Cigarette Regulation Plan Challenged

WASHINGTON —  Five major cigarette companies, pro-smoker groups and advertising and trade organizations filed thousands of pages of documents with the federal government Tuesday, alleging that the Clinton administration’s proposal to regulate cigarettes was illegal and unnecessary.

The groups argued that the Food and Drug Administration does not have jurisdiction over cigarettes, and that every state already now prohibits the sale of tobacco to minors.

“What the FDA proposes is a power grab,” said a statement issued by the Tobacco Institute, which called upon the agency to withdraw its proposal. “The agency has no legal authority to regulate tobacco products.”

A lawsuit filed by the industry in a North Carolina court against the FDA regulations is pending.

The FDA’s proposals, announced last summer by President Clinton, establish the FDA’s jurisdiction by declaring that nicotine is a drug and that cigarettes are drug-delivery systems. The documents filed Tuesday came at the deadline for public comment on the proposals.

Among other things, the proposals would prohibit tobacco sales to those 18 or younger--requiring proof of age for purchase--ban all cigarette vending machines and self-serve displays, and would impose severe restrictions on advertising geared to teens.

The administration proposals are intended to reduce teen smoking by 50% within seven years of implementation.

Recent studies have shown no abatement of teen smoking, and, in fact, levels have been increasing in recent years. Also, surveys indicate that, despite state laws, teenagers have little trouble obtaining cigarettes.

Also on Tuesday, numerous antismoking groups issued statements supporting the FDA proposals, including the National PTA and the Coalition on Smoking OR Health, which is made up of the American Heart Assn., the American Lung Assn. and the American Cancer Society.

The PTA said “this date is both an ending and a beginning in protecting the health of children.” And the coalition, responding to the flurry of filings by opponents, said it was “not surprised by the political, economic and legal muscle that the tobacco industry has put into fighting the FDA initiative.”

The attorneys general of 27 states released a letter to FDA Commissioner David A. Kessler supporting the proposals and insisting that a cooperative effort--that included federal regulations--was needed to keep cigarettes away from young people.

“As the chief law enforcement officers of our respective states, we are especially concerned about illegal tobacco sales to minors,” they wrote. “Although every state bans the sale of tobacco to minors, studies show that children have easy access to tobacco.”

The FDA almost certainly will not back down, and officials there will study the comments over the coming months before issuing a final regulation.

Before the last-minute spate of filings, the agency had received more than 57,000 different comments, totaling more than 570,000 pieces, including form letters, according to Jim O’Hara, an agency spokesman.

Presidential spokesman Mike McCurry, seeking to downplay the final-hour industry campaign, said: “There have been literally hundreds of thousands . . . of comments submitted, and not all of them reflect the viewpoint of those who have a vested interest in continuing to sell tobacco.”

Steven C. Parrish, senior vice president for corporate affairs for Philip Morris Companies Inc., said the tobacco industry supports efforts to discourage smoking by teenagers.

“Kids should not smoke; they should not have access to tobacco products,” he said.

But he said existing state laws were sufficient to do the job and that trade associations, including the retail trade, and the law enforcement community should make a greater effort to enforce the laws without federal interference.

Parrish inferred that the FDA had a hidden agenda, and that the proposals for teenagers would ultimately lead to greater restrictions that would affect other smokers.

These regulations “will not keep kids from smoking, but will interfere with the rights of adult smokers and the rights of the companies to sell their products,” he said.

Parrish, appearing at a press conference, blasted the FDA plan, claiming that Congress never gave the agency the “awesome power” to regulate cigarettes.

Furthermore, “equally troubling is the FDA’s cavalier attitude toward the 1st Amendment,” he said. “At every turn the FDA has chosen prohibitions and restrictions that would unconstitutionally and impermissibly burden our right to advertise.”

The Freedom to Advertise Coalition--made up of six advertising trade groups--also filed comments Tuesday with the FDA opposing the proposed restrictions on cigarette advertising.

John Fithian, counsel to the group, said the federal agency has no authority to regulate tobacco advertising.

Acknowledging that the agency has the authority to regulate the advertising of medical devices, the idea that cigarettes are medical devices “is absurd,” Fithian said. “FDA simply wants to ignore the purposes of its own statute to find a way to censor tobacco ads.”

The National Smokers Alliance also submitted thousands of letters from its members, saying that the agency was frustrated by “the failure of the antismoking movement to dictate the behavior of the 50 million adult Americans who use a legal product,” and “has turned to bureaucratic fiat for a solution.”