Don't stop fighting the FDA deeming regulations and EU TPD!

Just a week or so after the Royal College of Physicians released their report backing e-cigarettes and vaping, urging governments and regulators to "Promote e-cigarettes widely as substitute for smoking", the EU Court of Justice ruled that the TPD is valid, will be enforced and thereby making sure that the EU will not follow RCP's advice. Yesterday, just a couple of days later, the FDA released their new deeming regulations that basically will ban vaping as we know it in the US and hand the remains of the market over to Big Tobacco. Since I read about it yesterday, an image has been developing in my head of the ANTZ holding the arms of a guy called "Smoker" or "public health" on his back while Big Pharma commands the EU and FDA to take turns punching him in the face. Big tobacco stands on the side with a big grin on his face, cheering and rubbing his hands. Any cartoonists reading this... feel free to draw it up and publish it widely. The last days, the EU and the FDA has shown us very clearly that this is not about health at all, it's all about the money. Either that, or their incompetence have reached levels I did not think was possible for human beings. I'm not sure which one is most frightening.

A lot of people have commented on the two cases, which are indeed public health disasters bordering to political genocide, so I'm not going to go into the details on how these draconian regulations will shorten the lives of millions. However, I've found some good posts and articles for you below. I've written about the consequences of over regulating earlier and Clive Bates have summed up the unintended consequences of these regulations: Harmful and negligent to ignore unintended consequences of e-cigarette policies

On the TPD:

• The EU’s new rules for vapers: this is Brussels at its most petty and pointless (Christopher Snowden in the Spectator Health)
• Regulators and the compliance fallacy – buying 99% nicotine e-liquid from China (Clive Bates)
• What is wrong with the Tobacco Products Directive for vapour products? (Clive Bates) 
• Health? Yeah, Right (Dick Puddlecote)

On the FDA deeming regulations:

• FDA deeming regulation on e-cigarettes: an effective ban on most (and on most effective) products (Dr. Farsalinos)
• The FDA’s Vaporous Thinking About E-Cigs (Wall Street Journal)
• FDA E-Cigarette Deeming Regulations are a Disaster for Public Health (Michael Siegel)

It doesn't look very good for vaping right now I have to admit. Well, actually, for the lucky ones that have already made the switch it's not the end of the world. We've known about this, and expected these regulations for a while now and most of us will be able to continue vaping. It might mean that we have to turn to the thriving black market that undoubtedly will rise and shine brightly now, but we'll manage. For current smokers and future generations however, this last week has been a complete disaster. The regulations will cost a lot of people a lot of years of living, but who cares? I mean they never new that their governments deprived them of a better life so they won't be complaining about that right? Well, that's were we as vapers should prove the EU and the FDA wrong. We need to make sure that everyone knows what has been going on. We need to make sure that future generations will grow up knowing that we put an end to the tobacco epidemic. And we need to make sure the heads start rolling in certain organisations. Because they will, eventually, if we manage to expose to the world what their real motives are. A great way to start helping out is to support and promote Aaron Biebert's upcoming documentary "A billion lives". Sign up for their newsletter, pay attention to their facebook page, and start mentioning their movie everywhere where vaping or e-cigarettes are the topic of discussion. The EU and the FDA have now thrown a couple of hard punches our way, but there is no reason to give up now. This gives us even more reason to fight on, or start fighting if you're not there yet! "The tried to bury us. They didn't know we were seeds"... and we'll grow through concrete and break their castles apart I might add.

My comments on CDC Director Frieden's explanation to what he hates with e-cigarettes

I just finished reading this article in the Los Angeles Times where CDC (Centers for Disease Control and Prevention) Director Tom Frieden explains what he hates about electronic cigarettes, and I just can't resist the urge to comment on it. I know I'm a bit late but what the hell. How this man got this job is beyond my understanding.

“I’ve treated so many adults who are desperate -- desperate -- to get off tobacco. They all started as kids,” Frieden said. “I see the industry getting another generation of our kids addicted. To me, as a physician, when 1.78 million of our high school kids have tried an e-cigarette and a lot of them are using them regularly … that’s like watching someone harm hundreds of thousands of children.”

When the anti-e-cigarette movement is out of arguments, this is what they turn to. Think about the children. And Frieden even wants us to think about 1.78 million of them. Of course with no reference to any evidence whatsoever. To be honest I'm a bit surprised he didn't mention puppies and kittens while he was at it. Now dr. Frieden - how many patients have you treated that was desperate -- desperate -- to get off e-cigarettes? Well at least he kind of confirms that e-cigarettes gets these people off tobacco. Then he adds:

“people have a misconception that the tobacco epidemic is a thing of the past. Tobacco still kills more Americans than any other cause. It still kills more than 1,000 people a day. As a doctor, I can tell you it kills them in really unpleasant ways -- gasping for breath with emphysema, with cancer, with heart disease.” 

What on earth does that have to do with e-cigarettes? We all know cigarettes kills people in rather nasty ways, but why should that make one hate e-cigarettes? Again, he feels the need to mention he's a doctor, to give people the impression he knows what he's talking about. Some probably fall for that too and it is such statements that will keep your patients gasping for breath with emphysema and dying from cancer or heart disease, dr. Frieden.

I'm glad the journalist felt the same way that I did about the statement above and asked the obvious question next:

"What does that have to do with e-cigarettes?"
"E-cigarettes are a tobacco product," Frieden answers.

Oh really? By what logic? That the nicotine can be extracted from tobacco? That would also make nicotine gum and patches tobacco products. But maybe it's because it looks like you are smoking tobacco when you use them? By that logic however you also have to assume that electric cars are oil-products that lets out just as much CO2 as a regular car, right? I mean in some cases you can't really see the difference. Actually, when I think more about it, e-cigarettes does have something to do with this; they have the potential to shorten dr. Frieden's line of emphysema, cancer and heart disease patients. Maybe that's his problem?

Then there is the five reasons Frieden rattled off to why e-cigarettes are as dangerous as tobacco cigarettes:

--“If they get another generation of kids more hooked on nicotine and more likely to smoke cigarettes, that’s more harm than good”
--“If they get smokers who would have quit to keep smoking instead of quitting, more harm than good.
--“If they get ex-smokers who have been off nicotine to go back on nicotine and then back to cigarettes, more harm than good.
--“If they get people who want to quit smoking and would have taken medicines to think e-cigarettes are going to help, but they don’t, more harm than good.
--“If they re-glamorize smoking, it’s more harm than good.”

This makes it pretty obvious that Frieden actually has no reason to hate e-cigarettes, but has decided to do it anyway. And these are just a list of reasons he wish he had, that's why he put "if" in front of them. Well here is why I hate dr. Frieden and why he is as dangerous as a mass murderer:
-- "If he buys a machine gun and kills a bunch of people, he would do more harm than good".
Actually I've got another, more plausible one as well:
-- "If he takes advantage of his position to make sure smokers are deprived of a healthier alternative and hence keep on smoking, he would to more harm than good"

Just for good measure, Frieden threw in two more problems with e-cigarettes: People who use them can expose kids, teens and pregnant women to nicotine via secondhand smoke; and enterprising smokers can put marijuana or hallucinogens in an e-cigarette “tank.”

First of all there is no smoke involved in vaping. This just shows ignorant and uneducated this man is. Then there is a bunch of ways to consume marijuana and hallucinogens. Do you hate ovens since it can be used to bake hash cookies? And by the way Frieden, you missed another opportunity to throw in puppies and kittens. Stay focused please.

Frieden acknowledged that “stick to stick, they’re almost certainly less toxic than cigarettes" and that many people have quit smoking tobacco cigarettes with the help of e-cigarettes. However, he said, “the plural of anecdote is not data.”

So the fact that millions of people have quit with the help of e-cigarettes are just funny anecdotes and not data? If you ask everyone who quit smoking how they did it, the means they used are just irrelevant then? This argument just crumbles under it's own weight.

“If the e-cigarette companies want to market these to help people quit, then do the clinical trials and apply to the FDA,” he said, in a reference to the Food and Drug Administration. “But they don’t want to do that. They want to market them widely.”

Another example of how little common sense this man shows/has. This has nothing to do with whether or not e-cigarette companies want to apply to the FDA or not, it has to do with what they can afford and how long it would take to get a new product to the market. I would like to believe that Frieden understands this in his position, but based on his statements, sadly I don't.

“The challenge that the FDA has is that they will be challenged by the tobacco industry, as they have been at every step of the way,” he said. The federal agency “tried to regulate e-cigarettes earlier, and they lost to the tobacco industry. … So the FDA has to balance moving quickly with moving in a way that’s going to be able to survive the tobacco industry’s highly paid legal challenge.” 

You think the tobacco industry's lawyers will fight regulations that will effectively wipe out all their competition? The FDA's challenge is to balance between moving quickly and moving in a way that will convince the general public that their regulations are reasonable. And the tobacco industry will applaud every successful step the FDA takes in this direction.

Since I started this blog, I've read tons of articles about, and interviews of, anti-e-cigarette advocates, but never before have I come across any that managed to reel off this many contradictions and this much, excuse my language, bullshit in so few words.

FDA regulations, the devil in disguise?

Since the FDA released their proposal for new regulations yesterday a lot has been written about it, both in newspapers and by bloggers. Dr. Michael Siegel has commented in two excellent posts on his blog (http://goo.gl/FHSmkf, http://goo.gl/X6PVUP), Steve from Steve K's Vaping World has written a good article about it (http://goo.gl/D0HyAi) and ACSH has commented on their website (http://goo.gl/LRQYDU), just to mention a few. I highly recommend reading all of them.

The proposal looks to me kind of like the devil in disguise. They have given the industry some reasonable regulations that most will agree with, but then propose some other rules that when examined more closely turns out to have some devastating effects. When I first read about it it really didn't look that bad:

• An age limit of 18 years, which I think most of the industry agrees with and has already implemented on their own. (The EU TPD introduced no such limit to my knowledge).
• Labelling requirements, which is a good thing as well
• No advertising ban
• No flavouring ban
• No internet sales ban

I also saw some early comments yesterday, that this wasn't so bad, and in the short term it probably isn't. Business can carry on as usual for the time being. But then there is a couple of really bad ones:

• No marketing as "modified risk product" is allowed without FDA approval. This actually means you cannot tell the consumers what the real intention of the products are and that they are a safer alternative to smoking cigarettes. Vendors and manufacturers are then forced to market e-cigarettes as cool, sexy lifestyle products something that would be much more appealing to young non-smokers, and denied the opportunity to accurately target their real intended audience, the smokers.
• Premarket authorization, meaning that virtually everything on the e-cigarette market today (save cases and lanyards). And it looks like this means every single flavour of e-juice a manufacturer makes will need to be individually approved and even worse (or at least equally bad), if a manufacturer makes any product containing nicotine, all their products needs to be approved. There are only a few players in the market today that could possibly afford this, usually they go the name Big Tobacco. And even for the ones that can afford to get their current products approved, any innovation will be so expensive that they probably won't bother.

Another point I think should be made is that the FDA today (correct me if I'm wrong) has no authority to regulate the e-cigarettes. If this proposal gets approved they have full control of the market and the road to further regulations will probably be a lot shorter. As I said, in this proposal, some of the most feared regulations (advertising ban, flavouring ban and internet sales ban) were not put in. But once the FDA seizes control, I fear that they will tighten the grip in these areas as well.

Now this all looks bad, but as Steve K mentions, there will be a period of 75 days for public comments before the proposal can be approved so it's not written in stone yet. And if it's approved, who knows if the matter will end up in court again.