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Date: Friday, Aug. 23, 1996 FOR IMMEDIATE RELEASE Contact: Jim O'Hara, (301) 443-1130
President Clinton today announced the nation's first comprehensive program to prevent children and adolescents from smoking cigarettes or using smokeless tobacco and beginning a lifetime of nicotine addiction. The President's announcement comes a little more than a year after the Food and Drug Administration (FDA) issued its proposed rule to reduce the access and appeal of tobacco products for children and adolescents.
The FDA rule-making on children and tobacco prompted the largest outpouring of public response in the Agency's history with more than 95,000 individual comments received, totaling more than 700,000 pieces of mail when form letters are counted. The final rule was put on display today at the Federal Register and will be published in the Federal Register next week.
Each day, almost 3,000 young people in the United States become regular smokers, and nearly 1,000 of them will die prematurely from diseases related to tobacco use. Each year, more than 400,000 Americans die from smoking-related diseases, more Americans than are killed each year by AIDS, alcohol, car accidents, murders, suicides, illegal drugs, and fires combined.
In the past four years, the United States has experienced dramatic increases in tobacco use by youngsters. Between 1991 and 1995, the percentage of eighth- and tenth-graders who smoke increased 34 percent. In 1995, more than a third of 12th-graders reported smoking in the past month, and daily smoking in that group was up to 21.6 percent. Among 10th-graders, current use was up to 27.9 percent, and daily use was up to 16.3 percent.
The President's goal is to cut in half tobacco use by children and adolescents over the next seven years.
"This is the most important public health initiative of our generation," said Health and Human Services Secretary Donna E. Shalala. "Our children's futures are at stake. President Clinton's action will ensure that children get their information about tobacco from their parents -- and not from Joe Camel."
The President's initiative to protect children is based on the final FDA rule that will make it harder for young people to buy cigarettes and smokeless tobacco and will reduce the appeal of tobacco products to children under 18. The rule is based on the Agency's finding that cigarettes and smokeless tobacco products are delivery devices for nicotine, an addictive drug. In addition to the rule, the FDA will propose to require tobacco companies to educate children and adolescents about the health risks of tobacco use as part of the President's initiative. This national mass media campaign would be monitored for its effectiveness.
Cigarettes and smokeless tobacco products remain legal products that can be marketed and sold to adults, 18 years and older.
"Nicotine addiction is a pediatric disease that often begins at 12, 13, and 14 only to manifest itself at 16 and 17 when these children find they cannot quit," said Commissioner of Food and Drugs David A. Kessler, M.D. "By then our children have lost their freedom and face the prospect of lives shortened by terrible diseases."
The President's initiative follows the recommendations of major medical and scientific organizations such as the American Medical Association and National Academy of Science's Institute of Medicine. It is a prevention strategy based on reducing children's access to tobacco products and limiting the appeal of these products to children. The tobacco industry spends more than $6 billion annually on advertising and promotion.
Besides the final rule, the FDA will propose to require tobacco companies to provide strong educational messages for children on the real dangers of smoking and using smokeless tobacco. This national multi-media campaign would include television spots, and it would be monitored for its effectiveness. FDA intends to begin consultations about this campaign with the nation's six tobacco companies with a significant share of sales to children. Under Section 518 of the Federal Food, Drug, and Cosmetic Act, the FDA may require companies to inform consumers about the unreasonable health risks of their products.
"We have to tell our children the truth about the diseases caused by smoking," Kessler said. "For too long we have sent conflicting messages to our children and then have acted surprised when they begin to smoke."
In reviewing the public comments and developing a final rule, the FDA made a number of changes to more narrowly tailor provisions to children. For instance, there was little evidence presented that mail-order sales are used by children and adolescents, while they are used by adults in rural areas. Similarly, vending machines in facilities totally inaccessible to persons under 18 will accommodate adults while preventing easy access by young people.
The FDA rule reduces children's easy access to tobacco products by:
The FDA rule limits the appeal of tobacco products to children by:
These provisions will be phased in between six months and two years from the date of publication in the Federal Register to give businesses adequate time to comply.