COURT LOOKS AT THE FUTURE OF TOBACCO

WASHINGTON, April 23 (UPI) - The Supreme Court is expected to announce
soon, possibly as early as Monday, whether it will hear argument on the
authority of the Food and Drug Administration to regulate tobacco as a drug.

Industry officials warn that regulating tobacco as a drug - besides having
the effect of curtailing sales and advertising - would ultimately lead to
the banning of their product.

When it first tried to regulate tobacco, a move blocked in a lower court,
the FDA considered a ban on the sale of tobacco, then rejected that option
because "the sudden withdrawal from the market of products to which so many
millions of people are addicted would be dangerous.''

The agency also feared the effects of a black market.

Tobacco officials argued privately at backgrounding briefings this week
that even if the FDA doesn't want to ban tobacco outright, provisions of
existing law might compel the agency to ban it as a drug without
therapeutic value or as "an unsafe medical device.''

The officials insisted that if the FDA disagrees with that interpretation,
regulation would open the way for an immediate private lawsuit by
anti-tobacco activists to force a ban in compliance with federal law.

"I don't think anyone (on either side of the issue) would be surprised if
something like that happened,'' one official said.

In asking the Supreme Court to hear the regulation case - which is separate
from the damages settlement reached with the states and any future federal
damages lawsuit against the industry - the Justice Department said,
"Tobacco alone kills more Americans annually than AIDS, alcohol, car
accidents, homicides, suicides, illegal drugs and fires combined,'' more
than 400,000 deaths per year. "The average tobacco user loses 15 years of
his or her life.''

President Clinton announced in 1996 that the FDA would classify tobacco as
a drug. The Justice Department tells the Supreme Court that decision was
reached only after extensive study.

In 1938, Congress enacted the federal Food, Drug and Cosmetic Act, and
President Franklin Roosevelt signed it into law. The act expanded the legal
definition of a "drug'' to include non-food "articles intended to affect
the structure or any function of the body of man or other animals.

The act also authorized the FDA to regulate "devices'' as well as drugs. A
device is defined as the method by which as drug is introduced into the body.

The FDA, before its 1996 action, determined that tobacco products are both
"drugs'' and "devices,'' and therefore subject to regulation.

In documents filed with the Supreme Court, the Justice Department says the
FDA study found that nicotine in tobacco products "causes and sustains
addiction, and acts as a sedative, stimulant and appetite
suppressant...(and) those effects are clearly 'intended' by the
manufacturers of tobacco products.''

The evidence was gleaned from an FDA investigation, "congressional hearings
and disclosures by tobacco company officials and employees.''

The Justice Department tells the Supreme Court that FDA evidence shows
"nicotine in tobacco products produces chemical reactions in the brain that
motivate repeated, compulsive use and create dependence in the user.''

The department says internal company documents also show the tobacco
industry has recognized this dependence for decades.

Moreover, the Justice Department says, the FDA found evidence that tobacco
manufacturers were manipulating the nicotine content of their products in
order "to provide remarkably precise, pharmacologically active doses of
nicotine to consumers'' to foster this dependence.

The manipulation allegedly consisted of putting "nicotine-rich tobacco
blends in low-tar cigarettes,'' filters that ``selectively remove more tar
(than nicotine) from smoke,'' and "chemical additives that increase the
percentage of 'free' nicotine in cigarette smoke.''

The agency also determined that tobacco use is a "pediatric disease'' -
most people start smoking before age 18. If teenagers do not smoke, "most
will never start using tobacco.''

"Every year,'' the Justice Department says, "approximately one million
children and adolescents begin to smoke....Tragically, one of every three
young people who become regular smokers will eventually die prematurely
from a tobacco-related disease.''

The 1996 regulation prohibited the sale of tobacco anywhere to those under
18, required retailers to check the identification of those under 27 and
banned vending machines and self-service displays of cigarettes and
smokeless tobacco except those at adult-only locations.

The regulation also required that all tobacco advertisements appear in
black and white, text-only format - no more full-color magazine pictures of
attractive young adults smoking cigarettes - except in adult-only
publications and facilities; no outdoor ads within 1,000 feet of a school
or playground; no sale or distribution of hats, T-shirts and other
non-tobacco products that bear a tobacco product brand name or logo, and
finally, no tobacco-brand name sponsorship of events, such as sports or
cultural gatherings.

Almost as soon as the FDA regulation was drawn up, the major tobacco
companies filed suit against it in federal court in the tobacco-growing
area of Greensboro, N.C.

Though a federal judge ruled for the FDA, an appeals court panel reversed,
blocking all the regulations except for age limits on sales. The Clinton
administration then asked the Supreme Court for review.

But lawyers for the tobacco industry are urging the justices to let the
appeals court ruling stand.

In one of their own briefs to the Supreme Court, the industry lawyers argue
that the effects of tobacco upon health had been known or suspected for
centuries, and that Congress did not intend to give a federal agency power
over tobacco in the 1938 act.

"Prohibition of alcohol ended in 1933, the year Congress began considering
what was to become the (act),'' the lawyers say in the brief. "The idea
that Congress in 1938 intended to give an administrative agency the power
on its own to institute a new Prohibition defies common sense.''

If the Supreme Court decides to hear the FDA case, it should do so next
winter. (No. 98-1152, FDA et al vs. Brown and Williamson et al)