Stronger cigarette warnings likely to renew legal challenges Tiionline Follow Mar 25 · 3 min read

Soon, 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 year long delay, the agency says that if a court wants to throw out some images or warnings, it should let others stand.

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% 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 industry 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.