Pubdate: Tue, 21 Dec 1999 Source: San Jose Mercury News (CA) Copyright: 1999 San Jose Mercury News Contact: 750 Ridder Park Drive, San Jose, CA 95190 Fax: (408) 271-3792 Website: http://www.sjmercury.com/ Author: Patty Fisher, Mercury News editorial writer. COFFIN-NAIL LOGIC Supreme Court Mystified By Cigarette Companies NICOTINE is a wonder drug. It helps you sleep; it helps you wake up. It calms you down when you're edgy and sharpens your reflexes when you're groggy. It shows promise in treating Parkinson's disease, Tourette's syndrome, attention deficit disorder, schizophrenia and inflammatory bowel disease. It may even help prevent some kinds of cancer. When nicotine was introduced in chewing gum and skin patches, the Food and Drug Administration allowed it to be sold by prescription only. Later these products became available over the counter, but nicotine still is considered a powerful and addictive drug subject to FDA regulation. Unless you buy your nicotine in packs of 20 cylinders at 7-Eleven. Then, according to cigarette manufacturers, it's not a drug and the FDA has no jurisdiction. This month, the federal government and cigarette makers argued what should be an open-and-shut case before the U.S. Supreme Court: Food and Drug Administration v. Brown & Williamson Tobacco Corp. The FDA claims authority to regulate tobacco as a drug and cigarettes as drug-delivery devices under the 1938 46ood, Drug and Cosmetic Act, on grounds they are ``intended to affect the function and structure of the body.'' The tobacco industry challenged that authority, saying Congress never intended tobacco to be covered by the 1938 law. Therefore, the industry argues, expanding the FDA's jurisdiction to include tobacco needs congressional approval. When tobacco industry logic is involved, there is no such thing as an open-and-shut case. Fact and fiction, truth and lies blur. Simple questions become complicated in a sea of red herring. The oral arguments got off to a bad start when Justice Sandra Day O'Connor wondered aloud whether the FDA would one day decide it had power to regulate horror movies because they raise adrenaline levels in the body. (Well, Your Honor, if it ever becomes possible to ingest horror movies, then this might be worth discussing.) When Solicitor General Seth Waxman said no one suggested the FDA regulate horror movies, Chief Justice William Rehnquist piped in that 30 years ago, no one suggested the FDA regulate tobacco, either. Things deteriorated from there, and some of the government's best arguments never were discussed. After the hearing, news reports and editorials generally conceded victory to the tobacco industry and assumed the issue would be tossed back to Congress, where it's sure to go nowhere. But surely the justices will decide this case based on real logic, not tobacco industry logic. If they do, they must agree to let the FDA regulate tobacco. As laid out in numerous briefs, the case hinges on three questions: Does tobacco fall under the definition of a drug? Does the tobacco industry market its products for their therapeutic value? And are tobacco products so dangerous that the FDA would have to ban them if given authority to regulate them? The first question is easy. The drug is called nicotine and it's already regulated by the FDA. The second one is stickier: Do people smoke to calm down, concentrate and lose weight -- or do they smoke simply because they think it's glamorous to have that burning sensation in their lungs and breath that smells like a stale ashtray? Under law, for the FDA to regulate a product as a drug, the manufacturer must intend it to have some therapeutic value. Food supplements like vitamins and herbal remedies aren't considered drugs because their manufacturers don't claim they actually make you healthy. (Witness those radio ads for garlic pills that say ``Get the benefits of garlic without the odor'' and never quite say what those benefits are.) Congress has stated specifically that tobacco products aren't food supplements. But are they drugs? Not if you simply look at manufacturers' claims. For 50 years, cigarette companies have carefully avoided any reference to the benefits of nicotine in their packaging and advertising. Instead they sell sex appeal and ``pure smoking pleasure.'' They say: Smoke because its fashionable and seductive. Smoke our brand because it's a silly millimeter longer or it has more menthol or less tar. What if a manufacturer knows its product is a drug but fails to market it as one? Can a company sell chewing gum laced with Prozac, for example, and avoid regulation by failing to mention it's an anti-depressant? No. Courts have ruled that if manufacturers intend for consumers to get some benefit from the product, then it's a drug even if it isn't labeled as such. That's the crux of the government's case, and it explains why the FDA didn't try to regulate tobacco until 1996. Sure, everyone knew why people smoked, but there had been no hard evidence that tobacco companies intended smokers to get anything more from cigarettes than pure smoking pleasure. It would have been pointless for the FDA to take on a powerful industry, an institution older than the U.S. Constitution and more American than apple pie, without proof of the manufacturer's intent. Then came the famous smoking guns: confidential documents uncovered in other tobacco cases showing that the industry knew quite well the properties of tobacco and manipulated nicotine levels to give smokers just the right dosage. Finally the FDA had the ammunition it needed to prove intent beyond a doubt. So you see, Justice Rehnquist, it doesn't matter that 30 years ago no one suggested the FDA regulate tobacco. Thirty years ago, the FDA didn't have the case it has today. What mattered then, and what matters now, is that Congress gave the FDA broad responsibility to protect the safety of the American people by regulating drugs and drug-delivery devices. Which brings us to the third point: the safety of cigarettes. This is one of those through-the-looking-glass moments that only the tobacco industry can deliver. Up against a solid case for regulation, tobacco lawyers unveiled a new tactic. The law says the FDA must assure the safety of whatever it regulates. So, after denying for decades that smoking is harmful, the industry now says that cigarettes are so dangerous that they would have to be banned if regulated, and heaven knows we don't want to do that. Put all those tobacco farmers and factory employees out of work? Force 50 million smokers to quit cold turkey? You wouldn't dare. The resulting discussion before the Supreme Court was bizarre. The FDA has said it doesn't intend to ban tobacco. Rather than force 50 million smokers into the black market, it would focus on keeping kids from becoming hooked and helping adults quit. The FDA has authority to decide the safest way to regulate a product. Many dangerous drugs are both legal and tightly regulated. Tobacco products kill 400,000 people a year. If there were ever something that cried out for regulation, this is it. Congress gave the FDA authority to regulate drugs 60 years ago, but today's Congress doesn't have the political will to specifically regulate this drug. The Supreme Court need not play that political game. It need not get tied up in the mind-numbing world of tobacco industry logic. It need only look at the real world, the real problem, the real law -- and make the only logical decision. Patty Fisher, Mercury News editorial writer. - --- MAP posted-by: allan wilkinson