Federal Court Vacates FDA’s Graphic Warnings Rule For Tobacco Products and Advertising

In a 2-1 decision in RJ Reynolds Tobacco Company v. FDA announced on August 24, the U.S. Court of Appeals for the District of Columbia Circuit vacated the Food and Drug Administration (FDA) Rule requiring graphic new warnings on all tobacco products and advertising.

The FDA rule was mandated by Congress under the Family Smoking Prevention and Tobacco Control Act of 2009. The FDA issued its final rule on June 21, 2011, which included highly disturbing graphics of cadavers, smoke coming out of a hole in a throat, and a lung filled with cigarette butts. Five tobacco companies filed a lawsuit in federal court in D.C. challenging the new rules. ANA and the American Advertising Federation (AAF) filed a “friend of the court” brief in the case on November 21, 2011, arguing that the Rule is an illegitimate effort to deputize advertisers to promote the government’s message. In March, the U.S. District Court for the District of Columbia issued a permanent injunction blocking enforcement of the law. That decision was appealed to the Court of Appeals and on April 4, ANA and AAF filed another “friend of the court” brief in the case.

In Friday’s decision, the court held that the Rule would turn product packages and ads into miniature billboards for the government’s anti-smoking message. As the court noted, there are many other less intrusive alternatives the government can use to reduce smoking, but having the government compelling speech crosses a critically important constitutional line. Additionally, the FDA failed to present any data showing that enacting their proposed graphic warnings will accomplish the agency’s stated objective of reducing smoking rates, which it must do to justify any restriction on speech under the U.S. Supreme Court’s Central Hudson decision.