High Court: FDA Can't Regulate Tobacco
TUESDAY, March 21 (HealthScout) -- The Food and Drug Administration has no power to control tobacco as a drug, the U.S. Supreme Court ruled today.
In a split decision that knocks the breath out of the Clinton administration's antismoking campaign, the court held that Congress never gave the FDA jurisdiction over tobacco products. In essence, the court said, the agency borrowed its father's car without permission.
"The agency has amply demonstrated that tobacco use, particularly among children and adolescents, poses perhaps the single most significant threat to public health in the United States," the majority ruled. However, "an administrative agency's power to regulate in the public interest must always be grounded in a valid grant of authority from Congress."
The agency went too far when, in 1996, it created new rules designed to crack down on the sale of tobacco to minors, the court deemed in its 5-4 ruling. The move was an administrative about-face for the FDA, which for decades hadn't put tobacco within its purview.
The tobacco industry -- along with advertisers who thought the marketing rules would violate their free speech rights -- responded to the crackdown by suing. Lawyers cited decades of congressional action limiting the FDA's authority over tobacco and an appeals court agreed with them. The government appealed to the U.S. Supreme Court.
Justice Sandra Day O'Connor, writing for the majority, agreed with the lower court. "The agency believed that, because most tobacco consumers begin their use before reaching the age of 18, curbing tobacco use by minors could substantially reduce the prevalence of addiction in future generations and thus the incidence of tobacco-related death and disease," she wrote.
"In this case, we believe that Congress has clearly precluded the FDA from asserting jurisdiction to regulate tobacco products," she wrote.
Reno is disappointed
Justice Stephen Breyer, in his dissenting opinion, said nicotine is an addictive drug and therefore federal law does allow the FDA to regulate tobacco.
"The fact that only a handful of those who try to quit smoking actually succeed illustrates a certain reality -- the reality that the nicotine in cigarettes creates a powerful physiological addiction flowing from chemically induced changes in the brain," Breyer wrote.
However, the majority opinion noted that the FDA would have placed itself in an awkward position. The agency must deem a drug to be beneficial and safe in order to be marketed. But if the idea is to curtail what the FDA thinks is a patently dangerous substance with no therapeutic value, then its only choice would have been to remove tobacco from the market -- not simply restrict where and when it could be sold. "This is implausible," the court said.
Attorney General Janet Reno called on Congress to set matters straight. The government is "disappointed," Reno said in a statement. "I am however, encouraged that the court recognized the harmful effects tobacco products have on children."
"I hope, after today's decision, Congress will pass legislation that would protect children by restricting advertising, limiting access to tobacco products, and giving the FDA clear authority to regulate tobacco products," Reno said.
Such a move is already under way. Rep. Henry Waxman, D-Calif., introduced a bill today "that would just deal with the FDA," said Phil Schiliro, his chief of staff in Washington, D.C. "It would give the FDA the power to regulate tobacco."
Tobacco giant Philip Morris said today in a statement that regulating cigarettes as a medical device is "inappropriate."
"Federal regulation of cigarettes as cigarettes, dealing with youth smoking while respecting an adult's right to smoke, makes sense for smokers and manufacturers alike," the company said.
However, the company is "prepared to accept whatever Congress thinks is right," said Mike Pfeil, a vice president of Philip Morris.
About 47 million American adults are smokers, a number that has not changed much since 1990, according to the Centers for Disease Control and Prevention (CDC).
Smoking claims an estimated 400,000 lives a year from diseases including heart failure, diabetes, cancer and stroke, the CDC says.
The decision throws tobacco regulation back into Congress's lap, says a spokesman for Rep. Edward Markey, D-Mass., a well-known tobacco opponent.
"The Supreme Court decisions may now make it impossible to continue the pretense that the FDA has any kind of power,"said David Moulton, Markey's press secretary in Washington, D.C. "The leaves the problem for Congress and only Congress can correct it."