Saving our children from tobacco

President Clinton announced on Aug. 23 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 came a little more than a year after the Food and Drug Administration 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 published in the Federal Register of Aug. 28, 1996.

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 last four years, the United States has experienced dramatic increases in tobacco use by youngsters. Between 1991 and 1995, the percentage of eighth- and 10th-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.

President Clinton'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, 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.

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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, 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 multimedia 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, 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, 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 in-accessible 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.

Banning free samples and 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.

Final Rule Summary

Minimum age of 18 to buy tobacco products.

Ban vending machines and self-service displays, except in certain nightclubs and other "adult only" facilities totally inaccessible to persons under 18.

Ban "kiddie" packs, "loosies," or free samples.

Mail-order sales permitted.

Ban billboards within 1,000 feet of schools and playgrounds.

Other billboards and outdoor and in-store advertising limited to black-and-white text-only, except color, imagery permitted in "adult only" facilities if not visible from outside and not removable.

Advertising in publications with significant youth readership (more than 15 percent or 2 million) limited to black-and-white text only.

Ban brand-name sponsorship of sporting or other events, including cars and teams; only corporate name sponsorship permitted.

Ban brand names on hats, t-shirts, gym bags, etc.

LEGAL ISSUES RELATING TO FDA RULE ON CHILDREN AND TOBACCO

FDA Jurisdiction

FDA has concluded that cigarettes and smokeless tobacco are delivery devices for nicotine, a drug that causes addiction and other significant pharmacological effects. The Federal Food, Drug, and Cosmetic Act provides that a product is a drug or device if it is an article (other than food) "intended to affect the structure or any function of the body."

Nicotine in cigarettes and smokeless tobacco does "affect the structure or any function of the body" because nicotine in these products:

causes and sustains addiction

causes other mood-altering effects, including tranquilization and stimulation
controls body weight.

Manufacturers of cigarettes and smokeless tobacco "intend" these effects because:

The addictive and pharmacological effects are so widely known and accepted,a reasonable manufacturer can foresee the products will be used by consumers for these effects.

Consumers use these products predominantly for pharmacological purposes.

Manufacturers know that nicotine in their products causes pharmacological effects and consumers use their products primarily to obtain these effects.

Manufacturers of these products design the products to provide consumers with a pharmacologically active dose of nicotine.

An inevitable consequence of the design of these products to provide consumers with a pharmacologically active dose of nicotine is to sustain consumers' addiction to nicotine.

Rule Protects Appropriate Commercial Speech

The U.S. Supreme Court has upheld restrictions on commercial speech if certain standards are met. Given that selling cigarettes and smokeless tobacco to children under 18 is already illegal in every state, the rule is aimed at regulating commercial speech to ensure that an illegal activity is not promoted. Furthermore, the rule is narrowly tailored to meet the tests established by the U.S. Supreme Court in its opinions on commercial speech, including 44 Liquormart, Inc. v. Rhode Island.

Protecting the health of children under 18 is a substantial government interest justifying restrictions on tobacco advertising that appeals to children.

Advertising and promotion have been shown to play a material role in children beginning and continuing to use tobacco products, and therefore the regulations directly advance the government's interest.

Permitting unrestricted advertising in publications primarily read by adults and permitting companies to sponsor events in the corporate name--instead of the brand identifications so appealing to young people--are examples of how the rule is narrowly tailored to advance the government's interest.

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