FDA faced another setback to its graphic warnings mandate. Photo credit: US FDA.
A federal judge in southern Georgia blocked the US Food and Drug Administration’s (FDA) mandate for graphic health warnings on cigarette packaging and advertisements, siding with Philip Morris USA and several Georgia retailers.
The Atlanta Journal-Constitution reports that US district judge Lisa Wood found FDA did not provide all the raw data behind its 2020 rule, preventing stakeholders from offering meaningful input. While she dismissed most of the plaintiffs’ claims, Wood struck down the rule, citing a violation of the Administrative Procedures Act.
The Georgia plaintiffs, including the Georgia Association of Convenience Stores, argued that the regulation would cost millions, compel retailers to “speak against their own products,” and make stores less welcoming to customers. They also contended that FDA focused on certain smoking-related risks while ignoring others without explanation and overlooked issues in its research.
FDA defended its approach, stating the warnings were intended to enhance public understanding of the risks of smoking.
The ruling represents another setback for FDA’s efforts to enforce graphic warnings under the 2009 Family Smoking Prevention and Tobacco Control Act. That law directed the agency to pair graphic images with text statements about smoking risks. FDA’s first effort in 2011 was struck down by a federal appeals court for violating the First Amendment.
In 2020, the agency introduced a new rule with 11 graphic warnings tied to smoking-related diseases, supported by studies it said would enhance public understanding. Philip Morris and its co-plaintiffs argued the rule violated both the tobacco law and the Administrative Procedures Act.
Earlier this year, a Texas judge temporarily blocked enforcement of the warnings, finding that FDA likely violated procedure. The Georgia ruling went further, granting summary judgment to the tobacco companies and striking down the rules entirely.