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.