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Supreme Court Rules FDA Cannot Regulate Tobacco

Dateline: 03/21/00

The U.S. Supreme Court today ruled that the Food and Drug Administration has no authority to regulate tobacco products as addictive drugs.

Upholding an earlier ruling, the court found that the FDA had exceeded its authority when it issued regulations involving cigarettes and smokeless tobacco products in 1996.

In its 39-page, 5-4 ruling, the court stated that Congress intended to exclude tobacco products from the FDA's jurisdiction.

According to the court's decision, the Food Drug and Cosmetics Act requires that any product regulated by the FDA that remains on the market must be found by the FDA to be "safe and effective for its intended use." 

But, the court goes on to find that the FDA itself had "exhaustively documented that tobacco products are unsafe, dangerous and cause great pain and suffering from illness." This fact, according to the court, should have compelled the FDA to order the removal of tobacco products from the market. However, Congress precluded such a ban by "choosing instead to create a distinct regulatory scheme focusing on the labeling and advertising of cigarettes and smokeless tobacco," according to the court.

In its decision, the Supreme Court concludes, "The inescapable conclusion is that there is no room for tobacco products within the FDCA’s regulatory scheme. If they cannot be used safely for any therapeutic purpose, and yet they cannot be banned, they simply do not fit."

Reference Resources

FDA v. Brown & Williamson Tobacco Corp.
Complete text of today's landmark Supreme Court decision the FDA's lack of authority to control tobacco products. From the Cornell Legal Information Institute.

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