FDA Has No Power to Regulate Tobacco: Supreme Court

Oncology NEWS International Vol 9 No 5, Volume 9, Issue 5

WASHINGTON-While acknowledging that tobacco is a major health problem, the Supreme Court has rejected the Clinton Administration’s efforts to create a new federal control effort. It ruled 5 to 4 that “Congress has clearly precluded the Food and Drug Administration (FDA) from asserting jurisdiction to regulate tobacco products.”

WASHINGTON—While acknowledging that tobacco is a major health problem, the Supreme Court has rejected the Clinton Administration’s efforts to create a new federal control effort. It ruled 5 to 4 that “Congress has clearly precluded the Food and Drug Administration (FDA) from asserting jurisdiction to regulate tobacco products.”

The majority, led by Justice Sandra Day O’Connor, reasoned that regulating tobacco is not within the scope of the Food, Drug, and Cosmetics Act (FDCA). Under that law, the court reasoned, the FDA could not simply regulate sales of tobacco to teens (as it has done since 1997) but would have to ban cigarettes as unreasonably dangerous. This is an outcome Congress has not permitted, the Supreme Court declared.

Furthermore, the majority argued that since enactment of the FDCA, Congress has made clear its intent to reserve regulation of tobacco to itself by passing laws requiring warnings on cigarette packs and tying block grant money to state laws banning sales of tobacco to children under age 18.

President Clinton, calling the decision “a setback for the health of our children,” urged Congress to pass legislation enabling FDA’s antitobacco campaign to move forward. Several members of Congress, from both parties, did just that. However, Senate majority leader Trent Lott (R-Miss) said he did not agree that FDA regulation of tobacco was needed.

The case of Food and Drug Administration v. Brown & Williamson Tobacco Corp. began when the tobacco industry challenged a 1995 FDA decision to reverse its decades-long stand that it had no authority over tobacco. FDA issued a proposed rule that restricted the sale, distribution, and advertising of tobacco products to children and adolescents.

A final rule was issued on August 28, 1996, after FDA determined that nicotine is a drug, and cigarettes and smokeless tobacco products are drug delivery devices. In issuing the rule, FDA had declared that tobacco consumption was “the single, leading cause of preventable death in the United States.”

Voters Back Giving the FDA Authority Over Tobacco

Three quarters of 800 likely voters polled 1 or 2 days after the Supreme Court’s tobacco decision favored giving the FDA the power to regulate tobacco products. Respondents in the randomized telephone survey, sponsored by the Campaign for Tobacco-Free Kids, supported such action by a 75% to 22% margin, with the remainder undecided: 61% “strongly” favored such legislation, and 60% of smokers favored congressional action.

Support for new legislation was strong across the political spectrum, winning the backing of 78% of independents, 77% of Democrats, and 70% of Republicans. Among those polled, 67% said they preferred a candidate for Congress who would support giving FDA tobacco-control powers over one who opposed such a measure.

Support was strong among both sexes and across all geographic and demographic lines, including age, income, and education.

A group of tobacco manufacturers, retailers, and advertisers filed suit in the US District Court for the Middle District of North Carolina challenging the regulations. That district court upheld FDA’s right to restrict children’s access to tobacco products and to require labeling, but denied the agency the right to control advertising or restrict promotions.

The Fourth US Circuit Court of Appeals reversed even the limited regulatory powers allowed to the FDA by the lower court, holding that Congress had not granted FDA jurisdiction to regulate tobacco products.

In agreeing with the circuit court, the Supreme Court reasoned that there is no way that cigarettes can be made a safe device for delivering their intended effects. Therefore, the FDCA would require FDA to find that cigarettes are mislabeled, as there are no possible directions for safe use. If the FDA had jurisdiction to regulate tobacco products, Justice O’Connor declared, “it could not allow them to be marketed.”

She wrote for the majority: “Congress, however, has foreclosed the removal of tobacco products from the market.” She also said that Congress had addressed the problems of tobacco and health through legislation on six occasions since 1965. “The collective premise of these statutes is that cigarettes and smokeless tobacco will continue to be sold in the United States,” she wrote.

Speaking for herself and four fellow Justices, Justice O’Connor declared that “Congress has created a distinct regulatory scheme to address the problem of tobacco and health, and that scheme, as presently constructed, precludes any role for the FDA.”

She noted that on several occasions Congress had debated giving FDA this jurisdiction, but “none of these proposals became law.” Congress had also denied the Federal Trade Commission and the Consumer Product Safety Commission the power to regulate aspects of tobacco.

The Dissenters

The dissenters, led by Justice Stephen Breyer, insisted that tobacco products do fall within the scope of the law and that Congress neither forbade nor approved an FDA role in regulating tobacco in 35 years of legislation on the subject.

“This history shows only that Congress could not muster the votes necessary either to grant or deny the FDA relevant authority,” Justice Breyer wrote.

He and three other Justices argued that the original FDCA was broad enough to encompass tobacco. That allowed the agency to change its mind and decide that it does have the power to act once it received evidence that the tobacco companies knew that nicotine achieved its appetite-suppressing and mood-altering effects through chemically induced changes in the brain.

Justice Breyer insisted that the FDCA would not require FDA to ban cigarettes if the FDA’s actions were upheld. “But even if I am wrong about the ban, the statute would restrict only the agency’s choice of remedies, not its jurisdiction,” he wrote.

Justice O’Connor for the Majority

However, Justice O’Connor ruled for the majority that “Congress has affirmatively acted to address the issue of tobacco and health, relying on the representations of the FDA that it had no authority to regulate tobacco. It has created a distinct scheme to regulate the sale of tobacco products, focused on labeling and advertising, and premised on the belief that the FDA lacks such jurisdiction under the FDCA. As a result, Congress’ tobacco-specific statutes preclude the FDA from regulating tobacco products as customarily marketed.”

Justice O’Connor took great pains to clarify that the high court does not “question the seriousness of the problem that the FDA has sought to address.” She made it clear that tobacco use, especially among children and adolescents, is a serious threat to public health. But she said that Congress had not given FDA authority to address this major public health threat.

The high court’s decision negates FDA requirements that retailers selling cigarettes check photo identification of persons who appear younger than age 27 to determine that they are at least age 18.