New delivery, old drug

Forty years after the surgeon general concluded cigarettes were harmful and three years since the tobacco companies stopped lying about it, the industry has devised a handful of new ways for customers to consumer tobacco products, specifically nicotine. The new hook by the industry is that these products are safer than what they’ve been selling but a group of opponents properly say that claim should be the judgment of the Food and Drug Administration.

President Bush’s Justice Department announced last spring that it was unwilling to press the government’s years-long, health-care driven suit against the industry, but the president can show he was more interested in a fair settlement than total surrender by supporting the request that the FDA oversee these new products.

And what fine products they are. A Tic-Tac-size lozenge made from compressed tobacco powder is being test-marketed in Richmond, Va., and Dallas. Nicotine Water, said to contain the nicotine of two cigarettes, is now available on the Internet. A supposedly safer cigarette that advertises with the slogan “All of the taste … less of the toxin” is being test marketed in various cities, as is a cigarette that heats rather than burns tobacco and is claimed by its producers to be “a sophisticated technologically advanced nicotine delivery system” that “may present smokers with less risk of cancer.”

Or it might not because it, like the other new products, haven’t undergone the kind of standard testing under the federal Food, Drug and Cosmetic Act that Americans have come to expect of new food products. In March 2000, the Supreme Court observed that the purpose of the 1938 FDCA is to make certain that products regulated by the FDA are “safe” and “effective,” which no federal agency could do in the case of cigarettes and therefore the FDA did not have jurisdiction. This time a coalition that includes American Heart Association, American Cancer Society and the American Lung Association isn’t waiting decades for FDA oversight; it is demanding the FDA check out the safety and accuracy of the claims as the products are being introduced.

In a dissent in the 2000 case, Justice Stephen Breyer pointed out that the overly literal reading of the act made the court appear foolish: “The upshot is that the court today holds that a regulatory statute aimed at unsafe drugs and devices does not authorize regulation of a drug [nicotine] and a device [a cigarette] that the court itself finds unsafe.”

Now Congress, if it were interested, has new devices for an old drug that has proved unsafe in countless deaths. Both the administration and Congress should act to make it clear the FDA has oversight authority.