Saving Children from Tobacco, Part 2

by Food and Drug Administration (FDA)

(Page 2 of 2)

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 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.

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 that 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.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.