New Study: FDA Vastly Underestimated How Much Graphic Cigarette Warnings Would Reduce Smoking in U.S.

Statement of Matthew L. Myers President, Campaign for Tobacco-Free Kids

Nov. 25 2013

WASHINGTON, DC — A new study in the scientific journal Tobacco Control provides powerful new evidence that graphic warning labels on cigarette packs are effective in reducing smoking rates. The study also finds that the U.S. Food and Drug Administration (FDA) vastly underestimated the impact that proposed graphic warnings would have in reducing smoking in the United States.

In June 2011, when the FDA issued regulations requiring graphic warnings, the agency estimated the impact on U.S. smoking rates based on Canada’s experience after it adopted graphic warnings in 2000. The new study concludes that the FDA's analysis was "flawed" and greatly underestimated the actual impact of graphic warnings on smoking rates in Canada — and therefore the likely impact in the U.S. The study’s main findings include:

  • The graphic warnings reduced smoking rates in Canada by 12 to 20 percent from 2000 to 2009. Based on these findings, the study concludes that the impact of graphic warnings on smoking rates in the U.S. would have been 33 to 53 times larger than the FDA estimated.
  • Had the graphic warnings been implemented in the U.S. in 2012 as planned, they would have led to a decrease of between 5.3 and 8.6 million smokers.

This study's findings are critically important because the FDA’s flawed analysis was a key factor in the August 2012 decision by the U.S. Court of Appeals for the D.C. Circuit that struck down the proposed warnings. Based on the FDA's conclusion that the proposed warnings would have only a slight impact on smoking rates, the court found that the FDA’s analysis "essentially concedes the agency lacks any evidence that the graphic warnings are likely to reduce smoking rates." As a result, the court found that the FDA had not met the legal requirement of demonstrating that the proposed warnings would directly advance a substantial government interest.

As a result of this study, the Campaign for Tobacco-Free Kids has sent a letter to the FDA reiterating our call for the FDA to quickly develop new graphic warnings based on the best available science, including this study and numerous others that have documented the positive impact of graphic warnings. The FDA must take action in light of this powerful new evidence that graphic cigarette warnings significantly reduce smoking and save lives.

The graphic cigarette warnings are required by the landmark 2009 law that gave the FDA authority over tobacco products. While the DC Circuit's ruling blocked the specific warnings developed by the FDA, a separate ruling by the U.S. Court of Appeals for the Sixth Circuit upheld the law's underlying requirement for graphic warnings. The U.S. Supreme Court declined to hear a tobacco industry appeal of the Sixth Circuit ruling, preserving the FDA's authority to develop new graphic warnings.

The new study points to "several major problems inherent in FDA’s approach." For example, the researchers write, the FDA used cigarette excise tax rates rather than actual prices paid by smokers to quantify the changes in smoking rates attributable to cigarette prices. While cigarette tax rates rose significantly in Canada, the study documents that cigarette prices actually paid by smokers fell by four percent from 2002 to 2011. As a result, the FDA overestimated the impact of price increases and underestimated the impact of the graphic warnings on smoking declines in Canada.

This study provides some of the strongest evidence to date that graphic cigarette warnings reduce smoking rates. Other studies around the world have also shown that graphic warnings are most effective at informing consumers about the health risks of smoking, discouraging children and other nonsmokers from starting to smoke, and motivating smokers to quit (view our fact sheet summarizing this evidence). Because of this evidence, more than 60 countries now require large, graphic cigarette warnings.

Tobacco companies fight graphic warnings precisely because they know such warnings are effective. They spend billions of dollars to play down the health risks of smoking and glamorize tobacco use. Graphic warnings tell the truth about how deadly and unglamorous cigarette smoking truly is. As this study underscores, graphic warnings are a vital tool in winning the fight against tobacco, which is the number one cause of preventable death in the U.S. and kills more than 400,000 Americans every year.

The new study was conducted by Jidong Huang and Frank J. Chaloupka of the University of Illinois at Chicago and Geoffrey T. Fong at the University of Waterloo and the Ontario Institute for Cancer Research in Canada. Read the researchers' news release online.