It has been reported that Germany’s federal drug commissioner is hoping to use her country’s imminent EU Presidency to further obstruct vaping products all over Europe.
Die Welt writes that Daniela Ludwig has identified an opportunity to transfer her distaste for reduced risk products to a wider audience as Germany takes up its six-month Presidency for the second half of 2020.
The 44-year-old politician from Rosenheim also relies on the European Union. Regulation is still different from country to country. From this summer, Germany will take over the EU Council Presidency. “We have the opportunity to talk to the countries about this. I would have already prepared a catalogue for the e-cigarette,” said Ludwig. For example, the rules on taxation or ingredients should be standardized.
The drug commissioner leaves no doubt about her overarching goal. "I want people to get away from the cigarette, whether it's a tobacco cigarette or some other product," said Ludwig.
Ludwig is in favour of both banning advertising of e-cigarettes and taxing liquids in Germany at the same rate as cigarettes, along with strictly restricting flavours, which are a vital attraction to vaping for former smokers.
This is despite a drug and addiction report of the Federal Government presented by Ludwig in 2019 concluding that e-cigarettes are significantly less harmful than smoking, and The Institute of Addiction Research at the University of Applied Sciences in Frankfurt declaring that the potential of e-cigarettes in Germany has been “massively underestimated”.
ETHRA is concerned at the possibility of damaging policies Germany’s Presidency may generate for vapers in EU member states and would hope that it uses its term of office wisely instead of installing naïve and unthinking regulation across the continent.
It should be noted that e-cigarettes have been regarded with suspicion by the German government, which boasts a smoking prevalence rate of 27.5%, exceeding that of states which liberally regulate vaping. Europe does not need to be lectured about e-cigarettes by Germany and the EU would be wrong to bind member states to counterproductive legislation on taxation, flavours and advertising with regard to safer nicotine products.
“It is disappointing that Ms Ludwig wishes to see failed policies from Germany transferred to the EU as a whole”, says Hendrik Broxtermann of ETHRA partner ExRaucher (IG), “Regulation of vaping under the current EU Tobacco Products Directive is not perfect but may just be acceptable. We should be seeking to improve the regulation we have by liberalising in some areas, not imposing more restrictions which can only protect the cigarette trade.
“Taxation of vaping products will deter millions of smokers from trying out safer products; banning or restricting flavours will take away a major factor in the appeal of vaping as a substitute for tobacco smoking; and banning advertising will make vastly safer products invisible to the very people who need to see them in order to facilitate more uptake for the good of Europe’s health.
"What Ms Ludwig should be doing is engaging with the people who use these products instead of pronouncing from an ideological position, while also ignoring her own scientific experts on the subject.”
The EU TPD review presents many threats to beneficial harm reduction options, so ETHRA would urge German vapers to petition their elected representatives to ensure that the German Presidency of the EU is used for good, not as an opportunity to put a halt to products which have led to significant declines in smoking in the EU.
Press release
Europe-wide consumer organisation launches manifesto on behalf of millions of former smokers
- European Tobacco Harm Reduction Advocates (ETHRA) – comprised of 21 consumer associations in 16 European countries – today launches a manifesto declaring the rights of safer nicotine users in Europe
- The manifesto is on behalf of 27 million grass roots consumers across Europe who have quit smoking using safer products such as e-cigarettes and snus
- The ETHRA Manifesto calls on policymakers to recognise the benefits of tobacco harm reduction in advance of World No Tobacco Day
DUBLIN, May 26th, 2020: Reduced risk products such as e-cigarettes and snus are providing a gateway out of smoking for millions of Europeans, yet across the continent, consumer access to these products is being denied or is under threat. Today sees the launch of the ETHRA Manifesto, a document written by consumers to promote appropriate regulation of innovative solutions for people who wish to continue using nicotine in far safer forms than smoking tobacco, as well as on behalf of the many smokers who may be able to quit through switching to these products in the future.
Tobacco harm reduction refers to public health and other evidence-based policies, designed to lessen the negative social and/or physical consequences associated with smoking. It endorses the use of novel nicotine products and supports research into their safety and efficacy.
The 21 partners of ETHRA – representing millions of consumers in 16 countries – urge the EU, the WHO, and governments in Europe and beyond to consider these important principles when forming their policies.
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Access to harm reduction, including tobacco harm reduction, must be recognised as a human right.
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Consumers of safer nicotine products must be recognised as essential stakeholders in discussions of policy.
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Regulation for safer nicotine products must reflect the risks relative to the risks from smoking.
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Regulators must recognise that having a wide choice of products and flavours is key to the success of safer nicotine products in enabling people to stop smoking.
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Regulation must consider the harm to adults when considering bans intended to protect youth.
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Tax policy must take into account that high taxation of safer nicotine products increases rates of smoking.
Tobacco harm reduction is facing challenging times in Europe, as the review of the EU Tobacco Products Directive is already underway and the WHO’s Conference of the Parties will be held in the Netherlands next year. Consumers fear that both organisations are seeking to implement policies which would severely damage the progress of safer nicotine products which have had such a dramatic beneficial impact on the lives of millions of Europeans.
ETHRA is concerned that policies towards prohibiting flavours in reduced risk products, restricting publicity of far safer alternatives to combustible tobacco - and many more legislative burdens on smoking substitutes - are being considered by policymakers based on nothing but ill-informed ideology and cherry-picked research.
“Regulators should be aware of the overwhelmingly beneficial effect of reduced risk nicotine products to attract smokers away from lit tobacco” said Rob de Lange of ACVODA, a Dutch consumer association and partner of ETHRA, “Smoking rates in countries which regulate alternative nicotine products sensibly have collapsed, yet consumers are constantly fighting against public health organisations who seem to favour an ill-informed precautionary approach which can only perpetuate smoking and protect the most harmful nicotine delivery system of all, the cigarette”.
Peter Stigaard, of Danish consumer association DADAFO said “Tobacco harm reduction has been an unprecedented success story in enlightened European states, yet the EU and the WHO appear eager to wind back the clock and impose harsh and ill-conceived restrictions on products which are saving lives.”.
Issued on behalf of European Tobacco Harm Reduction Advocates
Note to Editors: ETHRA has been formed to increase understanding about the benefits of “new” risk-reduced nicotine products and a better recognition of long-term recreational use of nicotine as a powerful incentive for smoking cessation. ETHRA aims to represent the interests of nicotine consumers across Europe and to spread the word into states which are still sceptical about the benefits of harm reduction.
Contact:
Email This email address is being protected from spambots. You need JavaScript enabled to view it. Twitter: @europethra
Sources:
Estimate of 27 million consumers provided by ECigIntelligence/TobaccoIntelligence
The actual figure is likely to be far higher because the data for smokeless tobacco is taken from research (Leon et al 2016) using data gathered in 2010 in only 17 countries.
ETHRA manifesto, available in 14 languages
https://ethra.co/ethra-manifesto
EU attitude towards safer nicotine products is regressive
European Commission compares e-cigarettes to ‘poison’, EURACTIV.com
WHO Q&A on vaping is criticised by scientists
WHO warning on vaping draws harsh response from U.K. researchers, ScienceMag
Many thanks to Ingmar Kurg for this article about the good news coming out of Estonia this week.
Amendments passed in the Estonian Parliament on 4 May will allow menthol flavoured e-liquids and heated tobacco products to be sold.
The Bill had been initiated by the government and attracted a raft of amendments from MPs, who recognise the importance of introducing tobacco harm reduction policies.
Last year the sale of all flavoured e-liquid (with the exception of tobacco flavour and flavourless) was banned in Estonia. Monday’s decision to allow menthol flavours to be sold is a small but important step towards recognising the importance of less harmful nicotine products and supporting smokers as they transition away from the taste of tobacco. As menthol will be banned in conventional cigarettes later this month, the availability of menthol e-liquids will also provide an alternative for smokers who like the taste of menthol.
The amendment also removes the general ban on the sale of novel smokeless tobacco products like heated tobacco products.
The Bill amending the Tobacco Act and the Alcohol, Tobacco, Fuel and Electricity Excise Duty Act was passed in the Parliament with 74 votes for and 12 against. Some MPs voted against it because they felt the legislation does not go far enough in supporting tobacco harm reduction. Those MPs were unhappy that the flavour ban on e-liquids mostly remained and wanted that to be lifted. One reason is because flavours are allowed in other less harmful products and they want e-cigarettes treated equally.
Smoke Free Estonia, a group in the Estonian Parliament led by Parliament Member Tarmo Kruusimäe, had made many suggestions on how to widen the availability of tobacco harm reduction products for smokers. Suggestions included allowing online sales for vaping products and not applying excise duty to non-nicotine containing e-liquids.
This is a small but very important step, which rows back against the draconian anti-THR regulations made by previous governments. I am now seeing that some politicians are changing their minds and are starting to understand how less harmful nicotine products work. Reasons for this are probably different - but some of it might be thanks to our work, which includes introducing THR possibilities in media and also social media. We also present the experiences and research from other countries on how less harmful products can be used to stop smoking and thus reduce the damage to public health.
Another very important factor is the black market, which emerged after the flavour ban, the huge excise duty on e-liquids and other draconian regulations were introduced. According to NNA Smoke Free Estonia calculations, the black market for e-liquids accounts for 85% of the market. Many sellers on the black market are underage. They sell homemade e-liquids in supermarket parking lots, playgrounds and skateparks and there is also a lot of business taking place on Facebook. Sometimes these sellers mix what is needed on the spot. We can only assume that these sellers do not care about selling to other children.
This situation is bad in many ways: Firstly, e-cigarette users are in danger because they are somewhat forced to use e-liquids of highly questionable quality, which have not been laboratory tested. We all know from the USA how dangerous the black market can be. Secondly, e-cigarette products can end up in the hands of the under eighteens, which is not where they should be. Thirdly, it is scaring away smokers who might otherwise switch to less harmful products. After flavours were banned here last year we made some calculations and according to our estimates around 10% of vapers moved back to smoking after the flavour ban was introduced.
The problem is that there is no way that any government can effectively enforce such strict regulations, because all e-liquid components (except nicotine) are readily available in other markets. That makes it very easy to mix e-liquids together yourself and if you do not want to DIY you can easily find someone who does.
Then there is the loss of tax revenue. The government loses a lot when it imposes unreasonable taxation, because people will find a way to avoid taxes if products are easily available on the black market.
Previously, before Estonia had such harsh anti THR regulations, it was vape shops, selling quality laboratory tested e-liquids, which were responsible for much of the market.
I think all countries need to learn how fast and how wrong things can go if over regulation takes place. I am really pleased that so many Estonian politicians have understood these problems and want to make changes that will make the situation better. I hope that Estonia will be one of the few countries which has had very strict regulations and then takes this lesson from its mistakes: that harsh regulations do not work and we should return as fast as possible to reasonable regulations that actually protect youngsters and which work for smokers and vapers.
Ingmar Kurg
CEO of NNA Smoke Free Estonia
Board member of INNCO
*** UPDATE 28 SEPTEMBER 2020 ***
Danish media reported yesterday that the flavour ban proposals had been indefinitely postponed but then today issued a correction, saying that:
"The Ministry of Health has subsequently stated that it considers that e-cigarettes are not covered by the Commission's opinion. The Ministry is therefore continuing to work on banning e-cigarettes with flavor as of April 1, 2021.
At the same time, the Ministry considers that the Commission's opinion covers the planned ban on hookah tobacco and flavored chewing tobacco, which is therefore postponed immediately"
see: EU bremser dansk tiltag mod rygning, Jyllands-Posten
Also see: Le gouvernement Danois ajourne la prohibition du vapotage aromatisé [MàJ] ou pas ? from Vapolitique
*** UPDATE 25 AUGUST 2020 ***
DADAFO and ETHRA have written to the Danish Health Minister, MPs and MEPs to outline why some of the proposed measures in the Bill amending the Act on the ban on tobacco advertising etc will be detrimental to public health. We have also submitted the letter to the TRIS notification for the bill.
Read our letter here [ LINK ]
More on the current situation in DADAFO’s article:
ETHRA indsender også kommentar til EU-kommissionen / ETHRA also writes to the European Commission
https://dadafo.dk/ethra-indsender-ogsaa-kommentar-til-eu-kommissionen/
*** UPDATE 23 JULY 2020 ***
Comments are no longer being accepted via the website. However, comments can still be emailed.
The Commission and some member states have left detailed opinions and/or comments. These are not made public (see TRIS FAQ's).
*** UPDATE 16 July 2020 ***
Please leave a comment on the Denmark TRIS notification, here. Individuals and organisations can comment. After submitting your contribution please look out for the email where you will need to click a link to validate it.
It looks as though the deadline has been extended, as a result of several member states providing detailed opinions (see here for more on TRIS procedure). Those member state opinions are not made public.
DADAFO’s comment translated into English is now published on our website here. Please read this comment for our Danish colleagues' expert consumer view on the legislation, which includes a flavour ban and plain packaging for vaping products.
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WHY you need to respond to the Danish notification and HOW to go about it. Thank you to Danish Vapers Association (DADAFO) for writing this.
Denmark is set to introduce a flavour ban on both nicotine and non-nicotine containing e-liquids, where only tobacco and menthol flavours will be permitted. This will affect 85-90% of Danish vapers, who will be forced to vape only tobacco or menthol flavoured e-liquids, or go back to smoking, or take the risk and buy unregulated black market products, or DIY to get the flavours they prefer, to have success with remaining smoke free.
The proposed legislation, will turn many people (vapers and smokers) into criminals - people whose only crime is to try and stay smoke free, by switching to a low risk alternative such as vaping or snus. These proposed amendments will also force appx. 90% of the Danish vape shops to close, since there will be no legal market for a wide variety of e-liquids with different flavours. However, there will still be a market, albeit underground, and away from the authorities.
The Danish Ministry of Health sent a notification of this to the European Commission on the 17th of April 2020 - with a standstill period of three months. In this period, the Commission has to comment whether or not they think that the Danish government has a case and can legally amend the existing laws to include a total flavor ban on all tobacco and non-tobacco nicotine, and non-nicotine containing products, used as substitutes for smoking (except of course, medicinal nicotine replacement therapy products). So in fact, all products that are used as substitutes for smoking, will have the flavour ban imposed.
The notification also includes other proposals which will prevent smokers from being aware that safer nicotine products exist.
Banning flavours in Denmark would set a precedent for other member states to ban flavors and could even lead to a flavour ban in the next TPD.
The Danish government “forgot” to notify the European Commission prior to the negotiations regarding the proposed flavour ban, and now they have promised the majority of the political parties that have reached an agreement through negotiation that a flavour ban can go into effect, without any problems. This oversight is what the Danish government is trying to cover up at the moment. There is no transparency in the way they are handling the proposed ban, and they are trying to push the legislation amidst a COVID-19 crisis, where the media and the European Commission has their focus elsewhere.
BACKGROUND
The Tobacco Products Directive (TPD) covers the regulation of e-cigarettes. The TPD requires individual countries to notify the EU Commission if they wish to take further measures in “protecting public health” by further regulating products covered by the TPD (“gold plating”). As flavours are permitted under the TPD, Denmark has had to notify the Commission of their proposal to ban them. With a majority of the principal Danish political parties in favour, it is expected that the ban will be waved through, unless the EU Commission stops it first.
The EU Commission has three months to stop the legislation, if sufficient evidence on public health impact is not provided. But the notification has been buried under “the COVID-19 crisis” and it is not likely, that the Commission will find the time to read or reply to all the stakeholder contributions.
The Danish plans will see all flavors banned, including accessories that could provide flavour to e-cigarettes. The proposals also include plain packaging for all tobacco products, non-tobacco nicotine containing products and vaping products, restrictions on nicotine pouches, no visibility of products at point of sale - including on the internet - and a complete advertising ban.
MAIN CONTENTS OF THE PROPOSED LAW
- Display ban : Tobacco products, tobacco substitutes and electronic cigarettes are not to be visible to consumers at points of sale, including on the Internet, until a customer specifically requests them. This does not however apply to: Physical shops that specialise in the sale of cigars, pipes and pipe tobaccorespectively, and the sale of electronic cigarettes
- Stricter ban on advertising and sponsorship: All forms of direct and indirect advertising and sponsorship are banned and, as an additional element, tobacco substitutes and herbal products for smoking are also covered by the ban.
- Plain Standardised packaging: All tobacco products, herbal products for smoking and electronic cigarettes must have a uniform appearance. This does not however apply to cigars, pipe tobacco and pipes. The standardisation means, among other things, that the manufacturer and product name must appear in a standardised way, that logos must not stand out and that the colour etc. of the packaging must be standardised. Standardisation can limit the advertising effect of the packaging.
- Smoke-free school time: To avoid school pupils being confronted with smoking etc. during school hours, it is proposed that school time should be smoke-free in all primary schools, boarding schools, continuation schools and upper secondary education facilities.
- Smoke-free properties: Upper secondary education facilities including children and young people under 18 years of age and not covered by the current requirements for smoke-free properties are proposed to be included.
- Ban on the sale of tobacco, tobacco substitutes, herbal products for smoking and electronic cigarettes and refill containers with and without nicotine in primary schools, boarding schools, continuation schools and upper secondary education facilities.
- Ban on flavourings in tobacco products and electronic cigarettes: The sale of electronic cigarettes including refill containers with or without nicotine,. with characteristic flavours other than the taste of tobacco and menthol is banned. The same is proposed for those tobacco products that are not already covered by the ban on characteristic flavours, although not for pipe tobacco and cigars or herbal products for smoking.
- Regulation of tobacco substitutes (non-tobacco nicotine products): Not previously regulated in Danish law, but proposed to be covered by the same regulation as tobacco products with respect to for example, advertising regulations, age limits, etc. Requirements are also proposed on health warnings on the packaging in line with the current regulations for electronic cigarettes. This applies for instance to tobacco-free snus, and other products that do not contain tobacco.
- Age control system and stricter penalty levels: Requirements are laid down for all retailers marketing over the Internet to ensure a system that effectively verifies the age of the purchaser, and the penalty of breaching the age limit is proposed to be made stricter.
- Registration scheme for retailers of electronic cigarettes and refill containers with and without nicotine, registration scheme for tobacco substitutes and refill containers without nicotine.
- Stricter penalties for breaches of the Act on smoke-free environments.
- Easier access for municipalities to provide free smoking cessation medication - this program does NOT include free e-cigarettes for smoking cessation, since e-cigarettes are NOT considered a viable tool for smoking cessation.
The impact assessment report (see here for an unofficial English translation) focuses exclusively on children and youth and does not mention unintended consequences for adult smokers or vapers even once. “Think of the children” is a phrase that can be read between every line in the proposal for the law amendments. But - the politicians should also “think of the children's parents” so they can keep on being smoke-free, live longer, and be around to see their grandchildren as well.
The TPD is currently being reviewed, with a report due in May 2021. The stakeholder hearings are on their way soon, but it is unknown why Denmark has chosen to rush these restrictions through now, for legislation in the midst of a global pandemic, instead of feeding their wishes into the TPD review.
Why is Denmark in such a hurry to restrict adults access to safer nicotine products, without regard to the negative consequences for adult smokers and vapers? The government and the Ministry for Health have been told that “tobacco harm reduction” is not a part of the solution, but in fact THR is seen as a problem in regards to lowering the tobacco smoking prevalence in Denmark. The Ministry of Health believes in the dogma “Quit or die” for longterm smokers who wish to quit smoking. The only recommended way to quit smoking is through consultations with a cessation “expert”, combined with NRT or prescription drugs such as Champix (Varenicline) or Zyban (Bupropione).
The flavour ban is a part of a larger “Action Plan against Tobacco”, which includes plain packaging on all tobacco related products, a total display ban and severe fines if you sell tobacco or tobacco related products to persons under the age of 18. And on top of this, the Danish government has reached a consensus that all tobacco related products should be so expensive (price and excess tax to be levied) that youth can not afford to buy these products. But the Danish government could not gain support for the higher prices/taxes, so in order to look determined and energetic, they have “thrown” vaping under the bus, and included even more draconian legislation on a product that could be part of the solution for the so called “smoking epidemic”.
WHY DOES THIS MATTER TO YOU?
If the Danish government gets away with banning flavours in Denmark it will encourage flavour bans elsewhere and could affect how the upcoming TPD3 regulates flavours. Prohibition has already crept in, with flavour bans in Estonia, Finland and Hungary. These bans could ultimately affect every European country, and bring the general public health in jeopardy. Black markets, which have been mostly avoided in Europe, will very likely find a place in the market, and that is not good news for consumer safety. Need we remind what happened in the US, regarding EVALI? A national outbreak of a mysterious lung disease, occured in the US, and no one could explain why there were so many young people getting sick and dying in certain states in the US. The Center for Disease Control, CDC, took months to come to the conclusion that the products that were vaped were illicit cartridges with THC which had been cut with vitamin E acetate, to make the liquid maintain thickness despite dilution - so it would appear to be of “high quality”. Vapers almost immediately realised that the lung disease could not possibly have been caused by regular nicotine containing e-liquids: If that were the case, many more would have suffered from this disease, and have died before the outbreak in the US in 2019.
The same disaster could happen in Denmark, and subsequently in the rest of Europe, if flavours in the e-liquids are banned. Many of the current vapers, and the smokers who might want to switch to vaping will find themselves in a market where the flavours they desire are taken away. So - what to do? Do we buy the flavours from other outlets? Not knowing whether the flavours are OK to inhale, and not made with lipids/oils, glucose, diacetyl etc? Or do we find a “good neighbour”, who can still supply us with the flavours we want? The Danish government has said that they don’t anticipate that cross border sales will be an issue - since few teens have the time or money to make the trip to either Germany or Sweden. The Danish government probably hasn't noticed that it is very easy to get hold of anything, using social media, to obtain any kind of substance - as a pick-up within a short distance - so there is in fact no need to travel a long distance, to get what you desire.
PLEASE RESPOND TO THE NOTIFICATION
Please respond with your private or your organisation's contribution to the notification:
The main points for the notification are in English but the main documents are in Danish.
SUBMITTING A CONTRIBUTION
Link for submitting your contribution: https://ec.europa.eu/growth/tools-databases/tris/en/search/?trisaction=search.detail&year=2020&num=228
Link to an English translation of the notification:
You can either upload your contribution as a document or type directly into the webform.
***** The notification itself is in Danish but your submission can be in any of the official languages of the EU ****
WHEN?
Responses will be accepted until 20th of July 2020 (the end of the standstill period) but they prefer responses to be sent in at least one month before that.
WHAT DOES DADAFO, THE DANISH VAPERS ASSOCIATION, SAY?
We need your help. We hope that all the European tobacco harm reduction associations will back us on this – sending in comments from each of the organizations.
DADAFO warned in December (link to English translation) that a flavour ban could drive up to 70,000 Danish ex-smokers back to cigarettes and/or severely harm the general public health. At best (if the nonsense about teen vaping being due to flavors is assumed to be true) this ban will prevent 1,200 Danish teens from starting to vape each year. The official numbers for teen vaping have been declining since 2014, fewer and fewer teens are vaping, furthermore teen e-cigarette use is primarily amongst current or previous smokers. At the same time, smoking prevalence for youth is going up. There is indeed a problem, but the problem is NOT vaping or flavours. The problem is still tobacco cigarette smoking among youth.
DADAFO 's primary focus is on the ban on flavours in e-liquids other than tobacco flavours and menthol flavours - as well as a proposal that e-liquids should be charged an excise tax of DKK 2.00 per ml. There are no specific proposals on how the tax should be levied - is it a tax on the amount of liquid or on the content of nicotine per ml of liquid? Would a liquid with 3 mg. per. ml. be charged with the same amount as a liquid of 18 mg. per. ml.? What about liquids without any nicotine? A 10 ml bottle of non-flavoured e-liquid cost appx. DKK 30,00 - and after the excise tax is imposed, the same bottle will be DKK 50.00 - a price hike of nearly 70%! This means that vaping is probably going to be more expensive than smoking.
The Danish law amendments was put to a public hearing in January/February 2020 - and DADAFO sent in the response of the Danish vapers - Read the English translation here.
We implore you to read our response to the public hearing - it describes many of the issues that other countries in Europe might soon face.
If the Commission lets this pass it will set a dangerous precedent for banning flavours in other European countries and could ultimately affect every European country in the future.
We need your help, reach out to your organisations and ask them to write a contribution on why a flavor ban is counter-productive to public health. Focus on the fact that a comprehensive risk assessment has not been done, and that the adult vapers have been completely ignored and forgotten (250,000-300,000 Danes). This legislation WILL create new smokers.
RESOURCES
Notification detail - link
Stakeholders Contributions page - link
Impact assessment report, DADAFO's translation (English) - link
DADAFO's hearing statement, translated into English - link
DADAFO's possible points to include - link
DADAFO's E-cigarette and vaper consumer survey - link
DADAFO's short contribution, English translation - link