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:
- Requiring age verification by photo ID for anyone under the age of 27
purchasing tobacco products;
- Banning vending machines and self-service displays except in "adult"
facilities where children are not allowed, such as certain nightclubs
totally inaccessible to anyone under 18; and
- Banning free samples, the sale of single cigarettes, and packages
containing fewer than 20 cigarettes.
The FDA rule limits the appeal of tobacco products to children by:
- Prohibiting billboards within 1,000 feet of schools and playgrounds. Other advertising is restricted to black-and- white text only; this includes all billboards, signs inside and outside of buses, and all advertising in stores. Advertising inside "adult only" facilities like nightclubs can have color and imagery.
- Permitting black-and-white text-only advertising in publications with significant youth readership (under 18). Significant youth readership means more than 15 percent or more than 2 million readers under 18; there are no restrictions on print advertising below these thresholds.
- Prohibiting sale or giveaways of products like caps or gym bags that carry cigarette or smokeless tobacco product brand names or logos.
- Prohibiting brand-name sponsorship of sporting or entertainment events (including teams and entries), but permitting it in the corporate name.
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.
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