Policy/Biz

FDA Preparing To Relaunch Graphic Tobacco Warning Labels [VIDEO]

Tobacco Industry Challenges FDA 'Graphic Warning' Requirement As Unconstitutional
Public health policy experts are advising federal regulators on how to implement a 2009 law requiring graphic tobacco warning labels on cigarette packages. Creative Commons

A dream team of public health policy experts continues to advise U.S. regulators on beating tobacco companies in a fight over graphic health warnings on cigarette packaging.

American tobacco companies successfully challenged implementation by the U.S. Food and Drug Administration (FDA) of the Family Smoking Prevention and Control Act of 2009, which required graphic tobacco warning labels on cigarette products and gave the regulator authority to specify images and text to be carried as warnings.

Following the agency's issuance of nine images to be used on packaging, the tobacco industry successfully challenged the implementation on constitutional grounds, citing the First Amendment's speech protections. A federal judge last March agreed and, in August, the U.S. Court of Appeals for the District of Columbia affirmed that ruling.

The U.S. Department of Justice in April notified Speaker of House John Boehner that they would not ask the Supreme Court to review the case, instead choosing to research ways to implement the law under constraints imposed by the appellate ruling.

John Kraemer, a lawyer and assistant professor of health systems administration at Georgetown University, says the regulator may beat a First Amendment challenge on the cigarette warnings if they depict health consequences of smoking in a manner supported by empirical evidence. In a report Tuesday in the American Journal of Preventive Medicine, Kraemer outlines the legal and scientific standards required to make that happen — saying it's possible to meet the two most likely standards, rational basis review and intermediate review, with the right evidence.

Newly proposed labels for tobacco packaging would likely be analyzed under rational basis review, the lowest level of scrutiny applied to laws when considering the constitutional justification for government to intervene in the rights of individuals — and corporations — to speak and otherwise act. Labels backed with solid scientific evidence would almost certainly prevail "if the courts decide the warnings combat the industry's past deception" in tobacco marketing, Kraemer said.

In the past, the courts have applied the same review to other factual warnings in industry, such as information intended to help people make healthier decisions. The second standard likely to be imposed on regulatory implementation of the law, intermediate review, would require a stronger government interest and greater evidence of the efficacy of the warning labels.

"Under this review, the FDA could likely win, but the case will turn on how well the government can convince the courts about certain empirical evidence," Kraemer said. "Providing clear evidence of [graphic warning labels'] impact on smoking rates themselves or for the causal mechanism [by which they reduce smoking] would meet the Court's test."

The FDA must also avoid images that might be interpreted as opinion rather than fact, or those which fail to depict adverse health consequences of smoking, such as one of the images previously proposed by regulator, which showed a man with a "no-smoking" sign on his shirt.

The nine images initially selected by the FDA include a healthy and smoke-blackened lung side by side, a man smoking through a tracheotomy hole in his neck, and a staged photo of a corpse on a coroner's table.

Among the nine images initially proposed by the FDA were a healthy and smoke-blackened lung side by side, a man smoking through a tracheotomy hole in his neck, and a photo of a corpse at the morgue. Although common in other countries, the U.S. has not required graphic warnings on cigarette packaging and has not changed the standard textual warning in nearly 30 years, after becoming the first in the world in 1966 to require a warning.

Leslie Snyder, director of the Center for Health Communication and Marketing at the University of Connecticut, is also working to advise regulators on implementing the new law, with research funded by a $1 million grant from the National Cancer Institute.

Using focus groups and conducting interviews and surveys, Snyder's research team continues to ascertain how best to influence one of humanity's most intransigent adverse health behavior, one that kills some 433,000 Americans every year. Among the team's preliminary research findings is evidence that graphic warnings influence young adults who are occasional smokers, impelling them to think of smoking as a less desirable behavior.

Such smokers are rich targets for social marketers, Snyder says, given that many fail to realize the health and addiction risks they face — as opposed to daily smokers, already aware of their habit — and may have an easier time quitting.

The percentage of adult American smokers has fallen since 1965 from 42.4 percent to 18.9 percent in 2011, and continues to decline. The new federal law requires graphic warning labels to cover half of the packaging area of tobacco products, providing regulators lawfully implement their new authority.

Below is a video on cigarette warning labels:

 

Source: Kraemer J, Baig SA. Can New FDA Graphic Warning Labels For Tobacco Pass A First Amendment Legal Challenge? American Journal Of Preventive Medicine. 2013.

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