The government will seek review of this decision by the full Fourth Circuit. Under the court of appeals' rules, unless otherwise directed by the Fourth Circuit, the effect of the decision is automatically stayed, meaning the status quo is maintained until the court has the opportunity to rule on the government's rehearing request. This means, pending the court's review, the parts of the FDA tobacco program that have been in effect since February 1997 will remain in effect.
This case involves an appeal of an April 25, 1997, decision from Judge William Osteen of the U.S. District Court in Greensboro, N.C. The district court ruled that FDA does have jurisdiction under the Federal Food, Drug, and Cosmetic (FD&C) Act to regulate nicotine-containing cigarettes and smokeless tobacco as drug-delivery devices, upholding the restrictions that involved youth access and labeling, including the two provisions that went into effect Feb. 28, 1997: a prohibition on sales of these products to persons under age 18 and a requirement that retailers check photo IDs of purchasers under age 27. Judge Osteen, however, invalidated FDA's restrictions on the advertising and promotion of cigarettes and smokeless tobacco, finding that the agency exceeded its statutory authority. Both sides then appealed.
In the Fourth Circuit, the majority opinion held that FDA's jurisdiction to regulate drugs and devices does not include cigarettes and smokeless tobacco. The court, however, did not reject FDA's conclusion that these products fall within the FD&C Act's definitions of "drugs" and "devices." Instead, the majority opinion concluded, based on several sources of evidence, that Congress did not intend the FD&C Act to apply to these products. This evidence included what the court viewed as a lack of regulatory tools in the act appropriate for the regulation of tobacco products; prior statements by FDA that it lacked authority to regulate tobacco products in the absence of express claims; congressional inaction on bills to grant FDA explicit jurisdiction over tobacco products; and tobacco-specific legislation approved by Congress such as the Federal Cigarette Labeling and Advertising Act, the Comprehensive Smokeless Tobacco Health Education Act, and the Alcohol, Drug Abuse, and Mental Health Administration Reorganization Act of 1992.
Judge Hall agreed with FDA on all issues and dissented from the majority opinion. He concluded that tobacco products fit comfortably within the FD&C Act's "drug" and "device" definitions, and that the evidence falls far short of demonstrating that Congress intended to deny FDA jurisdiction over tobacco products. He wrote that he would have found that not only does FDA have jurisdiction to regulate tobacco products, but that all of FDA's regulations, including the advertising restrictions, are within the agency's authority. He explained that how FDA has chosen to regulate tobacco products has no bearing on the question of whether the agency has the authority to regulate them at all.
As noted earlier, the access restrictions in effect since February 1997 remain in effect pending the court's review of the government's rehearing request. Therefore, FDA is continuing to enforce the age and picture ID provisions of the tobacco regulations, which prohibit retailers from selling cigarettes and smokeless tobacco to persons younger than 18 years of age, and require retailers to examine the photo ID of persons younger than age 27 before selling these products to them. FDA will continue to disseminate an advertising campaign in states where contracts for enforcement are active, and will continue to bring civil money penalty actions against retailers who violate the provisions now in effect.