Deeming Finalized

The FDA has finalized their rule for pulling e-cigarettes into their regulatory grasp. Litigation has already been filed in response. How will it all turn out?

Nobody knows. It’s that simple. The rule itself has a lot of things that make it look like the FDA is twisting the knob to 11, if they can. But how it will end up remains to be seen.

For example, they may be trying to close over the nicotine-free liquid market with the vague phrase intended or reasonably expected. A court may push back on that.

For example, they may be trying to force a de facto prohibition on open systems, through a burdensome regulatory process that would require open systems to mix-and-match matrix-style until every new product would require every other product to be tested with it.

But what will happen? A black market? A return to smoking? We will see.

How does this magic phrase, “intended or reasonably expected,” work? You have a nicotine-containing liquid. It’s, under the rule, a tobacco product. You put it in a tank. Now that tank is a tobacco product. You attach a drip-tip to the tank. Now the drip-tip is a tobacco product. You screw on a mod to the tank. Now the mod is a tobacco product. You put a battery in the mod. Now the battery is a tobacco product.

But under the rule, if you change one and only one thing, you can strike the word tobacco out from the paragraph above. That one thing: the fact that the liquid contains nicotine.

Now, assuming that the liquid is not bathtub-juice, that the nicotine is of high purity, the actual performance and harm of the same device is unchanged whether there’s nicotine or not. Whatever harmful constituents exist in the nicotine-free version will be identical to those in the nicotine version. But the regulatory difference is enough to bring an industry to its knees, call its lawyers, for black markets to open up.

Should these devices, which people use to inhale a flavored vapor, be regulated? Yes. It makes good sense that they be manufactured to a standard, that the public be protected against adulterated liquids (regardless of whether they contain nicotine), and so on. But the whole idea that it should all hinge upon something that constitutes, at most, six percent of the liquid (in the case of some cigalikes)? Dumb as all hell.

And the fact that the regulatory framework for these devices and products include so much testing that you’d think they were capable of far more than merely heating a liquid to point of vaporizing it so people could inhale it. I mean, your kitchen on an average night produces more harmful and potentially harmful constituents than a heavy e-cig user will in a week or a month. Your car produces more in a few minutes than an e-cig user will in a year. And so on.

The FDA probably couldn’t see any other way. Hopefully the courts and congress will.