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UNITED STATES

Court orders FDA to expedite graphic warnings

06 Sep 2018. A federal court has ruled the US Food and Drug Administration (FDA) must issue its rule for graphic warnings on cigarette packs by late September after years of delay, the National Law Journal reported.

US District Judge Indira Talwani of the District of Massachusetts ruled the FDA had “unreasonably delayed” publishing the graphic warnings and issuing its rule for regulating them on cigarette packs, which Congress mandated with the 2009 Tobacco Control Act. Judge Talwani’s order said the FDA had estimated its final rule, which includes a schedule for implementing the warnings, would be November 2021 “at the earliest”, the journal reported.

“The remaining question is the proper time frame for the agency to act. The court orders that, no later than September 26, 2018, the FDA shall provide to this court an expedited schedule,” Talwani wrote. The court would review the schedule and take any action it deemed necessary and plaintiffs would have 14 days to respond after the filing, the journal reported.

The case was filed in 2016 on behalf of the American Academy of Pediatrics and other health and anti-smoking groups. Mark Greenwold, admitted pro hac vice as consultant for the plaintiff Campaign for Tobacco-Free Kids, told the journal the lawsuit had revealed delays by the FDA. “We didn’t realise at the time we brought the lawsuit how little the FDA had done and the fact that instead of developing graphics for the textual warnings … they decide to take several years to rewrite the text. And that came out after we filed the lawsuit,” Greenwold told the NLJ. “They had every chance to move forward, and we found out after we filed the lawsuit they were years and years away, and they weren’t even developing graphics they were required to use,” the journal quoted Greenwold as saying.

Plaintiffs had argued the FDA had “unlawfully withheld” action on getting graphic warnings onto packs by “unreasonably delaying” its issuing of a timeline for doing so. Plaintiffs had argued the FDA had “unlawfully withheld” action on getting graphic warnings onto packs by “unreasonably delaying” its issuing of a timeline for doing so. The Tobacco Control Act required the FDA to issue regulations on graphic warnings no later than 24 months after 22 June 2009.