A few months after being suspended, a Royal Decree in Belgium published on October 28, 2016, has transposed the EU’s Tobacco Products Directive (TPD) – but with a change in the classification of vaping products, according to a story by David Palacios for ecigintelligence.com.
From January, 17, 2017, when the law comes into force, electronic cigarettes and e-liquids containing nicotine will be considered to be consumer products and their former classification as medical devices will end.
After transposition of the TPD, electronic cigarettes will no longer be sold only by pharmacists, but they will be subject to the severe retail restrictions of the TPD.
The Belgian Association of Vapers (Union Belge pour la Vape/Belgische Damp Bond) considers the new legal framework contrary to the interests of the population and it warns that with the transposition of the TPD rules vaping will come under tobacco laws.
“We believe that, in the long term, this law, if implemented as it is, will put a major strain on the expansion of the e-cig in the Belgian market”, Yves Woot de Trixhe, vice president of the association, was said to have told ECigIntelligence.
Some of Belgium’s vaping industry figures have already introduced legal action to the Council of State (Conseil d’État), the supreme administrative court of the country, which will need to deliver a verdict by December, 13, 2017.
Today, the FDA issued the revised guidance, “Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments.” In the initial revised guidance issued in July of this year, U.S. manufacturers of newly regulated products faced a deadline of December 31, 2016 for compliance with the registration and product listing requirements of section 905 of the Tobacco Control Act.
The guidance has been revised again to clarify that for U.S. manufacturers of newly regulated tobacco products who first manufactured those products prior to August 8, 2016, the FDA does not intend to enforce the submission deadline for establishment registration and product listing as long as submissions are received by the FDA on or before June 30, 2017. However, companies which begin manufacturing newly regulated tobacco products in a domestic establishment on or after the August 8 effective date of the deeming rule must register and list immediately with the FDA.
The FDA is currently accepting submissions and encourages companies to register and list their products in advance of the new compliance date.
The Vapor Technology Association’s (VTA) national legislative director, Tony Abboud, says there is no credible evidence that vapor products are a ‘gateway’ to combustible cigarettes, however, there is scientific evidence that they provide adult smokers with a safer alternative. The VTA represents the manufacturers, wholesalers, small business owners and entrepreneurs.
“Like the Surgeon General, VTA and its members are committed to the health and safety of children. The VTA supports bipartisan legislation that will ensure the safety of vapor products, and will ensure vapor products do not fall into the hands of minors.
“What the Surgeon General does not acknowledge with this announcement are the millions of adult Americans who rely on vapor products to switch away from smoking deadly cigarettes. However, as long as government agencies perpetuate false information, the United States will continue to fall behind other countries such as England, which have acknowledged the significant public health benefits of vapor products.
“VTA and our partners are committed to working together with the federal government and state legislatures across the country to dispel this false information and promote the har
Tony Abboud, national legislative director of the VTA.
m reduction benefits of vapor products so that they remain available as a lifeline to adult consumers.”
A public health expert has warned that if people believe the US Surgeon General’s report on electronic cigarettes; it is going to do a lot of public health damage.
The Surgeon General, Vivek Murthy, yesterday published a report entitled, E-Cigarette Use Among Youth and Young Adults.
Dr. Siegel, a Professor in the Department of Community Health Sciences, Boston University School of Public Health, said in his blog, The Rest of the Story, that the report was scientifically dishonest.
It essentially lied about the single most important fact that the public needed to understand about electronic cigarettes and vaping products: that they do not contain tobacco and that therefore vaping is not a form of tobacco use.
Michael Siegel
Later in his piece, Siegel says that if, as stated by the Surgeon General, vaping is a form of tobacco use, then so is using nicotine replacement therapy. ‘And if the Surgeon General is serious in stating that “any form of tobacco use” is dangerous, then why isn’t he warning people who are using nicotine gum and nicotine patches,’ he asked.
‘Obviously, it would be terribly misleading and deceptive to tell the public that the nicotine patch is a form of tobacco use. It would be lying to tell the public that people who use the nicotine patch are tobacco users. But the nicotine in a nicotine patch is derived from the same tobacco as is the nicotine in e-cigarettes.’
New research has proved that electronic-cigarette aerosol droplets are effectively delivered to cell surfaces in laboratory-based biological tests, according to scientists at British American Tobacco.
The result of the research is important because it helps to validate the findings from such tests.
‘There have been several studies comparing the impact of e-cigarette vapor with that of cigarette smoke on cellular models, and there are a lot of great data out there,’ said Dr James Murphy, head of risk substantiation at BAT.
‘When there is a partial response or no response at all, this can be interpreted as e-cigarette vapor having a reduced biological impact compared to cigarette smoke. But what if it just means we are losing the aerosol and exposing the system to air? We had to be sure.
‘These latest results suggest that we can be confident that we are effectively delivering e-cig aerosol to cells in biological tests and that we can be confident, therefore, in the results of our biological tests.’
The results are published today in Chemistry Central Journal (DOI: 10.1186/s13065-016-0221-9).
The cellular tests mimic key events in the development of tobacco-related diseases such as cardiovascular disease or chronic obstructive pulmonary disease. They form part of a weight of evidence approach to assess the reduced risk potential of electronic cigarettes and other next generation products.
BAT reported that two different smoking/vaping robots had been used to produce aerosol from a reference cigarette (3R4F) and Vype ePen, a commercially available electronic cigarette. The deposited particle mass in exposure chambers was measured, as well as the amount of deposited nicotine. Exposure chambers are used to expose human lung cells to aerosol in the lab and to assess the impact of that aerosol (smoke or vapor) on the health of those cells.
The results had shown that, on a puff by puff basis and at a common dilution, the electronic cigarette aerosol deposited greater mass than cigarette smoke in both systems. In contrast, nicotine delivery was much greater from the cigarette than from the electronic cigarette.
‘It may seem counter intuitive that the aerosol that delivered the most mass had the least impact, but it’s about what that mass represents,’ said Murphy.
The aerosol particles produced by smoke and vapor might appear similar but they were compositionally very different, BAT reported. Smoke was drier and stickier, and therefore lighter than were the glycerine-based electronic cigarette droplets, which were moist and tended to be heavier.
In addition, smoke droplets carried the products of combustion: thousands of chemicals and hundreds of toxicants. Whereas electronic cigarette aerosol droplets contained the aerosolised form of the four main ingredients that made up e-liquids: humectants, water, nicotine and flavouring.
BAT pointed out that many in the public health community believed electronic cigarettes offered great potential for reducing the public health impact of smoking. Public Health England, an executive body of the UK Department of Health, had recently published a report saying that the current expert estimate was that using electronic cigarettes was around 95 percent safer than was smoking cigarettes, though more research was needed. The Royal College of Physicians had said that the public could be reassured that electronic cigarettes were much safer than were traditional cigarettes and that they should be widely promoted as an alternative to traditional cigarettes.
The U.S. Surgeon General is due to release a report on e-cigarette use today. Jeff Stier, director of the Risk Analysis Division at the National Center for Public Policy Research, a nationally-recognized authority on e-cigarette policy, says the topic should be of particular interest as the Trump transition team considers key appointments at the U.S. Food and Drug Administration (FDA), as well as when the time comes to appoint a new Surgeon General.
Dr. Vivek H. Murthy’s report concurs with the research consensus that e-cigarettes are less harmful than cigarettes because they don’t combust. But he said there isn’t enough evidence supporting the effectiveness of e-cigarettes as an aid for quitting conventional cigarettes. His report concludes that e-cigarette use among young people is strongly associated with the use of other tobacco products, including traditional cigarettes.
In anticipation of the release, Stier says, “If Surgeon General Murthy only addresses the serious risks of e-cigarette use by minors, something we all agree on, but fails to provide much-needed education about their benefits to adult smokers who would like to quit, he’ll have missed an important opportunity.”
Murthy writes in his report that e-cigs “are now the most commonly used form of tobacco among youth in the United States, surpassing conventional tobacco products, including cigarettes, cigars, chewing tobacco and hookahs.” The report claims that the use of e-cigarettes among high school students increased by 900 percent from 2011 to 2015.
Further, says Stier, “If the Surgeon General goes on to make policy recommendations based only on the risk part of the equation, without considering the benefits, he will have failed his fundamental obligation of improving public health. Without a deep and thorough analysis of the issue, the Surgeon General’s approach becomes little more than platitudes.”
In the report, the Surgeon General called for federal, state and local action immediately, such as including e-cigarettes in smoking bans as well as significant increases in taxes and the price of e-cigarette products.
While Murthy raised concerns about flavors that appeal to young users—such as gummy bear, cotton candy and chocolate—he stopped short of recommending restrictions on flavoring. The FDA has said it is looking at flavors that might appeal to youth.
The Surgeon General would have been wise to adopt the clear approach used by the Royal College of Physicians in its landmark report last year, by saying, “It’s very simple: adult cigarette smokers who switch to e-cigarettes dramatically reduce their risk, by using nicotine without smoke,” according to Stier.
That report avoids mentioning the role e-cigarettes most likely played in reducing combustible cigarette smoking by youth and young adults. Vaping among young adults between 18 and 24 years old more than doubled from 2013 to 2014, according to the report, while cigarette use has plummeted. However, it does note older adults are more likely to report using e-cigarettes to wean themselves off conventional cigarettes.
Murthy also writes that nicotine can damage the developing teen brain while leading to addiction. “Compared with older adults, the brain of youth and young adults is more vulnerable to the negative consequences of nicotine exposure.”
“This is just another politically motivated attack on an industry that is helping people to quit,” said Gregory Conley, president of the American Vaping Association, an vapor advocacy group.
Philip Morris International (PMI) has filed its highly anticipated Modified Risk Tobacco Product (MRTP) Application with the U.S. Food and Drug Administration (FDA). The company is seeking the right to make a health claim on its iQOS heat-not-burn vaporizer.
Filing the MRTP application keeps PMI on track with its goal to file by year end. If approved, the firm would be able to market iQOS in the U.S. as a modified exposure or a modified risk product.
The FDA has 60 days (“at minimum”) to accept the application for substantive review and then up to one year to make a final decision (early 2018). The application is rumored to be more than 2 million pages in length.
To commercialize iQOS in the U.S., PMI will need an approved Pre-market Tobacco Application (PMTA), which PMI is planning to file in the first quarter of 2017 with a decision expected as early as July 2017. A PMTA would allow iQOS to be marketed in the U.S. without a health claim, similar to how iQOS is currently being marketed in many countries, including Japan, with great success.
“While this designation could be very powerful from a global public health standpoint, PMI will need to file a Premarket Tobacco Product Application (PMTA) to actually commercialize the product in the U.S. via an exclusive licensing agreement with Altria,” said Wells Fargo analyst Bonnie Herzog. “We are encouraged by the timeliness of PMI’s first FDA application submission.”
Vape Forward, producer of the Cync compact vaporizer, has selected Greenville, North Carolina, USA-based Purilum as its long-term, preferred partner for filling its Cync pods. Cync is a closed system that utilizes the concept of sealed cartridges, called “refill pods,” which are pre-filled to 1.5 or 2.5 ml with e-liquid made by a number of premier e-liquid makers.
“Purilum is proud to be selected as a long-term filling partner for Cync pods,” said Anthony Dillon, Purilum board member. “The Cync device is recognized for delivering a consistent and excellent product for consumers, which directly aligns with Purilum’s commitment to stand at the forefront of quality and taste. We are excited to work closely with Vape Forward as we embrace the future of flavor.”
Purilum will fill the Cync pods from its state-of-the-art facility, which includes multiple ISO 8 class 100,000 clean room environments, segregated nicotine and non-nicotine mixing rooms, and fully-automated bottle and cartomizer/clearomizer filling and assembly.
“As we continue to grow and expand the Cync product, it is essential that we have partners who help us maintain the same quality and experience that our customers have come to expect,” said Charlie Kauss, CEO of Vape Forward. “Purilum is well-known for setting the standard of excellence in the e-liquid and e-cigarette industries, and therefore is an excellent partner to fill our Cync pods. We look forward to a strong partnership with them for many years to come.”
The EU Commission has said that it will continue to monitor developments relating to the use of electronic cigarettes and submit a report in 2021 as it is required to do under the Tobacco Productions Directive.
This was part of an answer given to a question raised by the French MEP Joëlle Mélin on the future of electronic cigarettes.
In a preamble to her question, Mélin said in part that though electronic cigarettes and e-liquids did not contain any tobacco, these devices and the products associated with them were included in the directive.
‘Placing electronic cigarettes — which do not burn or contain tobacco — in the same category as traditional cigarettes only dissuades smokers from turning to less harmful alternatives, which could amount to a direct contradiction of the Commission’s stated objective of public health protection,’ she said.
‘Given, then, that Commission studies (COM (2016) 269) have shown that “vaping” is not dangerous, that more than 21 percent of users have managed to cut down on their tobacco consumption, and 14 percent have given up tobacco altogether (2016 Eurobarometer survey), does the Commission intend to review the inclusion of electronic cigarettes in the Tobacco Directive,” she asked.
In its reply, the Commission said that, taking into account the characteristics, and in particular the nicotine content of e-cigarettes, it was deemed appropriate to consider them as tobacco-related products and to include them in the scope of the directive.
‘Given the lack of conclusive evidence relating to the long-term health effects of e-cigarettes, their use patterns and potential to facilitate smoking cessation, Article 20 of the directive adopts a precautionary approach to their regulation which places an emphasis on safety, quality and consumer protection,’ the commission said.
‘The rules for e-cigarettes nevertheless allow these products to remain widely available to consumers.
‘The Commission report COM (2016) 2692 does not conclude that vaping is risk free; it points to a number of potential risks to public health relating to the use of e-cigarettes whilst highlighting the need for further research.
‘The Commission has no immediate plans to review the regulation of e-cigarettes within Directive 2014/40/EU, the provisions of which began to be applied on 20 May 2016.
‘It will continue to monitor developments relating to the use of these products and will submit a report in 2021 as required under Article 28(1) of the Directive.’
Next year could mark a breakthrough for the Australian electronic cigarette market, with the regulator due to review a proposal that electronic cigarettes could be allowed subject to a maximum nicotine concentration, according to a story by David Palacios on ecigintelligence.com.
At present, all nicotine-containing products for therapeutic use must be approved as ‘registered’ medicines in the Australian Register of Therapeutic Goods before they can be marketed, but to date, no such approval has been granted.
But, Palacios said, a new proposal put to the Therapeutic Goods Administration by the New Nicotine Alliance Australia (NNAA), an independent consumer association, sought to make nicotine e-liquids legal from mid-2017 provided they did not exceed a maximum nicotine concentration.
‘Though each state and territory sets its own regulations, e-cig products containing nicotine are effectively prohibited across Australia, as nicotine is classed as a poison,’ he said.
‘The NNAA application suggests an exemption to this law for nicotine concentrations of 3.6 percent or less for e-cig systems.’
Palacios said that a decision was expected by March 2017 and possible implementation by June 2017.
