FDA, Tobacco Firms Spar Over Cigarette RestrictionsBy John Schwartz
The Washington Post
The tobacco industry Monday asked a federal judge to block the Clinton administration's controversial plan to impose tough new federal regulations to reduce smoking among young people.
During a daylong hearing in a crowded U.S. District Court courtroom, attorneys representing the tobacco industry and other businesses that would be affected by the plan argued that the federal Food and Drug Administration had grossly overstepped its authority.
"We are dealing with a revolutionary expansion of FDA authority over a major industry that it has never before regulated," said Washington attorney Richard Cooper, representing the tobacco industry.
Lawyers representing the government, meanwhile, countered that FDA Administrator David Kessler was well within his legal authority to take the action, which was necessary to counter a teen smoking epidemic.
"The commissioner hasn't acted willy-nilly here," said Justice Department attorney Gerald Kell. Kessler, he said, "has looked at a serious health problem," and tried to fashion a reasonable response.
The arguments came during a one-day hearing on the first court test of the FDA action - a request by the tobacco, advertising, publishing, convenience store and other industries for Judge William Osteen Sr. to issue a "summary judgment" blocking the plan. If Osteen rules against the industry, a full trial will be held. Any outcome is likely to be appealed, perhaps eventually as far as the Supreme Court.
Osteen said he would not announce a decision for between five and 10 weeks.
In the meantime, the first phase of the FDA regulations - a federal requirement that everyone buying tobacco products be required to produce photo identification to prove they are at least 18 years old - will go into effect Feb. 28.
Restrictions on tobacco advertising, including requirements that ads in magazines with a large youth readership be restricted to black and white text, are scheduled to go into effect in August. A ban on tobacco industry name-brand sponsorship of sporting events would take effect a year later.
The hearing focused on three broad issues: whether the FDA has jurisdiction over tobacco, whether it had applied its own rules properly, and whether the agency's advertising restrictions violate the First Amendment.
On the first issue, tobacco industry attorneys argued that Congress had never granted the FDA authority to regulate tobacco and that the agency itself had expressly rejected requests in the past from anti-tobacco activists to assert such authority.
The industry attorneys relied largely on congressional deliberations from 1964 and 1965 after the first Surgeon General's warning on tobacco's health risks. Congress gave some authority for tobacco to the Federal Trade Commission and took on the task of crafting cigarette warning labels itself.
Attorneys for the government contended that the agency must have the flexibility to change course when new evidence emerges. Recent revelations about tobacco industry practices and knowledge of nicotine's addictive qualities justified a shift, they argued.
"These are not the same products they were in 1938," when the federal Food, Drug and Cosmetics act was first passed, said Justice Department attorney George Phillips. "They are a highly manufactured, engineered product."
Even if Osteen finds that the agency has jurisdiction over tobacco products, the notion that cigarettes and smokeless tobacco can be classified as a combination drug and medical device was "truly strange" and "an amazing series of evasions and distortions," Cooper said.
It was absurd for the government to contend that the tobacco industry has shown its intent to sell tobacco because it contains nicotine - an essential element of the agency's jurisdictional claim - when the industry does not make explicit claims for its products' drug effects, Cooper said.
Some of the strongest language against the FDA rules concerned the advertising restrictions. Dan Troy, a Washington attorney representing advertising companies, called the plan "patently overbroad," and said that the agency "cannot attack with a blunderbuss what it should attack with a scalpel."