FDA Proposes New Health Warnings for Cigarette Packs

SILVER SPRING, Md. — Cigarette packs could look different in the near future.

On Aug. 15, the Food and Drug Administration (FDA) issued a proposed rule requiring new health warnings on cigarette packages and in advertisements. The proposed warnings, which feature photo-realistic color images, would represent the most significant change to cigarette labels in more than 35 years.

When finalized, the rule would fulfill a requirement in the Family Smoking Prevention and Tobacco Control Act, according the agency.

Health warnings first appeared on cigarette packages in 1966 and were last updated in 1984 to include the U.S. Surgeon General's warnings that appear on packages and in advertisements today.

As outlined in the proposed rule today, the unchanged content of these health warnings, as well as their small size, location and lack of an image, impairs their ability to convey relevant information about the negative health consequences of cigarette smoking in an effective way to the public, the FDA said.

According to the FDA's announcement, the agency undertook a science-based approach to develop and evaluate the new proposed cigarette health warnings announced today. These warnings focus on serious health risks — such as bladder cancer, diabetes, erectile dysfunction and conditions that can cause blindness — that are lesser known by the public as being negative health consequences of smoking.

Once finalized, the new cigarette health warnings will appear prominently on cigarette packages and in advertisements — occupying the top 50 percent of the area of the front and rear panels of cigarette packages and at least 20 percent of the area at the top of cigarette advertisements.

The warnings would be required to appear on packages and in advertisements 15 months after a final rule is issued.

"Cigarette packages and advertisements can serve as an important channel for communicating health information to broad audiences that include both smokers and nonsmokers. In fact, daily smokers potentially see warnings on cigarette packages more than 5,100 times per year, and all members of the public, including adolescents, are exposed to cigarette advertisements in print and digital media, as well as in and around stores where cigarettes are sold," said Mitch Zeller, director of the FDA's Center for Tobacco Products. 

Years in the Making

Signed into law in 2009, the Tobacco Control Act requires the FDA to include new warning labels specifically on cigarette packages and in advertisements. In June 2011, the agency published a final rule requiring color graphics depicting the negative health consequences of smoking to accompany nine textual warning statements specified the legislation.

However, the final rule was challenged in court by several tobacco companies and was ultimately vacated in August 2012 after the U.S. Court of Appeals of the District of Columbia held that the rule violated the First Amendment. In March 2013, the federal government announced its decision not to seek further review of the court’s ruling.

Following another lawsuit filed by several public health groups, a judge in the U.S. District Court for the District of Massachusetts issued an order in March directing the agency to publish the proposed rule by August 2019 and issue a final rule in March 2020.

The proposed rule will be open for public comments for 60 days through Oct. 15.