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FDA Ordered to Stop Delaying Graphic Cigarette Warnings

By Lisa M. Schaffer, Esq. on September 10, 2018 | Last updated on March 21, 2019

Almost 10 years ago, in 2009, a bipartisan Congress passed the Tobacco Control Act, requiring graphic health warnings on all cigarette packs and ads. Have you seen them? Undoubtedly not, since the FDA never created the necessary guidelines.

In 2016, eight public health and medical groups filed a lawsuit, claiming the FDA has both "unlawfully withheld" and "unreasonably delayed" agency actions on the guidelines, and sought to compel the FDA to issue guidelines immediately. And they just won.

Get Cracking on the Packaging

In a ruling this week, U.S. District Judge Indira Talwani set a deadline of September 26, 2018 for the FDA to "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 final graphic warnings rule in accordance with the Tobacco Control Act." It is unclear why the FDA has delayed so long, but it is clear the courts are fed up.

Back in 2011, the FDA did create a set of guidelines, based on the Act, which required graphic warnings covering the top half of the front and back of cigarette packs and 20 percent of cigarette advertising. However, the tobacco companies sued, claiming it was a violation of their First Amendment Rights. A U.S. Court of Appeals for the D.C. Circuit ruled in favor of the tobacco companies with respect to those specific guidelines, but they did not address the constitutionality of the Act. In 2012, a separate case in front of the U.S. Court of Appeals for the Sixth Circuit ruled that the Act was indeed constitutional.

Lives Up in Smoke

The FDA knew as far back as March 2012 that the Act was constitutional, and that it needed to create new guidelines. The agency announced a year later, in March 2013, that it would create new guidelines. And then it just never got around to it. Which is a real shame. A 2013 study based on Canada's experience with graphic warnings found that, had the U.S. implemented such warnings in 2012, the number of adult smokers in the U.S. would have decreased by around 7 million in 2013.

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