• President Clinton today established the nation's first-ever comprehensive program to protect children from the dangers of tobacco and a lifetime of nicotine addiction with the publication of the Food and Drug Administration's final rule on tobacco and children, and with FDA's initiation of a process to require tobacco companies to educate children and adolescents -- using a national multi-media campaign -- about the dangers of cigarettes and smokeless tobacco.

  This comprehensive and coordinated plan is intended to reduce tobacco use by children and adolescents by 50 percent in seven years. It builds on previous actions taken by Congress and others such as the ban on television advertising and state laws to prohibit the sale or use of tobacco by children. It follows recommendations by the American Medical Association and the National Academy of Science's Institute of Medicine. Experts have consistently recommended that the keys to achieving the goal are reducing access and limiting the appeal to children. This ambitious initiative accomplishes that objective while preserving the availability of tobacco products for adults.

Reducing Easy Access by Children

Children and adolescents continue to have easy access to tobacco products. In 13 studies reviewed by the Surgeon General, minors were successfully able to buy cigarettes 67 percent of the time. Of the nine studies of vending machines, illegal sales were successful on average 88 percent of the time. The FDA rule will:

• Require age verification and face-to-face sale (except for mail orders), and eliminate free samples, and the sale of single cigarettes and packages with fewer than 20 cigarettes.
• Ban vending machines and self-service displays except in facilities where only adults are permitted, such as certain nightclubs totally inaccessible to persons under 18.

Reducing Appeal to Children

Tobacco products are among the most heavily advertised and promoted products in the United States, with the tobacco industry spending more than $6 billion annually. Children and adolescents are widely exposed to and influenced by this advertising and promotion. One study found that 30 percent of 3-year-olds and 91 percent of 6-year-olds could identify "Joe Camel" as a symbol of smoking. Another study found that 86 percent of underage smokers who buy their own cigarettes purchase one of the three most heavily advertised brands. The FDA rule will:

• Ban outdoor advertising within 1,000 feet of schools and publicly-owned playgrounds. Permit black-and-white text- only advertising for all other outdoor advertising, including billboards, signs inside and outside of buses, and all point-of-sale advertising. Advertising inside "adult only" facilities like nightclubs can use color and imagery.
• Permit black-and-white text-only advertising in publications with significant youth readership (under 18). Significant readership means more than 15 percent or more than 2 million. There are no restrictions on print advertising below these thresholds.
• Prohibit sale or giveaway of products like caps or gym bags that carry cigarette or smokeless tobacco product brand names or logos.
• Prohibit brand-name sponsorship of sporting (including teams and entries) or entertainment events, but permit it in the corporate name.

Educating Children About Real Dangers of Smoking

In addition to the rule and its provisions aimed at reducing access and appeal, the FDA will propose to require each of the six tobacco companies with significant sales to children to educate young people about the real health dangers associated with the use of tobacco products. This national multi-media campaign, including television spots, would be monitored for its effectiveness.

The FDA will initiate the process under Section 518 of the Federal Food, Drug, and Cosmetic Act, which allows the FDA to require companies to notify consumers about the unreasonable health risks of their products.

Focusing on Children

In reviewing the more than 95,000 individual comments received from the public during the comment period, the FDA made a number of changes aimed at more narrowly targeting the rule to its goal: reducing the use of tobacco products among children and adolescents under 18. Changes include:

• Vending machines and self-service displays will be allowed in facilities where only adults are permitted. By removing vending machines and self-service displays from sites accessible to children, the rule's goal will still be achieved, and the Agency will closely monitor the effectiveness of this provision for two years to determine if additional restrictions are necessary.
• Mail-order sales will be permitted. This provision will allow adults in rural or isolated areas to have access to these products. There was little evidence presented that children use mail order at the present time, but the Agency will monitor future trends.
• Advertising using color and imagery will be permitted in "adult only" facilities totally inaccessible to persons under 18, provided that the advertising is not visible from the outside and is not removable.

Some state and local laws that are different from, or in addition to, this rule will be preempted under this rule. However, the Agency is establishing an expedited process for state and local government to apply for waivers for more stringent laws or regulations. The FDA believes the requirements it is establishing set an appropriate floor but as a matter of policy, the Agency should leave open the possibility for state or local governments to adopt more restrictive requirements. State laws not related to the rule -- such as local bans on smoking in restaurants -- will not be affected.

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