In 2009, the Congress of the United States passed the Family Smoking Prevention and Tobacco Control Act, giving the FDA the authority to regulate tobacco products. The law also specifically mandated warning labels to appear on packs of cigarettes. The FDA responded by developing and testing nine graphic warning labels each addressing a mandated theme and accompanied by an image, sometimes a graphic one. The tobacco companies challenged the mandate in the courts with one appellate court upholding the mandate However, in a subsequent 2012 decision R.J. Reynolds vs. the FDA, the court sided with the tobacco companies on constitutional grounds and the FDA decided not to appeal.
This commentary lays out the basis for the court's decision and provides evidence that will support the revision process.
Published in Volume 164, pages 130-132