FDA's View: Tobacco Ad Regulations Pass Central Hudson Test In a First Amendment analysis outlined in the final rule's executive summary, the FDA concludes that, "at least to the extent that tobacco advertising is related to sale of these products to children under 18, it is not speech protected by the First Amendment." Nonetheless, the FDA "did not rest its regulation solely on this rationale," but applied the Central Hudson test with the following results: (1) Threshold test: Advertising not false or misleading. FDA did not address this point directly, but asserted that tobacco ads are in part related to an "unlawful activity" (smoking by minors). (2) Is the government's interest substantial? "Even those who opposed the regulation did not seriously contest that the government had a substantial interest in protecting the health of individuals under 18 years of age." (3) Do the regulations directly advance the government's interest? "The agency found. . . that advertising plays a material role in children's tobacco use, and that the l regulation will contribute to a reduction in young people's use of tobacco." (4) Are the provisions of the regulation narrowly drawn? "The agency agreed with the ['reasonable fit'] interpretation [rather than 'least restrictive means'] and found that its regulation meets this requirement by restricting only those elements of advertising and promotion that affect young people, while preserving those aspects of advertising that provide information to adults." -RTK

FDA Restrictions on Tobacco Advertising To Be Challenyed in North Carolina Court By Richard T. Kaplar President Clinton ignited a constitutional firestorm Aug. 23 when he unveiled sweeping restrictions on tobacco advertising as part of a "comprehensive program" to prevent tobacco use by minors. The tobacco ad restrictions, part of the FDA's broader package of marketing restrictions spelled out in the agency's 922page final rule, are already headed for court. The U.S. District Court for the Middle District of North Carolina (Greensboro) is considering two requests for declaratory judgment and injunctive relief -- one from a group of six tobacco manufacturers and another from a coalition of advertiser and agency groups. Both groups amended existing complaints before the court to include the FDA's final rule. The industry groups charge that the FDA has no regulatory authority over cigarettes and that the agency's asserted jurisdiction violates, among other things, the First Amendment. Tobacco ad restrictions in the final rule are similar in most respects to the proposed rules issued in August 1995 (see side-by-side comparison). Billboards would be banned within 1,000 feet of schools and playgrounds; much advertising would be limited to a black-and-white "tombstone" format; brand name sponsorship of sporting events would be banned, as would brand names on caps, shirts, and other items; and tobacco companies would be required to mount an anti-smoking educational campaign aimed at young people. The FDA requirements would preempt comparable state and local regulations. Among the key differences reflected in the final rules: Color and imagery would be permitted in advertising within "adult only" facilities such as nightclubs. The ban on brand name sponsorship of sporting events would be extended to include cars and teams. A $150-million annual educational campaign funded by tobacco manufacturers would be replaced by plans to invoke Section 518 of the Food, Drug, and Cosmetic Act to require six tobacco companies "to educate young people about the health risks of using their products." No dollar amount is specified. Industry sources and outside experts were quick to challenge the advertising restrictions. "Nobody quarrels with the goal of stopping teen tobacco use. But a governmentimposed restriction of truthful speech about a legal product is not the way to do it," said Hal Shoup, executive vice president of the American Association of Advertising Agencies. "The Supreme Court keeps saying this loud and clear. Let's hope the anti-tobacco folks get the message and focus on far more narrowly tailored solutions." "There are many ways to protect children from tobacco without trampling on the U.S. Constitution. We wish the president had limited himself to those methods," said Amy Moritz, president of the National Center for Public Policy Research. "The FDA's rule sets the stage for restrictions that could lead the agency to do even more to deprive adults of their rights," said Steven Parrish, senior vice president of corporate affairs for Philip Morris Companies Inc. Parrish said the company "will continue to support a legislative solution in the Congress to solve underage tobacco use." "The Founders of this country made no distinction between commercial and political speech. Each was fully protected under the First Amendment," said Craig R. Smith, president of the Freedom of Expression Foundation. "Since many of the Founders were tobacco farmers, it is hard to imagine that they would've restricted information to consumers about tobacco products." Implementation. The ad restrictions are scheduled to take effect one year after the final rule's Aug. 28 publication in the Federal Register. However, the ban on brand name sponsorship of events would take effect in two years, given the long-term nature of sponsorship contracts. Meanwhile, many court observers believe that legal and constitutional challenges will keep the regulations from being enforced well beyond next August -- and possibly for years.

Tobacco Ad Restrictions at a Glance
Proposed Rule	Final Rule	Department of Health and Human Services, FDA, "Regulations restricting the sale and distribution of cigarenes and smokeless tobacco to protect children and adolescents; final rule," 21 CFR Part 801, et al., Federal Register, Vol. 61, No. 168 (Part II), Aug. 28,1996. Contact: Jim O'Hara, HHS, 301-443-1130
Ban billboards within 1,000 feet of schools and playgrounds	Same
Other billboards, outdoor, and instore advertising limited to blackand-white text only	Same 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 % or 2 million) limited to black-and-white text only	Same
Ban brand-name sponsorship of sporting or other events; only corporate name sponsorship permitted	Same, INCLUDING cars and teams
Ban brand names on hats, t-shirts, gym bags, etc.	Same
$150-million annual fund, paid by tobacco manufacturers, to conduct a national educational campaign.	Using Section 518 of the Federal Food, Drug, and Cosmetic Act, the FDA will propose to require the six tobacco companies with significant children's sales to educate young people about the health risks of using their products.
Source: U.S. Department of Health and Human Services