Surprise! Tobacco products get their butts kicked
Surprise! Tobacco products get their butts kicked
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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