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August 28th, 2015:

Could nearly all E-Cigarettes disappear?

http://www.bocaratontribune.com/bocaratonnews/2015/08/could-nearly-all-e-cigarettes-disappear-fda-regulations-to-dramatically-change-the-face-of-vaping-forever/

Could nearly all E-Cigarettes disappear? – FDA Regulations to dramatically change the face of vaping forever

E Cigarettes are electronic devices which allow a user to inhale liquid nicotine, generally flavored, which can contribute to helping a user wean themselves off cigarettes. But is this all good news?

Could E-Cigs be spawning a new health damaging habit?

E-Cigs have yet to be fully studied. Therefore customers are not fully aware of:

Potential risks of E-Cigs.

If there are any benefits associated with using vaping products.

How much nicotine or chemicals are being inhaled while using these products.

If E-Cigarettes influence young people to try tobacco products, which they would have not otherwise have tried. We already know the risks of regular cigarettes. Do we want to potentially influence the next generation to get addicted to something which could lead to regular smoking?

Evidence so far suggests that e cigarettes on the whole are a great idea and the health risks are massively reduced in comparison to regular smoking. But how is the FDA (Food and Drug Administration) going to influence the massive up trend of vaping? E-Cigarettes are facing a possible rapid decline due to upcoming FDA regulations. Mainly they will affect how the products are sold, and what hoops the e cig and e liquid vendors have to jump through. The effects could be catastrophic for the industry. Here are some of the guidelines that could come into place:

Only market new products after FDA review

Vendors and manufacturers to register with FDA and report product and ingredient list

Only make direct claims of health benefits over regular smoking if the FDA confirms the scientific evidence that it will be beneficial to public health overall

No distribution of free samples

Minimum age requirements to stop sale of products to minors

Requirement to show health warnings

No vending machine sales (apart from maybe casinos etc)

Complete overhaul of the way the eliquid is sold – maximum nicotine per ml and maximum sizes making some current products completely obsolete

This might not seem so damaging, but lets take for example the many small vaping shops which have popped up everywhere. In the UK and America, over the last 5 years there has been thousands of small businesses investing into this and opening shops, will they cope with the new regulations?

Effect on small Vaping businesses

Lets take your local vaping shop as an example. Due to new regulation, they will need to get packaging for all their products, and get each tested. They currently generally have a generic packaging for their eliquid, and don’t have to get it tested.

Currently they sell 6mg, 12mg, 18mg & 24mg nicotine strength eliquid. They sell this in a normal PG/VG (propylene glycol and vegetable glycerin) and they generally sell one with a higher VG ratio, this is due to the users preference. They also have 180 flavors.

180 flavours x 4 strengths x 2 types = 1440 different packaging requirements. Can you imagine your local e cig vendor being able to produce that many different types of packaging, and store them? They could possibly get away with having only one box for eliquid per flavor and list the difference in nicotine, but even then the ingredient list may not be accurate enough for the FDA.

Further to this, they will now need to retrospectively apply for each product to be approved. The cost for this is said to run into the millions. We are not sure about the implied cost associated with this, but the New York Times have estimated a pre-market review demonstrating each specific product to be beneficial to smokers and how it would affect non-smokers to cost around $300,000.

There are also many other minor problems vendors will have to deal with. Such as the fact the Eliquid can only be sold in 10ml bottles. So the current 30ml bottles sold, will now be obsolete. On the tech side of things, the batteries and products are going to be regulated to only a few devices, possibly spawning more mass producing of smaller “cigalike” devices – generally the only ones you see on TV advertising at the moment, such as the Vype advertisements. Advertising is likely to take a huge hit as well. There will be no advertising until they can convince the FDA otherwise.

The final word

It seems to us, the astronomical costs of getting Ecigs and Eliquid to market, will not be something which is achievable for a small e cig vendor. That would mean closure of up to 99% of e cigarette businesses. However is this an opportunity for larger companies to absolutely dominate the market? Example being BAT (British American Tobacco). They own Vype, and according to wikipedia, BAT have an annual Revenue of $42 billion, compared to your average ecigarette shop having an annual revenue of around $108,000. Seems to us its a perfect opening for a company with an unlimited budget, it would also be fair to say BAT were all for FDA regulations before they released their own brand of Ecigs. Now they have done a total 180 and consider the FDA to be hindering them, they are calling for the FDA to revisit the proposed guidelines. Despite all this, it would seem it is not deterring some vendors from coming up with new products, VG E Liquid from the UK by Pure E Liquids for example. However it seems this particular brand is ahead of the game in some respects. They already get their eliquid batch tested, so that will make the changeover easier and do not sell anything larger than 10ml. They seem to be preparing for the guidelines as best they can – but will it be enough? With 135,000 comments being reviewed by the FDA though, it doesn’t look like we are facing a British American Tobacco domination, or a catastrophic decline in our local ecig vendors, just yet.

TTIP deal: Business lobbyists dominate talks at expense of trade unions and NGOs

http://www.belfasttelegraph.co.uk/news/politics/ttip-deal-business-lobbyists-dominate-talks-at-expense-of-trade-unions-and-ngos-31485109.html

Green MEP Molly Scott Cato: This is a corporate discussion, not a democratic one.

European Commission officials have held hundreds of meetings with lobbyists to discuss the proposed Transatlantic Trade and Investment Partnership (TTIP) treaty – yet only around one in ten is with public interest groups.

The world’s biggest companies in finance, technology, pharma, tobacco and telecoms are dominating discussions with the EU executive body’s trade department responsible for the proposed EU-US free trade treaty, which could become the biggest such deal ever made.

Between January 2012 and February 2014, as TTIP discussions began, the Commission’s trade department (DG Trade) had 597 behind-closed-door meetings with lobbyists to discuss the negotiations, according to internal Commission files obtained by research group Corporate Europe Observatory (CEO).

There were 528 meetings (88 per cent) with business lobbyists while only 53 (9 per cent) were with groups such as trade unions and NGOs. The remainder were with other parties such as public institutions and academics.

European Trade Commissioner Cecilia Malmström took office in November last year promising a “fresh start” for the TTIP negotiations. More civil society involvement and listening to public concerns was her “top priority”, she said. Yet in her first six months in office Ms Malmström, her Cabinet and the Director General of DG Trade had 121 one-on-one private lobby meetings in which TTIP was discussed.

CEO said 100 of these declared meetings (83 per cent) were with business lobbyists – but only 20 (17 per cent) were held with public interest groups. The other meeting was with a standard setting institution. Although the EU has a transparency register for lobbyists it is only voluntary and CEO revealed that one in five corporate groups lobbying DG Trade on TTIP are not on it.

Politicians have joined campaigners in calling for greater transparency in the Commission’s TTIP negotiations after The Independent published the heavily redacted correspondence between ‘Big Tobacco’ companies British American Tobacco (BAT) and Philip Morris obtained by CEO.

Green MEP Molly Scott Cato said: “The censoring that the Commission has undertaken regarding its discussions with big tobacco reaffirms the secrecy surrounding these negotiations and is symbolic of the way MEPs, the European Parliament and European citizens are being treated.

“Looking through the smoke haze we can see why these documents appear blacked out. Nine out of ten lobby contacts during the preparatory phase of the TTIP negotiations were with companies and corporate lobby groups. Corporations are effectively co-writing the treaty. Yet the vast majority of citizens are against TTIP.

“A worrying aspect of this particular cover-up is that tobacco control policies are vital for public health. We know that Big Tobacco have used comparable trade treaties to take legal action against Australia and Uruguay as those nation have attempted to take action in the interests of public health.”

BAT, the world’s second largest tobacco group with brands in 180 countries, spends between 1.5m and 1.75m euros a year employing seven lobbyists in the EU. Philip Morris spends between 1.25m and 1.5m on employing six lobbyists, although not all working full-time on EU-related activities.

Yet even that spend is dwarfed by companies such as European Federation of Pharmaceutical Industries and Associations and ExxonMobil Petroleum and Chemical spend even more on lobbying – 5m euros each annually, according to the register.

By contrast the European Network for Smoking and Tobacco Prevention NGO spends less than 10,000 euros a year employing two lobbyists in Brussels in a part-time basis. It survives with the help of a 200,000 euros grant from the EU.

Politicians are only allowed to read documents relating to TTIP in a secure European Parliament restricted reading room. They are also required to sign a 14-page document ultimately promising not to share the information with their constituents.

Ms Scott Cato described the experience earlier this year comparing it to “a scene from a James Bond film”.

She said: “I don’t feel what I was granted access to contained the important details. Key information seems to have been retracted; there was little of interest. But what I did see did not leave me with any sense of reassurance, either that the process of negotiating this trade deal is democratic, or that the negotiators are operating on behalf of citizens. It reconfirmed that this is a corporate discussion, not a democratic one.”

No smoke without fire: Negotiations with tobacco firms must be transparent

http://www.independent.co.uk/voices/editorials/no-smoke-without-fire-negotiations-with-tobacco-firms-must-be-transparent-10475680.html

Despite the almost comical redacting of entire pages of material, the release of documents by the European Commission on the implementation of TTIP (Transatlantic Trade and Investment Partnership) sheds useful light on the Commission’s dealing with the big tobacco firms.

The suspicion is that these powerful multinationals are using their influence in a (literally) unhealthy manner, and attempting to make the European Union agree to provisions that would seriously harm efforts to cut back on tobacco smoking across Europe – a large and profitable market for the cigarette makers. While rates of smoking, among men at least, have been coming down across Western Europe since the cancer link was discovered more than half a century ago, Eastern Europe may hold greater opportunities for expansion for tobacco companies, as those economies grow in prosperity.

Despite the efforts of Corporate Europe Observatory to make a reality of freedom of information, Brussels still clearly has a good deal to learn about transparency. TTIP will have a dramatic effect on Europe’s peoples. There remain deep concerns that the benefits of trade liberalisation will be negated by a raft of concession to big business.

Your Body Immediately After Vaping an E-Cigarette

While much research has been done on conventional cigarettes, data on e-cigs is much more sparse. This is because e-cigs were only invented in 2003 by a Chinese pharmacist, while tobacco has been around for centuries.

Because of e-cigarettes’ relative newness, their potential risks or benefits are not well-understood. There aren’t decades-long epidemiological data for researchers to analyze. Even the U.S. Food and Drug Administration says it’s unclear whether e-cig users are inhaling potentially harmful chemicals. The California Department of Health earlier this year declared them a public health threat.

The general consensus is that e-cigs are less harmful than conventional cigarettes, mainly because there is no smoke or burning involved. “They’re simpler than cigarettes,” Jonathan Foulds, PhD, professor of public health sciences and psychiatry at Penn State University’s College of Medicine and Cancer Institute, tells Yahoo Health. “You burn it, cigarettes creates 7,000 different chemicals into your body. But with e-cigarettes, there’s no combustion. The good news is that you’re inhaling a vapor that’s got four to five things as opposed to 7,000 things.”

But not all e-cigs are created equal. There are hundreds of brands with simple products resembling conventional tobacco cigarettes to more high-end, sophisticated vape pens. The FDA has found inconsistencies with some e-cigs containing nicotine when they’re marketed as free of the substance, not to mention varying levels of quality. At this point, e-cigarettes are not regulated by the FDA, although the agency seeks to change that soon.

Not all e-cigarettes contain nicotine. And some of the products let users control the amount and potency of the liquid solution. What’s inside the liquid solution vary by brand and flavors, such as butter popcorn and cookies and cream, which carry different chemical agents. Other e-cigs are more straightforward, with about five ingredients.

“The question is: What’s the effect on the body of the four to five things?” says Foulds.

The problem remains: lack of data. “There’ve been few studies that investigated the extent of biological effects,” says Jake McDonald, PhD, director of Environmental Respiratory Health Program and the Chemistry and Inhalation Exposure Program at Lovelace Respiratory Research Institute in New Mexico.

So here’s what we know so far about how e-cigarettes may affect your body:

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Mouth

Users have complained of cotton mouth, scratchy throat, and coughing. It’s unclear why this happens to some people other than due to hydration issues.

Lungs

One of the main ingredients used in e-cig liquid solutions is propylene glycol (which is used as fog in concerts and theater) and glycerin (which is proven safe in foods).

“We’re putting things in e-cigs proven safe in foods, but it’s not the same as putting it into a vapor and inhaling it,” Foulds explains. “A Mars bar is safe to eat, but I wouldn’t want to inhale it. If something is safe as a food, it’s not highly harmful, but we don’t know what happens when you inhale it.”

There are concerns that nanoparticles from the vapor can be embedded in the lungs, causing inflammation and leaving the lungs vulnerable to infection. A study published in the journal PLOS this year found that the vapors damage the epithelial cells in the airways, leaving them vulnerable to infection.

“E-liquids without nicotine and with nicotine inhibit the lungs’ innate immunity, which helps it defend itself against infections,” study author, Qun Wu, MD, Ph.D, told Yahoo Health earlier this year.

The American Lung Association has called for more governmental oversight because “the reality is that without FDA regulation and review, we don’t know what is in e-cigarettes.”

Heart

The few studies that looked at e-cigarettes’ cardiovascular effects find that the ones containing nicotine raise heart rate and blood pressure. This is from the nicotine kick, which acts as a stimulant and prompts an adrenaline rush in the body. But studies have also found that e-cigarettes didn’t cause the type of disruptions in the body seen with tobacco smoking.

One small European study compared the heart functions of 20 young tobacco smokers versus 22 e-cigarette users seven minutes after using their products. The study conducted in Greece found none of the heart problems associated with tobacco cigarettes among e-cigarette users. Its lead researcher, Dr. Konstantinos Farsalinos, said in a statement: “This is an indication that although nicotine was present in the liquid used (11mg/ml), it is absorbed at a lower rate compared to regular cigarette smoking.”

The American Heart Association says there needs to be more research into this topic and called for rigorous examination of the “long-term impact of this new technology on public health, cardiovascular disease and stroke.”

Brain

When nicotine enters the brain, it releases a feeling of pleasure as dopamine levels increase.

Nicotine, while not considered a carcinogen, is still addictive and may “prime the brain to become addicted to other substances,” according to the National Institute on Drug Abuse.

One of the biggest concerns by anti-tobacco advocates is that e-cigarettes will get users hooked on nicotine and will serve as a gateway to tobacco use.

Your Baby

Nicotine can be detrimental to your baby if you’re pregnant. It affects the development of the baby’s lungs and brains, and can cause problems like preterm birth, low birth weight, and stillbirth in higher rates, research shows.

“For smokers of e-cigarettes, we know it’s going to increase premature birth [and] increase intensive care state,” Foulds says. “These are things that affect babies for life. Some believe e-cigs are completely safe — it’s not quite true.”

Estimating the Harms of Nicotine-Containing Products Using the MCDA Approach

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The tobacco endgame: a qualitative review and synthesis

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