New Cigarette Health Warnings Proposed by FDA

Packaging would feature images of the serious health risks of smoking under the agency’s plan.

August 16, 2019

WASHINGTON—The Food and Drug Administration (FDA) Thursday released a proposed rule seeking to include graphic health warnings on cigarette packaging and advertisements. Public comments on the proposal open today and are due to the FDA by October 15. 

The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) directed the FDA to issue a rule requiring cigarette manufacturers to include color graphics and health warning statements on cigarette packaging.

The proposed rule would require the new cigarette health warnings to appear on the top 50% of the area of the front and rear panels of cigarette packages and at least 20% of the area at the top of cigarette advertisements.

The proposal would require retailers to ensure that warning labels on cigarette packages are not obscured by stickers or other labels. What’s more, the proposed rule would require that the health warnings on cigarette advertisements be rotated quarterly. Retailers would be required to submit a plan on the “random and equal display and distribution of the required warnings on packages and the quarterly rotation in advertisements for approval by FDA,” the agency states.

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

As defined in the proposal, advertisements include promotional materials (point-of-sale or non-point-of-sale), billboards, posters, placards, published journals, newspapers, magazines, other periodicals, catalogues, leaflets, brochures, direct mail, shelf-talkers, display racks, internet web pages, electronic mail correspondence, and also may include those communicated via mobile telephone, smartphone, microblog, social media website, or other communication tools.

NACS is analyzing the proposal and the retail impact. Please stay tuned to NACS Daily for further updates.

Health warnings first appeared on cigarette packages in 1966 and were most recently updated in 1984 to include the Surgeon General’s warnings that appear on packages and in advertisements today, according to the FDA.

The Tobacco Control Act requires the agency 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 in the Tobacco Control Act. 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, the FDA said. In March 2013, the federal government announced its decision not to seek further review of the court’s ruling. Following a 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.