Friday, 25 April 2014

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.
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