USA: Court Orders FDA To Move Forward With Graphic Cigarette Warnings
September 05, 2018; by Salynn Boyles
A federal court has ordered the FDA to move forward by the end of the month to issue a plan for requiring graphic health warnings on cigarette packs and advertising.
On Wednesday, Judge Indira Talwani, of the U.S. District Court for the District of Massachusetts, ruled in favor of a lawsuit filed by the American Academy of Pediatrics, the American Lung Association, and six other public health and medical groups contending that the FDA had "unreasonably delayed" and "unlawfully withheld" the final rule on graphic labels, which were originally mandated close to a decade ago.
The judge gave the agency 3 weeks to come up with a plan.
"The court orders that, no later than September 26, 2018, the FDA shall provide to this court an expedited schedule for the completion of outstanding studies, the publication of the proposed graphic warnings rule for public comment, review of public comments, and issuance of a final graphic warning rule in accordance with the Tobacco Control Act," the ruling stated.
The plaintiffs in the case will then have 2 weeks to submit a response to the proposed schedule.
FDA spokesman Michael Felberbaum told MedPage Today that the agency is analyzing the ruling.
“We’re continuing to move forward on the work to support a new rulemaking, and the agency will comply with any court order,” he noted.
The 2009 Family Smoking Prevention and Tobacco Control Act, which regulated cigarettes, called for graphic warnings covering the top half of the front and backs of cigarette packs and 20% of cigarette advertising. The FDA was originally given until June of 2011 to issue a final rule requiring the warnings.
The FDA met the initial deadline, but tobacco companies filed lawsuits and the graphic warnings were struck down in August of 2012 by a three-judge panel of the U.S. Court of Appeals for the D.C. Circuit, which ruled 2-1 that the specific warnings proposed by the agency violated the First Amendment.
Ruling in a separate case in March of 2012, the U.S. Court of Appeals for the Sixth Circuit upheld the law's requirement for graphic warnings, stating that they are "reasonably related to the government's interest in preventing consumer deception and are therefore constitutional."
In March of 2013, the FDA stated that it planned to issue a new rule requiring graphic warnings, but the agency has not done so.
In a joint press statement, the eight health groups that brought the lawsuit charging the FDA with unlawfully delaying graphic warnings called Wednesday's ruling a "major victory for the nation's health and the fight against tobacco."
"In accordance with the court's order, we urge the FDA to quickly issue, finalize and implement a rule requiring graphic cigarette warnings," the groups noted. "The current U.S. cigarette warnings, which are printed on the side of cigarette packs and haven't been updated since 1984, are stale, unnoticed and a major impediment to greater progress in reducing cigarette smoking."
At least 122 countries or jurisdictions including Australia, Canada, Mexico, and New Zealand either have graphic warning label requirements in place or have plans to implement them, according to the anti-tobacco group Campaign for Tobacco-Free Kids.
Studies suggest that warning labels on cigarette packaging are most effective at communicating health risks when they contain both pictures and words and are large and in color. They also suggest that warning labels must be rotated to avoid overexposure.