November 08, 2013

FDA Prepared to go to Court for eCig Regulations

Here's an interesting nugget of information. The Robert Wood Johnson Foundation (a pharma-funded charity) published an interview with the FDA's tobacco tzar, Mitch Zeller. Much of the interview was about regular cigarettes, but you can bet e-cigarettes were featured in there as well. Zeller wouldn't spill the beans, but he did seem to indicate the FDA is going to have to defend its regulation in court, and its preparing to do just that.

Regulating Tobacco: Q&A with FDA’s Mitch Zeller

It’s not really about barriers. It’s about what is the reality if you're in the business of regulation and what do you need to be thinking about as set policy. At the end of the day we’re regulators and because there are potential violations of law that we’re talking about, both civil and criminal, what we have to think about when we take agency action is that any interested party that disagrees with a final decision that we’ve made through rulemaking can sue us.

So, we’re always thinking about the evidence base in support of any regulatory policy decision that we’re making, knowing that there is a potential for litigation, and we have to be able to prevail in whatever litigation comes down the road following final agency action through rulemaking. That’s why we’re constantly exploring the evidence. We’re making an enormous investment in research because with these new products such as e-cigarettes, we have far more questions than answers about how they work, what kind of nicotine is being delivered, who is using them and how they are being used.

Now, remember a while back the FDA and NIH ponied up a bunch of cash to provide grants for e-cigarette research, and much of it went to known blowhards and prohibitionists? Is this starting to become clear now?  I should also note, Zeller mentioned they can only address studies that have been registered with the FDA as evidence, so I wonder how many, if any at all, of the more positive studies are on record with the agency.

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