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CONGRESS NEEDS TO FIX FDA VAPOR RULE

By Phil Kerpen

After a lengthy and heavily contested regulatory process, a final rule deeming vapor products to be subject to pervasive FDA regulation is currently in the White House Office of Management and Budget for a final review before it is published and takes effect this year.  Leaks of the purported final rule suggest it remains deeply flawed and will impose a draconian, one-size-fits-all model that risks disrupting the fast-growing vapor industry and denying access to products that pose vastly less health danger than conventional tobacco cigarettes.  Unfortunately, in the final negotiations over last year’s omnibus bill a provision addressing this issue was dropped, but that should not be the last word on the issue from Congress.

Mitch Zeller, the FDA’s top tobacco regulator, told Congress “If we could get all of those people [who smoke] to completely switch all of their cigarettes to noncombustible cigarettes, it would be good for public health.”

Indeed, vapor products are displacing regular cigarettes.  The most recent data from the CDC show the percentage of the adult population that smokes has dropped six consecutive years, from 20.6 percent in 2009 to 14.9 percent in the first half of 2015. An estimated two million ex-smokers are using vapor products.

So we’re on the right track, and Zeller warned: “Let’s not lose our focus on what the primary cause is for those 480,000 avoidable deaths each year—it’s primarily burning, combusting cigarettes.”

Unfortunately, his agency is poised to do precisely that with its deeming rule.

“This is not really regulation. It’s prohibition,” says Boston University community health sciences professor Dr. Michael Siegel.

He’s referring to a feature of the rule that sets a grandfather date of February 15, 2007 – effectively denying grandfather status to nearly every vapor product on the market and forcing each to go through a lengthy approval process or be pulled from the market within 24 months.

That date and timeline were established by the Family Smoking Prevention and Tobacco Control Act, passed by Congress in 2009 – and it grandfathered all but the very newest cigarette products.  By now deeming vapor products subject to regulation seven years later, the FDA is subjecting these safer products to more draconian regulation.

Jan Verleur, co-founder and CEO of VMR Products, a major manufacturer of vapor devices, said: “It’s essentially a death sentence for industry. It could be held up in litigation for many years.”

That’s only slight hyperbole.

Once the rule is final, manufacturers would be required to submit to the FDA, for each product, a Premarket Tobacco Application (PMTA) or a Substantial Equivalence (SE) report.  The PMTA process is complex and expensive and would be challenging for all but the largest manufacturers – the major tobacco companies – to navigate.  The SE choice depends upon showing that a predicate product is already approved, but vapor technology is new and rapidly evolving, ruling this option out. The investment driving that innovation would be chilled by time and expense of submitting every product for regulatory approval – and the agency already has a substantial backlog.

The solutions are simple but will require Congress to act quickly, because the rule currently sits at OMB and could be published any day.  On the next appropriate must pass vehicle Congress should include language that either delays the rule completely or fixes its most egregious flaws – the imposition of an inappropriate grandfather date and an insufficient approval period.  Failure to do so will result in regulating vapor more strictly than cigarettes, destroying thousands of small businesses, and, tragically, likely increasing tobacco-related sickness and death.

http://www.americancommitment.org/content/congress-needs-fix-fda-vapor-rule

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Trends in e-cigarette use in England

Study on formaldehyde in e cigs

Over the past week there have been headline grabbing statements in press.   News on studies of formaldehyde in e cigs, begging for the attention of the public and smoker too.  Statements like “high levels of formaldehyde hidden in e-cigs” and  “researchers find cancer-causing agent in electronic cigarettes or vape pens”.  As the week passed it evolved into ” e-cigs are worse than normal cigarettes studies show”.

What is amazing amongst these Chinese whispers are the facts that remain still: smoking is within the top 5 killers in the UK and US and note that it is the tobacco, not the nicotine, that kills. Unfortunately vaping is linked to smoking because you mimic the actions and there is nicotine. But that is where the similarities end. The public are being brain washed into thinking that vaping is worse than smoking- there are no facts to prove this.  The press has recently sensationalized these studies on formaldehyde in e cigs but it’s worth remembering that their conclusions are misleading.  Furthermore it’s difficult to deny that vaping is a smarter and safer alternative to smoking tobacco.

The study conducted by the Portland State concluded that vaping at high voltage will cause formaldehyde releasing agents to develop. We dont believe this is typical of vaping.   There are few vapers who use high voltage hardware. Why? well it is like drinking burnt coffee, the taste is simply not the same. When you vape at high voltage the taste changes, in fact, it can be unbearable.

The press hasn’t been completely thorough.  What they have neglected to highlight is that vaping at normal voltage does not produce formaldehyde in e cigs.

There is no proof that e-cigs / vaping are worse for you than smoking.  This is a fact.  We at Matchless will continue enjoying our vaping sessions, while remaining sensible about the voltage levels we vape at

All You Need to Know About the Vaper’s Tongue

Vaper’s tongue… it doesn’t sound too pleasant, does it? The good news is it’s not a medical condition. The bad news is, it still isn’t that pleasant to have.

So what exactly is it? Well, it’s basically a situation where you stop sensing the flavour in whatever e-liquid you are using. Let’s say you’ve bought a nice mint e-liquid to use. At first you can taste it fine, but after a while you realise you can’t actually taste anything at all. This is vaper’s tongue.

Except that isn’t actually an accurate name. The proper name for the experience is olfactory fatigue. As you may or may not know, olfactory relates to our sense of smell. This means it’s your nose that has the issue, not your tongue or mouth.

Is it dangerous?

No – just a bit frustrating. The effect can last for anything from a few days to several weeks. Even though there is nothing actually wrong with your tongue, your nose’s temporary inability to smell the particular flavour you like to vape with means you won’t be able to taste much either.

Who is most likely to get it?

New vapers are particularly prone to being affected in this way. Remember, you’re coming from smoking a certain number of cigarettes a day. Smoking reduces your ability to smell and taste things to the same degree non-smokers do. As such, it won’t be any surprise to find you might have trouble identifying the milder flavours used in some e-liquids.

You might also get it if you like a particular flavour of e-liquid and you never change to anything else. Your senses will get used to that same flavour time and time again, and you’ll suddenly realise you can’t taste it like you used to.

People taking various types of medication might also be affected. For example, drugs that treat depression, high blood pressure and thyroid problems can all contribute to vaper’s tongue.

Can you avoid it happening to you?

You may not be able to avoid it completely, but you can certainly reduce the odds of this affecting you.

For example, we mentioned that it can happen to people who vape the exact same flavour all the time. If this includes you, you might want to try experimenting with a few different flavours. Some people have one flavour for first thing in the morning, one for during the day and another one to enjoy after dinner. This is just an example of course, but you get the idea. As you switch from one flavour to another, you’re giving your taste buds and senses something different to experience.

You should also make the effort to drink more water. This is always a good idea for your general health anyway, but it helps to rinse out your mouth and you’ll avoid dehydration too. Surprisingly, it’s the latter that can lead to vaper’s tongue, since vaping can dehydrate the parts of your body that inhale the vapour. If you can avoid this, you can hopefully avoid vaper’s tongue as well.

Trying different flavours, drinking more water and even brushing your teeth twice a day (if you don’t already) is all going to help you. But if you are still experiencing problems, you should consider whether any medication you are taking could be having a side-effect you are not aware of.

Trying to avoid being ill is a good move to make too. You can’t always avoid it of course, but colds and illnesses can deaden your senses more than you might believe. Try and think back to the last time you had a cold. How many foods did you really enjoy eating? Chances are you lost your appetite completely – and not just because you didn’t much feel like eating anything. If you lose your senses of taste and smell because you’re feeling poorly, you won’t get any enjoyment out of your food.

If you do suffer from vaper’s tongue, don’t just try swapping flavours. Swap to something stronger than you would normally vape with, too. Many people recommend menthol to help things start moving along again. A stronger tobacco flavour or even cinnamon can also work. If you want to steer clear of tobacco flavours because you’ve left those behind, stick with menthol and cinnamon and see how you get on with those.

Persevere

Sometimes you might be afflicted with vaper’s tongue even when you have done everything possible to try and avoid it. If so, keep on repeating all the steps and suggestions given above. These should at least help keep the period of ‘suffering’ to a minimum, and get you back onto vaping you can taste and enjoy again in the near future. Most importantly of all, don’t give up and go back to cigarettes!

E-Cigarette Vapour as harmless as air

When taking up vaping, many people, including myself, ask if e-cigarettes are harmful – a sensible question to ask. After spending some time reading through articles, reports, opinions and advice from medical circles it became apparent that the most toxic element I would need to be concerned about in e-cigarettes was Nicotine and this was only toxic in large volumes, massively larger than the amount inhaled through e-cigarette vapour. Coming to the world of vaping as a smoker, it was clear that there were fewer health risks associated with vaping and that vaping instead of smoking would be extremely positive change in my lifestyle.

Despite the occasional ‘scare tactic’ article in the media about vaping, the prevailing wisdom in heath circles and in the general public is that vaping is by far a healthier alternative to smoking. To further add to the body of evidence which supports this claim, a recent study shows that e-cigarette vapour is almost as harmless as air, which even to the already convinced vapour, will come as a pleasant surprise.

The tobacco giant – British American Tobacco recently funded research which seems to suggest that e-cigarette vapour could be as safe as air. The study uses human lung cells and robotic smokers to investigate the health risks and effects of smoking cigarettes and e-cigarette vapour.

The research was a joined venture between British American Tobacco and MatTek Corporation, which produces models of human cells used in laboratory experiments. The experiment involved using a smoking robot designed to emulate the smoking / inhaling process of humans. The smoking robot was used to expose the model lung cells to cigarette smoke, e-cig vapour from two different brands and plain air.

When the cells were exposed to traditional cigarette smoke for six hours, the cells died – not a surprise. However, much more surprisingly, when the cells were exposed to an aggressive and continuous dose of e-cigarette vapour, the damage to the airway tissue was “similar to that of air”.

British American Tobacco plans to conduct further research and test a wider range and brand of e-cigarettes and e-liquids to further prove their findings.
The new findings have been welcomed by health professionals and those campaigning for healthier lifestyles. Health officials are being encouraged by such professionals to promote vaping to smokers in a bid to achieve a public health victory.

So, no doubt the debate on whether or not e-cigarette vapour is safe will continue, and despite the arguments, the science and research based argument continues to add to the ever growing body of evidence that e-cigarettes are not as harmful as some misleading opinions and thoughts on the subject suggest.

Eleaf iStick 100W TC VW APV Box Mod

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  • Parallel Circuit Structure: The iStick TC100W can be used, either with one high-rate 18650 cell or two such cells. When installed with one cell, the output power can be 75W and can be 100W when two cells are installed
  • Temperature control: 100’C-315’C / 200’F-600’F
  • Output mode: VW / Bypass / TC (Ni / Ti / SS / TCR-M1, M2, M3) mode
  • Resistance range: 0.05 – 1.5ohm (TC mode), 0.1 – 3.5ohm (VW / Bypass mode)
  • Hidden fire button
  • Special function: firmware upgradable, parallel circuit structure
  • Zinc alloy + stainless steel construction
  • 510 threading connection
  • Spring-loaded center pin
  • Magnetic back cover
  • Houses single or dual 18650 batteries (batteries sold separately)
  • Micro-USB charging port

Twisted messes and DOVPO cooperate released 150W mod would like to introduce
to you.
TM-150:
— Twisted Messes and Dovpo cooperate released;
— Operating Wattage: 3-150W;
— Unique 24k Gold-Plated Buttons and Battery Hatch;
— Using 2 *18650 External battery;
— Support normal coil,Nickel coil,and Titanium coil.
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Electronic cigarette brand approved as a licensed medicine in UK

ecig_hero

UK’s medicines licensing agency has cleared the way for a brand of e-cigarette to be marketed as a quit-smoking aid.

“The evidence so far suggests e-cigarettes are far safer than tobacco cigarettes, and are likely to have health benefits for smokers who can’t otherwise quit” – George Butterworth, Cancer Research UK

British American Tobacco, the makers of the e-Voke, won approval from the Medicines and Healthcare Products Regulatory Agency (MHRA), meaning the device could eventually be prescribed on the NHS in the same way as other Nicotine Replacement Therapy.

“The MHRA has licenced this product as a medicine, which removes a barrier to it being prescribed by medical practitioners as part of a quit attempt, like other Nicotine Replacement Therapy,” said George Butterworth, tobacco control manager at Cancer Research UK.

While early research suggests that e-cigarettes could prove a worthwhile aid in the fight to eradicate the single biggest preventable cause of cancer worldwide – opinion is still divided on their long-term safety.

In the year up to April 2015, two thirds of people who used them in tandem with the health service’s Stop Smoking Service successfully quit, according to the NHS. And results from the Cancer Research UK-funded Smoking Toolkit Study have shown that e-cigarettes have become the most popular quitting aid in England.

“The evidence so far suggests e-cigarettes are far safer than tobacco cigarettes, and are likely to have health benefits for smokers who can’t otherwise quit,” said Butterworth.

But some expert groups – including The British Medical Association and The Royal College of GPs – still hold reservations, particularly around the possibility of the devices being prescribed as medicines on the NHS.

A further concern lies with the question of who would profit from the wide-scale take-up of prescribed e-cigarettes, with e-Voke itself produced by British American Tobacco.

Cancer Research UK’s George Butterworth, said: “It’s concerning that all of the currently licenced e-cigarettes are owned by tobacco companies, an industry responsible for a product which kills more than 100,000 people in the UK every year.

“We hope that independent e-cigarette companies apply to the licencing process so it isn’t Big Tobacco profiting from a solution to a problem it has caused.”

Researchers criticise study claiming e-cigarettes may lower chances of successfully quitting

ecig_hero

A new US study claims that smokers who don’t use e-cigarettes are more likely to quit smoking than those who use them.

“Despite being wide-ranging the paper’s conclusions are tentative and sometimes incorrect.” –Professor Linda Bauld, Cancer Research UK

But experts have been quick to point out the numerous limitations of the study, with the conclusions being at best preliminary or at worst “grossly misleading” according to Professor Peter Hajek, Director of the Tobacco Dependence Research Unit, Queen Mary University of London.

Researchers from the University of California, San Francisco, reviewed the findings of 38 e-cigarette use studies from around the world and concluded that smokers who use the “vaping” devices were 28 per cent less likely to successfully give up smoking tobacco compared to those not using e-cigarettes.

The contested results are in direct conflict with many of the claims made by tobacco-control scientists and advocates, as well as previous reviews that suggest e-cigarettes are safer than conventional tobacco cigarettes and may lead to cessation.

“The irony is that quitting smoking is one of the main reasons both adults and kids use e-cigarettes, but the overall effect is less, not more, quitting,” co-author Stanton Glantz said in a statement issued by the university.

“While there is no question that a puff on an e-cigarette is less dangerous than a puff on a conventional cigarette, the most dangerous thing about e-cigarettes is that they keep people smoking conventional cigarettes.”

However, Professor Linda Bauld, Cancer Research UK’s prevention champion, said: “Despite being wide-ranging the paper’s conclusions are tentative and sometimes incorrect.”

She went on to explain that the studies included in the review were too different in design to directly compare and many don’t include adequate measures of use or cessation.

Further, some of the devices they included are no longer available on the market, some relevant literature is excluded and the way some of the studies are set up means they miss the people who have succeeded in quitting using e-cigarettes.

“We should be very cautious about assuming that this review tells us that e-cigarettes don’t help smokers quit. Other evidence suggests they do – and this is particularly relevant for the UK where smoking rates have continued to decrease as e-cigarette use has increased,” she concluded.

References

  • Kalkhoran, S. Glantz, SA. “E-Cigarettes And Smoking Cessation In Real-World And Clinical Settings: A Systematic Review And Meta-Analysis”. N.p., 2016. Web. 15 Jan. 2016. DOI:10.1016/S2213-2600(15)00521-4

Advocates of vapor cigarettes tout their benefits

Former smokers in the Waterville area say ‘They’re a million times better than tobacco.’

WATERVILLE — Steven Clark started smoking cigarettes at 18, but only in social situations when others would light up.

As time went on, however, he began smoking regularly and like many others became addicted.

Cigarettes aren’t cheap at $6 to $8 a pack. One day Clark, now 25, did the math. He figured he was spending about $100 a week— or about $4,800 a year — on the unhealthful, dirty habit.

Clark, of Winslow, vowed to kick the habit. He tried quitting cold turkey, chewing nicotine gum, even took prescribed medicine from his doctor, but nothing worked.

Then he stepped into Empire Vape Shop on Main Street and got set up with an electronic cigarette or “mod.” He tried different flavored vape juices such as strawberry-banana, experimented with intensity of flavor and decided to include nicotine as well with a plan to use it on a decreasing basis until he eliminates it altogether.

For the first time, he found a method for quitting smoking that really worked, he said.

“I went from smoking a pack-and-a-half a day to three cigarettes a day within 24 hours of vaping,” Clark said Sunday. “Tomorrow actually marks two weeks without a cigarette.”

He said he doesn’t smell like an ashtray anymore, has more money in his pocket — he spends between $12 and $24 a week on electronic cigarette ingredients — and feels a whole lot better.

“I have more energy, I sleep better, I’m able to smell better,” he said.

What has so far proved to be a godsend for Clark is stirring controversy among many people who think the ingredients in vapor cigarettes may be dangerous for people, including children who may pick up the hobby.

The federal government is considering regulating liquids used in vapor cigarettes. Maine officials are considering taxing them.

Clark is concerned about such proposals and says he will do anything in his power to prevent that from happening.

“To me, it’s the government’s way of saying, ‘Hey, let’s make money off this’ because it’s a growing industry. That’s just my personal opinion,” Clark said. “I think it’s our job as a community to properly educate people on how vaping is safer than smoking cigarettes.”

He purchases his vapor cigarette supplies at Empire Vape Shop at 251 Main St.

Shop owner Graham Vinson also is a former cigarette smoker who quit by using vapor cigarettes.

Like Clark, Vinson is convinced that vaping is a more healthful alternative to smoking cigarettes and helps wean people off nicotine.

Vinson has been in the industry about six years and worked for his competitor before opening his own shop Dec. 7, he said. He says he is conscientious, keeps up with the latest studies on ingredients for vapor cigarettes and does not use ingredients that have been deemed poor. He says the vaping industry in the U.S. has done a good job of regulating itself.

“We’re here because we know that cigarettes are killing people. We’ve known it for years,” Vinson, 36, said.

Unlike Clark, his patron, Vinson feels strongly that the vapor cigarette industry should be regulated to keep “shoddy manufacturers” out of the picture.

“I don’t know that I’m going to agree that it should be taxed,” he said. “Yes, by all means, regulate it so we don’t have to deal with shady producers. Regulations are coming. I’m personally all for it because I vape what I make. We make sure it’s very clean.”

Vinson and his fiancee, Stephanie Hawkins, a former case worker, are partners in the business and feel strongly that it is important to give back to the community, he said. They donated gifts, food, clothes and other items to a family through the Salvation Army at Christmas. They sponsored a dog at the local humane society by buying it special food and paying its adoption fee and veterinarian bills. The couple also are running a special drawing to benefit the local food pantry.

“I’m just trying to be a good business and be part of the community,” Vinson said.

Vinson said he is not going to claim that electronic cigarettes are an end-all — and perfectly healthful.

“But I do know they’re a million times better than tobacco,” he said.

Clark concurs.

“It’s a lot more environmentally friendly, if you will,” Clark said. “The more people we get into vaping, the less cigarette butts we’re going to have littering streets or filling landfills.”

While some people argue there are unhealthful chemicals in the liquid in vapor cigarettes, Clark maintains there are fewer chemicals in an electronic cigarette than in a traditional one.

“The ultimate plan of vaping in general for most people is to wean off nicotine completely but continue vaping,” he said. “That’s the main goal across the entire industry — is weaning people off while keeping the hobby.”

Amy Calder — 861-9247

acalder@centralmaine.com

Twitter: @AmyCalder17

http://www.centralmaine.com/2016/01/10/advocates-of-vapor-cigarettes-tout-their-benefits/

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