Go to Tobacco on Trial
Decades After Declaration, War on Smoking BeginsBy Glenn Frankel
Washington Post Staff Writer
Saturday, August 24, 1996; Page A01
For a declaration of war, the 387-page document in retrospect seems surprisingly tepid. "Cigarette smoking is a health hazard of sufficient importance in the United States to warrant appropriate remedial action," concluded Surgeon General Luther L. Terry in the historic 1964 report that for the first time officially linked cigarettes to disease.
It has taken more than three decades for federal regulators to respond to the challenge Terry's report put before them. But anti-smoking activists and tobacco industry officials alike agree that the Food and Drug Administration rules announced yesterday amount to a watershed moment in which the federal government, after decades of false starts, conflict and delay, has finally chosen to move decisively to restrict a product that health experts consider America's primary cause of preventable disease and death.
"Thirty-two years after the surgeon general's first report, the government has finally replaced rhetoric with substance," said Matthew Myers, general counsel for the Center for Tobacco-Free Children and a longtime anti-smoking campaigner.
Both sides also agree that the regulations, which focus on restricting sales of tobacco products to young people, are a first step that, if not reversed, is certain to lead to a growing federal role in regulating cigarette sales and eventually to a reduction in their use and health impact on Americans of all ages.
"It is the epitome of the slippery slope," said Thomas Humber, president of the National Smokers Alliance, an industry-supported group opposed to the new rules. "Someone smart figured out that this is a first acceptable step. This is not where [FDA Commissioner] David Kessler wishes to stop."
"Clinton had to pump this through under the rubric of protecting kids," said Gregory Connolly, director of the Massachusetts Tobacco Control Program. "But seven years hence, if the rate of youth smoking hasn't been knocked in half, the agency is empowered to take the next logical steps." The goal, Connolly and others predict, is a federally-mandated gradual reduction in the amount of nicotine, the addictive agent in tobacco, to the point where cigarette smoking is strictly a matter of choice rather than compulsion.
The industry is certain to launch a mighty counterattack against the new regulations in the courts -- it already has a lawsuit pending in a North Carolina federal court -- at the polls and on Capitol Hill, where tobacco interests have invested large amounts of money in campaign contributions and have won most of their battles over the years. But even in Congress, their dominance is now in dispute. Industry lobbyists privately concede they are uncertain whether they can muster the votes to overturn or preempt the FDA, and anti-tobacco activists are expressing new confidence.
"My sense is the stench is too great now," said Michael Pertschuk, former chairman of the Federal Trade Commission and a veteran anti-smoking activist. "Any effort by those who have taken tobacco money to try to pay back by stopping FDA will create a sufficient public uproar to prevent them from trying."
Why did this day take so long in coming and why, at a time when federal regulation of business is under a cloud of popular suspicion, has it finally arrived? Both sides cite many causes, including the decline in political clout of the once-unassailable tobacco industry, the growing power and sophistication of the anti-smoking movement and the impact of disclosures in court and congressional hearings about the industry's culpability in covering up data on the harmfulness and addictiveness of tobacco. They also credit the work of a handful of determined public officials, including former surgeon general C. Everett Koop, FDA chief Kessler and President Clinton.
Politics also played a major role. The Democratic Party, which ruled Capitol Hill during most of the 32 years since the first surgeon general's report, no longer counts the tobacco-growing states of the South as a crucial part of its power base. At the same time, polls suggest that because the new measures seek to protect children, they are popular not only in havens of anti-smoking fervor such as California, New York and Massachusetts, but also in the South itself. Only now, analysts say, could a former Arkansas governor steeped in the Democratic politics of his region feel free to take such a dramatic and unprecedented step.
The federal effort to regulate tobacco actually began on the same Saturday in 1964 that the surgeon general's report was released. According to "Ashes to Ashes," Richard Kluger's epic history of the industry, staff members of the Federal Trade Commission drafted a rule requiring warning labels for cigarette packs and advertisements that day, but FTC chairman Rand Dixon later backed down when faced with opposition from Lyndon B. Johnson's White House and from Congress.
Two cronies of Johnson, Abe Fortas and Earle Clements, then the industry's chief lobbyist, led the effort, which resulted in Congress preempting the FTC by passing its own watered-down labeling requirement. The resulting labels not only were vague, they gave the industry a new defense against liability lawsuits by claiming that smokers had been sufficiently warned about the hazards of cigarettes and had taken up the habit at their own risk. It was, then-commissioner of FTC Philip Elman later said, "one of the dirtiest pieces of legislation ever."
Dirty or not, the legislation set a pattern that lasted 30 years. Every time a federal agency sought to enact some sort of restriction on smoking or tobacco sales, Congress would step in to bury the measure or preempt the agency with its own, weaker substitute. Presidents from Johnson through George Bush stood to the side, seldom expressing a position and never supporting measures against smoking. And attempts by anti-tobacco forces to get stronger legislation through Congress always wound up, in the words of anti-smoking activist Scott D. Ballin, "basically dead on arrival."
Each time Congress passed a new law regulating consumer product safety or toxic substances, tobacco industry supporters inserted a clause excepting tobacco products. Cigarettes remained what one assistant secretary of health described as "this nation's least-regulated legal product."
Throughout the three decades, the industry's position remained steadfast: It denied cigarettes were either harmful or addictive and concealed any evidence to the contrary. "They're so smart they're dumb," said Kluger, who interviewed more than 60 present and former executives of Philip Morris for his book. "They let themselves be lured into a corner. Their lawyers said, in effect, `Once you concede you have a lethal product, you're opening the door to being sued out of business. So don't do it. Stonewall.' And that, in retrospect, was the wrong advice."
The stone wall began to collapse in the 1980s. While the industry continued to win in court, the Cipollone liability case in New Jersey, brought by the family of a smoker who died of cancer in 1984, unearthed thousands of pages of documents showing companies had long been aware of the health risks of their products. At the same time, reports by the Surgeon General's Office and the Environmental Protection Agency focused on the addictive nature of nicotine and the alleged dangers of secondhand smoke. The implications were clear: If companies were consciously manipulating the addictive agents in tobacco and if cigarettes harmed not only those who smoked them but innocent bystanders as well, then the industry could no longer claim smoking was merely a lifestyle choice freely made by adults. Instead, it became a compelling public health issue.
This decade has brought a new onslaught of lawsuits both from individual smokers and from 14 states claiming the industry owes them compensation for the medical costs of tobacco-related illnesses. It also brought a new embarrassment to industry executives, who two years ago stood before a congressional subcommittee to swear under oath they did not believe smoking was either addictive or harmful. Several federal grand juries are now exploring whether those executives should be indicted for perjury.
But perhaps the biggest challenge has come from the FDA, led by a Bush administration appointee who at first shied away from the issue. Kessler, trained as both a pediatrician and a lawyer, took nearly four years to decide that cigarettes were indeed within the FDA's jurisdiction. Going against the tide of decreased government regulation of business, Kessler eventually concluded that the industry was feeding the addiction of its customers by manipulating nicotine levels in cigarettes. He argued that this made cigarettes a drug delivery device and placed them clearly under the FDA's mandate. Labeling smoking "a pediatric disease," he decided to focus on cigarette sales to children. Then, with much help from first lady Hillary Rodham Clinton, Vice President Gore, Health and Human Services Secretary Donna E. Shalala and others, he helped persuade Clinton to move ahead.
"A regulator alone couldn't have done it," said Pertschuk, himself a veteran of the regulatory wars over tobacco. "But a regulator and a president are a fairly formidable team."
Philip Morris and the United States Tobacco Company, which makes smokeless tobacco products, have already offered to enact voluntary restrictions -- but only if the FDA rescinds its rules. Officials say the industry will continue to fight the measure in the courts and will work hard to elect candidates who oppose it. But the court of last resort remains Congress.
An experienced tobacco industry lobbyist who insisted on anonymity said the industry's success in fighting the new regulations on Capitol Hill next year would depend not only on whether Republicans retained control of both houses of Congress but on how many members of the staunchly conservative freshman Republican class of the House of Representatives survive the November elections. Most of that class would oppose the new rules for ideological reasons despite the fact tobacco was involved, he argued.
Otherwise, he said, nothing was certain: "Quite frankly, our only real champions these days are [Sens.] Jesse Helms and Wendell Ford and maybe 20 members of the House. It'll be quite a battle."
BILLBOARDS AND SIGNS: Billboards and signs limited to black-and-white text only, except in adult-only facilities. Tobacco billboards banned within 1,000 feet of schools and playgrounds.
PRINT ADS: Black-and-white text only ads in publications whose youth readership is more than 2 milliion or 15 percent of total readership.
VENDING MACHINES: Cigarette vending machines limited to facili-ties where children are prohibited.
GIVEAWAYS: No product give-aways with brand names or logos.
SPONSORSHIP: Entertainment or sporting events sponsored only in the corporate name, not the brand name.
PHOTO IDS: Buyers under age 27 must produce photo identification.
EDUCATION: Industry-run educational campaign, including TV ads, about health risks.
SINGLES: No free samples, single cigarette sales or packages of fewer than 20 cigarettes.
SOURCE: Department of Health and Human Services
HISTORY OF CIGARETTE REGULATION
1950: Three published epidemiological studies indicate a correlation between cigarette smoking and lung cancer.
1957: Surgeon General Leroy E. Burney issues a report stating that "excessive" smoking appeared to be one of the "factors in lung cancer."
1964: Surgeon General Luther L. Terry issues a "Report On Smoking and Health" linking cigarette smoking and lung cancer.
1966: The Federal Cigarette Labeling and Advertising Act takes effect, requiring warning labels on cigarette packaging.
1967: Surgeon General William H. Stewart's report concludes that smoking is the principal cause of lung cancer. Federal Trade Commission releases the first tar and nicotine report.
1970: Congress strengthens cigarette warning labels.
1971: TV and radio ads for cigarettes are banned as the Cigarette Smoking Act of 1969 takes effect.
1973: Civil Aeronautics Board requires no-smoking sections on commercial flights. Arizona becomes the first state in modern times to restrict smoking in public places.
1975: Cigarettes discontinued in military rations.
1983: San Francisco bans smoking in private workplaces.
1986: Surgeon General C. Everett Koop issues reports on involuntary smoking and smokeless tobacco.
1988: Koop issues report declaring cigarette smoking "addictive."
1990: Smoking ban on intercity buses and domestic flights of 6 hours or less takes effect. HHS secretary denounces black-targeted Uptown cigarettes and manufacturer cancels marketing plans.
1993: EPA issues report identifying secondhand smoke as a health risk. President bans smoking in the White House.
1994: Food and Drug Commissioner David A. Kessler announces FDA is studying regulating tobacco products. OSHA proposes regulations banning workplace smoking or requiring separate, ventilated smoking rooms.
1995: In July, AMA endorses regulation of cigarettes as "drug delivery vehicle," and severe restrictions on sales.
In August, President Clinton and FDA announce proposed restrictions on tobacco marketing and sales. In its Federal Register filing, the FDA states that "based on the evidence now before the agency, cigarettes and smoke-less tobacco products are drug delivery systems whose purpose is to deliver nicotine. . . ."
1996: Yesterday, President Clinton approved the proposed rules, allowing the FDA to enforce them as law.
SOURCES: Centers for Disease Control and Prevention; "Ashes To Ashes" by Richard Kluger, Alfred A. Knopf, 1996; Washington Post research
© Copyright 1996 The Washington Post Company