FDA Issues Final Cigarette Warning Label Rule

Manufacturers must include graphic labels on at least half of the pack’s front and back.

March 18, 2020

WASHINGTON—The U.S. Food and Drug Administration (FDA) issued its final rule yesterday requiring cigarette health warnings for cigarette packaging and advertisements, which will be published in the Federal Register today. In October, NACS filed a letter on the proposed rule on graphic warning labels on cigarette packages.

The final rule requires cigarette manufacturers to include graphic health warnings on cigarette packaging and advertisements. According to the final rule, “new cigarette health warnings must appear prominently on 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.”

In addition, retailers of cigarettes are responsible for ensuring those health warnings are visible to the public and unobscured. In terms of packaging requirements, retailers of cigarettes will not be in violation of the final rule if the cigarette packaging: (1) contains a warning; (2) is supplied to the retailer by a licensed manufacturer or distributor; and (3) is not altered by the retailer. However, retailers are responsible for ensuring that the health warnings are visible on packages and unobscured by stickers, sleeves or other materials.

Retailers will not be in violation of the advertisement requirements if that retailer receives the advertisements from a cigarette manufacturer or distributor. However, if retailers are creating the advertisements, then they must ensure the health warnings meet the new requirements. In all cases, however, the retailer is liable if the retailer publicly displays an advertisement that does not contain a warning or if that warning has been altered by the retailer in a material way or is obscured from view.

In the proposed rule, FDA would have required retailers to submit plans for the random and equal display of the required warnings for cigarette packages and required retailers to rotate the warnings in advertisements quarterly. In its letter to the agency, NACS raised concerns with this proposal given that retailers have no control over how manufacturers display and distribute the health warnings, nor do retailers create the advertisements. In response, the FDA explains in the final rule that retailers selling cigarettes would not be required to submit a plan for packaging, as long as the cigarette packaging: (1) contains a warning; (2) is supplied to the retailer by a tobacco manufacturer or distributor; and (3) is not altered by the retailer in a way material way.

Two years ago, a federal judge mandated that the FDA issue final labeling regulations fast. In 2012, a court had negated the agency’s first attempt at a warning label because it had been designed to “evoke an emotional response” without presenting health risks. The cost to change the labeling will run around $1.6 billion, according to agency estimates.

The final rule will take effect in 15 months on June 18, 2021.