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;

   

  -- nicotine in these products causes other mood-altering effects, including tranquilization and stimulation;

   

  -- nicotine in these products 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; and

   

  -- 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; and

   

  -- 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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