By mid-March, the Food and Drug Administration is expected to require cigarette packs to carry stark images depicting the health consequences of smoking, but legal challenges are likely to slow the rule from taking effect more than a decade after Congress first called for it.
The tobacco industry is likely to challenge the rule in court by pointing to the First Amendment, say lawyers following the rule-making. The industry’s public comments on the proposal show that they take issue with the FDA’s process and its cited evidence to support the new warnings.
The exercise could be a repeat of 2011, when the FDA originally issued graphic warnings but tobacco manufacturers sued. After federal judges found the warnings unconstitutional, the FDA started over.
This time, the FDA and health groups that support the rules argue the warnings will stand up to legal scrutiny — and if they don't, the FDA has tried to provide a backstop. To avoid another yearslong delay, the agency says that if a court wants to throw out some images or warnings, it should let others stand.
“The FDA learned a very hard lesson after the first round,” said Mary Rouvelas, senior counsel at the American Cancer Society Cancer Action Network. “I think that they’ve tried to be responsive to that.”
The FDA is under a court-ordered deadline to issue the final rule on warning labels by March 15, after it issued a proposal in August and collected public comments.
Congress mandated the graphic warnings in a 2009 smoking prevention law that gave the FDA the power to regulate tobacco.
The proposed rule would provide new options for the text-only statements already on cigarette packs, with an emphasis on lower-profile smoking risks, such as diabetes, eye damage and the effect of secondhand smoke on children. The agency is choosing from a combination of 13 text statements and images, depicting things like diseased lungs, a neck tumor, a cup of bloody urine and a low-birthweight infant.
Under the proposal, the text and graphic warnings would have to consume at least the top half of a cigarette pack’s front and rear, and half of the front and rear of cartons on the left side. In print and digital advertisements, the warnings would have to take up 20 percent of the top.
The tobacco industry is already signaling that its likely legal arguments after the rule is finalized will mirror its approach in 2011, according to extensive comments filed by parent companies of cigarette brands such as Marlboro, Newport and Camel.
Major tobacco companies Reynolds American Inc. and Altria Group, Inc., didn’t respond to requests to comment for this story. The written public comments by RAI argue broadly that the 2009 law’s graphic warning mandate violates First Amendment free speech provisions.
Altria’s comments appear more open to some kind of warning label. But both companies say the FDA’s current proposal is so flawed that it doesn’t pass constitutional muster.
Whether the government can compel companies to issue warnings hinges on several factors, including whether the government has an interest in requiring the disclosure and whether it is truthful and noncontroversial.
In the 2011 rule, the FDA said the government’s interest in the warnings was that they would reduce smoking. The tobacco companies successfully argued that the FDA didn’t have evidence to prove smoking rates would decrease as a result, and the images the FDA developed — like a man with smoke coming through a hole in his throat — stretched the bounds of truth.
In the new proposal, the FDA did “the best possible job that they could to really document the science behind this and to make it clear that this is purely factual and noncontroversial,” Rouvelas said.
But tobacco companies are repeating their arguments, saying once again that the warnings are designed to be visceral and emotional, and therefore push a point of view rather than stating fact.
A key question could be how courts view the new proposal’s stated interest in the policy. Rather than reducing smoking rates, the FDA said this time that the government’s interest was in educating consumers about the risks of smoking. The FDA conducted research to show that the new warnings would effectively educate consumers, and the idea is backed up by the experience of other countries who have graphic warnings.
Some doubt that the FDA can state a different government interest.
Marc Scheineson, a partner at the law firm Alston & Bird who advises small tobacco companies and was an associate FDA commissioner during the first Bush administration, called the move “clever lawyering” but said the courts may look at it as “subterfuge.” Judges would not, he said, “think that really is the compelling government interest behind graphic warning labels — it’s to get people to stop buying the product.”
But supporters of the rule say that courts typically grant agencies a lot of leeway in how they carry out their rules and that it’s hard to argue the government doesn’t have an interest in educating consumers about the risks of smoking.
“It will be self-evident to the courts that this is a substantial governmental interest,” said Dennis Henigan, vice president for legal and regulatory affairs at the Campaign for Tobacco-Free Kids. “It’s hard to imagine a more substantial governmental interest in light of the death toll from smoking. The notion that there is something in the statute that is inconsistent with that conclusion is simply a misreading of the statute.”
Tobacco companies also argue that the FDA’s rule-making process was flawed. During an initial comment period that ended in October, they complained that the agency didn’t release the results of the studies it conducted to develop the warnings and images. The FDA then released that information in November and reopened the comment period for another 15 days. But the industry argues that was still too short of a timeline and the research still didn’t reveal how the FDA chose its proposed warnings and images.
If lawsuits are filed and courts take up the case, it’s possible that a resolution wouldn’t be as black and white as in 2011. This time, the FDA proposed that each warning and image would be severable, so that if the courts had issues with some combinations, others could stand.
Public health groups support that approach. Some said that while the graphic images are the best approach, they would be satisfied even with just updated text warnings that take up more space than they currently do.
“The draft rule was very strong,” Rouvelas said. “Even if all of it didn’t stand, we would support whatever remains of it.”
Scheineson said the FDA could consider public comments and change the final rule so it would “accomplish the bulk of what it seeks, but it won’t be so onerous that industry will challenge it in courts.”
For example, he said the agency could reduce the amount of space the warnings must take up on the packages, or reduce the number of warnings and images that cigarette makers would have to rotate, and provide flexibility about requirements that each image be distributed equally around the country.
“There would be a point in which they would say, ‘We can live with this,’” Scheineson said.
Others are more skeptical.
“Nothing is going to satisfy these companies,” Henigan said. “Their history is to try to defeat any efforts by the government to require them to tell the truth about their products.”