Surprise! Tobacco products get their butts kicked

Did YOU know there were large numbers of people just itching to put more restrictions on cigarettes?

Not just any people, mind you, but federal legislators and the President, too. No wonder it took so little time for Congress to pass and President Obama to sign the Family Smoking Prevention and Tobacco Control Act in June.

Proponents of more tobacco restrictions, who had been evidently itching for this law for years, said, Whew. The rest of us said, Huh? Smokers are already relegated to hanging out in alleys and on sidewalks thanks to bans on smoking in most public buildings, including bars and casinos. I don’t even smoke, but I mean, come on. It’s almost like taking hot dogs out of ballparks.

Even if you like the idea of new restrictions on tobacco, it seems unfortunate that the law dumps all these new chores in the lap of the U.S. Food and Drug Administration. This is a bad idea. With FDA undertaking significant new activities in several areas, including food safety, drug safety, imports of all kinds, and other issues, this isn’t the time to hand them this, from a resources point of view, if nothing else.

But cigarettes are rather undeniably associated with a range of serious health problems, so they present a somewhat unique tension between freedom of choice and public health protection. Congress has evidently decided it’s time to restrict cigarettes more than they already are in order to reduce the numbers of new young smokers and to try to make cigarettes themselves safer.

The law leaves lots of small strokes to FDA, but gives them some significant new powers that look and smell a lot like how FDA regulates drugs and other products. The law allows FDA to make tobacco product companies register with the agency, and FDA can inspect them and can restrict sale and advertising to “protect the public health,” and can make rules for how the products are made, packaged and stored. They’ll even start looking over and pre-approving new tobacco products. And the manufacturers will have to pay for all these new privileges, thanks to new user fees.

Within 24 months of enactment, FDA will create and publish a data list of harmful and potentially harmful constituents, including smoke constituents, in each tobacco product. FDA also gets the power to require disclosure of tobacco product constituents including those in smoke.

But really, haven’t we been through all this before? Yes and no. FDA tried to regulate tobacco in the 1990s but reached a dead-end. FDA commissioner Dr. David Kessler led the move to have FDA assert its power over tobacco products, which it historically had said the law didn’t give it. The cigarette companies fought FDA’s new assertion of power, and the U.S. Supreme Court ultimately ruled that the law didn’t give FDA the power to regulate tobacco, but did suggest that Congress could change the law and give it to them. And that’s what Congress just did.

That episode leaves us with an interesting anecdote that’s useful for understanding some basic FDA law concepts. FDA had found that cigarettes were both a drug and a device, in that nicotine was a drug and that the cigarette itself was a medical device for delivering nicotine. Essentially they found this because that was what cigarettes were intended by the manufacturer to do, a reminder of the centrality of intended use to FDA regulatory power. Also, while usually label statements on a product are the first and best source of indications of a product’s intended use, in the case of cigarettes FDA had no label statements to rely on, so they determined the intended use by looking at how consumers actually used the product, then attributed that back to the manufacturers.

And so now Congress has changed the law and with a vengeance. But it seems odd to dump it all in FDA’s lap. FDA was already complicating its own life and now it gets a pack of complicated new powers to develop and carry out regarding tobacco products.

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