Court knocks down requiring graphic warnings on cigarette packs

Judges say the Food and Drug Administration failed to show how the images would reduce smoking.

By — Posted Sept. 12, 2012

Print  |   Email  |   Respond  |   Reprints  |   Like Facebook  |   Share Twitter  |   Tweet Linkedin

Physicians and public health advocates say they are disappointed by an appeals court decision that blocks graphic warnings from appearing on cigarette packages.

The U.S. Court of Appeals for the District of Columbia Circuit declared unconstitutional a Food and Drug Administration rule requiring the images, which include pictures of a man smoking through his tracheotomy hole and a dead person with a surgery-scarred chest.

The ruling ignores strong scientific evidence supporting the effectiveness of larger graphic warning labels in communicating the health dangers of tobacco use, said Robert W. Block, MD, president of the American Academy of Pediatrics.

“With 10 million cigarettes sold every minute and almost 3,000 children under the age of 18 starting to smoke each day, this ruling puts children’s lives at risk,” Dr. Block said in a statement. “Warning labels play a critical role in educating children, teens and parents about the negative health impacts of tobacco.”

The FDA proposed the text and graphic health warnings in June 2011, saying tobacco companies should prepare to place them on all cigarette packs, cartons and advertisements beginning in September 2012. The warnings were part of the Family Smoking Prevention and Tobacco Control Act, which became law in 2009.

R.J. Reynolds and other tobacco companies sued the government in August 2011 to prevent the images from appearing on cigarette packages.

The American Medical Association joined other health organizations in submitting three friend-of-the-court briefs in support of the warnings. A district court ruled in favor of the tobacco companies in March. In its Aug. 24 opinion, the appellate court said the FDA failed to prove how the warnings would reduce tobacco use (link).

“The First Amendment requires the government not only to state a substantial interest justifying a regulation on commercial speech, but also to show that its regulation directly advances that goal,” judges said. “[The] FDA failed to present any data, much less the substantial evidence required under [federal law] showing that enacting their proposed graphic warnings will accomplish the agency’s stated objective of reducing smoking rates.”

High court likely to decide issue

R.J. Reynolds Tobacco Co. applauded the ruling, saying the FDA has not provided “a shred of evidence” to justify the unconstitutional requirement.

“We are pleased that the Court of Appeals agreed with Reynolds that consumers can and should be fully informed about the risks of tobacco use in a manner consistent with the U.S. Constitution,” said Martin L. Holton III, executive vice president and general counsel for R.J. Reynolds.

The Justice Dept. is still reviewing the court’s decision, a department spokesman said. The FDA declined to comment.

Legal analysts have said the U.S. Supreme Court will most likely decide the matter because of conflicting rulings by other courts. For example, the 6th U.S. Circuit Court of Appeals in March upheld the FDA’s graphic warnings requirement.Physicians and others stressed the importance of the graphic warnings and pledged to keep battling to get them on packaging.

“As part of our long-standing commitment to protecting the health of the public, the AMA supports efforts requiring tobacco companies to include large, picture-based warning labels on cigarettes,” AMA President Jeremy A. Lazarus, MD, said in a statement. “Tobacco remains the No. 1 cause of preventable death in the U.S., and graphic warning labels have been shown to be effective in communicating the health risks of smoking. The AMA will continue to support the fight in the courts and advocate for efforts designed to prevent youth smoking and promote smoking cessation.”

Back to top



Read story

Confronting bias against obese patients

Medical educators are starting to raise awareness about how weight-related stigma can impair patient-physician communication and the treatment of obesity. Read story

Read story


American Medical News is ceasing publication after 55 years of serving physicians by keeping them informed of their rapidly changing profession. Read story

Read story

Policing medical practice employees after work

Doctors can try to regulate staff actions outside the office, but they must watch what they try to stamp out and how they do it. Read story

Read story

Diabetes prevention: Set on a course for lifestyle change

The YMCA's evidence-based program is helping prediabetic patients eat right, get active and lose weight. Read story

Read story

Medicaid's muddled preventive care picture

The health system reform law promises no-cost coverage of a lengthy list of screenings and other prevention services, but some beneficiaries still might miss out. Read story

Read story

How to get tax breaks for your medical practice

Federal, state and local governments offer doctors incentives because practices are recognized as economic engines. But physicians must know how and where to find them. Read story

Read story

Advance pay ACOs: A down payment on Medicare's future

Accountable care organizations that pay doctors up-front bring practice improvements, but it's unclear yet if program actuaries will see a return on investment. Read story

Read story

Physician liability: Your team, your legal risk

When health care team members drop the ball, it's often doctors who end up in court. How can physicians improve such care and avoid risks? Read story

  • Stay informed
  • Twitter
  • Facebook
  • RSS
  • LinkedIn