FDA published two Federal Register notices Friday, March 19th related to its oversight and regulation of cigarettes and smokeless tobacco, including a much heralded final rule to restrict the sale of cigarettes and smokeless tobacco to children, and an advanced notice of proposed rulemaking asking for comment on potential outdoor advertising restrictions such as requiring stores to post graphic anti-tobacco messages. The notice regarding outdoor advertising restrictions likely will intensify debate about the constitutionality under the First Amendment of FDA's proposed restrictions on commercial speech.
FDA’s final rule is intended to reduce the appeal of cigarettes and smokeless tobacco to children and to make it difficult for children to access cigarettes and smokeless tobacco. Among other things, the rule would prohibit: the sale of cigarettes or smokeless tobacco to people younger than 18; the sale of cigarette packages with less than 20 cigarettes; distribution of free samples of cigarettes; distribution of free samples of smokeless tobacco; gifts or other items in exchange for buying cigarettes; sale or distribution of items with tobacco logos; and tobacco brand name sponsorship of any athletic, musical or other social or cultural events. The rule goes into effect on June 22, 2010.
The final rule finalizes many provisions of a proposed rule the agency issued in 1996 under the leadership of then-commissioner David Kessler. Among other things, that proposed rule included restrictions on the outdoor advertising of cigarettes and smokeless tobacco “including billboards, posters, or placards, may be placed within 1,000 feet of the perimeter of any public playground or playground area in a public park (e.g., a public park with equipment such as swings and seesaws, baseball diamonds, or basketball courts), elementary school, or secondary school.” However, the U.S. Supreme Court invalidated the entire rule when it held that the agency did not have the authority to regulate “tobacco products” (cigarettes and smokeless tobacco) in Food and Drug Administration v. Brown & Williamson Tobacco Corp. et. al., 529 U.S. 120, 161 (2000). Congress granted FDA that authority last year in the Family Smoking Prevention and Tobacco Control Act. The act explicitly ordered FDA to re-issue the 1996 rule, but directed FDA to “include such modifications to [the section on outdoor advertising restrictions], if any, that the Secretary determines are appropriate in light of governing First Amendment case law, including the decision of the Supreme Court of the United States in Lorillard Tobacco Co. v. Reilly (533 U.S. 525 (2001)).” In Lorillard, the U.S. Supreme Court struck down Massachusetts's ban on cigarette advertising within 1,000 feet of a school.
Accordingly, FDA's Final Rule that it published today does not implement the outdoor advertising restrictions of the 1996 rule. Instead, FDA is requesting comment in a separate Federal Register notice on how FDA might want to implement that part of the 1996 rule. According to that request for comments, the agency is considering several options, including a regulation proposing to (1) Prohibit or otherwise limit billboards located within 1,000 feet of any elementary or secondary school (k-12) and (2) prohibit or otherwise limit large signs or collections of advertisements greater than 14 square feet at retail establishments located in close proximity to any elementary or secondary school (e.g., within 350 feet or approximately one city block). FDA also announced that it is seeking data, research, information, and comments related to several questions, including the following:
Would narrower restrictions on advertising, such as permitting some size greater than 14 square feet at retail establishments located within 350 feet of an elementary or secondary school, still achieve the public health goal?
Or would a broader prohibition be necessary? For example, by prohibiting outdoor advertisements in addition to billboards, or by prohibiting small notices on store windows?
Should FDA require stores that sell tobacco products to post graphic anti-tobacco messages in order to counter the effects of advertisements on children?
As we have reported earlier, a Federal District Court has already invalidated part of the Family Smoking Prevention and Tobacco Control Act on First Amendment grounds, although FDA is appealing that decision. FDA has recently grappled with First Amendment concerns in other areas too, such as the promotion of off-label indications of drugs, and advertising the services of pharmacy compounders. FDA’s request for comment on outdoor advertising restrictions of cigarettes is yet another reminder that the agency must consider carefully the First Amendment as it attempts to exercise its authority under the Federal Food, Drug, and Cosmetic Act.