The Future of E-cigarettes Guided be Regulation USA and Europe Source from www.weecke.com

Souring from speech made by Mr Ray Story , Chief Executive Officer of Tobacco Vapor Electronic Cigarette Association ,Cecmol China ECIG Forum ,2014/9/2

Ladies and Gentlemen,

It is a pleasure and an honour for me to be speaking to you today and I would like to thank the organisers of this conference for the invitation. This conference brings together many distinguished executives of the electronic cigarette industry. The fact that we are gathered with so many today is a token of the truly revolutionary growth of this industry and of the incredible potential that is still ahead of us for this product that provides smokers with a viable alternative to conventional tobacco products.

Those of you who know me, and I am pleased to see so many friends and colleagues today, know I am not a newcomer to this industry. I came to this industry many years ago when ecigarettes were not as present and appreciated as now and I take pride in the fact that I have been contributing to building up the industry as well as the regulatory framework in different parts of the world.

I am the owner of the UTVG, a leader in the development, manufacturing and marketing of e-cigarettes in primarily the U.S. and Europe. In my capacity as CEO of “Smoking Everywhere” I
brought the initial legal challenge FDA against the U.S. Food and Drug Administration (FDA) in 2009 when several shipments of my products were confiscated by the FDA. Thus began a long legal and regulatory history with which many of you are well familiar.

Today I want to focus on my role as the founder and chief executive of the Tobacco Vaporizer Electronic Cigarette Association, in short TVECA.
TVECA is the only truly global e-cigarette association, representing manufacturers, distributors, marketers and importers of a variety of e-cigarette products constituting a majority of the e cigarette market world-wide. TVECA represents businesses and individuals from across the United States, as well as many of the 28 Member States of the European Union (EU).

TVECA has been intimately involved in the regulation of e cigarettes both in the U.S. and in the European Union (EU).

As the CEO of the UTVG, a founding member of the TVECA, I also launched the legal challenge to the proposed 2011 ban on e cigarettes by the Dutch Ministry of Health, resulting in a 2012 Court of The Hague decision overturning the ban.

Subsequent to this decision, TVECA worked closely with European Union Institutions on e cigarette regulation, ultimately resulting in adoption of the EU’s Revised Tobacco Products Directive (TPD), regulating e-cigarettes for the first time in a clear, logical and responsible manner. The TPD governs the manufacture, presentation, advertisement and sale of tobacco vaporizer , dry herb vaporizer products (now including e-cigarettes) in the European Union.

More than 10 years after the adoption of the first European Union’s Tobacco Products Directive in 2001, new scientific and market developments in the tobacco sector made it necessary to update the existing regulatory framework to bring it in line with the new conditions and requirements. Besides the objective to improve the functioning of the internal market for tobacco and related products and ensure high health and safety standards, the revision also set out to provide, for the first time, a regulatory framework for electronic cigarettes, which had not been regulated specifically under prior EU legislation.

At the time of the beginning of the TPD revision, e-cigarettes faced varying regulatory frameworks across the EU, with some Member States regulating e-cigarettes as a consumer or a tobacco vaporizer product, and others as a medicine. This variety of different approaches caused regulatory fragmentation and undermined the principles of the EU Single Market, prompting the European
Commission to propose a way to uniformly regulate e-cigarettes.

It took roughly one year from the Commission’s initial proposal to regulate e-cigarettes as pharmaceutical products until the EU Member States and the European Parliament agreed to regulate them as a distinct category within the TPD. TVECA was instrumental in building the credibility of the e-cigarette industry in Europe, assisting EU institutions in reaching a constructive compromise where e-cigarettes would be both widely available to consumers as a less harmful alternative to conventional tobacco vaporizer products while complying with strict quality, safety and reporting obligations in the interests of consumers and society at large.

TVECA believes the result in the EU, while not perfect, does represent a solid, fact- and evidence-based approach to the regulation of e-cigarettes, balancing real public health concerns with respect for consumers and commerce.

As you well know, EU regulations tend to take a more conservative approach in favour of protecting consumers compared to other parts of the world. The final TPD agreement honours this approach, and in that respect serves as a useful model for U.S. regulators. This is also what the TVECA has written in its official submission to the FDA in response to its proposed so-called Deeming Rule earlier this year. We believe the U.S. should seek to harmonise its regulations with the EU’s TPD.

We also believe that recent regulatory experience in the EU and now in the U.S. can in many aspects be a source for other parts of the world to follow good practice and to avoid pitfalls we encountered and are still encountering in our ongoing dialogue with politicians and regulators.

In this respect I am following with great interest the developments in China and I would like to reiterate here publicly what I have said to some of you involved in the Chinese regulatory framework for e-cigarettes: the TVECA is offering our knowledge and experience to you.

 Source from  www.weecke.com 

IMPACT OF FDA REGULATION ON CHINESE E-CIG, E-LIQUID AND VAPOR MANUFACTURERS

IMPACT OF FDA REGULATION ON CHINESE E-CIG, E-LIQUID AND VAPOR MANUFACTURERS

The 2014 Cecmol China ECIG Forum came to a close successfully last week , Amanoo has involved in the whole Forum during Sep. 2 to Sep.4 2014 . The Speech gave by Ron Tully ( VP of The National Tobacco of USA ) will be a good instruction of Chinese Manufactures like Amanoo.

US FOOD & DRUG ADMINISTRATION
• FDA given statutory/legal authority to regulate tobacco product in 1999 under Family Smoking and Tobacco Protection Act (Tobacco Control Act)
• Created a new Center For Tobacco Products
• Industry pays $750m in user fees each year to fund the FDA. Agency has over 600 employees.
• All tobacco companies must register, and all individual brands and sub-brands, and their ingredients must be registered
DEFINITION OF A TOBACCO PRODUCT
• Anything “made” or “derived” from tobacco
• Any ‘additive’ or ‘component’ of a tobacco product
• The TCA does not address non-tobacco-derived and synthetic nicotine – as such these products are not subject to regulation by FDA if no therapeutic/cessation or other health related claim are made.
WHAT IS CURRENTLY REGULATED?
• Currently regulated products include e-cigarettes, cigarette tobacco, smokeless tobacco
• Currently regulated components include e-cigarette papers, cigarette tubes and cigarettes and smokeless additives and flavorings.

DEEMING REGULATIONS
• FDA issued for comment a proposed deeming regulation that will extend its statutory authority to regulate additional tobacco products and components of tobacco products
• Newly deemed products will include cigars, hookah (shisha) tobacco, pipe tobacco, e-cigarettes and e liquids and novel tobacco products.
• To be considered a newly deemed tobacco product, it must be ‘made’ or ‘derived’ from tobacco.

HOW WILL E-PRODUCTS BE IMPACTED?
• Any e-product made or derived from tobacco will be subject to FDA regulation as a tobacco
product
E-liquids containing tobacco derived nicotine
• E-liquids containing tobacco derived flavor extracts
E-cigarettes or cartomizers containing liquids made or derived from tobacco
• Components of e-cigarettes/vaporizers that are marketed or used by the consumer with tobacco, for example, batteries, clearomizers

FDA REQUIREMENTS – ONCE DEEMED
• All manufacturers, importers must register with FDA
• All brands, sub-brands must be registered with the FDA including
• Packaging and marketing samples
• Ingredients used in the manufacture of a tobacco product
• Health related information on a product
• Manufacturing facilities in China will be subject to inspection for ’adulteration’ or ‘misbranding’ of products

FDA REQUIREMENTS – ONCE DEEMED
• Ban on the use of ‘modified risk claims’ – cannot use words such as ‘light’, ‘mild’, ‘safer’, ’healthy’ on packaging or in brand marketing
• Testing of ingredients to show the levels of hazardous or potentially hazardous components (HPHC List) of a tobacco product, for examples the tested levels of nitrosamines,benzo(a)pyrenes, formaldehyde, etc

FDA REQUIREMENTS – ONCE DEEMED
• Good Manufacturing Practice
• May raise issues for Chinese manufacturers between different customer supplied from the
same factory
• Health warnings on Packaging and Advertising, for example, ‘NICOTINE IS ADDICTIVE’ALL OF THE ABOVE WITHIN 24 MONTHS of ENACTMENT

DEEMING – DEADLINES
• Establishment registration and product listing to be specified by FDA based on timing of publication of Final Rule
• Ingredients listing – 6 months from effective date of Final Rule
• Health document submission – 6 months from effective date
• Modified risk descriptor removal – 1 year from effective date to cease manufacture, 13 months
from effective date to cease distribution

SOME POSITIVES FROM DEEMING
• No ban on internet sales of deemed products (all sellers are required to ID consumers under 27)
• No self-service display restrictions for deemed products (other than a vending machine ban)
• No ban or limitations on types of advertising of deemed products
• No ban on flavors in deemed products (but there could be future rulemaking on ‘product standards’)

DEEMING -GRANDFATHER DATE
• Feb 15, 2007 statutory ‘grandfather’ date for currently regulated tobacco product remains
the same for newly deemed products

DEEMING – TIMING
• General misbranding prohibitions, requirement to label product with its established name, and requirement to include name and “brief statement” in all advertising and other printed materials – 1 year from effective date
• Warning statement requirements – 24 months + 30 days from publication of Final Rule
• All other labeling requirements – 2 years from publication of Final Rule • HPHC physical state, smoke/vapor analysis – 3 years from effective date

DEEMING REGULATION
• The Tobacco Control Act requires that any tobacco product not on the market after February 15, 2007 must file:
• A ‘substantial equivalence’ (SE) report proving that the product being registered is the same or identical to a product that was on the market prior to the February 15, 2007 date. This requires companies to show they have a ‘predicate’ product upon which to base the SE. Or must file:
• A Pre-Market Tobacco Application (PMTA), which requires a complete analysis of all aspects of a product, including design, manufacture, integrity parameters, HPHC ingredients testing, consumer use studies, marketing impact studies, and a requirement to demonstrate through epidemiological and other survey data that the use of the product does not raise new issues of public health among smokers, non-smokers and the public.

DEEMING EGULATION – EFFECTIVE DATE
• Comment period (August 8, 2014) – multiple issues on which industry offered comment.
• FDA will review comments and submit proposed final rule -could take 18-24 months.
• Final rule likely published late 2015/ early 2016
• Potential industry litigation on the 2007 ‘grandfather’ date or other issues (e.g., ‘premium cigar’ exemption and warning labels, etc.)

OTHER USA LEGISLATIVE ISSUES
• Bills are currently in Congress now to regulate:
• Marketing and advertising of e-products through the Federal Trade Commission
• Safety of e-cigarettes, liquids and devices through the Consumer Product Safety Commission
• US Federal Paraphernalia Statutes – claiming that a device is suitable for use with a controlled substance can make the device subject to importation controls by US Customs

 

Letter of Invitation to the AMANOO Inter-Tabac 2014

AMANOO cigDear Sirs/Madam,

We, Weecke Technology Co.,LTD /AMANOO, hereby warmly invite you to visit our booth at the 2014 Inter-Tabac in the Mess Westfalenhallen Dortmund. The International Trade Fair for Tobacco Product and Smoking Accessories.

Here is the details of the exhibition address:
DATE:19-21 September,2014
Address: Messe Westfalenhallen Dortmund GmbH-Strobelallee 45 D-44139 Dortmund Germany
Booth: 6F20–4

Weecke is recognized as a leading professional e-cigarette designer and manufacturer with a strong team of research and development elites. Besides, we are committed to providing the highest level of customer service, competitive pricing, speedy delivery and a comprehensive, cutting-edge product offering. That’s the reason why we get customers all over world, US, Russia,UK, France, Spain, etc.
During this international exhibition, is going to make a comprehensive show for latest tech products, good service and the unique enterprise culture to customers.

It would be a great pleasure to meet you at the exhibition. We expect to establish long-term partnership with you in future.

Best Regards
Weecke Technology CO.,LTD

VPOR CEO Issues Letter to Shareholders

Ecigarfan — DAVIE, FL / ACCESSWIRE / August 22, 2014 / Vapor Group, Inc. (VPOR), (the “Company” or “Vapor Group”), today released a letter to shareholders from it’s . The electronic cigarette vendor Amanoo would like to set this as a model, in the coming month to providing customers with further updates and the progress that they are making.

President and CEO, Dror Svorai. In the letter, Dror Svorai discusses the results for the first 6 month of 2014:

Dear Shareholders:

This past six months have been very eventful for us, and as a result we have great expectations for 2014

First, for the six months ended June 30th, as reported in our 10-Q, our revenues were $1,991,776, an increase of $1,897,049 or approximately 2003% from 2013 for the same period. Overall year-to-date, Vapor Group’s sales have continued strong and steady month over month this year.

To accelerate our sales further, we added several additional persons to our salesforce who are all experienced and expert in the sales of e-cigarette products and accessories.

In the past few months, we opened our first two “Total Vapor” company stores in the greater Miami area, selling our full line of products. We are working on opening a total of ten retail locations in metropolitan Florida this year.

In July we began the process to franchise our “Total Vapor” store concept in Connecticut, New York, New Jersey, Pennsylvania, Delaware, Maryland, Virginia, North Carolina, and Washington D.C. We will have more to report on progress here in the coming weeks. Each of these market areas represents great sales potential and we are excited by the projects.

In March we increased our percentage ownership of online retailer, American Vaporizer, LLC, and due to slower growth than projected, and the need for incremental investment, sold off our 51% interest of this company in June, so that we could refocus our marketing strategy and inventory investment and obtain a better return on our working capital. Important, the sale allows us to better focus our efforts on our core brands and the new products that they will bring to market this fall.

That said, we are currently in development of a line of low-cost, affordable vaporizers, including one available as a blister pack, and a limited edition series of vaporizers as well, all of which will be available by the holiday season.

Separately, in the coming month, we will update you on our considerable progress in establishing broad distribution in the State of Colorado.

In the coming months I look forward to providing you with further updates and the progress that we are making.

Very truly yours,

Dror Svorai
President and CEO
Vapor Group, Inc.