FDA Decides Not to Appeal Court Decision on Graphic Warnings

Thomas A. Briant, NATO Executive Director

According to a news report issued today by the Associated Press, U.S. Attorney General Eric Holder sent a letter on Friday, March 15 to House Speaker John Boehner informing him that the U.S. Food and Drug Administration and the U.S. Department of Health and Human Services will not appeal a District of Columbia U.S. Circuit Court of Appeals ruling issued last August that invalidated the FDA's graphic cigarette health warnings. As AP reports, the Attorney General's letter states, in part, that "In light of these circumstances, the Solicitor General has determined … not to seek Supreme Court review of the First Amendment issues at the present time."

The First Amendment to the U.S. Constitution protects free speech and the U.S. Supreme Court has extended this protection to what is known as "commercial speech," which includes advertising and product packaging. In its decision last August, the District of Columbia Circuit Court stated that the First Amendment requires the federal government to not only demonstrate a substantial interest justifying a regulation on commercial speech, but to also show that the regulation directly advances that goal. With the Circuit Court finding that the FDA did not present any data showing that the graphic cigarette warning labels would accomplish the agency's objective of decreasing smoking rates, the graphic warning label requirement was found to be unconstitutional.

The manufacturers that commenced the litigation against the FDA seeking to declare the graphic cigarette health warnings unconstitutional include R.J. Reynolds Tobacco Co., Lorillard Tobacco Co., Commonwealth Brands Inc., Liggett Group LLC, and Santa Fe Natural Tobacco Co. Inc.

In a blog statement, Dr. Howard K. Koh, the Assistant Secretary for Health for the U.S. Department of Health and Human Services, said, "Although we pushed forcefully for graphic health warning labels to appear on cigarette packages, the D.C. Circuit's ruling against the warning labels won't deter the FDA from seeking an effective and sound way to implement the law. The FDA has announced it will undertake research to support new rulemaking on graphic warning labels consistent with the Family Smoking Prevention and Tobacco Control Act."

The FDA intends to conduct research and develop regulations for new warning labels that would meet the requirements under the federal law known as the Family Smoking Prevention and Tobacco Control Act and also comply with constitutional free speech standards.

The District of Columbia Circuit Court case is separate from another pending lawsuit filed by American Snuff Co., Commonwealth Brands, NATO retail member Discount Tobacco City & Lottery, Lorillard Tobacco, National Tobacco Co. and R.J. Reynolds Tobacco against the Food and Drug Administration and the Department of Health and Human Services seeking to overturn the graphic cigarette health warnings and other marketing and promotion restrictions. In this second lawsuit, the U.S. Circuit Court of Appeals for the Sixth Circuit upheld the graphic cigarette health warning labels as being constitutional and the plaintiffs have filed a petition with the U.S. Supreme Court requesting that the high court accept the case on appeal. The Supreme Court has not issued a decision on whether to accept the case for appeal.