WASHINGTON – When the U.S.
Food and Drug Administration (FDA) imposes new graphic warning labels for
tobacco products, they can survive a First Amendment challenge if they depict
health consequences and their effectiveness is supported by adequate scientific
evidence, according to a Georgetown University Medical Center public health
expert and attorney.
Graphic tobacco warning
labels — which combine images with health warnings — are a widely used tool for
reducing tobacco use in other countries, but the tobacco industry argues they
are unconstitutional in the United States.
In an analysis of legal
and scientific issues for graphic warning labels published in the American Journal of Preventive Medicine,
John Kraemer, JD, MPH, outlines how the courts will likely analyze graphic
warnings and identifies what health evidence must be presented to survive a
legal challenge. Kraemer is an assistant professor of health systems
administration at Georgetown University School of Nursing & Health Studies
and member of the O'Neill Institute for National and Global Health Law.
Despite the fact that
smoking kills 443,00 Americans each year, “the U.S. has some of the weakest
tobacco warning labels in the world, and they haven't been updated in almost 30
years,” said Kraemer, in a press release.
In 2009, Congress passed
the Family Smoking Prevention and Control Act requiring graphic warning labels
on tobacco products, giving the FDA authority to specify the images and text
that must be included. The FDA issued nine graphic warnings in June 2011, but
withdrew them after two federal appeals courts came to opposite conclusions
about their constitutionality.
Though ambiguity exists
over what constitutional standard would be applied in a legal challenge to the
labels, Kraemer argued that it is possible for the FDA to meet the two most
likely standards — rational basis review and intermediate review — with the
right scientific evidence.
Kraemer said the labels
would likely be analyzed under rational basis review and almost certainly
prevail “if the courts decide the warnings combat the industry's past
deception.” He says some courts have also applied this review to
uncontroversial, factual warnings, such as information intended to help
consumers make healthier decisions.
The second possibility is
intermediate review, which requires a stronger governmental interest and
greater certainty that warning labels would be effective. “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,” said Kraemer. “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.”
He added that the FDA must
also take care to avoid images that could be interpreted as opinions instead of
facts or which do not show a negative health consequence of smoking, such as an
image previously adopted by the FDA, which depicted a man with a no-smoking
sign on his shirt.