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Senate Votes for F.D.A. Rules on Tobacco

More than four decades after the surgeon general declared smoking a health hazard, the Senate on Thursday cleared the final hurdle to empowering federal officials to regulate cigars and other forms of tobacco for the first time.

The legislation, which the White House said President Obama would sign as soon as it reached his desk, will enable the Food and Drug Administration to impose potentially strict new controls on the making and marketing of products that eventually kill half their regular users. The House, which passed a similar bill in April, may vote on the Senate version as soon as Friday.

"This is a historic step changing the nature of tobacco in society forever," said Clifford E. Douglas, the director of the University of Michigan Tobacco Research Network, which has extensively studied the health effects of smoking and was one of many groups that have long pushed for tobacco regulation.

The Congressional Budget Office has estimated the new law would reduce youth smoking by 11 percent and adult smoking by 2 percent over the next decade, in addition to reductions already achieved through other actions, like higher taxes and smoke-free indoor space laws.

The Family Smoking Prevention and Tobacco Control Act, as it is called, stops short of empowering the F.D.A. to outlaw smoking or ban nicotine — strictures that even most antismoking advocates acknowledged were not politically feasible and might drive people addicted to nicotine into a criminal black market.

But the law would give the F.D.A. power to set standards that could reduce nicotine content and regulate chemicals in cigarette smoke. The law also bans most tobacco flavorings, which are considered a lure to first-time smokers. Menthol was deferred to later studies. Health advocates predict that F.D.A. standards could eventually reduce some of the 60 carcinogens and 4,000 toxins in cigarette smoke, or make it taste so bad it deters users.

The law would also tighten restrictions on the marketing and advertising of tobacco products. Colorful ads and store displays will be replaced by black-and-white-only text. Beginning next year, all outdoor advertising of tobacco within 1,000 feet of schools and playgrounds would be illegal.

And cigarette makers will be required to stop using terms like "light" and "low tar" by next year and to place large, graphic health warnings on their packages by 2012.

"This is a bill not for a one-year or two-year splash, but for a long-term impact," said Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, a Washington advocacy group that took a lead in coordinating support for the legislation.

Industry analysts say that the imposition of fees on cigarette companies to pay for the creation and administration of a new F.D.A. tobacco oversight department, which could eventually reach 6 cents a pack, could further raise the cost of smoking.

Industry analysts, though, predict that federal regulation, like higher taxes, will be manageable for the tobacco companies. As long as they have a market of addicted customers, even if that clientele is dwindling, they can raise prices to remain profitable.

The law would be the first big federal step against smoking since the 1971 ban against tobacco advertising on television and radio and the 1988 rules against smoking on airline flights — but potentially much more sweeping than either of those moves.

The law might also address the perceived shortcomings of the $206 billion "master settlement" agreement that seven tobacco companies reached with 46 states in 1998 to resolve lawsuits and change their marketing practices. Afterward, cigarette companies nearly doubled their marketing spending and increased their advertising in stores.

Although the nation's smoking rate has gradually declined in recent years, an estimated one in five people in this country still smoke. And more than 400,000 of them die each year from smoking-related disease.

For decades, though, despite influential studies in the early 1950s linking smoking to cancer and even after the surgeon general's report in 1964, Congressional efforts to regulate tobacco met stiff opposition from lawmakers from tobacco-growing states and their political allies.

And when the F.D.A. tried on its own to start regulating nicotine as a drug, the Supreme Court struck down that effort in 2000, saying the agency could not take such a step without Congressional authority. Cigarettes remained less regulated than cosmetics or pet food.

But this time the antitobacco forces came into alignment, with broad bipartisan support in Congress, where Mr. Obama — himself a smoker who has acknowledged his trouble in quitting the habit — had been a sponsor of the legislation when he was still in the Senate. The Senate passed the bill Thursday by a vote of 79 to 17. The only Democrat voting against it was Kay Hagan of the North Carolina, the leading tobacco-growing state.

Another political factor was the willingness of the nation's biggest tobacco company, Altria Group — owner of Philip Morris and its industry-leading Marlboro brands — to accede to federal regulation. No other tobacco company supported the legislation.

Publicly, Altria pushed the legislation for "the greater predictability and stability we think it will bring to the tobacco industry," as a spokesman, Brendan J. McCormick, said this week.

But the impulse dates to the 1990s, when according to Philip Morris documents released during lawsuits, the company decided to remake its image as a responsible corporate citizen. Part of that strategy was to advocate legislation to reduce the risks in cigarettes, and avoid smoking's being outlawed outright.

Moreover, as the industry's richest company, with profits last year of more than $3 billion, Altria, based in Richmond, Va., has built an extensive scientific research operation. It may thus be the company best equipped to deal with the F.D.A.'s new review process for new, ostensibly safer tobacco products.

Under the law, new smokeless tobacco and other products pitched as having lower health risks could be approved only if makers could demonstrate health benefits to society as a whole — meaning the products would not induce too many nonsmokers or would-be quitters to try them, rather than abstaining.

As Altria's competitors have repeatedly argued in opposing the legislation, Altria stands to retain more market share if the advertising crackdown makes it harder for other companies to improve their sales standing.

Yet, even Altria said Thursday the legislation, while "an important step forward," was "not perfect." The Association of National Advertisers says the act's "unprecedentedly broad advertising restrictions" violate First Amendment protections for commercial speech. Legal experts say a court challenge on that ground is virtually certain.

Thursday, June 11, 2009

Source: The New York Times

Senate Votes for F.D.A. Rules on Tobacco