The most excellent Center for Regulatory Effectiveness

Posted by doodlebug , in MHRA, FDA 03 March 2011 · 253 views


Well, well, well. Who would have thought that the USA could have something as effective and efficient as the Center for Regulatory Effectiveness (CRE)? And, perhaps more to the point, who would have believed that such an agency would openly (and with authority!) challenge the FDA?

Well, believe it or not, this is precisely what is happening right now – and better still, they want to talk to US! Yes, we, members of the ecig community, have comments, knowledge and information which the CRE is directly asking for! This is a truly wonderful opportunity to tell those who are really in power what we think of the megalomaniac (and frequently insane) policy makers who insist on telling us to quit or die. Well pfft to you all, I say! YOU go ahead and quit or die if you want to; we’re going to carry on vaping, and choose the better way, because we are not stupid enough to fall for your lies anymore!

Many, many thanks to Bill Godshall for including this in his Tobacco Harm Reduction newsletter, and alerting us to the possibilities now available to us.

In a publication entitled “A note to the e-cigarette community”, the CRE tell us they are “interested in the views of the e-cigarette community on the February 17 post which describes the extremely adverse health effects sustained from smoking counterfeit cigarettes.”

Now, at first blush, this doesn’t sound particularly relevant to us, since I am not aware of ANYONE in the vaping community who considers that they are ‘smoking counterfeit cigarettes’! However, if we excoriate the surface – just a little bit, mind! – we find that the Tobacco Products Scientific Advisory Committee (TPSAC) believes that the e-cigarette community “may be a great source of analytical and newsworthy information on counterfeit cigarettes.” This is followed by an invitation from the CRE to us!

There is an Interactive Public Docket (IPD) – my word, but they do love their alphabet soup, don’t they? – “dedicated to counterfeit cigarettes”, where we are invited to leave our comments. There is, however, a “note of concern”: “In order to maximize public participation, we have no registration but the posts are moderated, meaning we have control over the posts.” They go on to explain that they do this merely to “control crude language” and “to limit posts to meaningful data and studies”, which seems fair enough.

Don’t panic! We shall be returning to the core issue for us – electronic cigarettes, not counterfeit cigarettes – momentarily! However, first of all, this particular IPD is concerned with counterfeit cigarettes, but it DOES give us an opportunity to ram home the message. Here’s one perspective: would there be a significant problem surrounding counterfeit cigarettes if every smoker were truthfully informed about the options available to them, instead of constantly being told that their ONLY options are quit or die? Just a thought.

The CRE also has an “Enforcement” Forum, which is “limited to posts dealing with actions taken to enforce counterfeit laws, these could include newspaper articles and related materials” and a “Public Comment” Forum which “is for the public to express their views, but one sentence views are not helpful, we would like reasoned replies like ECF members made on this post”. No, you didn’t misread that, or lose track of where the quotation marks are; the CRE actually said “we would like reasoned replies like ECF members made”.

No matter what issues you may or may not have with ECF – which, if nothing else, is a mine of information! – this opens the door for the WHOLE community to express its views. It would be a dreadful shame if we were to waste such an opportunity!

The CRE even goes on to underscore its respect for certain members of our community: “You will note the depth of these posts are higher than the norm.” They also have a Study Forum which is “for you to post any studies on counterfeit. Yes our technology allows you to attach lengthy documents.” (Like this monster blog?) And finally, “the news forum is to post newspaper articles or blog articles on counterfeit.”

This IPD is yet to go live, but they do seem to be very genuine about wanting to hear from us, since they have given us this link to which we can start posting comments immediately.

Have no illusions about this, my friends: the CRE is the USA’s regulators of the FDA! And in much the same way as our UK Regulatory Policy Committee criticised the MHRA over its misguided Consultation MLX364, the CRE is seriously – and intelligently – critically examining the FDA’s behaviour over tobacco control.

So as promised, I shall now return to ecigs specifically, because this marvellous group, the CRE, has done something very similar directly concerning ecigs, too! In a separate document, they ask the specific question: How Safe Are E-Cigarettes? and say:

TPSAC and CTR have a lot on their agenda but eventually they are going to have to develop an algorithm for addressing the “reduced harm” provisions of the new tobacco statute. In doing so they will have to be mindful of the applicability of the Data Quality Act to the resultant proceedings. Smokeless tobacco and e-cigarettes will be two issues leading the parade.

(Do you think we get to twirl batons? But I digress....)

There follows a rather long but extraordinarily well-balanced and intelligent article, which gives both sides of the story with a stronger nod to the truth than we have seen for a sadly long time. I urge you all to grab a cuppa, or a beer if you prefer, and read the whole article, but for those who won’t (you know who you are!), I’ll give you some highlights:

…criticisms clash with equally strong arguments for the value of e-cigarettes. The devices, which are tobacco-free, may be a safer alternative to cigarettes, say advocates, who point to testimonials from thousands of smokers who say they have used e-cigarettes to help them quit.

As the U.S. Food and Drug Administration struggles to gain regulatory control, and as safety studies remain works in progress, the debate continues.

The most striking difference about this article, as compared to so many others, is that the author actually bothered to find out about ecigs first, before rushing to print:

Electronic cigarettes typically use a rechargeable battery-operated heating element to vaporize the nicotine in a replaceable cartridge. Nicotine is usually dissolved in propylene glycol, a clear and colorless liquid that is commonly found in inhalers, cough medicines and other products.

Some e-cigarettes are made to look like real cigarettes, cigars or pipes. Others look like pens or USB memory devices. There is no tobacco involved, and no smoke either. Instead, users do what’s called “vaping.” As they inhale, they take in nicotine-filled vapor.

Now THAT description, I can recognise, unlike the usual lies that are printed about ecigs.

This article gives approximately equal ‘column inches’ to Professor Michael Siegel and to nay-sayer Prue Talbot, but it is immediately obvious that it is Mike Siegel who knows what he is talking about (not least because Prue Talbot states “We just don’t know”)! Professor Siegel finishes with:

“'What New York is doing is equivalent to outlawing lifeboats on a sinking ship because they haven’t been FDA approved,' he added. 'It’s a really crazy approach to public health.'”

The article draws to its conclusion as follows:

New York’s move is a reaction to what can’t yet happen on the national level. According to a series of recent court decisions, e-cigarettes cannot qualify as drug delivery products, said Jeff Ventura, a spokesman for the FDA. As a result, the agency cannot ban them or require more arduous testing.

But even though they are now considered tobacco products, they are not mentioned in the Tobacco Control Act, either. For now, then, they remain unapproved and unregulated.

And this is indeed the case in the USA, although mercifully not here, since ecigs ARE regulated in the UK, by Trading Standards. However, the CRE is seeking our input as they begin to oversee the construction of a regulatory framework for ecigs which can ‘fit’ in the USA, with its decidedly odd legal statutes!

The Electronic Cigarette Industry Trade Association (ECITA Ltd) is currently working with the US, (and US vendors have started to join our Association to support our efforts in this regard), and we hope to be able to offer a sensible, reasonable, proportionate and legally-relevant regulatory framework for the USA – yes, even notwithstanding the inherent absurdities of their system! – and we hope to have similar success there as we have had here.

The thing is, if you base your proposals on the original legal statutes (which is precisely what we are doing at ECITA) then it is enormously difficult for policy-makers to argue against it. The law, after all, is the law.

Clearly, these policy-makers and governments are often able to make up the laws themselves, as is evident in the utter nonsense which is so often produced, here in the UK, over in the USA and everywhere else! But having seized legal jurisdiction over tobacco products as well as medicines, food, cosmetics, and probably US air (when used for breathing, you understand!), the Food and Drug Administration will have to abide by the laws they have had a hand in creating, i.e. the Family Smoking Prevention and Tobacco Control Act (FSPTCA) under which the Courts have 3 times ruled ecigs must be regulated.

Just to be absolutely clear about this, since the FDA's having power over everything muddies the waters somewhat, the Courts have categorically ruled on all 3 occasions so far that the FDA is not allowed to regulate ecigs as medicinal products. (I can’t help but think that this does not bode well for the MHRA…. I almost feel sorry for them, really. Almost!)

No fewer than 119 of the members of our vaping community have already commented on this piece (as at the time of writing), and I am sure that many of you will want to make your voices heard too. I sincerely hope so.

Here is a flavour of what our friends have been saying:

Dennis Jorgenson: “E-cigarettes are here. There here to stay. In one form or another, legally or otherwise, this product will continue to exist and will continue to save lives regardless of who oversteps their authority in an attempt to remove this technology from those that use it.

And here is what is possible when an intelligent adult without a hidden agenda considers ecigs from the outside:

Nathan T, M.D.
February 16, 2011 at 6:43 am

I am a board-certified pediatrician. I don’t smoke cigarettes, and I’ve never tried an e-cigarette or any other type of personal vaporizer.

In my practice, I have yet to meet a child or teenager who uses e-cigarettes. I have not yet met a child or teenager who can’t wait to get their hands on bubblegum- or chocolate-flavored water vapor, either. Anecdotally, it seems to me that kids in general would be much happier with actual bubblegum or chocolate.

I do, however, see more asthma in my practice than any other single diagnosis. I also see a number of children with obesity, poor grades, and ADHD, and ALL of these chronic medical problems
[OMG! Are poor grades recognised as a chronic medical condition now!] have known associations with passive smoke exposure. Many of the children I see with asthma don’t have parents who smoke; however, many are unfortunate enough to live in apartment buildings or other type of multi-unit housing, which are known to expose inhabitants to higher levels of passive smoke.

From a harm reduction standpoint, it is my opinion that the benefits to children when their parents or neighbors quit smoking far outweigh any theoretical risk that children might be enticed to use an e-cigarette.

Disclaimer: I do not own stock in any e-cigarette companies, or have any other financial or otherwise beneficial relationship with the e-cigarette industry.

I am going to take a little time to prepare a comment for these two IPD's, and hope that you will do the same, if you feel inclined and are able. I shall publish my comment here in the blog for anyone who's interested. This is one of the best opportunities we have yet had to tell people who can really make a difference how we feel.

Bear in mind that the CRE has moderation rights over the comments submitted, and yet there are pages and pages of comments like this attached to this article already! And they’re asking for more! I think, on this occasion, we might just want to oblige them, don’t you?