Pediatricians, American Cancer Society Take FDA To Court Over Delayed Graphic Warning Labels On Cigarettes

It’s been more than seven years since the Family Smoking Prevention and Tobacco Control Act became law, directing the Food and Drug Administration to bolster warnings on tobacco labels and to create graphic warning images to be printed on cigarette packaging. Even though the U.S. Supreme Court rejected the tobacco industry’s challenge to these labels in 2013, they have yet to materialize. In an attempt to force the FDA’s hand, a coalition of doctors, public health advocates, and anti-smoking groups have filed a lawsuit against the government.

In the FDA’s defense, it’s really only been about six years since it unveiled its first proposal for more graphic warning labels, followed by the industry’s legal challenge in 2011.

In Feb. 2012, a District Court judge sided with the tobacco industry, agreeing that the proposed warning labels were not narrowly tailored enough to outlast a First Amendment challenge.

But only weeks later, in a separate but related case, a panel for the Sixth Circuit Court of Appeals ruled differently, finding that the FDA did indeed have a compelling interest in “preventing juvenile smoking and in warning the general public about the harms associated with the use of tobacco products.” The Supreme Court later rejected the tobacco industry’s appeal of that decision.

However, that ruling did not address the content of the labels; just the FDA’s authority to require the warning labels. Meanwhile, in Aug. 2012, the D.C. Circuit Court of Appeals upheld the lower court’s ruling that these proposed images crossed the legal line.

The matter of these labels was remanded back to the FDA to effectively start over; the government even dropped its plan to appeal the panel’s decision. In 2015, more than two years after it had decided to start over, the agency would only tell Consumerist that the FDA “will undertake research to support a new rulemaking consistent with the Family Smoking Prevention and Tobacco Control Act.”

Now, we’re almost through 2016, and there has been no indication in years that the FDA is actively pursuing the graphic warning labels that the 2009 law prescribes. In fact, that law originally put a June 22, 2011 deadline for the FDA to issue a final rule on these graphic warnings.

“No proposed rule even appears on the FDA’s Unified Regulatory Agenda for action during 2016,” notes the complaint [PDF] filed today in a U.S. District Court in Massachusetts by the American Academy of Pediatrics, the American Cancer Society, the American Heart Association, the American Lung Association, the Campaign for Tobacco-Free Kids, and others. The lawsuit seeks to compel the FDA to comply with its obligations under the law and finally issue the graphic warning labels rule.

Under the Administrative Procedure Act, federal courts can “compel agency action” that has been “unlawfully withheld or unreasonably delayed.” The plaintiffs contend that if the original law only gave the FDA two years to create a final rule, there is no reason it should take four years just to pick the photos.

“The FDA has been in violation of [the relevant law] for more than four years,” reads the complaint. “During that time, over three million Americans, the vast majority of them minors, have begun to smoke on a regular basis. Half of them will die prematurely as a result of tobacco-related disease.”

During this same timeframe, argues the lawsuit, nearly two million Americans have died of tobacco-related disease.

The plaintiffs note that one of the reasons the courts struck down the earlier proposed labels was the FDA’s supposed lack of evidence showing that these labels are effective. However, they now point to research` released in the years since that seems to indicate that these warning labels would have saved potentially millions of lives if they had been put in place in 2012.

The graphic labels aren’t the only tobacco warnings that have been significantly delayed. Back in 2006, as one of the remedial measures coming out of a tobacco industry racketeering trial, the defendant tobacco companies were ordered to pay for national TV, radio, and print ads warning people about the dangers of their products.

The dickering over the wording of these warnings has resulted in at least five visits to the appeals courts, and one very irate judge who earlier this year let her feelings on this drawn-out drama be known.

“That is ridiculous — a waste of precious time, energy, and money for all concerned — and a loss of information for the public,” said the judge after yet another apparent delay effort from tobacco industry lawyers. “[I]t is obvious that Defendants are, once again, attempting to stall any final outcome to this long-standing litigation.”

We think this could all be solved if the tobacco industry just adopted John Oliver’s pro-smoking mascot “Jeff, the Diseased Lung in a Cowboy Hat” —