EPA vs. FDA and regulation in general

[kristin]

Note: This is a continuation of a discussion on a now-closed thread in the News forum.

Wow, Kristin! Positively 'War and Peace'! And I thought I was prolific. LOL

Thing is, I agree with pretty much every word you say here, particularly about the importance of suppliers' being able to spread the TRUTH about their products, instead of having to remove any reference to getting away from smoking just to satisfy the clipboard nazis (although, as we all know, this doesn't satisfy them anyway!).

I am also in complete agreement with what you say about the regulatory framework you are stuck with. Now that I am beginning to get more of an idea of the ins and outs of your system, I can see why they went the tobacco route as an 'easy option'. I still maintain that this was a mistake, and believe that even the EPA would have been a better choice, if it had been done properly, but there wasn't time when this all kicked off. You guys have been handling these issues longer than we have!

Clearly, we are just extraordinarily fortunate in Europe to have regulatory frameworks that do allow for correct and appropriate regulation of ecigs. Whether we will be granted the right to remain within these is yet to be confirmed, but the evidence base is building well.

Unfortunately, Katherine, the EPA has no jurisdiction over nicotine products in the U.S., so that wasn't an option. How would e-cigarette vendors have approached this other than how they did?

If someone came out with a new dairy product, they couldn't just go to the ATF and ask them to regulate is instead of the FDA, right? They have to go through the body of government which oversees the active ingredient.

The tobacco route wasn't simply the "easy route" it was the obvious route. These devices were created to be recreational products used in the same manner as cigarettes. The most logical assumption is that they would be embraced as a healthier alternative and regulated the same as other smokeless tobacco products. Who could have forseen that there would be such an opposition to e-cigarettes and that the FDA would insist they actually treat nicotine addiction and are therefore a drug product? A product that endorses nicotine use is a nicotine addiction treatment? How would that even make sense?

Since the main reason for their existence is nicotine consumption, it only made sense that they would be regulated by the FDA - which oversees all nicotine products - and not the EPA, which I would think regulates airborne propylene glycol. So, had e-cigarette manufacturers approached the EPA first (or any other regulatory body), I believe they would have been simply turned over to the FDA.

Honestly, the fact that e-cig manufacturers and merchants DIDN'T try to go through the EPA or FDA first is the only reason that there is even a community to fight for them now. Had they tried to go through appropriate channels and get approved by the FDA or EPA first, they would have found impossible hurdles and we would never have even heard of them - other than reports from other countries, which are largely about them being banned. Imagine if there were no U.S. testimonials to e-cigarettes and the only info out there was coming from the government and public health groups. No one would be here to testify to what e-cigarettes are doing for them and hundreds of thousands of people would still be smoking. E-cigarettes would have been caught up in the same red tape that stopped the early electric & ethanol cars.

Really, the only reason that there is debate over how e-cigarettes should be regulated is because manufacturers bypassed the red tape to get on the market. I'm thankful for that, otherwise there would be no debate at all, because the majority of the public wouldn't have even known that e-cigarettes exist.