Tobacco companies question FDA's authority before Supreme Court

Tobacco companies question FDA’s authority before Supreme Court

• Justices heard arguments challenging a 1996 FDA regulation designed to protect children from exposure to tobacco products by restricting tobacco advertising.

While tobacco products are not “safe,” they are not entirely “unsafe,” the U.S. government told the nation’s highest court in early December. The Court is considering arguments from the government and tobacco companies regarding a 1996 FDA regulation designed to protect children by restricting tobacco advertising.

At the heart of the justices’ questions was whether the FDA has the authority to regulate tobacco product sales. Solicitor General Seth Waxman argued for the government that the FDA derives its authority from the Food, Drug, and Cosmetic Act, which allows the agency to regulate “drugs” and “devices” that deliver drugs. Justice David Souter, however, noted the FDA has conceded in the past that it lacks jurisdiction over tobacco products. Furthermore, Souter pointed out that the FDA’s act of choosing to regulate an unsafe product but not ban it suggests an “unusual analysis,”and Congress already has supplied a sufficient regulatory scheme for tobacco products.

Representing the tobacco industry, attorney Richard Cooper argued that the FDA’s assertion of jurisdiction over tobacco products is “lawless,” hurts the Food, Drug, and Cosmetic Act, and severely weakens consumer protection provisions of the law.

Justice Sandra Day O’Connor questioned Waxman about the FDA’s authority to regulate tobacco products based solely on their effects on the body. O’Connor asked whether the FDA could regulate the film industry because a person can be scared by a movie, and that would have an effect on his body.

The issue of whether the FDA’s regulation unconstitutionally limits commercial speech has not been addressed in the appeal, because the tobacco companies first alleged the FDA does not have regulatory authority at all in this area.

In mid-August 1996, the U.S. Court of Appeals in Richmond (4th Cir.) held that the FDA regulation designed to protect children by restricting tobacco advertising and promotion exceeds the agency’s jurisdiction.

The Food and Drug Administration issued a rule in August 1996 that classified tobacco products as drugs and drug-delivery devices, which enabled the agency to regulate the sale and distribution of tobacco to children and adolescents. The new regulation prohibits outdoor tobacco advertising within 1,000 feet of public playgrounds and schools, and limits advertisements in all existing media forms to “black-and-white, text-only format.” Additionally, the tobacco companies are not allowed to sell or distribute promotional items with their brand names or logos, nor can they use their logos or brand names when sponsoring sporting, musical, or cultural events, or teams or entries in those events.

(FDA v. Brown & Williamson Tobacco Corp.)

© 1999 The Reporters Committee for Freedom of the Press

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