Opinion: 529 U.S. 120 (2000)

HOLDING:  The Food, Drug and Cosmetic Act, as then in effect, did not give the FDA authority to regulate tobacco products as customarily marketed without any claims of therapeutic benefits because Congress had created a separate statutory scheme to regulate it. This ruling was later superseded by statute.

The Food and Drug Administration began regulating tobacco products in 1996 when it classified tobacco as a drug within the meaning of the Food, Drug, and Cosmetic Act, a law which gives the FDA the authority to oversee the safety of food, drugs, medical devices, and cosmetics.  It found that tobacco use caused more than 400,000 deaths annually, with most adult smokers picking up the habit when they were minors.  The FDA then issued regulations targeting the promotion, labeling, and accessibility of tobacco to children and adolescents, including prohibition of the sale of cigarettes to people under the age of 18.

A group of tobacco manufacturers, retailers, and advertisers challenged the FDA’s regulations in the Middle District of North Carolina.  They claimed that tobacco products did not qualify as a drug under the FDCA, which meant the FDA had no authority to regulate tobacco products.  They also claimed that the regulations against tobacco advertisements violated the First Amendment.  The District Court agreed that the advertisement regulations exceeded the FDA’s authority but concluded that regulations governing access and sale of tobacco to minors were within the FDA’s statutory authority. 

The Fourth Circuit reversed, holding that Congress had not granted the FDA authority to regulate tobacco products.  The Supreme Court affirmed.  The Court noted that Congress had enacted several other laws regulating tobacco at times when the FDA had consistently stated that it lacked authority to regulate tobacco.  Congress had also considered and rejected bills which would have granted the FDA the necessary authority.  These actions showed that Congress created a distinct statutory scheme to regulate tobacco and did not intend for the FDA to have that power.  Regulations, the Court held, “must always be grounded in a valid grant of authority from Congress.”

This decision was superseded in 2009 by the Family Smoking Prevention and Tobacco Control Act, a statute which gave the FDA the authority to regulate tobacco products.