Innokin Endura T18 ready for TPD notification

Innokin Endura T18 ready for TPD notification

Link: Endura T18
Innokin is very proud to announce that the Endura T18E (European Version) Complete Vaping System is prepared and ready for notification as soon as the European Commission submission portal opens on May 20th 2016.

Innokin has been working closely with Nerudia in a strategic partnership in order to achieve full compliance with the EU Tobacco Products Directive and to lead the way in creating safer vaping  technologies.

Innokin and the Nerudia science team worked closely together to design and implement a rigorous new vaporizer/ecig testing protocol to ensure more than just compliance. The T18E tank emissions were tested in a way which emulates real life as we are not only testing for compliance; we are testing because we have a responsibility to our consumers.

In order to ensure full compliance and maximum harm reduction the T18E aerosol was carefully and intensively studied and tested for a range of possible toxins as well as potentially harmful metals. The Endura T18E was tested with the most advanced scientific testing procedures available which have been fully validated.  For safety, the levels of carbonyls detected have been multiplied to estimate the “daily dose”, 500 inhalations in a day have been taken to be a maximum foreseeable vaping regime. A 12 mg/ml nicotine concentration unflavoured commercially available e-liquid was used in testing.

T18E tanks were tested at the start, middle, and end of a simulated day of vaping to collect a range of data and the mean result was calculated. No metals were detected. A mean nicotine dose of 940 µg/10 inhalations was determined.

For nicotine and carbonyls, a validated LC-MS method was used. For metals, a validated ICP-MS method was used. Both of these techniques are sensitive enough to quantify levels well below that which would be expected to have any physiological impact.

The following metals were assessed in the emissions from the Endura T18E:

  • Lithium
  • Cobalt
  • Lead
  • Mercury
  • Iron
  • Copper
  • Selenium
  • Nickel
  • Aluminium
  • Chromium
  • Vanadium
  • Arsenic
  • Molybdenum
  • Antimony
  • Barium
  • Cadmium
  • Tin

Background levels were analysed and subtracted. No metals were detected above the reporting thresholds. The reporting level has been derived by taking 50% of the permitted daily exposure stated in ICH Q3D.

Of the six carbonyl compounds assessed, only three were detected, all in extremely low amounts. There are no official “limits” for the levels of carbonyl emissions produced by electronic cigarettes, however to put the results in context they have been compared to the United States Department of Labor Occupational Safety & Health Administration’s (OSHA) permitted exposure levels. The lowest levels found in the OSHA literature have been used.

  • Acetaldehyde
    • Detected at 0.01 % of ACGIH (American Conference of Governmental Industrial Hygienists)
  • Acrolein
    • Detected at 0.75 % of NIOSH (National Institute for Occupational Safety and Health)
  • Formaldehyde
    • Detected at 167 % of NIOSH

Crotonaldehyde, propionaldehyde and butyraldehyde were not detected.

The level of formaldehyde in 500 inhalations from the Innokin T18E device compares favourably to other environmental sources of formaldehyde.

Low levels of Formaldehyde are common in modern life and it is all around us. Formaldehyde is released by many different materials including fabrics, furniture and insulation and it occurs naturally and is produced by most living organisms. There are also low levels of Formaldehyde in beers, wines and spirits.

Therefore it is important to compare this result to levels of formaldehyde in the environment:

Endura T18 Vape pen-TPD

  • Household cleaner and plug in air freshener data from Norgaard et al, Ozone initiated VOC and particle emissions from a cleaning agent and an air freshener: Risk assessment of acute airway effects. Environment International, Volume 68, July 2014, Pages 209–218.
  • House conventional and low VOC build data from Hult et al, Formaldehyde and Acetaldehyde exposure mitigation in US residences: In home measurements of ventilation control and source control. Indoor Air, Volume 25 issue 5, 2014, page 523-525.
  • Example metropolitan area data from Jurvelin J et al, Personal exposure levels and micro-environmental concentrations of formaldehyde and acetaldehyde in the Helsinki metropolitan area, Finland.
  • Lowest limit found in literature was NIOSH at 0.016 ppm 8 hour time weighted average. This has been converted to daily mg using 0.012 m3/min respiratory rate, light intensity for a 21 to <31 year old (Exposure Factors Handbook, USEPA, 2011)

Nerudia has worked with Innokin and provided key information and guidance on the requirements for TPD and has provided guidance on what is needed in terms of the packaging and user manual contents and warnings for each of the main European markets. The Endura T18E is ready for regulations and we are ready for May 20th, 2016 and the TPD. For advice on how Nerudia can assist with TPD compliance please contact compliance@nerudia.com.

Wholesalers and distributors can continue to sell the internationally bestselling Endura T18E with confidence, safe in the knowledge that it is 100% compliant with the new regulations.

For more information on the Endura T18E visit http://www.innokin.com/vaporizers/endura/ or contact regulatory@innokin.com

Hospitals Abandon Vaping Ban After Evidence On E-Cigarette Safety

Two UK hospitals abolished a ban on the use of e-cigarettes Thursday thanks to overwhelming evidence showing they’re vastly safer than tobacco cigarettes.

A National Health Service Trust, which runs two hospitals in the city of Nottingham, revised its position on vaping in light of a groundbreaking report from the Royal College of Physicians (RCP), which enthusiastically endorsed e-cigarettes as a safer alternative to smoking.

An earlier report published by Public Health England concluded e-cigarettes are 95 percent safer than tobacco cigarettes.

“We have a duty to help our patients and staff make healthy life choices, and can’t ignore the potential benefits of electronic cigarettes as a nicotine replacement therapy,” said Dr. Stephen Fowlie, medical director at the trust.

“We’re now allowing e-cigarettes on our grounds to give our patients, staff, and visitors more choice in how they quit smoking,” Fowlie added.

“We need to encourage all patients and visitors who smoke and find it difficult to abstain while in hospital grounds to use medicinal nicotine or an electronic cigarette,” said Professor John Britton, a respiratory consultant at the trust and contributor to the RCP report.

The RCP’s position is e-cigarettes are 95 percent safer than regular cigarettes and are likely to be hugely beneficial to public health. (RELATED: Game Changer: World Leading Medical Group Backs E-Cigarettes)

“This report lays to rest almost all of the concerns over these products, and concludes that, with sensible regulation, electronic cigarettes have the potential to make a major contribution towards preventing the premature death, disease and social inequalities in health that smoking currently causes in the UK,” said Britton, who also chairs the RCP’s Tobacco Advisory Group. “Smokers should be reassured that these products can help them quit all tobacco use forever.”

Source:  http://dailycaller.com/2016/05/13/hospitals-abandon-vaping-ban-after-evidence-on-e-cigarette-safety/

SEVIA USA Responds to the FDA Deeming Regulations

SEVIA USA Responds to the FDA Deeming Regulations

The FDA Deeming Regulations were published on May 10th 2016. The effect on vaping will be dramatic for the industry as well as consumers who depend on these products to stay off combustible tobacco.

The Shenzhen Electronic Vaporizer Industry Association (SEVIA) USA, the nation’s only association representing Chinese manufacturers Aspire, Innokin, Kanger and Smok today pledges support to defend the vaping industry from the onerous and burdensome FDA deeming regulations.

We believe in fair, reasonable regulations to protect the consumers however the current frame of regulation introduced by the agency will eliminate 99% of eliquid and hardware manufacturers and also eliminate freedom of choice for vapers and millions of smokers that might not have the chance to switch from deadly combustible tobacco.

As an association we are currently going to assist the Right 2 Be Smoke Free Coalition in challenging the unconstitutional federal law affecting the vaping industry. They will play a key role in organizing and funding industry activities. We believe the FDA regulations should be contested and legally challenged
You can contribute to become a member of the Right 2 Be Smoke Free Coalition.

We also want to express our support for the Cole/Bishop amendment which we believe is the essential first step to saving the industry by moving the predicate date from February 2007 to the effective date of the deeming regulations.
Moving the grandfather date will keep companies alive, allow every vapor company (small or large) to continue to sell their existing products without having to file costly applications and keep our industry alive while we develop legislative strategies to save our industry.
See the “Cole-Bishop is the Essential First Step to Saving Vapor” VTA Guidance Document“.

We will also financially support on the national level various organizations such as http://casaa.org http://vaping.org and others so they can continue to fight for consumers and industry.

This is an open invitation to all Chinese manufacturers that want to continue to offer their products on the market. SEVIA USA and it’s founding members are committed to offer their resources to fight back and we ask the industry to join us. These FDA regulations are far over reaching government authority. But most importantly they are detrimental to public health and the safety of the consumer. If we as manufacturers find out there is an issue with our products on August 7th and want to make changes to improve and protect the consumer, the proposed regulations would prohibit us from doing so. Innovation and improvement would come to a complete stop. You can see how these regulations actually introduce safety concerns that would not otherwise have been present if we were permitted to make improvements without pre-market authorization.

The battle begins now, united we stand!

Dimitris Agrafiotis
Chairman – SEVIA USA
Phil Busardo
Executive Assistant – SEVIA USA
http://seviausa.org
https://www.facebook.com/seviausa/posts/501522056700223

 

Source: http://www.tasteyourjuice.com/wordpress/archives/12880

Innokin Issues Statement on FDA’s Deeming Regulations

Innokin Issues Statement on FDA’s Deeming Regulations

The vaporizer and electronic cigarette industry was shaken when the Food and Drug Administration’s Deeming Regulations for tobacco products were published on May 5th and went into effect on May 10th, 2016.

These FDA regulations are overreaching, costly, and place an enormous burden on an industry made up of tens of thousands of independent retailers. The regulations hamper innovation, ignore science & research data, and in their current form will prove hazardous to all of us who rely on this beloved alternative to combustible tobacco.

Innokin continues to be committed to our vision of harm reduction through advanced vaporizer technologies. We are proud to have been working with top independent American and European labs on improved aerosol emission testing protocols and the testing of our bestselling tanks. Through aerosol emissions testing we have worked to minimize any possible negative impacts of our products caused by a wide range of known toxins and metals.

Innokin is a responsible manufacturer and is committed to restricting the sales of our products to minors. All packaging has clear labels and warning information and we have worked closely with vendors to increase awareness of responsible sales.  Innokin has developed and launched SecureCap child safety lock technology on our bestselling tanks for added security and peace of mind.

18+-sticker

The high quality materials of our tank materials and advanced designs is evident in the exceptional results produced by our T18 and iSub tanks and coils which we are using to apply for European TPD registration. Our commitment to lab testing and tank development is a demonstration that we continue to be committed to releasing only the best possible atomizers and tanks.

There is always more to do, however these regulations go too far.

The Shenzhen Electronic Vapor Industry Association – USA is the only American association representing a coalition of Chinese manufacturers. Innokin Technology and our fellow members in SEVIA USA – Aspire, Kanger, and Smok – today pledge our collective support for the vaping industry in defending it from these overly burdensome regulations.

We believe in freedom of choice, we believe in fair & reasonable regulations to protect consumers and the public health, and we believe in this lifesaving technology that provides millions with an alternative to lethal combustible tobacco products. The current regulatory framework introduced by the FDA will eliminate 99% of all eliquid, 99% of all hardware. All of the rapid innovations that we have experienced in recent years along with the potential for increased public good that these technologies can provide to society will be stopped. Furthermore if any technical problems should happen, such as finding out there is an issue after August 7th, manufacturers will be prohibited by the federal government to address this and fix it.

As members of SEVIA USA, we are announcing our full backing to the Right 2 Be Smoke Free Coalition in challenging these deeming regulations. The Coalition will be playing a key role in organizing and funding industry activities. We believe the FDA regulations should be justly contested in every arena with every available resource. To find out more please visit http://www.r2bsmokefree.org/contribute/

In this spirit, we are expressing our support for the HB2058 and Cole/Bishop Agricultural Appropriations Amendment and encourage everyone to support these vital and responsible bills. The Cole/Bishop Agricultural Appropriations Amendment for the 2017 Federal Budget is the foundation of saving vaping by moving the predicate date from February 2007 to the effective date of the deeming regulations.

Moving the grandfather date will keep all of the thousands of independent retailers alive and save the jobs and livelihoods of tens of thousands of employees and their families. It will keep these companies from having to file extremely costly applications and will keep our industry alive while we cultivate further legislative strategies to save the industry.

https://www.docdroid.net/KHr46XQ/vta-guidance-cole-bishop-is-the-essential-first-step-to-saving-vapor.pdf.html

SEVIA USA and leading manufacturers will also financially support a variety of national organizations such as CASAA and the AVA and the VTA. These organizations are champions in this challenge for every single vaper and manufacturer.
We also invite all Chinese manufacturers to join us at the table by joining SEVIA USA. We need one another at this time more than ever. We are not just competitors; we are family and we must overcome this challenge together.

If these regulations stand, innovation and product improvements will come to a total halt. Safety issues will by mandate go unaddressed and new advanced technologies will not be allowed to be introduced to the American market. Smokers who have yet to quit may never find the setup that is right for them do so and more Americans will continue to suffer and die needlessly.

This is for every single one of us and for the millions more who have yet to switch. This is just the beginning.

Innokin releases new Temperature Control mod with replaceable 18650 battery

Innokin releases new Temperature Control mod with replaceable 18650 battery

Vapers have demanded it and we’ve listened! The Innokin CoolFire4 TC18650 75Watt Vaporizer with a replaceable 18650 battery is now available for order!

Innokin CoolFire4 TC18650

Powered by the ultra-fast and accurate AETHON temperature control board, the new CoolFire4 TC18650 runs on a single 18650 battery and delivers 75Watt with temperature control! The CoolFire4 TC18650 is compact, durable and ultra-fast at 0.2 seconds from Click to Vape!

The CoolFire4 TC18650 easily calibrates SS316L, Ni200, and Titanium coils for precise temperature control as well as Wattage mode output.

The CoolFire4 TC18650 is available in two editions: the Complete Kit which includes an iSubV Tank and a protective silicon 18650 battery cover and a Limited Edition Vape Travel Kit (without iSub V tank) which includes an added Vape Travel Case with an integrated 18650 Battery power level checker.

Innokin CoolFire4 TC18650

Complete kit is available in three colors: Black and Silver (brushed metal), and pure White.

Limited Edition Vape Travel Kit is available in four durable finishes (brushed metal): Black, Silver, Blue and Red.

Innokin Endura T18 and T18E (2ml) are now available in C-Store and Gas Station Packaging

The internationally bestselling Innokin Endura T18 and the T18E (EURO-TPD2ml) complete vaping systems are now available in compact and stylish CStore and Gas Station Packaging.

Innokin Endura T18E Vape Pen

Innokin Endura T18E Vape Pen

Endura T18E has a 2ml tank that was designed to be TPD compliant. Additionally, T18E tank with SecureCap Technology offers child safety lock (sold separately).

Incredibly easy to use, the Endura T18 is optimized to be a hassle free, pick it up and go, great vaping experience.

This Endura T18/T18E CStore Kit includes a high quality micro USB charging cable, one T18 battery, one T18 Tank with a coil inside ,a comprehensive user manual and a bright and clear visual user guide on the back.

Quality materials matter. The Prism T18 tank is made of high quality Stainless Steel and Pyrex Glass and the organic cotton wicking delivers full delicious flavors and smooth clouds.

Innokin Endura T18E Vape Pen

Safety at the forefront. The Endura T18/T18E has an internal 1000mAh battery, with integrated advanced protections, that is compact and conveniently recharged via microUSB.

Testing ensures quality. The aerosol emissions of the Endura T18 & T18E have been independently tested at top laboratories for key toxins and a wide range of metals. The T18/T18E tanks were tested with rigorous testing methods and performed exceptionally well with very low toxin and heavy metal results in all tests.

Available in four beautiful colors (Black, Silver, Pink, Aqua-Blue) with matching CStore and Full Kit packaging; give your customers the best in vaping with the Endura T18/T18E kit.

E-cigarettes should be offered to smokers, say doctors

Smokers should be offered and encouraged to use e-cigarettes to help them quit, says a leading medical body.

The UK’s Royal College of Physicians says there is resounding evidence that e-cigarettes are “much safer” than smoking and aid quitting.

With the right checks and measures, vaping could improve the lives of millions of people, it says in a new, 200-page report.

It says fears that e-cigarettes are a gateway to smoking are unfounded.

But, by and large, people who want to use electronic cigarettes will still need to buy them rather than get them on the NHS.

UK doctors can only prescribe e-cigarettes if they have been licensed as a “quit smoking aid” – something that requires strict regulation.

Few manufacturers go down this route and instead sell products to satisfy users’ desire for nicotine without the harmful chemicals produced by tobacco.

Best way to quit?

Sales of e-cigarettes have been rising steadily since the first went on sale in 2007 in the UK.

Since 2012, they have replaced nicotine patches and gum to become the most popular choice of smoking cessation aid in England.

Around one in 20 adults in England uses e-cigarettes, and nearly all of these are ex-smokers or current smokers who are trying to cut down or quit.

E-cigarettes have remained controversial and this year ministers in Wales attempted to ban them from public places.

The Royal College of Physicians says smokers who use e-cigarettes or prescribed medications – with support from their doctor – are more likely to quit permanently.


Graphic: What's inside an E-cigarette?

1. On some e-cigarettes, inhalation activates the battery-powered atomiser. Other types are manually switched on

2. A heating coil inside the atomiser heats liquid nicotine contained in a cartridge

3. The mixture becomes vapour and is inhaled. Many e-cigarettes have an LED light as a cosmetic feature to simulate traditional cigarette glow.

Different brands of e-cigarettes contain different chemical concentrations.


And in terms of long-term health hazards, e-cigarettes are at least 95% safer than regular cigarettes – something Public Health England has also said.

But that does not mean they are entirely risk-free.

Prof Simon Capewell, of the Faculty of Public Health, said there were still many unknown factors.

“We don’t know enough yet about the long-term effects of vaping on people’s health, which is why we need more research.

“The best thing anyone can do if they want to quit smoking is talk to their GP: there’s solid evidence that NHS quit-smoking services help people kick the habit for good.”

But Prof John Britton, who co-authored the RCP report, says e-cigarettes are extremely positive for public health and should be “encouraged and endorsed”.

He said: “The public need to be reassured this is not a new nicotine epidemic in the making. E-cigarettes have very little downside and a lot of potential benefit.”

According to Public Health England, smokers should consider using e-cigarettes alongside NHS quit-smoking services.

Around a third of UK smokers try to quit each year, but only one in every six of those succeeds.

New EU laws are due to come into force in May that will set safety and quality standards for all e-cigarettes and refills. Manufacturers will be required to disclose the purity of their products to consumers.

Dr Tim Ballard, from the Royal College of GPs, said: “Moving forward we would be looking for clear evidence that making e-cigarettes available on prescription as part of a wider smoking cessation scheme is a wise use of both scant NHS funds and GP practice resources, before the College could get behind it.

“It is not just the cost of the product that needs taking into account, but the time and resources that are involved in assessing patients, and monitoring their progress over a prolonged period of time.

“We reiterate our calls for NICE to take a leading role in establishing whether making e-cigarettes available on prescription is the best way forward.”

A Department of Health spokesperson said: “The best thing a smoker can do for their health is to quit smoking.

“We know that there are now over a million people who have completely replaced smoking with e-cigarettes and that the evidence indicates that they are significantly less harmful to health than smoking tobacco.

“We want to see a wide range of good quality e-cigarettes on the market including licensed products whose safety, quality and effectiveness are independently assured.”

Source: http://www.bbc.com/news/health-36139618

RCP statement on e-cigarettes

Tobacco is still the UK’s biggest public health issue, causing 100,000 deaths per year. For every death caused by smoking, approximately 20 smokers are suffering from a smoking-related disease. In England it is estimated that, in 2010–11, among adults aged 35 years and over, around 460,000 NHS hospital admissions were attributable to smoking, accounting for 5% of all hospital admissions in this age group.

The RCP has published several reports advocating harm reduction for people addicted to tobacco smoking, and particularly Harm reduction in nicotine addiction in 2007 [i]. The emergence and rapid growth in the use of electronic cigarettes since that report was published require a specific policy statement on their use. This statement was agreed by RCP Council in June 2014.

  • The RCP recognises that electronic cigarettes and other novel nicotine devices can provide an effective, affordable and readily available retail alternative to conventional cigarettes. These innovations could make harm reduction a reality for smokers, as proposed in our 2007 report. [i]
  • The RCP also recognises that these new products present potential risks as well as opportunities for individual and population health, and therefore advocates proportionate regulation to maximise the overall public health benefit.
  • Regulation should ensure that products deliver nicotine effectively and safely; that advertising and promotion do not target young people or other non-smokers; and that advertising and use (for example, in public places) do not undermine smoking prevention policies. The RCP therefore supports regulation of electronic cigarettes and other novel nicotine products as medicines. [ii]
  • Close monitoring of the use of electronic cigarettes in UK society is essential to ensure trends that are counter to public health are identified and acted upon promptly.
  • On the basis of available evidence, the RCP believes that e-cigarettes could lead to significant falls in the prevalence of smoking in the UK, prevent many deaths and episodes of serious illness, and help to reduce the social inequalities in health that tobacco smoking currently exacerbates.

 

[i] Royal College of Physicians, 2007. Harm reduction in nicotine addiction.

[ii] The UK Medicines and Healthcare Products Regulatory Agency (MHRA) announced in 2013 that, from 2016, electronic cigarettes and other nicotine-containing products would be subject to medicines regulation, thus requiring manufacture to medicinal purity and delivery standards, and proactive controls on advertising. In addition, the European Tobacco Product Directive (TPD) will, from mid-2016 at the latest, prohibit most advertising of unlicensed nicotine devices and require products to carry health warnings, meet as yet undefined purity and emissions standards, require data on nicotine uptake, limit nicotine content, and require suppliers to take full-responsibility for quality and safety when used ‘under normal or reasonably foreseeable conditions’.

Source: https://www.rcplondon.ac.uk/news/rcp-statement-e-cigarettes

Nicotine without smoke: Tobacco harm reduction

This report aims to provide a fresh update on the use of harm reduction in tobacco smoking, in relation to all non-tobacco nicotine products but particularly e-cigarettes. It concludes that, for all the potential risks involved, harm reduction has huge potential to prevent death and disability from tobacco use, and to hasten our progress to a tobacco-free society.

Key recommendations

  • Smoking is the biggest avoidable cause of death and disability, and social inequality in health, in the UK.
  • Most of the harm to society and to individuals caused by smoking in the near-term future will occur in people who are smoking today.
  • Vigorous pursuit of conventional tobacco control policies encourages more smokers to quit smoking.
  • Quitting smoking is very difficult and most adults who smoke today will continue to smoke for many years.
  • People smoke because they are addicted to nicotine, but are harmed by other constituents of tobacco smoke.
  • Provision of the nicotine that smokers are addicted to without the harmful components of tobacco smoke can prevent most of the harm from smoking.
  • Until recently, nicotine products have been marketed as medicines to help people to quit.
  • NRT is most effective in helping people to stop smoking when used together with health professional input and support, but much less so when used on its own.
  • E-cigarettes are marketed as consumer products and are proving much more popular than NRT as a substitute and competitor for tobacco cigarettes.
  • E-cigarettes appear to be effective when used by smokers as an aid to quitting smoking.
  • E-cigarettes are not currently made to medicines standards and are probably more hazardous than NRT.
  • However, the hazard to health arising from long-term vapour inhalation from the e-cigarettes available today is unlikely to exceed 5% of the harm from smoking tobacco.
  • Technological developments and improved production standards could reduce the long-term hazard of e-cigarettes.
  • There are concerns that e-cigarettes will increase tobacco smoking by renormalising the act of smoking, acting as a gateway to smoking in young people, and being used for temporary, not permanent, abstinence from smoking.
  • To date, there is no evidence that any of these processes is occurring to any significant degree in the UK.
  • Rather, the available evidence to date indicates that e-cigarettes are being used almost exclusively as safer alternatives to smoked tobacco, by confirmed smokers who are trying to reduce harm to themselves or others from smoking, or to quit smoking completely.
  • There is a need for regulation to reduce direct and indirect adverse effects of e-cigarette use, but this regulation should not be allowed significantly to inhibit the development and use of harm-reduction products by smokers.
  • A regulatory strategy should, therefore, take a balanced approach in seeking to ensure product safety, enable and encourage smokers to use the product instead of tobacco, and detect and prevent effects that counter the overall goals of tobacco control policy.
  • The tobacco industry has become involved in the e-cigarette market and can be expected to try to exploit these products to market tobacco cigarettes, and to undermine wider tobacco control work.
  • However, in the interests of public health it is important to promote the use of e-cigarettes, NRT and other non-tobacco nicotine products as widely as possible as a substitute for smoking in the UK.

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