What was the recent court ruling in the suit against FDA?
On April 25, 1997, Judge William Osteen of the Federal District Court in Greensboro, North Carolina, ruled that FDA has jurisdiction under the Federal Food, Drug, and Cosmetic Act (the Act) to regulate nicotine-containing cigarettes and smokeless tobacco. The Court held that tobacco products fit within the Act’s definitions of ‘drug’ and ‘device,’ and that FDA can regulate cigarettes and smokeless tobacco products as drug delivery devices under the combination product and restricted device provisions of the Act. With respect to the tobacco rule, the Court upheld all restrictions involving youth access and labeling, including the two access provisions that went into effect Feb. 28. The Court also upheld access and labeling restrictions originally scheduled to go into effect Aug. 28, 1997, including the prohibition on self-service displays and the placement of vending machines where children have access to them. The Court also upheld the ban on distribution of free samples, the sale of s
