The FDA was challenged by tobacco companies for its new rules that required the tobacco companies to put one of the FDA's 12 picture labels on its packaging. The tobacco companies argued that their First Amendment rights were violated by the rules, forcing them to speak in a certain way using government-mandated materials. The new labels were promulgated by both the FDA and the Department of Health and Human Services (HHS) pursuant to authority granted by Congress in 2009 under the Family Smoking Prevention and Tobacco Control Act.

Under the law, the following nine textual statements were to be included on cigarette labels:

• WARNING: Cigarettes are addictive.
• WARNING: Tobacco smoke can harm your children.
• WARNING: Cigarettes cause fatal lung disease.
• WARNING: Cigarettes cause cancer.
• WARNING: Cigarettes cause strokes and heart disease.
• WARNING: Smoking during pregnancy can harm your baby.
• WARNING: Smoking can kill you.
• WARNING: Tobacco smoke causes fatal lung diseases in nonsmokers.
• WARNING: Quitting smoking now greatly reduces serious risks to your health.

The act required that these warnings and graphic labels take up 50 percent of the cigarette package label and 20 percent of all cigarette ads.

After publishing the proposed rule and receiving more than 1,700 comments, the FDA published its final rule in June 2011.

Explain how the tobacco companies could challenge the rules.

Discuss whether the rules will be set aside.

It is helpful to define what is an administrative agency and the purpose it serves, specifically what the FDA regulates.