The new rule is made possible by last year's passage of the FamilySmokingPrevention and Tobacco Control Act, which gave the FDA the long-sought power to regulate tobacco.
The rule, which has the force of federal law, takes effect on June 22. Among its provisions:
- Bans sale of cigarettes or smokeless tobacco to anyone under age 18.
- Forbids tobacco brand-name sponsorship of any "athletic, musical, or other social or cultural event, or any team or entry in those events."
- Bans sale of cigarette packs containing fewer than 20 cigarettes.
- Bans sale of cigarettes via vending machines or self-service displays "except in very limited situations."
- Prohibits free samples of cigarettes and limits samples of smokeless tobacco.
- Forbids gifts in exchange for buying tobacco products.
- Allows only words -- and no music or sound effects -- in audio ads for tobacco products.
- Bans the sale or distribution of gear, such as hats and T-shirts, with tobacco brands or logos.
Defending the restrictions on youth-oriented tobacco ads, Health and Human Services Secretary Kathleen Sebelius noted that the indirect advertising allowed under current rules is effectively reaching young people.
"Despite a ban on direct marketing to young Americans, tobacco companies have still found a way to reach out to them," Sebelius said at a news conference. "It's no accident that Marlboro, Camel, and Newport, the three brands that spend the most on ads, are more preferred by children than by adults."
Sebelius has asked Health and Human Services Assistant Secretary Howard K. Koh, MD, MPH, to lead the enforcement effort. Accepting the job, Koh said the key to antismoking efforts is preventing youth smoking.
"We all know and understand that tobacco dependence is recognized as a pediatric disease," Koh said at the news conference. "Ninety percent of users begin before 19 years of age. Many die too early, and for them prevention comes too late."
Koh said the Department of Health and Human Services and the FDA would team with states to help them inspect retail sites and to enforce the new rule. FDA Director Margaret Hamburg, MD, said that the FDA would provide grants to states in order to help defray the costs of inspection and enforcement.
Hamburg was asked whether lawsuits already filed by tobacco interests would delay enforcement of the new rule.
"We are committed to implementing the law and the issuance of the regulations we announce today. That is in the law and we are moving forward with that," she said at the news conference.