News & Events


As a Result of Anderson & Kreiger Lawsuit, FDA Proposes New Graphic Warnings For Cigarette Packs

by Anderson & Kreiger
August 19, 2019

In accordance with an order by the U.S. District Court for the District of Massachusetts, the U.S. Food and Drug Administration (FDA) has given notice of a proposed rule requiring tobacco companies to include new textual warnings and graphic images on cigarette packs and in cigarette advertising.

Many studies have shown that graphic warnings are more effective than the verbal warnings that have long been on cigarette packs and can significantly reduce the number of children who begin to smoke and help existing smokers to quit. More than 120 countries require graphic warnings on packs of cigarettes, but the United States has yet to do so.

In 2016, Scott Lewis and Jessica Wall at Anderson & Kreiger LLP and Dennis Henigan and Mark Greenwold at the Campaign for Tobacco-Free brought suit against the FDA on behalf of a group of public health advocates alleging that the agency had violated its legal duty to promulgate a graphic warnings rule.  In September 2018, the Court agreed with the plaintiffs, finding that FDA had “unlawfully withheld” and “unreasonably delayed” promulgating a graphic warnings rule, as mandated by Congress in 2009.  The Court ordered FDA to submit its notice of proposed rulemaking for publication in the Federal Register by August 15.  FDA complied with this requirement.  The Court has also ordered FDA to complete its rulemaking and submit the final rule for publication by March 15, 2020.