Fourth Circuit Court rules against FDA regulation of tobacco products

American Cancer Society
Friday, 14 August 1998

Washington 1998/08/14 -Today, the Fourth Circuit Court of Appeals ruled the U.S. Food and Drug Administration does not have the authority to regulate tobacco products as a drug or device.

"The American Cancer Society is confident that the Supreme Court will reverse the decision," said Linda Crawford, ACS national vice president for state and federal government relations. "In the meantime, we will continue to encourage Congress to pass legislation to control the content of tobacco products, their labeling, marketing and advertising as well as other measures designed to prohibit our children from becoming addicted."

Previously, the FDA asserted jurisdiction over cigarettes and smokeless tobacco under the drug and medical device provisions of the Federal Food, Drug and Cosmetic Act. Specifically, the FDA concluded cigarettes and smokeless tobacco are "combination products" consisting of both nicotine, a drug that causes addiction and other significant pharmacological effects on the human body, and a device component that delivers nicotine to the body.

"We believe proper regulatory authority must be maintained by the Food and Drug Administration so that our nation begins to affirm a permanent, long-term approach to the harmful effects of smoking. Only through the regulatory authority of tobacco products can the tobacco industry be made accountable for its actions and practices -- practices which addict our children to assure future generations of smokers and perpetuate the loss of 418,000 Americans a year," Crawford added. "This is yet another reason that the Senate should have passed the comprehensive tobacco control legislation it was considering earlier this summer. The American Cancer Society calls on Congress to pass constructive, comprehensive tobacco control legislation. ACS is available to work with Congress to develop legislation which affirms the proper governmental regulation of tobacco products."

For more information, or to contact American Cancer Society, see their website at: www.cancer.org