FDA proposes graphic health warnings for cigarette packaging

The Food and Drug Administration (FDA) has issued a proposed new rule that would require photo-realistic health warnings on all cigarette packages and tobacco advertisements.

The purpose of the new warnings is to provide “greater public understanding of the negative health consequences of smoking,” states the FDA in a press release.

If the rule goes through, it will mark the first change to health warnings on tobacco products in 35 years. It will also mean the United States is finally joining the 122 other countries that require similar types of graphic health warnings on cigarettes and tobacco products.

Research has shown that realistic warnings — ones with color illustrations or photos that graphically show the potential health consequences of smoking — can motivate existing smokers to quit and prevent young people from starting to smoke.

The 13 new health warnings proposed by the FDA include not just well-known smoking-related risks, such as lung cancer and heart disease, but also several lesser-known ones, such as blindness, type 2 diabetes, bladder cancer and impotence.

“Given that tobacco use is still the leading cause of preventable disease and death in the U.S., there’s a lot at stake to ensure the public understands these risks,” said Dr. Ned Sharpless, the FDA’s acting commissioner, in the agency’s press release. “We remain committed to educating the public, especially America’s youth, about the dangers associated with using cigarettes and other tobacco products.”

In the United States, more than 34 million adults and 1.4 million young people (aged 12 to 17) are cigarette smokers, according to the Centers for Disease Control and Prevention. The U.S. rate of smoking has fallen by more than 20 percent over the past two decades, but it is still the leading cause of preventable death, killing more than 480,000 Americans each year, including 41,000 from exposure to secondhand smoke.

“Smoking kills more people each year than alcohol, HIV, car accidents, illegal drugs, murders and suicides combined, and over 16 million Americans alive today live with disease caused by cigarette smoking,” the FDA press release points out.

Earlier attempts

In 1966, the United States became the first country to put a health warning on its cigarette packages. But the warning — “Caution: Cigarette Smoking May Be Hazardous to Your Health” — was both ambiguous and ineffective. So, in 1984, government health officials updated it to include four rotating messages from the Office of the Surgeon General:

• Surgeon General’s Warning: Smoking Causes Lung Cancer, Heart Disease, Emphysema and May Complicate Pregnancy.
• Surgeon General’s Warning: Quitting Smoking Now Greatly Reduces Serious Risks to Your Health.
• Surgeon General’s Warning: Smoking By Pregnant Women May Result in Fetal Injury, Premature Birth, and Low Birth Weight.
• Surgeon General’s Warning: Cigarette Smoke Contains Carbon Monoxide.

Research has shown that these warnings, like the earlier one, “have become virtually invisible to both smokers and nonsmokers — not attracting much attention and not leaving a very memorable impression of the risks of smoking,” the FDA points out.

Congress mandated that the FDA upgrade its cigarette labels back in 2009, but three years later a federal court struck down the agency’s attempts to adhere to that mandate. The court said the nine images proposed by the FDA at that time violated the First Amendment rights of tobacco companies. (The companies had taken the agency to court.) It also said that any visual warnings that appeared on cigarette packaging or advertising had to be completely factual and not aimed solely at scaremongering.

A renewed effort

The FDA went back to the drawing board. The agency believes its proposed new set of 13 health-warning images will satisfy the mandate given to it by Congress, while also being well within the limits of “both science and the law.”

“The FDA undertook a comprehensive, science-based research and development process, and took the necessary time to get these new proposed warnings right by developing distinct and clear messages about the negative health consequences of smoking,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products, in the press release. “We are especially encouraged that the research we conducted on these new proposed warnings demonstrated they would lead to improved understanding among both youth and adults, smokers and nonsmokers.”

The warnings would take up the top half of both the front and back of cigarette packages and at least 20 percent of the top area of cigarette advertisements, the FDA says.

The new rule is open for public comment through October 15. If the rule becomes finalized (and is not delayed by another court challenge from the tobacco industry), the labels would appear on cigarette packages and advertisements 15 months later.

That would be during summer 2021, at the earliest.

FMI: You can comment electronically on the FDA’s proposed rule at the Federal Register.