Can a new regulation be something to celebrate? If it stands to save lives, absolutely.
Here’s one that does: the Food and Drug Administration’s proposal to require warnings, including graphic images, on cigarette packages and in cigarette advertisements. The regulation, now out for a 60-day comment period, also appears to fix the problems that hobbled previous attempts to mandate graphic cigarette warnings.
It's been 10 years since Congress first directed the FDA to require graphic warnings, and that job was supposed to be done by mid-2011. The FDA duly aimed to meet the deadline, proposing labels that were indeed graphic. (As administrator of the Office of Information and Regulatory Affairs at the time, I helped oversee that process.) But the tobacco companies convinced a federal court that, by compelling speech, the FDA's regulation violated their First Amendment rights.
Importantly, the court did not say Congress lacked the power to mandate graphic warnings. It ruled more narrowly that the FDA had not provided sufficient evidence that its warnings would substantially cut U.S. smoking rates — either by discouraging people from starting to smoke or by encouraging smokers to quit.
For reasons that remain unclear, President Barack Obama’s administration did not seek an alternative way to comply with Congress’ direction. And Americans continued to die from smoking-related causes at the rate of 480,000 per year (12 times as many as who die from gun-related causes).
Finally, the Campaign for Tobacco-Free Kids (which is supported by Bloomberg Philanthropies), the American Cancer Society, the American Lung Association, and several other organizations sued the FDA for failing to carry out the 2009 law. And last September, A federal District Court ordered the agency to get to work.
The new warning labels that resulted are significantly less graphic than the originals, but they're plenty disturbing nonetheless. To smokers and would-be smokers, they vividly portray what cigarettes can do to the human body.
And the FDA is now providing a new justification for them — one that should much reduce the risk of further legal challenge. Rather than insist that the labels will directly cut smoking rates, the agency says they will promote "a greater public understanding of the negative health consequences of cigarette smoking."
The text-only warnings that have been displayed on cigarette packs and ads since 1984, the FDA argues, are inadequate: Many people, including adolescents, "do not see or read, and do not remember" them, or give them much thought. Pictorial warnings, in contrast, heighten attention and awareness, and thus increase smokers' knowledge about health outcomes, including stroke and cancer.
Employing focus groups, individual interviews and online research panels, the FDA tested various textual and graphic warnings, and homed in on the kinds that best attract attention and are most likely to be remembered. "Smoking can harm your children," for example, made the cut.
Like any agency issuing a new regulation, the FDA also had to quantify the benefits and costs of the new rule, and show that the former justify the latter. The agency found that for the tobacco industry, the annual expense of adopting, designing, rotating, and advertising the various labels will be in the vicinity of $110 million — a reasonable estimate.
As for benefits, the agency acknowledges that they "are difficult to quantify." The reason is simple: When you're aiming to increase public understanding rather than reduce illness and death, it's hard to assess monetary savings.
So, as agencies often do in such situations, the FDA undertook a "break-even analysis," by which it asks how great the benefits would have to be in order to justify the costs. It noted that if the benefits of graphic warnings were as low as $0.01 per pack, they would be worthwhile. Surely, greater public understanding of the health risks of smoking is worth at least a penny a pack.
The FDA’s new label requirement is set to be finalized in March. Let’s hope the agency meets that deadline — and that cigarette makers have the good sense to stay out of court this time.