Statement from ASH Executive Director Laurent Huber on FDA and Graphic Warning Labels: Glacial and Unwilling, but in the Right Direction Arendtm August 16, 2019 ASH in the News, Breaking News, Featured News & Events, News & Events, Press Releases, Related News This week the Food and Drug Administration announced a comment period for a proposed rule to require graphic health warnings on cigarette packages and advertisements (pictured above). If this sounds familiar then you must be at least ten years old, because that’s how long ago Congress mandated FDA to adopt these warnings under the 2009 Family Smoking Prevention and Tobacco Control Act. But kudos to FDA for finally moving in the right direction. Or perhaps put a hold on those kudos. Wednesday August 14th was the court-imposed deadline for FDA to announce a proposed rule after losing a lawsuit filed by a group of pediatricians and public health organizations. Judge Indira Talwani of the U.S. District Court for the District of Massachusetts found that FDA “unlawfully withheld” and “unreasonably delayed” action on graphic warnings. In summary, FDA is now moving forward on graphic warnings a decade after Congress told them to, and only because of a court order. In case you are wondering, no, federal agencies are not permitted to simply ignore laws passed by Congress. FDA can be forgiven for a couple of those ten years. Its first attempt at graphic warnings was successfully challenged by the tobacco industry. In that case, the judge said the industry’s first amendment rights had been violated, but only because of the specific warnings FDA had chosen. For some reason, FDA decided to use faked images of diseased lungs, heart surgery scars, etc. rather than real photos. The court basically said that the government can force companies to tell the truth, but cannot compel them to lie. This left open the possibility that FDA could simply use new, actual images. But for some reason, they decided to just drop the whole thing. I wonder, what is the reason?