FDA Deeming Regulations: Are Independent Vape Labs About To Get Muscled Out of The Market They Helped Create?

America is an odd country. I travel there a lot and, generally speaking, positively love the place, its culture and most of all its people. Shame the same thing cannot be said for its government which seems to thrive on making knee-jerk decisions about everything and everybody it encounters.

Vaping, for instance, is now Enemy Number 1 in a lot of people’s eyes in the US. Ditto Canada and many places in Asia, like China which is apparently considering a complete ban on vaping (including the manufacture of vaping and ecig hardware, too — odd seeing just how many products are made and shipped from there).

They wanted vaping regulations and today the FDA announced its Deeming Regulations. This will effectively mean vaping products — juice, hardware — are treated like cigarettes.

The entire vaping community — users, shops and suppliers — have been waiting with baited breath for the release of the FDA’s Deeming Regulation. And what was announced today is not good. Not good at all. The FDA has effectively setup on its plan to completely destroy the vaping industry — and industry that has helped MILLIONS of people quit smoking.

“Without action by Congress, the FDA’s proposed regulations threaten to ban 99%-plus of vapor products currently available on the market. This would be a disaster not only for thousands of small businesses, but also public health.

“This proposal does not remove the FDA’s ability to regulate vapor products. The FDA will retain the authority to immediately move forward with science-based product standards, disclosure requirements, and many other measures. Anyone who claims that this bill would somehow render the FDA toothless is either not familiar with the law or not being forthright.

“We are thrilled to see movement on this issue. Clear evidence is emerging from around the world that vapor products are helping smokers quit. It is unconscionable to effectively ban the sale of tens of thousands of vapor products while leaving combustible cigarettes freely available.”

Here’s what Alex Clark of CASAA had to say on the matter via Vaping360:

“Please keep in mind that this is not the end of the process. CASAA will continue to focus our efforts to develop sensible regulation of vapor products that will have maximum benefit to consumers. The most important thing to remember is that consumers will continue to have access to the wide variety of vapor products for a period of time before the regulations take effect. But, for now, vaping as we know it will continue and we are not done by any means. Keep calm.”

But the real issue is the testing they want implemented, as it will cost small companies millions of dollars to have it done — millions of dollars 99% of them DO NOT have. And if they do not comply, well, they will not be able to sell their ejuice.

This would make it next to impossible for smaller, independent vape labs to stay in business. Only the biggest players can afford to do this, and even then it’d be a push.

Here’s some comment from DIRECTVAPOR:

“Today, the U.S. Food and Drug Administration released a rule extending its authority to all tobacco products, including e-cigarettes. We are aware, and have been preparing for the FDA to release regulations since 2013.  As always DirectVapor will be here to serve you and continue to be a leader in the vapor business for many years to come.  In the meantime join us and sign the petition to the white house to overturn the FDA’s ruling on ecigarette classification as a tobacco product, and let the white house hear your voice.”

It is also VERY important we ALL now make our voices heard; this is very much a dogfight now. And we need to show the FDA and congress that we will not be pushed around. PLEASE — if you’re in the US — Sign this Petition 

Because if everything goes to plan for the FDA and its cronies, small, independent vape labs are going to be squeezed out of the market place they created in order to make way for big tobacco-produced eliquids and cig-alike products. And that would SUCK big time.

“I’m not a fan of Big Tobacco,” said A Billion Lives’ director, Adam Biebart, in a recent interview with Vape Beat, “but I don’t think it’s the biggest enemy of vaping. They just want to make money and that’s something we can always trust. They are starting to do that by selling E-cigarettes now. At the Global Forum for Nicotine, I ended up sitting by a Vice President of a major tobacco company. He indicated that they’d like to switch as much of their business to E-cigarettes as possible. He said they make more money on that business.”

But is anyone going to want to give their money to Big Tobacco? I mean, that’s like going out of your way to become a Jedi and then re-joining the Dark Side because they have slightly better pension options. A few people will, but most will not want anything to do with such businesses, not when home-grown brands have been forced out of business by crippling regulation likely sponsored in part by tobacco and big pharma lobby money.

But here’s the rub: vaping is not as bad as they’re making out, especially when compared to smoking. This has been proven time and time again, should you care to look at the research, of which there is plenty of (as you can see below).

• Scientific Errors in the Tobacco Products Directive: A letter sent by the very scientists whose research was cited by the EU Commission to draft legislation geared towards ecigarettes and their usage. The letter details the many ways in which their research was wrongly used and misinterpreted.
• Ecigs Do Not Stiffen Arteries (PDF): Researchers from Onassis Cardiac Surgery Center in Greece have found that while smoking just 2 tobacco cigarettes caused significant stiffening of the aorta, no difference was observed after the use of an e-cigarette by smokers AND vapers. Published December 2013.
• Smoking Kills, and So Might E-Cigarette Regulation: Gilbert Ross MD, is a medical and executive director of the American Council on Science and Health. In this special report on The American, he states “simple common sense would dictate that inhaling the fewer, less harmful ingredients of e-cigarettes as compared to inhaling the thousands of chemicals in the smoke from burnt tobacco, many of which have been shown to be carcinogenic, is highly likely to be healthier.” Published November, 2013.
• Research on Safety of Electronic Cigarettes (PDF): Dr. Konstantinos Farsalinos’ comprehensive presentation on existing data relating to the safety of ecigarettes. Presented at The E-Cigarette Summit, Royal Society, London in November 2013.
• Nicotine Safety in the Context of E-Cigarette Use (PDF): Contrary to popular belief, the fatal overdose level for nicotine may be far higher than the generally accepted 50 to 60 mg (adult) says Dr. Jacques Le Houezec. This research was presented at the The E-Cigarette Summit, Royal Society, London in November 2013.
• E-Liquids Shown To Have Low Cytotoxicity (PDF): The results of testing of 20 e-liquids, has revealed the majority of the vapor samples were found to have no adverse effects on cardiac cells. Even on the several that did have some effect (two of which were tobacco derived), the worst was 3 times less toxic compared to cigarette smoke. Published October 2013 in the International Journal of Environmental Research And Public Health.
• Nicotine Levels Selection and Patterns of Electronic Cigarette Use: Study from Dr. Konstantinos E. Farsalinos that concludes nicotine levels seem to play a crucial role in achieving and maintaining smoking cessation in a group of motivated subjects. The study involved 111 participants who completely substituted smoking with electronic cigarette use for at least 1 month. Published September 2013.
• Vaping: coronary circulation and oxygen supply (PDF): Recent research indicates that electronic cigarette use does not affect the oxygenation of the heart. Lead by principle investigator Dr Konstantinos Farsalinos; results of the research were presented at the European Society of Cardiology annual congress in Amsterdam in August, 2013.
• Eliquids: No Health Concerns: A study by Professor Igor Burstyn of Drexel University School of Public Health based on a review available data has confirmed chemicals generally found in ecig eliquids pose no health concerns. Published August 2013 (PDF).
• MHRA Ecigarette Research: The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) carried out extensive research on ecigarettes, arriving at the conclusion there was little concern that e-cigarettes can harm users by delivering toxic nicotine levels and little evidence of non-smokers taking up electronic cigarettes. Published in June 2013.
• Evaluation of Electronic Cigarette Use And Liquid Consumption: This 2013 study challenges an EU proposal that would result in eliquids containing more than 4 milligrams of nicotine per milliliter being banned unless approved as medicinal products.
• Electronic Cigarettes Do Not Damage The Heart: Electronic cigarettes appear to have no acute adverse effects on cardiac function according to research by cardiologist Dr Konstantinos Farsalinos.  He says based on currently available data, ecigs are safer and that substituting tobacco with electronic cigarettes could be beneficial to health.
• Principles to Guide AAPHP Tobacco Policy: The American Association of Public Health Physicians recommends electronic cigarettes as a safer smoke-free tobacco/nicotine product.
• Athens University Ecig Study Challenged: Dr. Michael Siegel questions a University of Athens study claiming e-cigarettes can cause lung damage.
• Regulation: When Less Is More (PDF): Presentation slides from Clive Bates (of the Counter-factual) concerning the dangers of over-regulating ecigarettes. Mr Bates urges positively about the vast potential about e cigs, to put the (minor) risks in perspective and regulate as though the 1 billion who are predicted to die from tobacco related illnesses in the 21st century matter most. Presented at The E-Cigarette Summit, Royal Society, London in November 2013.
• Vaping profiles and preferences: 1,347 vapers were surveyed in an effort to characterize e-cigarette use, users and effects. Results generally showed respondents found ecigarettes to be satisfying to use; cause few side effects; considered healthier than smoking, resulted in improve cough/breathing and lowered levels of craving. The survey was hosted at the University of East London. Published March 2013.

Granted, a lot of this is speculation on my part. But looking at the way things are at the moment and the way corporate interests and government seem to work indicates to me that something is brewing behind the scenes. Even more so when you consider all this talk about banning every type of ecig except for cigalikes, which everybody knows SUCK.

Is this more corporatist manoeuvring from the US federal government and big tobacco, or am I just barking up the wrong tree entirely? I mean, I’m all for safe ejuice — even more so in light of recent events — but there has to be a better way of doing this type of thing, or, failing that getting tests done for cheaper?

I’d just hate to see all the good the vaping community has achieved get buried in a landslide of bureaucracy and regulation.