U.S. Federal Issues

FDA Authority over Tobacco:
Legal Filings and Decisions

Tobacco companies have filed two lawsuits challenging the 2009 federal law granting the U.S. Food and Drug Administration authority over tobacco products:

In the first lawsuit, the tobacco companies challenged several aspects of the law, including its marketing restrictions and requirement for large, graphic warning labels on cigarette packs and advertising.

In a January 2010 ruling, Judge Joseph H. McKinley of the U.S. District Court for the Western District of Kentucky upheld most provisions of the law, including the warning labels requirement. Both sides appealed aspects of this ruling. In a March 2012 ruling, the U.S. Court of Appeals for the Sixth Circuit also upheld most provisions of the law, including the warning labels requirement.

In the second lawsuit, the tobacco companies challenged the specific cigarette warning labels required by the FDA in implementing the law. In a February 2012 ruling, Judge Richard J. Leon of the U.S. District Court for the District of Columbia ruled that the warning labels violate the First Amendment to the Constitution and blocked them from taking effect. The U.S. Department of Justice has appealed this ruling, and oral arguments were held April 10, 2012, before the U.S. District Court of Appeals for the DC Circuit.

Here are decisions and key filings in each lawsuit, organized by the appellate court involved:

U.S. Court of Appeals for the Sixth Circuit

District Court Ruling: Judge Joseph H. McKinley upheld most provisions of the law, including the warning labels requirement (1.05.10)

Appeals Court Ruling: U.S. Court of Appeals for the Sixth Circuit upheld most provisions of the law, including the warning labels requirement (3.19.12)

U.S. government’s opening brief (7.28.10)

Amicus brief by public health organizations (8.04.10)

U.S. Court of Appeals for the D.C. Circuit

District Court Ruling: Judge Richard J. Leon blocked implementation of the warning labels (2.29.12)

Appeals Court Ruling: Not yet issued. The government’s appeal of Judge Leon’s ruling is pending before the U.S. Court of Appeals for the D.C. Circuit. Oral arguments are scheduled for April 10.

U.S. government’s opening brief (12.12.11)

U.S. government’s reply brief (2.13.12)

Amicus brief by public health organizations (12.19.11)