Supreme Court Holds F.D.A. Cannot Regulate Tobacco:
Tobacco Industry Dodges Another Bullet

By Melanie R. Margolis

On March 21, 2000, the United States Supreme Court held that the Food and Drug Administration (F.D.A.) cannot regulate tobacco as a drug in F.D.A. v. Brown & Williamson Tobacco Corp. (98-1152), 153 F.3d 155. The bullet narrowly missed the tobacco industry in a 5-4 decision affirming the Fourth Circuit court's decision (discussed at Food/980819Tobacco.html). Justice O'Connor delivered the opinion in which she was joined by Justices Rehnquist, Scalia, Kennedy, and Thomas. Justice Breyer, joined by Justices Stevens, Souter, and Ginsburg, filed a dissenting opinion. The question before the Court was whether F.D.A. had authority under the federal Food, Drug, and Cosmetic Act (F.D.C.A.) to regulate tobacco products as customarily marketed.

In August 1996, the F.D.A. put in place regulations aimed at curbing smoking by minors. The regulations prohibited tobacco sales to person under 18, required a photo identification of all tobacco purchasers under age 27, and restricted vending machine cigarette sales to adults-only locations. According to the F.D.A., more than 400,000 people die annually from tobacco-related illnesses, 82% of adult smokers had their first cigarette as a minor, more than 50% of adult smokers became regular smokers before the age of 18, smoking is a pediatric disease because 1 in 3 youths who become regular smokers will die prematurely as a result of it. The theory behind the F.D.A.'s regulations was that by reducing the number of children who smoke, the tobacco-related illnesses can be reduced because people who do not begin smoking as minors are unlikely to pick up the habit.

The Court outlined the F.D.A.'s arguments that nicotine is a drug and tobacco products are devices for purposes of the F.D.C.A., and concluded that if they are, the F.D.A. would have to ban them because it would be impossible to adequately protect consumers from their dangers and the products could not be made safe. The Court determined that tobacco products do not fit within the F.D.C.A.'s regulatory scheme because the F.D.C.A. did not permit a drug or device that cannot be used safely for any therapeutic purpose to remain on the market.

Furthermore, Congress has enacted six pieces of legislation pertaining to human health and tobacco use since 1965, that addressed, for example, requiring health warnings on cigarette packages and prohibiting advertising of tobacco on television. In addition, the F.D.A. had expressly disavowed having the authority to regulate tobacco numerous times before it changed course. The Court stated that Congress had created a distinct regulatory scheme for tobacco that focuses on labeling and advertising. Although it acknowledged the seriousness of the problem the F.D.A. seeks to address, the Court concluded that Congress has plainly not given the F.D.A. the authority to regulate tobacco.

Thus, the tobacco industry, which has been under fire for years, dodged another bullet. In 1998, it dodged the bullet of comprehensive regulation by Congress.

The industry has been facing a barrage of lawsuits. Last September the U.S. Department of Justice filed a suit that is pending against major tobacco companies alleging that they conspired to defraud the public about the effects of smoking and seeking to recover the costs of smoking-related illnesses that cost the federal government billions of dollars through Medicare, Veterans' health, and other federal health care programs. The states have already sued the tobacco industry over tobacco-related health care costs, and some of the money received by the states will be used to try to curb teen smoking. Even individuals harmed by the use of tobacco have been winning lawsuits against tobacco companies. These lawsuits merely chip away at the industry.

Yesterday President Clinton urged Congress to pass a law that would give effect to the F.D.A.'s tobacco regulations. The tobacco industry says it wants to work with the government to keep tobacco products out of the reach of children, but it continues to fight every attempt by the government to put controls in place. The bottom line is that the industry's narrow victory in this lawsuit has the immediate effect of endangering children's health. Yesterday afternoon when the Supreme Court ruling came down, the Texas Department of Health (T.D.H.) received instructions from the F.D.A. to stop conducting F.D.A.-sponsored retailer compliance checks immediately. The F.D.A. had given T.D.H. $277,000 to conduct inspections of retail outlets throughout Texas to determine whether stores were complying with federal regulations on tobacco sales to minors. As a result, it will be easier for children to buy cigarettes today than it was yesterday. It is now clear that Congress must act if Americans are to have any hope that tobacco will not continue to jeopardize children's health.

03/22/00