Will The FDA Ever Get Around To New Warning Labels For Cigarettes?

Image courtesy of John Wayne Hill

In June 2009, the Family Smoking Prevention and Tobacco Control Act became law, directing the Food and Drug Administration to not only create larger health warnings, but to include graphic images in the labels. And when the U.S. Supreme Court shot down a tobacco-industry fight against these labels in April 2013, it was supposed to get the ball rolling again on these new warnings. But in the years since, there’s been no apparent movement on the matter and the FDA won’t say when, or even if, these Congressionally mandated labels will become a reality.

Tobacco has been in the news a lot this week, in the wake of John Oliver’s scathing report on the industry’s questionable legal efforts against warning labels and a hollow response from cigarette giant Philip Morris, so we thought we’d check in with the FDA to see where things stand regarding the warning labels called for in the 2009 law.

How We Got To Nowhere

Congress gave the FDA two years to come up with regulations requiring that tobacco warnings contain “color graphics depicting the negative health consequences of smoking.”

And in June 2011, the FDA revealed its first go at labels with disturbing images, including photos of diseased lungs, a corpse, smoke-wrecked mouths and others that were less grotesque, like the one of a guy wearing a shirt that says “I quit.”

The new labels were supposed to start showing up on cigarette boxes — where they would take up half of the front label of the package — and on printed ads in Sept. 2012, but the tobacco industry’s legal machine kicked in before that could happen.

First, in the fall of 2011, a U.S. District Court in D.C. issued an injunction against the warning labels after several tobacco companies filed suit.

A few months later, in Feb. 2012, a divided federal appeals panel also came down on the industry’s side, ruling that the images selected by the FDA were both too vague and too restrictive of the cigarette companies’ constitutional rights.

“For example, the image of a man smoking through a tracheotomy hole might be misinterpreted as suggesting that such a procedure is a common consequence of smoking,” reads the majority opinion [PDF], which takes issue with the FDA’s assertion that the image was intended to convey “the addictive nature of cigarettes,” as that would require a “significant extrapolation on the part of the consumers.”

The appeals panel also said the images selected by the FDA lacked a “factual” basis for inclusion on the warnings and that they were intended primarily to evoke an emotional response or “at most, shock the viewer into retaining the information in the text warning.”

With little explanation, the FDA chose to not appeal this case, which dealt primarily with the images selected by the FDA, to the Supreme Court. And so the the rule that had been drafted by the FDA was vacated, though the graphic warning label requirement of the 2009 law still remained in place.

The validity of that part of the law was already being challenged in a separate lawsuit, filed in 2009 by several tobacco producers and sellers in a federal court in Ohio.

Only weeks after the D.C. appeals panel shot down the FDA’s choice of images for the warning labels, the Sixth Circuit Court of Appeals upheld the law’s requirements for bigger and more graphic warnings.

“[T]he warning labels required by the Act do not impose any restriction on Plaintiffs’ dissemination of speech, nor do they touch upon Plaintiffs’ core speech,” reads the panel’s opinion [PDF] “Instead, the labels serve as disclaimers to the public regarding the incontestable health consequences of using tobacco.”

The Big Tobacco plaintiffs then petitioned the U.S. Supreme Court to hear a further appeal, but SCOTUS rejected the petition without comment in April 2013.

So What Now?

Image courtesy of mendhak

It’s been three years since the D.C. court remanded the rule back into the hands of the FDA, and just as long since the Sixth Circuit upheld the constitutionality of the law. So by this point, the agency should have come up with some new version that it thinks will pass the next inevitable legal challenge from the tobacco industry.

But there have been no recent public updates on the matter from the FDA and several consumer health advocates we spoke to say the agency has been incredibly tight-lipped about what, if anything it’s doing regarding new labels.

When reached for comment by Consumerist, an FDA spokesperson merely said that the agency “will undertake research to support a new rulemaking consistent with the Family Smoking Prevention and Tobacco Control Act.”

You may have noticed that the FDA rep specifically used the words “will undertake research,” which implies that no research has begun. When asked if there is any general timeline in place for the rulemaking, the FDA rep said he could not provide any additional information at this time.

Which may be cause for concern when you consider the FDA’s history of putting Congressionally mandated research on the back burner.

Will New Warnings Even Help?

Image courtesy of Janice

Outside of the question of the legal requirement for these labels, one might reasonably ask whether they are necessary at this point. After all, fewer people are smoking than ever in the U.S.

But supporters of the labeling effort say that it’s the warning labels we have that have helped to drive the smoking rate down from nearly 50% of adults to 18% in the last half-century.

“Warning labels have been proven to be an effective tool for educating smokers about the health risks associated with tobacco,” explains Katie McMahon, policy principal for prevention at the American Cancer Society Cancer Action Network. “Smokers get most of health-related information from the cigarette pack itself. The warnings provide an immediate point of sale deterrent.”

In 2001, Canada increased the size of the warnings on tobacco products, and a 2006 study from researchers at the University of Waterloo in Ontario found that smokers who looked at packages with more prominent health alerts were nearly three times more likely to be mindful of the stated risks.

“Warnings that are graphic, larger, and more comprehensive in content are more effective in communicating the health risks of smoking,” concluded the study.

According to research from the International Tobacco Control Policy Evaluation Project, graphic warning labels “stimulated more cognitive responses, such as thinking about the health risks of smoking,” than text-only warnings.

Going beyond warnings and graphic images of lungs and hearts, some countries are moving toward requiring that cigarettes are sold in standardized packaging. It’s a new and controversial idea, as tobacco companies say it robs them of decades of expensive branding investments, but early research seems to indicate that it may also help to curb smoking.

Some opponents of tobacco labels point out that obesity is a growing problem in America while smoking is on the decline, so why not slap huge warning labels with grotesque images of clogged arteries on Big Mac wrappers and Coke bottles?

McMahon tells Consumerist that this isn’t really an apples to apples comparison.

“Tobacco is different from fast food,” she explains, “in that there is not another product out there that will cause you harm when simply used as intended.”