DRUG-DELIVERY DEVICES -- CIGARETTES -- SHOULD BE REGULATED

Five years ago the top tobacco CEOs held up their right hands and swore to a
congressional committee that tobacco wasn't addictive, that it didn't cause
cancer and that they didn't market to kids or manipulate nicotine.

This week a tobacco executive, briefing journalists under the protection of
anonymity, asserted, "We are not safe and effective." The Philip Morris Web
site not only proclaims that cigarettes aren't safe, but notes they
contribute to "cancer, heart disease, emphysema and other serious diseases."

After years of duplicity, has tobacco finally come clean? Not a chance.
These are cynical and calculated confessionals meant to sway a current case
before the Supreme Court as to whether the Food and Drug Administration can
regulate tobacco. This is Big Tobacco's latest scare tactic, aimed at
persuading the public--and the justices--that if the government were to
regulate cigarettes, its only choice would be to ban them.

In an argument of legal heavyweights Wednesday, U.S. Solicitor General Seth
Waxman asserted that it is now clear that tobacco is a "highly addictive"
substance that falls within the mandate of the Food and Drug Act. Tobacco,
he said, is the only "product ingested in the body that is regulated and
inspected by no agency and yet is so dangerous."

Richard Cooper, representing the industry, insisted that nothing has changed
in the six decades of the FDA's existence that would suddenly give that body
the authority to regulate tobacco. He argued that since cigarettes aren't
marketed as affecting health, or as safe products, regulation would be
"lawless."

This case is critical, as it's very unlikely that either side could get
Congress to overturn a Court decision. If tobacco wins, says Matt Myers of
the Campaign for Tobacco-Free Kids, "the status quo that allowed them to
hide the truth from the American people will continue."

The industry's strongest argument, forcefully advanced by Mr. Cooper, is
that Congress, in passing the 1938 Act creating the FDA, never envisioned
that the body would regulate tobacco. And until a few years ago the FDA
specifically rejected a role regulating cigarettes.

These facts are undeniable. But since the FDA last considered regulating
tobacco, notes Walter Dellinger, the Clinton administration's former
solicitor general who argued the initial stages of this case, "every major
health agency has concluded that tobacco is addictive and dangerous."

Notably, while the 1938 legislation didn't envision FDA regulation of
tobacco, it did authorize the new agency to regulate products as "drugs" or
"devices" when they are "intended to affect the structure of any function of
the body." Of course, for years tobacco insisted their product didn't do
that--that is what the CEOs denied when they raised their hands under oath
in 1994.

It all, of course, was a lie, as subsequent documents revealed in suits
against tobacco have overwhelmingly demonstrated. Indeed, Mr. Waxman's
strongest ally may have been the tobacco companies' private memoranda.
Internal documents at RJ Reynolds called nicotine "habit forming" and
tobacco "a vehicle for delivering nicotine." A Brown & Williamson senior
official called smoking "a habit of addiction."

In a Minnesota case a few years ago it was revealed that the legal strategy
at Philip Morris was to conceal research that might make FDA regulation more
palatable. An internal document from the company warned, "The
psychopharmacology of nicotine" will be from where most of the important
research will come, but "it is where our attorneys least want us to be."

The virtually unanimous conclusion of the scientific and health community is
that tobacco is "intended to affect the structure and function of the body,"
even if cigarettes aren't marketed this way. It thus will be interesting to
see the reasoning of the cigar-smoking conservative intellectual, Justice
Antonin Scalia, who has so powerfully argued in favor of a "plain-meaning"
approach to interpreting law. In any plain-meaning interpretation, tobacco
would fall under the realm of the Food, Drug and Cosmetic Act.

Tobacco hopes that if it can win this case the pressure will subside. They
are banking on a Republican presidential victory next fall with George W.
Bush, rather than their GOP nemesis, John McCain. Big Tobacco's investment
in Republicans is considerable. In the last two election cycles Philip
Morris was the top soft-money donor to the GOP, while RJ Reynolds ranked
second and fourth.

In 1999 the tobacco interests have doled out more than $1.2 million, almost
90% of it to Republicans and $62,000 to the Bush candidacy. (They also hedge
their bets; prior to the 1996 election they surreptitiously funneled
millions of dollars into state Democratic parties to buy influence.)

With the pressure off they hope to buy respectability, or at least
acceptability. Tobacco ads now focus more on the horrors of abused women
than the Marlboro Man. Publicly, tobacco companies vow they are working for
a "safe cigarette" and say they dissuade teen smoking. Yet they know that
almost 90% of the smokers start in their teens. Their rhetoric
notwithstanding, they don't want the FDA to stop their clever entrapment of
kids.

Yet, no matter the Court decision, the pressure won't disappear. The public
knows that the industry for decades has lied and covered up the danger of
its products, which, in reality, are drug-delivering devices.

The initial reaction, however, to yesterday's arguments was that the key
swing votes on the Court were skeptical about the government's case. That
may be, but they'll have to weigh this against the alternative of an even
greater rash of legal actions against tobacco.

This, speculates Mr. Dellinger, may well tilt the case in favor of the
government. "The Supreme Court is increasingly skeptical about private
litigation brought by the plaintiff bar," he notes. "The Court will realize
there has to be a method of regulating tobacco and having a responsible
federal agency staffed by experts is a better method than lawsuits, states
attorneys general and contingency fees."

'More than four million kids ages twelve to seventeen are smokers.' -- U.S.
Dept. of Health and Human Services, 1998

'In 1997 36.5 % of high school seniors smoked, a nineteen year high.' --
University of Michigan's Monitoring the Future study, 1998

'During the decade of the 1990s smoking among eighth and tenth graders
increased by one third.' -- University of Michigan's Monitoring the Future
study, 1998

'More than five million children under the age of 18 today eventually will
die from smoking-related causes.' -- U.S. Center for Disease Control and
Prevention, 1998