CAN FDA REGULATE TOBACCO INDUSTRY?

WASHINGTON - Several Supreme Court justices expressed doubts yesterday about
whether the Food and Drug Administration (FDA) can regulate tobacco as a
drug and crack down on cigarette sales to minors.

Solicitor General Seth Waxman asked the court to let the FDA regulate
tobacco because the nicotine it contains is a "highly addictive" substance
that acts as a stimulant, a sedative and an appetite suppressant.

But tobacco-industry lawyer Richard Cooper argued the government's 1996
decision to regulate tobacco was "lawless" because cigarettes are not
promoted as having effects on health.

Justice Sandra Day O'Connor said that federal law says drugs and devices
have to be safe and effective.

"Is it the position of the government that the use of tobacco is safe and
effective?" she asked Waxman. "If not, you know, it just doesn't fit."

A lower court threw out the government rules, saying the FDA had no
authority to regulate tobacco.

Indeed, the FDA itself had said for decades that it lacked authority to
regulate tobacco so long as cigarette makers did not claim that smoking
provided health benefits. It said its 1996 policy switch was prompted by new
evidence that the industry intended its products to feed consumers' nicotine
addictions.

The Supreme Court is expected to decide on the ruling by July.

Chief Justice William Rehnquist - a smoker - questioned why the FDA decided
to regulate tobacco in 1996 when the Surgeon General's Office determined
during the 1960s that smoking was dangerous to people's health.

Waxman noted that executives of seven major tobacco companies testified
before Congress in 1994 that nicotine was not addictive and that cigarette
makers did not manipulate their products' nicotine content.

"As far as the former is concerned, nobody believed them," said Justice
Antonin Scalia, another smoker.

Even if the 1938 Food, Drug and Cosmetic Act gave the administration the
authority to regulate tobacco, Scalia said, "There's a lot of water over the
dam since then" during which the government said it could not regulate the
industry.

However, Justice Stephen Breyer said, "Nobody can kid themselves anymore"
about the effects of smoking. "Is the word `safety' in this statute supposed
to stop the FDA from looking at the real world?"

All 50 states already ban tobacco sales to anyone under 18. In addition to
adopting that rule, the FDA required stores to demand photo IDs from all
tobacco purchasers under age 27 and limited vending-machine cigarette sales
to adults-only locations, such as bars.