Letter from the Danish Medicines Agency

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I just wrote to the Danish Medicines Agency to enquire if it was legal to sell the e-cigs in Denmark and got this reply:

Dear Bjarke

Thanks for your mail


I can tell you that elektronic cigarettes is not aproved as a medicine in Denmark and they cant be sold as one in this country. It is not legal to buy the product from another country and import it into Denmark.


the Danish Medicines Agency is investigating the possibilities for aproval of electronic cigarettes as a medicine in the future.


I hope the answer is to your satisfaction. If not or if you have any further questions please contact us again.



Translated from danish by me.

I answered that I wasnt at all interrested in selling or buying it as medicine but rather as a normal consumer product like normal cigarettes. No answer from that yet.
 

Kate

Moved On
Jun 26, 2008
7,191
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If the ads they are closing down sell 'smoking cessation devices' then it's because esmoking has not been proven to be a smoking cessation therapy and those ads were misleading. That is a medical issue.

If esmoking devices and juice are sold in line with the guidelines (whatever they are) for Snus and snuff they might be allowed. They probably won't be allowed under the same laws as cigarettes though, as far as I know, no new smoking products are allowed. They are trying to phase them out.

It's difficult to know which department would be appropriate for proper regulation of esmoking. As you've shown, they certainly will not qualify as medical devices yet.
 

dc2k08

Ultra Member
ECF Veteran
May 21, 2008
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www.e-cignews.com
i dont see how they could ban an electronic cigarette that contains no liquid. just like the can't ban bongs, glass pipes, vaporizers etc etc. likewise i dont see how they can ban e-liquid without also banning insecticide which contains nicotene. perhaps a seller just has to label that the e-liquid as not being meant for consumption. there's a dozen loopholes to any any ban they try to invoke.
 
I agree that it would be nice to have some sort of regulation. But I dont think it should be sold as medicine. It should undergo some rules though. f.x. as mentioned elsewhere, we should know the ingredient list, we should know what kind of plastic we put in our mouth and there should be an expiration date and production date on the cartridges and so on..
 
another thing.. Some sites claim their cigarette is CE aproved which is a european aproval for products. And as far as I know it cant be ilegal if its CE aproved.

Do any of you have a link to something that can prove this CE aproval?? I can see the jpg's on some sites selling it, f.x. here: http://theelectroniccigarette.co.uk/shop/images/ce2008.gif but that is not a proof that it REALLY is CE aproved.
 

Kate

Moved On
Jun 26, 2008
7,191
47
UK
The CE mark is only a declaration of conformity to certain standards, it doesn't prove official approval. It is necessary to sell the devices we use but not the eliquid.

Do Your Products Need CE Marking?

CE mark - Wikipedia, the free encyclopedia

Since we have no proof of medical suitability our devices are drug paraphernalia, they are designed to deliver nicotine which is known to be hazardous to health. If authorities choose to ban anything I would bet it will be nicotine eliquid first.
 

pillbox38

Unregistered Supplier
ECF Veteran
By the way the Ce approval is only as you all probably know on the electronic device..Not the fluids, cartridges etc..

Bjarke, on our site we have the marks, but we also have in paper form the CE approval docs and the ROHS docs.

One of the sites closed today was an agent of mine.

he translated an article that i saw as being positive, the Danish authoritys only want the products legitamised with lab testing, sell by dates etc..

It is understandable, i was concerned but now im not, it just proves that any seller who wants to go all in with electronic smoking will have some big hurdles to clear before the ride smooths out.

I am up for the challenge, tomorrow we will start chasing trading standards and RCOS try and get people onboard who can guide us.

everyone says clinical trials will cost a fortune... they might but none of us know for sure, might even be worth contacting Nicorette and working with them..:)
 

pillbox38

Unregistered Supplier
ECF Veteran
Claus the dutch version below.. maybe you have seen it.. the converted uk doc was hard to follow, but my understanding of it was it did not seem disastrous..please correct me if im wrong..

Forbrugerbeskyttelse af e-cigaretterne
e-cigaret firmaet U2LifeStyle går i clinch med det grå Kina marked pga. manglende forbrugerbeskyttelse gennem et utraditionelt initiativ, ved at introducere PrimusBLUE – et lavpris koncept for e-cig’s – der vil udkonkurrere mange tvivlsomme udbydere.

Det grå marked for elektroniske cigaretter vågner her til morgen op til en stor massiv overraskelse. Det er et faktum at de meget populære elektroniske cigaretter gerne må sælges over internettet i Danmark, men kun når der samtidig er givet tilladelse i det land hvorfra produkterne sælges og afsendes. Det er lægemiddelstyrelsen herhjemme der skal sikre at dette går rigtigt for sig, men U2LifeStyle er trætte af at vente på at der bliver sat ind overfor de virksomheder der arbejder i den ’grå’ zone og handler billige Kina produkter fra deres privatadresse i Danmark. ”Det er ikke det, at de gør noget der er ulovligt – men det faktum, at de ikke forbrugerbeskytter deres produkter, der er problematisk for e-cigaretternes udbredelse” hedder det fra U2LifeStyle – selskabet der markedsfører produkterne PrimusNo.1®.
Skal der sælges filtre til e-cig’en – de filtre som indeholder smagsstoffer fra fødevare industrien og evt. nikotin – bør der som minimum være en udløbsdato på produkterne. Ligeledes må det være et forbrugerkrav at produkterne er testet og accepteret af et laboratorium her i Europa, således at alle kan være sikre på hvad der gemmer sig inde i et nikotinfilter. Og endelig må forbrugerne være sikre på at produkterne ikke indeholder bly, nikkel og andre skadelige metaller. ”Det koster penge og tid at få alt dette på plads, og det gør man ikke bare lige over køkkenbordet” udtaler Bestyrelsesformand Jørn W. Phigalt.

Vi mener ikke at det er rimeligt at udsætte forbrugere for dette og derfor annoncerer vi i dag PrimusBLUE – der er en kvalitetssikret serie af e-cigaretter, der helt på lovlig vis sælges over internettet og hvor produktet samtidig er laboratorium undersøgt af bla. Eurofins, har en synlig udløbsdato og U2LifeStyle står indenfor tests af nikkel, bly og kviksølv forekomster i alle PrimusNo.1® produkterne – tests der klart viser at alle produkter er fritaget for disse.

PrimusBLUE tæller den velkendte og populære lange e-cig, den almindelige e-cigar og den super nye Shorty – den korte e-cig, der til forveksling ligner en almindelig cigaret.

Produkterne ligger alle på 100 € - en pris et godt stykke under de ’grå konkurrenter’ og kommer efter kvalitetskontrol og testning fra Primus-Lageret i Maribor i Slovenien, med posten.

Alle ordre skal afgives på internettet og alle produkter har naturligvis 2 års garanti og en ombytningsret, der giver forbrugeren mulighed for at afprøve produktet – og ønsker man efter afprøvning at opgradere dette til et af selskabets TOP PrimusNo.1® produkter, kan dette gøres.

Vi har rigtig mange kunder der nyder godt af vores udvidede service med fornyelse af atomisere og batterier, på PrimusNo.1® Produkterne – ordningen der principielt giver livsvarig garanti, hvis produktet anvendes jævnligt – ingen andre giver dette.

Vi opfordrer naturligvis ingen til at begynde at ryge, men vi ønsker at give etablerede rygere en frihed til at ryge når de har lyst, samtidig med at de får muligheden for at være mere hensynsfulde og bevidste, ved at reducere passiv rygning. ”Vores PrimusNo.1 Cigarillo – den elektroniske cerut, som vi for nyligt annoncerede til vores ældre medborgere, har allerede bevist at vi med vore produkter kan give noget af en fortabt livsstil tilbage, give frihed og beskytter”

”Efter annonceringen i dag af PrimusBLUE råder U2LifeStyle nu over 2 produkt linjer – den eksklusive PrimusNo.1 linje med 7 lange cigaretter, PrimusLight cigaretten, 4 piber og 4 cigarer, samt cigarilloen – og PrimusBLUE linjen med 4 lange cigaretter, 2 cigarer og så Shorty, som vi forventer os meget af” slutter Lars Lindberg, direktør for PrimusNo.1®

For yderligere information kontakt
Bestyrelsesformand Jørn W. Phigalt
jph@u2lifestyle.eu
direkte telefon +40271221

www.primusblue.dk
PrimusNo.1® e-cig, e-pipe and e-cigar from U2LifeS

Baggrundsviden
PrimusBLUE og PrimusNo.1® er de elektroniske cigaretter, cigarer, cigarilloer eller piber – der giver traditionelle rygere friheden til at indtage nikotin uden at dette generer andre, udsætter dem for passiv rygning - enheder der undlader at forurene miljøet, uden brandfare og samtidig fjerner de negative virkninger ved almindelig tobaksrygning – så som tjære i lungerne og indtagelse af de mange skadelige stoffer der findes i traditionel tobak.
PrimusBLUE og PrimusNo.1® er ikke designet til at få folk til at stoppe med at ryge – det vil vi ikke blande os i” udtaler Jørn W. Phigalt, formand for bestyrelsen i U2LifeStyle der markedsfører og sælger den elektroniske cigaret, cigar, cigarillo og pibe. ”Vi har udviklet et livsstils koncept for rygning, fordi der efter vor mening bør være en mere begavet måde at håndtere ryge politikken på. Det er ikke vores opgave at opdrage rygere – men at levere produkter der giver brugerne alternativer til at bevare den livsstil man ønsker.”
De elektroniske cigaretter, cigarer, cigarilloer og piber (de såkaldte e-cig’s) arbejder alle efter et atomiserings proces hvor høj opløselig nikotinholdig væske, suppleret med aromasubstanser, forstøves i mikroskopiske partikler, der ved hvert sug bringer nikotin i forbindelse med slimhinderne. Effekten af dette, samt smagsoplevelsen som aroma stofferne giver og ens egen udåndingsluft (damp der illudere røg), får rygeren til at opleve en tæt relation til rigtig rygning.
”Gennem aromastofferne og de atomiserede nikotin doser, snyder vi den menneskelige organisme til at tro at den rent faktisk ryger” udtaler Lars Lindberg fra U2LifeStyle. Lars Lindberg er en af pionererne bag PrimusBLUE og PrimusNo.1® der ikke er bleg for at fremhæve at man som storryger er så tæt på at komme til at ryge rigtigt på et Primus Produkt. Endvidere leveres filtrene til produkterne med forskellig nikotin indhold fra 16mg over 11mg til 6 mg for cigaretterne og cigarerne – ja der findes endog et filter med 0mg nikotin – for dem der blot vil have oplevelsen – men ingen nikotin. Der er 4 smagsvarianter.
PrimusBLUE og PrimusNo.1® sælges udelukkende over internettet og leveres fra U2LifeStyle’s selskab i Slovenien. ”Vi har bygget et ServiceCenter og Lager i Maribor – i et af de nyere lande i den Europæiske Union – dels for at servicere vore mange kunder i SydEuropa og Balkan, men også fordi vi som livsstils virksomhed ønsker at arbejde globalt” udtaler Klaus Bryld der er adm. direktør for U2LifeStyle. ”Vi har nu kunder i 19 Europæiske lande og sælger til distributører på 9 andre markeder. Vores sorte cigar er et hit på Balkan, medens den gyldne cigar går som varmt brød i MellemØsten”.
”Lige nu koncentrer vi os om at tage os kærligt af de godt 25 markeder vi allerede har fat i – men vi vil naturligvis fortsætte med at introducere nye produkter indenfor livsstilsområdet.” siger bestyrelsesformand Jørn W. Phigalt.
Yderligere information
U2LifeStyle International
Jørn W.Phigalt
Tlf.: 35120200
PrimusNo.1® e-cig, e-pipe and e-cigar from U2LifeS
Jph@u2lifestyle.eu

Filer og billeder
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PrimusBLUE_cigarette3.jpg


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pillbox38

Unregistered Supplier
ECF Veteran
And the not so brilliantly translated uk version.

Preview of Get2Press 29th September 2008 at. 14:38:57
________________________________________
Press release issued on 14 September 2008
Consumer e-cigarettes
e-cigarette company U2LifeStyle yesterday in Battling with the gray China market due to lack of consumer protection through a unique initiative by introducing Primus BLUE - a low-cost concept of e-CIG's - which will outperform many dubious providers.
The gray market for electronic cigarettes woke up this morning with a big huge surprise. It is a fact that the very popular electronic cigarettes like to be sold over the Internet in Denmark, but only when there is also licensed in the country where products are sold and shipped. The Medical Products Agency here at home to ensure that this is true for themselves, but U2LifeStyle are tired of waiting for to be deployed to the companies working in the 'gray' zone and is cheap Chinese products from their home address in Denmark. "This is not what they are doing something which is illegal - but the fact that the consumer does not protect their products, which are problematic for e-cigarettes prevalence" states from U2LifeStyle - the company which markets the products PrimusNo.1 ®.
To be sold filters to e-cig'en - the filters containing flavors from the food industry and possible. nicotine - should at least be an expiration date on the products. Also, it must be a consumer claims that products are tested and accepted by a laboratory here in Europe so that all can be sure what is hiding inside a nicotine filter. And finally, consumers must be sure that products do not contain lead, nickel and other harmful metals. "It costs money and time to get all this in place, and it does not happen just over the dinner table" said Chairman Richard W. Phigalt.

We believe that it is reasonable to postpone consumers for this and therefore we announce today Primus BLUE - who are guaranteed quality series of e-cigarettes, which quite legitimately sold on the Internet and where the product is also the laboratory examined by blah. Eurofins, has a visible expiration date and U2LifeStyle stands in tests of nickel, lead and mercury deposits in all PrimusNo.1 ® products - tests which clearly shows that all products are exempt from these.

Primus BLUE count on well-known and popular long e-CIG, the general e-cigar and the new super Shorty - the brief e-CIG, which is confusingly similar to a conventional cigarette.

The products are all at € 100 - a price well below the 'gray competitors' and comes after quality control and testing of Primus-store in Maribor in Slovenia, in the mail.

All orders must be placed on the Internet and all products are of course 2-year warranty and a replacement, giving the consumer the opportunity to test the product - and do you want after testing to upgrade it to one of its TOP PrimusNo.1 ® products, this can be done.

We have a huge number of customers who benefit from our enhanced service with the renewal of nuclear expression and batteries at PrimusNo.1 ® Products - the system which basically provide life-time warranty if the product is used regularly - no one else offers this.

We encourage course to take up smoking, but we want to give an established smokers' freedom to smoke when they want, while giving him the opportunity to be more thoughtful and deliberate, by reducing passive smoking. "Our PrimusNo.1 Cigarillos - the electronic cheroot, which we recently announced to our senior citizens, have already proven that with our products can give something of a lost life back, give freedom and protects"

"After the announcement today of Primus BLUE U2LifeStyle now has more than 2 product lines - the exclusive PrimusNo.1 line with 7 long cigarettes, Primus Light cigarette, 4 pipes and 4 cigars, and cigarillos - and Primus BLUE line with 4 long cigarettes, cigars 2 and then Shorty, as we expect much of "ending Lars Lindberg, director of PrimusNo.1 ®

For further information contact
Chairman Richard W. Phigalt
jph@u2lifestyle.eu
direct phone +40271221

www.primusblue.dk
PrimusNo.1® e-cig, e-pipe and e-cigar from U2LifeS

Background
Primus BLUE and PrimusNo.1 ® is the electronic cigarettes, cigars, cigarillos or pipes - which gives traditional smokers freedom to take nicotine without that bothers others, exposing them to passive smoking - units which do not pollute the environment, without the fire hazard, while removing the adverse effects of general smoking - such as tar in the lungs and consumption of the many harmful substances found in traditional tobacco.
Primus BLUE and PrimusNo.1 ® is not designed to get people to stop smoking - we will not get involved in "says Richard W. Phigalt, Chairman of the Board of U2LifeStyle which markets and sells the electronic cigarette, cigar, cigarillo and pipe. "We have developed a lifestyle concept for smoking, because we believe should be a more clever way to handle smoking policy. It is not our job to educate smokers - but to deliver products that give users alternatives to maintain the lifestyle you want. "
The electronic cigarettes, cigars, cigarillos and pipes (known as e-CIG's) are all working for a atomisation process where high soluble nikotinholdig fluid, supplemented with aromatic substances, atomised into microscopic particles that are at each suction putting nicotine in connection with mucous membranes. The effect of this, and taste the experience as flavoring substances and gives one's breath (steam there illudere smoke), the smoker to experience a close relation to the real smoking.
"Through substances and the atomised nicotine doses, we are cheating the human body into believing that it was actually smoke" said Lars Lindberg from U2LifeStyle. Lars Lindberg is one of the pioneers behind Primus BLUE and PrimusNo.1 ® is not afraid of highlighting that as heavy as close to come to smoke right on a Primus Product. Furthermore supplied filters for products with varying nicotine content from 16mg to 11mg to 6 mg of cigarette and cigar markets - yes there is even a filter with 0mg nicotine - for those who just want the experience - but no nicotine. There is 4 flavors variants.
Primus BLUE and PrimusNo.1 ® is sold exclusively over the Internet and shipped from U2LifeStyle's company in Slovenia. "We have built a service center and Storage in Maribor - in one of the newer countries of the European Union - in order to serve our many customers in southern Europe and the Balkans, but also because we as a lifestyle company wants to work globally" said Klaus Bryld who is CEO of U2LifeStyle. "We now have customers in 19 European countries and sells to distributors in 9 other markets. Our black cigar is a hit in the Balkans, while the golden cigar goes like hot cakes in the Middle East ".
"Right now we concentrated on taking us fondly of the roughly 25 markets we have already grasped - but we will of course continue to introduce new products in the lifestyle area." Said Chairman Richard W. Phigalt.
________________________________________
More information
U2LifeStyle International
Richard W. Phigalt

Tel: 35120200
Jph@u2lifestyle.eu
PrimusNo.1® e-cig, e-pipe and e-cigar from U2LifeS


The article can be found at: Forbrugerbeskyttelse af e-cigaretterne - U2LifeStyle International - Get2Press
 
Ohh.. That statement is from the guys selling primus, and has nothing to do with any government documents.

The only thing in that document is that the primus guys wants the cheaper cigs out of the market, because of health issues?... Nothing more to that.

But maybe this document is what started the health department getting nosy?
 
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