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  • My Take on the FDA vs E-cigs. Why e-cigs shouldn't have to be banned.

    So the seen looks set for e-cigs to banned in America. The FDA fuelled many alarming headlines media last week with the release of some test results which they carried out on nineteen samples of liquid from two e-cig companies which showed:

    1. Certain tobacco-specific nitrosamines which are human carcinogens were found.
    2. Tobacco-specific impurities suspected of being harmful to humans were found
    3. Cartridges that were labelled as containing no nicotine had low levels of nicotine present.
    4. 1 cartrdige containing 1% diethylene glycol - a poisonous and deadly toxin

    What they failed to mention and has been pointed out by Michael Siegel and reiterated by many but not picked up on in the mainstream media is that tobacco-specific carcinogens are Found in pharmaceutical grade NRT's also. This is because the nicotine is derived from tobacco so trace amounts will inevitably occur. The fact that the liquid used in e-cigarettes contains minuscule levels of toxins found in tobacco is moot.

    What happened in the past concerning diethylene glycol

    It's harder to talk around the fact that diethylene glycol was found. E-cigs should not contain diethlyene glycol. Yes, it is deadly, Yes, there have been a number of cases where products, often originating from China, have caused either serious illness or death because the factory which produced the product decided to use DEG instead of PG, due to either negligence or corner-cutting.

    But does this justify allowing the FDA to halt the sale of all electronic cigarettes? Hardly. The last time the FDA discovered diethylene glycol in a product, it was in cheap toothpaste from China destined for the dollar stores. Did the FDA ban toothpaste? Of course not. Did they even confiscate all shipments of Chinese made toothpaste. No, they took the correct and sensible course of action.

    They confiscated the brands of toothpaste where diethylene glycol was found and Companies whose brands had been found to contain DEG would have to prove that their toothpaste was free of the chemical before it was allowed back in the U.S.

    Is a blanket ban fair?

    Why should it be any different for the e-cig companies? Why can't the FDA halt imports of 'Smoking Everywhere' - the brand where DEG was found and require them to submit tests to prove their product is free of the chemical before it allowed to be sold again? They are a number of factories which make the liquid, not only in China but in the UK and USA as well. Why should they be tarred with the same brush?

    Dekang who have previously claimed that they produce 90% of the e-liquid on the market released a statement in response to the FDA's findings in which they declared that their e-liquid does not contain diethylene glycol and that the e-liquid which tested positive for DEG was not produced by Dekang. They went on to say that their e-liquid and cartridges has been thoroughly tested and confirmed to be safe by SGS, Korean FDA and German TUV LFGB.

    Ruyan who make their own liquid this week found their product banned in Israel on the heels of the FDA tests despite the fact they had previously received Health Ministry approval and their product has undergone rigorous independent safety checks by a team of doctors at Health New Zeland.

    Vested interests in the pharmaceutical industry

    But I'm afraid any protest is falling on deaf ears. There are powerful organisations at work which are intent on having e-cigs banned and 'regulated'. The American Lung Association stepped up their call for sales to be halted and as soon as the results were made known. They've been vocal on their position with e-cigs for quite a while.

    In March of this year, along with The American Cancer Society, The American Heart Association, and The Campaign for Tobacco-Free Kids all applauded Senator Frank Lautenberg of New Jersey when he requested the FDA to exert its authority and immediately remove e-cigarettes from the market.

    Prior to Mr Lautenberg's request, the FDA had acted justly. They had made it known that they had no power to remove electronic cigarettes from the market. Unless an e-cig company made either health or cessation claims with a product - or their product contained ingredients they deemed hazardous, they could do nothing. Cases would be dealt with individually.

    Nicotine is not a controlled substance in much the same way caffeine is not a controlled substance. The smart companies knew this and marketed their product accordingly. They mentioned nothing about quitting tobacco. The companies who were ignorant of this law were caught out and had their shipments confiscated on entry.

    You can still buy a couple of non e-cig related nicotine products in the US that remain unregulated and are not produced by a pharmaceutical company; Nicowater - a drink obviously enough, which initially encountered problems due to cessation claims they made and Nicogel - a nicotine based gel you rub on your hands. Both products are marketed as a means to stimy nicotine withdrawal in locations where smoking is prohibited.

    This is how Ruyan, the company who first looked into marketing e-cigs in the US, marketed their product (They actually worked with the company who later went on to form Njoy to find out the correct way to market their product). Then along came a few rivals who took similar caution but next a wave of competition they were not prepared for.

    Bedroom entrepreneurs were discovering that e-cigs were extremely profitable and in high demand and that there were a multitude cheap Chinese factories willing to supply them at a fraction of the cost they could retail for. Sites were set up, business cards were passed around.

    Many were unfamiliar with laws governing devices that make health claims or threw caution to the wind. One business in Pennsylvania errected a Billboard announcing 'Obama, yes you can quit smoking with The Safecig'. He was chided by the e-cig community who told him he would draw the wrong kind of attention and was making claims with no evidence but he persisted nonetheless. E-cigs were becoming 'the next viagra' as one forum member put it. They were being spammed everywhere.

    E-cig Spam

    In April of this year, a thread ran on a Black Hat marketing forum entitled 'Just like slinging crack'. The thread advertised a multi-level-marketing affiliate plan for one e-cig company. It become one of the most popular threads on the site for a while, running pages deep as many had not heard of this fast selling new product. Consequently It became impossible to search for for e-cigs on craig's list without being bombarded with offers to show you how to make easy money selling e-cigs.

    About the same time, another e-cig supplier called Blucig started operating. They appear to be owned by someone who has a connection to a massive on-line porn empire and ads were rolled out for the product on some of the most visited pages on the web. A huge portion of internetters were discovering e-cigs for the first time about a year and a half after they had first started being marketed.

    Blucig either under-estimated the level of interest their product would receive or else their stock was confiscated at customs as a massive influx new users flooded the forums complaining that they had not received their blu in over a month and wondered what to do. Many new members of the forums started discussing Blu and the old-timers started to wonder whether these discussions were plants by shills aiming to garner interest in the brand.

    If you are in any doubt about the level of e-cig spam on the internet, just have a search for e-cig on twitter. Spammers are tweeting wave after wave of links to affiliate products. Twitter is currently trying to position itself as a real time search engine, the idea being that if you want to hear up to the second news about a particular item, you search for the item on twitter.

    Spammers are using this do their advantage repeating the same tweet over and over using popular keywords so the search results are nothing but ads and consequently any useful information is removed from the search results almost as soon as it enters it.

    This all shows that there is an increasing demand for electronic cigarette products and an ever increasing amount of people who are wiling to supply them - for maximum profit - a recipe for disaster perhaps? I was once told by a supplier that he could purchase liquid from China for pennies but that he chose not to as he was unconvinced that their operation was perfectly sanitary.

    Why did the FDA suddenly decide to ban e-cigs?

    But just why did the FDA decide to submit to Frank Lautenberg's request? Why didn't they continue to single out the companies who were making illegal claims? Why did they suddenly decide confiscate the shipments of two of the biggest e-cig suppliers on grounds they are now fighting for in court? In short, the conspiracy theories doing the rounds are:

    1: They are submitting to the will of the government who stand to lose revenue from tobacco tax and

    2: They are in bed with Big Pharma who put them up to the task.

    Both theories are only conjecture unless incriminating documents and e-mails suddenly turn up on wikileaks one day. It's certainly true that Frank Lautenberg was the recipient of more than $128,000 from pharmaceutical companies in 2008 alone and it's certainly true that connections can be made from Big Pharma to all the organisations agreeing with his position and it is Big Pharm who stand to lose the most if e-cigs remain openly on sale but unless there is concrete proof of their meddling, there is no smoking gun.

    It should also be noted again that the FDA conducted these tests as far back as May but they have only released the results some three months later. If they were really concerned for the public's health, shouldn't they have released the results as soon as they were known?

    The fact stands that they cloistered their results until no further evidence could be admitted to a trial in which they are being accused of having no justification in confiscating shipments of e-cigs by the two e-cig companies whose liquid they tested. Surely this should have been their prime argument. Why weren't their tests exhibit A? Were they afraid that their tests would have been to easily shot down in court? Why Did they prefer to start their scaremongering only now when the judge is set to make his decision. Surely he will now be inadvertently influenced by the all the alarming headlines. To be frank, the course of action the FDA has taken seems to smells worse than cigarettes. It's no wonder so many are calling foul.

    The dangerous products that are FDA approved

    And here's what really annoys me. There are any number of products already on the market that contain potentially dangerous ingredients. The bread you eat is probably made from chemically bleached white flour (illegal in Europe but not a concern for the FDA when a Pilsbury worker was made its head). Putting fluoride in water is banned in many countries but it is still common in many household products and what about the Monsanto milk scandal? There is evidence that chantix, an FDA approved NRT is thought to lead to depression and suicide.

    Then there is the diacetyl. In the 90s, inhalation of this synthetic butter flavoring had been blamed for destroying the lungs of hundreds of workers in microwave popcorn plants throughout the Midwest. Ronald Kuiper died last march, just one day before a jury decided that a maker of the chemical butter flavouring owed him $7.5 million for the destruction of his lungs. As many as 300 other cases are pending but the FDA does not restricts or monitors its use even though food scientists estimate that today more than 14,000 individual products use diacetyl for butter flavour. It's not something I would want in an e-cig but since the FDA determined it was GRAS (generally regarded as safe) in the 80's, they refuse to change their position. So if the liquid they had tested contained diacetyl, would it have even been a concern?

    There is a new e-cig flavour out every other week. Any of them could be potentially dangerous to inhale. But would any of them even be a concern for the FDA?. Likewise with propylene glycol. According to the FDA, it is completely safe when used properly and found in everything from common pharmaceuticals to shampoo and room deodorisers. It is of course notably present in fog machines used in stage productions, film sets and night clubs.

    In the 1940's tests ran which discovered it was a potent germicide. One part of glycol in 2,000,000 parts of air would within a few seconds kill concentrations of air-suspended pneumococci, streptococci and other bacteria numbering millions to the cubic foot. It very nearly would have become the standard procedure to use it to sterilise working spaces and hospitals (a patent was written for such a device that administered a PG mist intermittently) had ultra-violet light not been discovered to act the same way.

    Is PG really safe?

    But is PG really safe? Here's is one concern I have with the substance: One reason propylene glycol is used in skin moisturisers and sun tan lotions is because it has shown to act very successfully as a penetration enhancer, It maximizes the activity of what other drug or substance it is used as a vehicle to support because it enables it to permeate more deeply into the skin. My worry is that if it enhances the skin penetration of other chemicals it is mixed with, it will do the same in our lungs.

    Now what if an e-cig user is switching between smoking regular tobacco and using an e-cig? Will the chemicals in the tobacco then mingle with the PG already coating their lungs and allow these nasty chemicals to permeate more deeply and make a person worse off than they would have been if they only stuck to smoking cigarettes? I am not ashamed to say I have no clue, but perhaps it is a legitimate concern.

    One one occasion when I was making a purchase from a distributor in China, I was told that I could have my lequid prepared with polypropylene glycol or PEG400 as it is known. I asked why she thought I might need that. 'Propylene glycol very dangerous' I was told 'PEG400 much safer' The advice of some random Chinese lady who is trying to close a sale is hardly confirmation that PG is potentially dangerous but it did give me pause to wonder. One brand from Belgium called Sedansa has completely switched their liquid from PG to PEG400 but they wouldn't say why exactly.

    Where the responsibility lies

    So yes, e-cigs need to be studied, the long lasting effects the liquid have on a user's health needs to be determined. The ingredients that the liquids contain needs to be clarified and tested. When a supplier in the UK had his liquids tested once, he discovered his mint e-liquid contained methanol - an extremely toxic chemical. He quickly discontinued its sale. How many others are using that same liquid? And how many other liquids contain ingredients which are harmful?

    But all this can be accomplished without banning them completely and allowing only pharmaceutical companies to take them as their own, which is what is feared will happen and is the reason so many people are up in arms.

    The responsibility ultimately lies on the manufacturers of the liquid. They could quite easily preform tests on their liquid (and some have done) and identify exactly which ingredients they contain and in what quantity. If the liquid contains only ingredients the FDA as identified as GRAS, then there is no reason why the liquid could not be sold openly as long as it is properly labelled and factory sealed. The FDA can preform spot checks as they do with all products already and if they find any liquid contains something that shouldn't be there, they could confiscate the liquid and allow it only to be sold again, once it had proved to be safe. This is how the FDA operate with every other product. Why should it be any different with e-cigs? Anyone marketing e-cigarettes as a cessation device should be stopped but it simply not fair and not ethical to ban the product completely when there are sellers who are obeying the rules on the grounds that some others don't like to follow them.

    4 points by dc2k08 to Regulation 12 months ago
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