President Clinton and the FDA Announce New Tobacco Regulations

TOBACCO September 1996

On August 23, President Clinton announced an executive order placing new restrictions on tobacco advertising and other measures to reduce teenage smoking ("Stephen Barr and Martha M. Hamilton, "Clinton Curtails Tobacco Ads In Bid to Cut Sales to Youth," Washington Post, August 24, 1996, p. A1; Glenn Frankel, "Decades After Declaration, War on Smoking Begins," Washington Post, August 24, 1996, p. A1). The Food and Drug Administration regulations are at 61 Federal Register 44396 through 45318 (28 August 1996); and the Federal Trade Commission regulations are at 61 Federal Register 45883 through 45886 (30 August 1996).

Most of the new FDA regulations will become effective in one year. Regulations include limiting billboards and signs to black-and-white text only and banning them within 1,000 feet of schools and playgrounds. Print ads will be also be limited to black-and-white text in publications whose youth readership is 15% of total readership or more than two million. Cigarette vending machines will be limited to "adults only" facilities. Tobacco companies will not be able to give away free samples or products with brand names or logos. In addition, cigarettes must be sold in packages of at least twenty. In six months, buyers under 27 will be required to produce photo identification. Entertainment and sporting event sponsorship will be limited to the corporate name, not the brand name. That restriction will take place in two years so alternative event sponsors can be arranged if needed. The FDA is also requiring six companies that have attracted the largest percentages of underage consumers to run an educational campaign, including TV ads, warning children and adolescents about the dangers of smoking.

Presidential spokesperson Mike McCurry told reporters that the regulations are aimed at reducing underage smoking and that they would have "no practical effect" for adult consumers. Clinton said the goal of the regulation, one of the largest public health initiatives ever, is to cut teenage smoking in half over the next seven years. "With this historic action we are taking today. Joe Camel and the Marlboro Man will be out of our children's reach forever," said Clinton. He added that the rule "is the right thing to do, scientifically, legally and morally." According to the president, about 3,000 young people start smoking every day and nearly 1,000 will die prematurely from smoking-related illnesses.

The Federal Food, Drug and Cosmetic Act allows the Food and Drug Administration to regulate drugs and drug delivery devices. FDA Commissioner David Kessler argued that cigarettes are under the FDA's mandate because they are engineered as a delivery device for the drug nicotine. Tobacco companies have challenged that jurisdiction in a suit filed last year in a federal court in North Carolina. The judge put the case on hold until the rules were finalized, but with Clinton's announcement, the suit is expected to move forward.

Additional court challenges are expected from advertising and tobacco companies who are fighting the regulation as an unconstitutional restriction on free speech. "Our quarrel is with the violation of the right to speak truthfully about legal products," said Hal Shoup, executive vice president of the American Association of Advertising Agencies. Similar "commercial speech" won a victory in the Supreme Court earlier this year in a Rhode Island liquor advertising case. In that case, the court rejected the idea of special government restrictions on ads for "vices." However, some appellate courts have upheld greater government regulation in children's health and safety cases. "In cases where juveniles are involved, the courts are more likely to find a compelling state or government interest," said Clay Calver, an assistant professor of communication at Pennsylvania State University. Kessler said, " the rule is very defensible in court" (44 Liquormart v. Rhode Island, No. 94-1140, --U.S.--, 116 S.Ct. 1495, 1996WL241709, (May 13, 1996); Rajiv Chandrasekaran, "FDA's Tobacco Ad Rules Face Lengthy Court Challenge," Washington Post, August 24, 1996, p. A9).

Tobacco officials contend that the youth advertising regulations are certain to lead to a growing federal role in regulating all cigarette sales. They also predict a federally mandated reduction in the amount of nicotine. "It is the epitome of the slippery slope," said Thomas Hember, president of the National Smokers Alliance. "Someone smart figured out that this is a first acceptable step. This is not where David Kessler wishes to stop." Kessler and Health and Human Services Secretary Donna Shalala said they were not interfering with the rights of adult smokers. "We have absolutely no plans to ban smoking in this country," said Shalala. She said she hoped the rules would "break the cycle of nicotine addiction."

Economic issues are implicated. Opponents to the regulation, such as the National Tobacco Council, argue that the rules could cost up to 10,000 jobs in the tobacco growing sector. McCurry said the administration estimates that 2,500 jobs would be lost over the next decade. McCurry added that if teenage smoking is cut in half over the next seven years, a health care savings of $28 billion to $43 billion could be generated. The price of tobacco stocks fell sharply on August 21 in response to word of the president's decision to sign the executive order.