgment
Regulation is complicated and vapor industry rules are no different. The reason why vapor products (which the FDA has deemed tobacco products) may be renamed or rebranded without a premarket tobacco authorization (PMTA), is due to a 2016 court decision, Philip Morris USA v. FDA (U.S. District Court for the District of Columbia, No. 15-1590).
In that case, Judge Amit Mehta vacated an FDA draft guidance, which stated that a label change made a tobacco product a “new product” and thus subject to premarket review. In other words, all products subject to the TCA may change their labels (which may include a name change, as well as a color and branding change) without any premarket review requirement by the FDA.
Therefore, a vapor product marketed under a specific name and packaging color on Aug. 8, 2016, may be rebranded at any time without any need to obtain an FDA premarket authorization (new products must be reviewed and approved by the FDA before they can be legally marketed) under either of the two premarket review pathways provided. The FDA also has a substantial equivalence (SE) pathway, which allows products similar to an approved product to have an easier path to market than the PMTA process.
What should be noticed by vapor industry representatives, however, is that in the same ruling, Mehta found that changing the quantity of the product in the packaging does make the respective product a new product, and thus subject to premarket review by the FDA before such changes can be made. So, if a pod size in a closed system were to be increased or if the tank size or battery capacity increased after the deeming deadline, according to the ruling, this would create a new product and would require a PMTA before being sold.
Complicating matters, the FDA has not reviewed and does not have under review any vaping product PMTA as of the writing of this article. There are also no suitable predicate products available (the deadline for grandfathered products under the TCA was Feb. 15, 2007) for vaping products to pursue the less onerous SE premarket authorization pathway. This has been a point of contention for many in the vapor industry who say a new date should be realized by the FDA, possibly the date the deeming rule was made public. The FDA contends that only the U.S. Congress can change the grandfather date.
Another problem plaguing the industry is that even if a product is sold under the exact same name and packaging, manufacturing records can only be accessed by the FDA during an authorized inspection. Only the FDA can require that a company demonstrate that a product is completely unchanged since the deadline. Meaning that a product’s recipe, ingredients, parts and materials used in the manufacturing of the product (whether a liquid, device or combination of the two) remain the same.
“Because of the proprietary nature of the ingredient and technology information, there is no way for any of us to know if a certain product being sold today has the exact same formulation or technology as on August 8, 2016 (which is legally required, or else the product is termed ‘adulterated and misbranded’ under the TCA),” said Patricia Kovacevic, an experienced tobacco attorney who has been working in the vapor industry for nearly a decade. “However, the Tobacco Control Act is not self-executing—meaning it takes an enforcement act by the FDA to remove a product found to be violative from the market.”
To date, the FDA has not acted to take any vapor product off the market for changes made after Aug. 8, 2016. Many vape shops also mix and create new liquids every day. The deeming rule clearly states that vape shops creating their own in-house e-liquids are considered manufacturers and must file a PMTA for every “new” bottle produced.
Numerous vapor companies have expressed concern to the FDA stating that the lack of any enforcement creates extremely unfair competition issues for manufacturers who try to remain compliant. “There is no exception for ‘test markets’ or ‘small batch’ sales, as it is sometimes implied,” says Kovacevic. “In fact, there is no exception explicitly sanctioned by the FDA, period.”
One of the tools the FDA does have at its disposal is to encourage innovation in spite of the prohibition against product changes. The FDA could issue a guidance describing an enforcement discretion policy regarding a defined set of product changes, according to Kovacevic.
“[The] FDA has the ability, if there is political will, to allow innovation in the vaping space by announcing a policy of enforcement discretion with respect to vaping product changes made after August 8, 2016,” she told Vapor Voice. “This was required in various comments to the proposed deeming rule docket when introduced in 2014. The agency has, in the past, exercised enforcement discretion on numerous occasions.”
This means that the FDA could state in a supplemental draft guidance that any changes to a vaporizer’s battery, coils, or other parts of the device with similar (but not identical) parts that are functionally interchangeable, would not trigger a premarket review requirement. “It is unlikely—though highly desirable – that the FDA will do so in the near future. With over 1.5 million individual SKUs registered with the FDA (some say over 2.5 million), there is a clear impossibility to enforce against product changes anyway,” says Kovacevic. Some believe that the FDA will simply remove vaping products from the market only after Aug. 8, 2022 (the FDA’s due date for applications to market deemed non-combustible products, such as vapor products) and only those products that either fail to file a PMTA by the deadline or file an insufficient/not compelling PMTA.
In the meantime, industry and public health advocates alike will continue to be confused and frustrated by the myriad of products being trumpeted as “new” to the consumer, without any real possibility to verify if a product adheres to the FDA’s deeming rule (absent FDA intervention). Kovacevic adds another twist: “Of course, consumer-driven litigation for deceptive practices could change all that, but it would take time for the litigation to percolate through the court system.”
The US Food and Drug Administration says that it is taking steps to improve the efficiency and transparency of its ‘tobacco product application review process’.
‘Specifically, the agency is improving transparency regarding applications for a subset of tobacco products – known as “provisional substantial equivalence (SE) tobacco products,” the FDA said in a note issued yesterday through its Center for Tobacco Products (CTP).
‘As part of this process improvement, starting this week, a copy of the summary review (TPL Review) and the final cycle primary discipline reviews that serve as a basis for the NSE decision will be made available to companies concurrent with issuance of NSE orders for these provisional SE applications,’ the note said. ‘Companies previously obtained such documents by filing a Freedom of Information Act (FOIA) request. Any review document other than those issued with an NSE order may still be obtained by submitting a FOIA request.
‘Under the Family Smoking Prevention and Tobacco Control Act, tobacco products introduced into interstate commerce after February 15, 2007 – but before March 22, 2011 –could remain on the market legally if an SE Report was submitted no later than March 22, 2011, unless FDA issued an NSE order. To receive an SE order, the manufacturer must demonstrate that the new tobacco product has the same characteristics as a valid predicate tobacco product, or if it has different characteristics, that those changes do not cause the new tobacco product to raise different questions of public health.
‘Earlier this month, FDA Commissioner Scott Gottlieb, M.D. and CTP Director Mitch Zeller co-authored a blog outlining new efforts and initiatives under the Comprehensive Plan for Nicotine and Tobacco Regulation, including today’s action. FDA plans to announce additional process improvements ahead of the tobacco product application review public meeting on October 22-23, 2018.’
If the UK Government increased the cost of vaping through the imposition of taxes on electronic cigarettes it would discourage the very thing it was trying to encourage: the switch from smoking to vaping.
This was the essence of a statement by Dan Marchant, director of the Vape Club and board member of the UK Vaping Industry Association, following the publication of stories suggesting that the Government was considering taxing electronic cigarettes as part of its autumn budget.
One aim of the tobacco control plan, Marchant said, was to reduce smoking prevalence among people within the lowest earning brackets. Increasing the cost of the most effective alternative to smoking would not help achieve this goal. In fact, it would do the opposite.
Switching from smoking to vaping provided harm reduction benefits, but another of its attractions was that it offered significant monetary savings. Increasing the cost of vaping would decrease its attractiveness to smokers and have a detrimental effect on encouraging people to move away from tobacco.
The best thing smokers could do for their health, Marchant said, was to quit smoking. However, the evidence was increasingly clear that the use of e-cigarettes was significantly less harmful than was smoking tobacco. The government sought to support consumers in stopping smoking by adopting the use of less harmful nicotine products. At the same time, Public Health England (PHE) had produced guidance for employers and organizations looking to introduce policies on e-cigarettes and vaping in public, and had recommend such policies be evidence-based. PHE recommended that e-cigarette use was not covered by smoke-free legislation and should not routinely be included in the requirements of an organization’s smoke-free policy.
Meanwhile, Marchant said that maintaining high duty rates on tobacco products was a proven and effective means to reduce smoking. As well as providing an incentive to quit for those who smoked, it provided a disincentive for young people to take up smoking.
‘Although national smoking prevalence continues to decline, the picture is not so positive for all groups and communities across England,’ he said. ‘Smoking remains highest among populations who already suffer from poorer health and other disadvantages.
‘In 2015, there were almost three times as many smokers among the lowest earners in our society in comparison to the highest earners. In 2016, the prevalence of smoking among people working in jobs classed as routine and manual was more than double that of people working in managerial and professional occupations. If we are to achieve the first smoke-free generation and break this cycle, we must support those populations where smoking rates remain high to quit.’
Marchant said that rather than taxing vapers, the Government should further increase the ‘sin-tax’ on cigarettes. This would raise more money since there were more than seven million smokers and 2.8 million vapers, half of whom still smoked to some degree. Such a strategy would fit with the Government’s tobacco control-plan guidance.
Voke, the nicotine inhaler that was granted a medicinal-product licence in the UK in 2014, is expected to be launched onto the market next year.
In a press note issued earlier today, Kind Consumer Holdings Limited, the company behind Voke (pictured as it was in February 2017), said the product had been delayed getting to market by issues surrounding the scaling-up of its manufacturing process.
However, the company, which in January 2017 took direct responsibility for manufacturing the product, had now raised further funding from existing and new investors, funding that would be used ‘to complete set up of state-of-the-art manufacturing capacity for Voke and to start recruitment of key marketing personnel to support the UK market launch due in 2019’.
“This funding is another step towards commercialisation of Voke, a product which promises to make a real difference to the health burden of smoking by offering an alternative to smoking for smokers and those around them,” Paul Triniman, CEO of Kind Consumer, was quoted as saying.
The Voke 0.45mg Nicotine Inhaler was granted a medicinal product licence from the UK Medicines and Healthcare products Regulatory Agency in September 2014, but it will be launched as an over-the-counter General Sale List product in the UK.
The product delivers a nicotine formulation via a breath-operated valve in a cigarette-sized medical device. Its technology, which is protected by more than 340 granted worldwide patents, contains no electronics, and does not use heat or combustion.
Kind Consumer said the 0.45 mg nicotine dose had been clinically proven to provide effective craving relief.
It said the product could be used discreetly, generating no visible exhalation and no odor.
The US Centers for Disease Control and Prevention (CDC) has found that electronic-cigarette vapor contains no more formaldehyde than the level present in the average US home, according to a story by Matt Rowland for vapes.com.
The CDC recently published the results of an air-quality study entitled Evaluation of Chemical Exposures at a Vape Shop, which was published on the CDC website.
In addition to testing the quality of the air inside the vape shop, the CDC swabbed countertops, storage systems, and commonly-touched surfaces located in the back of the store. They swabbed the fingers and hands of several employees.
The air quality testing did not produce measurable concentrations of formaldehyde or other toxins. Area sampling results showed that background formaldehyde concentrations were similar to the personal sampling results, the CDC said.
‘Low concentrations of formaldehyde exist in many indoor environments because of off-gassing from furnishings, clothing, and other materials,’ it pointed out.
The US Food and Drug Administration has done the tobacco industry a service by tackling head-on the issue of what to call certain new generation products. In a note issued through its Center for Tobacco Products, the FDA said that media reports and descriptions of these products had referred to them as heat-not-burn or heated tobacco product, and it could have added other names.
‘These colloquial terms do not appear to have universally-agreed-upon definitions (although they seem to be used on an interchangeable basis),’ the note said. ‘For the FDA’s purposes, a tobacco product that meets the legal definition of a cigarette, but for which there is evidence that the heat does not reach a level sufficient to cause combustion of the tobacco product is currently categorized as a “non-combusted cigarette”.’
The note was focused on pointing out that its system of Substantial Equivalence worked in respect of non-combusted cigarettes. ‘On July 19, FDA issued Substantial Equivalence (SE) orders for two R.J. Reynolds Tobacco Company tobacco products, Eclipse and Eclipse Menthol,’ the note said.
‘This marks the first time that FDA has issued SE orders on regular SE Reports for non-combusted cigarettes. This action demonstrates that the SE premarket review pathway is viable for non-combusted cigarettes. In addition, each of these products could serve as a predicate product for future SE Reports.’
To receive an SE order, the manufacturer must demonstrate that the new tobacco product has the same characteristics as the predicate tobacco product; or if it has different characteristics to those of the predicate tobacco product, that those differences do not cause the new tobacco product to raise questions of public health different to those raised by the predicate product. ‘The SE order permits the marketing of the new tobacco product.
The SE order means that FDA determined that these products met the statutory standards of the SE pathway. The review did not assess the harm or risk of these products compared to other tobacco products beyond the finding that the differences in characteristics between the new and corresponding predicate tobacco products do not cause the new tobacco products to raise different questions of public health.
‘FDA’s scientific review of the SE Reports for these two products found that there were differences in characteristics between the new and predicate products, but that these differences do not cause the new tobacco products to raise different questions of public health.
The predicate tobacco product was a non-combusted cigarette with the same name. The differences include, but are not limited to, differences in ingredients and the incorporation of a functional filter. This action is specific to the comparison between these new tobacco products and their respective predicate tobacco products.
Comparative risk communication might encourage smokers to switch to lower-harm tobacco products, according to the results of a study by US researchers at the Tobacco Center of Regulatory Science, School of Public Health, Georgia State University, Atlanta.
The researchers found also that comparative risk messages with more negative anti-smoking elements in the design might be particularly effective, because they led to ‘higher self-efficacy to quit smoking’.
They concluded that regulatory agencies might want to consider using comparative risk messages with more negative anti-smoking elements ‘to educate the public about lower risk of e-cigarettes’.
An abstract of the Tobacco Control study is available on the BMJ Journals website.
