FDA ruling overturned

After failing to assert its authority over tobacco products since 1914, the Food and Drug Administration (FDA) in the United States published a final rule on 28 August 1996 entitled “Regulations restricting the sale and distribution of cigarettes and smokeless tobacco to protect children and adolescents”. That final rule is available at

< http://www.fda.gov/opacom/campaigns/tobacco/frule.html >.

On 25 April 1997 Federal Judge William Osteen, a former tobacco lobbyist, upheld the FDA initiative in part, writing that “Tobacco products fit within the Food and Drug and Cosmetic Act’s definition of ‘drug’ and ‘device’.” Although blocking plans to initiate restrictions on tobacco advertising and promotional activities, Judge Osteen let stand the FDA’s crackdown on tobacco sales to minors that required stores to demand identity cards with photographs from people in their 20s and imposed government regulation of cigarette sales from vending machines. That decision is available at

< http://www.tobacco.neu.edu/FDA/osteen.htm >.

On 14 August 1998 a three-judge panel of the fourth Circuit Court of Appeals voted two to one to reverse Judge Osteen’s ruling imposing the FDA crackdown on tobacco sales to minors by denying the FDA authority to regulate tobacco products as drug-delivery devices. The appellate court ruled that such regulation was left up to Congress. The appellate court decision is available at

< http://www.law.emory.edu/4circuit/aug98/971604.p.html >.

On the same day that the court issued its decision, President Bill Clinton announced that the solicitor general had “authorized the filing …