The FDA deeming reality

kristin;8999185 said:

Don't take this the wrong way, because I am a Libertarian and if I had my druthers, the FDA would be dismantled in its current form and recreated as a much smaller agency that simply addressed consumer complaints without regulatory powers. So I totally "get" the self-regulation argument. That said...

To whom do we make the no regulation argument? The FDA, which has already shown its attitude about e-cigarettes and already has the power under the FSPTCA to regulate them? The FDA that would regulate everything under the sun if it could?

Or the public health groups that lobbied the FDA to regulate e-cigarettes?

Or legislators who are also lobbied by the ANTZ and have shown they trust anything the FDA and health groups claims over any facts, testimony and science we have shown them?

How do we not show or tell the FDA we know they intend to try to regulate e-cigarettes? CASAA has not suggested any regulations to the FDA. All we have done is acknowledged its intent to regulate and testified that any regulations the FDA proposes should keep e-cigarettes available, affordable and effective. In a way, that is acknowledging regulation, but if we don't do that our only other option is to remain silent until the regulations are proposed (while the ANTZ and lobbyists for BT & BP are pushing for what THEY want) or testify to the FDA that we think it shouldn't regulate e-cigs at all, simply because we "believe" they are a harm reduction product already covered. (To claim a product reduces tobacco harm the FSPTCA requires the product to get FDA approval to make that claim - a company or consumer cannot just deem a product as a MRTP.) They'd look at us like naive amateurs if we said that.

Today CASAA directors Greg and Elaine testified at the ongoing FDA workshop for third party governance of industry sponsored tobacco product research. We listen to what the ANTZ and FDA panelists are saying at these things to learn which way the wind is blowing and testify to get us represented as a legitimate voice as stakeholders in this process. If people followed all of these proceedings as we do, they would see that regulation is being discussed as a given, not as a possibility. They are just sitting around discussing how its going to be done now. For us to act like regulation is not going to happen simply because of ideology accomplishes nothing and just keeps us sitting at the kiddies table while the "grown ups" decide what is best for us.

In a perfect world, where the FDA didn't have the power given to it by the FSPTCA to regulate e-cigarettes and hadn't made it so blatantly obvious that it intends to do so, arguing for no additional regulation would be feasible. But in this world, the best we can do is minimize the potential damage as much as possible.

(My personal opinion. These comments do not represent official CASAA policy or the opinion of other CASAA directors.)

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