SPECIAL RULE FOR CIGARETTES. - Beginning 3 months after the date of enactment of the Family Smoking Prevention and Tobacco Control Act, a cigarette or any of its component parts (including the tobacco, filter, or paper) shall not contain, as a constituent (including a smoke constituent) or additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or spice, including strawberry, grape, orange, clove, cinnamon, pine- apple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee, that is a characterizing flavor of the tobacco product or tobacco smoke.
—HR1256-24 Sec 907(a)(1)(A)
I'm not sure how many kids read this blog (though I imagine it is a very round number). For the sake of propriety, however I should take a moment to address any readers under 18: please avert your eyes. An otherwise reasonable adult is about to confess to occasional acts of disregard for personal and public health. Do not try this at home.
Now that it's just us grownups here, I want to confess something. On occasion (perhaps three or four times per year) I have been known to smoke a clove cigarette, sometimes two.
At least, that's what I used to (very occasionally) do. As of September 22, of course, there is no such thing as a clove cigarette in the US. Our 111th Congress decided flavored cigarettes were an inducement to children and therefore flavored cigarettes should be banned. And banned they have been.
Protecting children by banning clove cigarettes makes perfect sense, of course. We all know that if there's one thing kids can't get enough of, it's the rich, savory taste of mulling spices.
I realize that it's heresy to question the wisdom of anti-tobacco measures when it comes to matters of public health and the protection of our precious snowflakes. I do find it a bit odd that the "flavored" cigarettes FDA banned include exotic flavors such as cherry, but not the far more obvious and insidious menthol flavor. But that's not the truly hilarious part of all this.
What's funny is I saw cloves for sale at the gas station yesterday. And yet there is no longer any such thing as clove cigarettes. How can this be? Simple... they weren't clove cigarettes. They were clove cigars. What a difference that "ette" makes!
I bought a pack (purely for research purposes) and the product inside was (at casual inspection) indistinguishable from the product previously offered. The cigarettes appear to come 12 to a pack instead of 20 and are wrapped in brown-colored paper, which I am told is tobacco, not paper. But they're cigarettes. Except they're not, you see, because they use "cigar tobacco" and say "cigar" on the box. There's even a notice on the box that points out that "cigars are not a safe substitute for smoking cigarettes." That's good to know.
FDA is normally a science-minded organization, so anytime something truly stupid becomes policy, you have to immediately suspect the involvement of Congress. And, indeed, this distinction was apparently their idea (PDF). FDA is being sued by the makers of Djarum in federal court to prevent them from enforcing cigarette rules on cigars. No doubt someone in Congress has already drafted up the perfect 85-page finding that can put the world back on its axis. But for now, this is what we have.
Perhaps cloves are doomed and this is just the (ahem) last gasp of an industry on life support. Taking the long view, a few months (or years) of regulatory inconsistency is not that big a setback in the long, valiant march to improve public health. But it's also possible this cigar gambit might just work... although if I were advising Djarum, I'd tell them to get busy launching a US version of their website that scrubs all reference to their products being cigarettes. Seriously, folks.
We all know that shenanigans play some role in the regulatory process. Even so, it's rare to find a play like this one where a regulation contains a glaring (and entirely unambiguous) recipe for evading enforcement. The flavor ban isn't framed as a special rule, but as a special rule on cigarettes. In an Act that takes pains to carefully define both cigarettes and cigars as meaningful terms.
You aren't likely to find such glaring loopholes in IVD regulation, though many have tried. We regularly debate whether something is a "device" or merely a "component" of a device and whether a particular sale constitutes "marketing" a product or making it available for "research use" alone. Whether a device is "high risk" might depend on how you define "risk" and (depending how far you're stretching it) whether or not you're high. Definitions matter and sometimes definitions can be interpreted in a way that carves out a little bit of latitude where none was probably intended.
Even so, the opportunity for shenanigans is greatly reduced by the time rules are written down. The strength of Djarum's argument depends not on a novel interpretation of the law, but on the specific wording of the law itself. I have no idea how this particular sausage was made, but I suspect that the special rule in question was written a lot more broadly in early drafts. You're not supposed to admire the work of lobbyists, but if they had an annual awards program (the Weasels?) you have to imagine this change would get at least a nomination.
Like it or not, lobbying is a key part of the regulatory process. Rules change as a result of a changing world and shifts in public opinion. Lobbyists may not always initiate changes but they are almost always involved. Sometimes these changes are for the better (IVDMIA), other times (DSHEA) they make a mockery of decency and common sense. Either way, the real opportunity to get your gambit a decent hearing is before the reg is committed to paper. By the time they're written down, regulations are typically susceptible to only a narrow range of specific gambits.
Once that window closes, you're mostly stuck with the regs you've got. It's difficult to pass a law exempting yourself from scrutiny, as the desperation and self interest involved in such an act are incredibly transparent.
Like them or not, the regulations we have are the ones we're going to have to respond to. We'll continue to explore the boundaries between overlapping definitions and look for opportunities to find the best fit between our clients' needs and the existing regulatory framework. But the most important piece of advice we give our clients is this: react to the regulations as they are written, not as you hope to convince the agency to reinterpret them. Notwithstanding the occasional act of Congress and cleverness of tobacco companies, FDA regulations are pretty well-understood and unyielding to self-interested creativity.
You can prepare a contingency plan for the regulatory environment you hope to bring about by lobbying. By all means, be prepared for a variety of outcomes. Whatever you do, however, don't put all your eggs in that basket. Among your various contingency plans, you should at least prepare a strategy that engages the world you currently inhabit. Odds are, that's the only world your products will ever inhabit.