WASHINGTON, D.C. – By issuing a final rule requiring large, graphic health warnings on cigarette
packs and advertising, the U.S. Food and Drug Administration today has taken a
critical and long-overdue step forward in the nation’s battle against tobacco
use – the number one cause of preventable death. The new warnings show and tell
the truth about the deadly consequences of smoking and will promote greater
public understanding of the many ways in which smoking harms the human body.
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The graphic warnings are a dramatic improvement over the current
text-only warnings, which have become stale and unnoticed since they were last
updated in 1984. They are supported by extensive scientific
evidence and will help the United States catch up to
countries that have adopted this best-practice
strategy to reduce tobacco use and save lives.
By law, the new warnings are required to appear on
cigarette packs and ads 15 months after a final rule is issued (June 18, 2021).
The FDA must now ensure these warnings are fully implemented and vigorously
defended against likely legal challenges by the tobacco industry. Congress
first mandated graphic cigarette warnings more than 10 years ago and we cannot
afford more delays – not when tobacco use still kills half a million Americans,
sickens millions more and costs the nation $170 billion in health care expenses
each year. The FDA’s rule makes a comprehensive and compelling case for the
graphic warnings that shows they stand on firm scientific and legal ground. The
rule is also entirely consistent with what Congress required in the 2009 Family
Smoking Prevention and Tobacco Control Act.
The FDA faced a court-ordered deadline of March 15 to submit
to the Federal Register a final rule requiring the graphic warnings as a result
of a successful lawsuit filed
by our public health and medical organizations and several individual
pediatricians in October 2016 (the court’s order required
that the final rule be submitted to the Federal Register for publication by
March 15). Our lawsuit sought to force the FDA to comply with provisions of the
Tobacco Control Act, which required graphic warnings covering the top half of
the front and back of cigarette packs and 20 percent of each cigarette ad.
In a September
2018 ruling, Judge Indira Talwani of the U.S.
District Court for the District of Massachusetts found the FDA “unlawfully
withheld” and “unreasonably delayed” agency action to require the graphic
warnings. Judge Talwani subsequently ordered the FDA to issue a proposed rule
by August 15, 2019, and a final rule by March 15, 2020.
The lawsuit was filed by the American Academy of
Pediatrics, the Massachusetts Chapter of the American Academy of Pediatrics,
the American Cancer Society, the American Cancer Society Cancer Action Network,
the American Heart Association, the American Lung Association, the Campaign for
Tobacco-Free Kids, Truth Initiative and several individual pediatricians. The
plaintiffs have been represented by the legal staff of the Campaign for
Tobacco-Free Kids and the Boston law firm of Anderson & Kreiger LLP.
Background on Graphic Warnings
The graphic warnings are a dramatic improvement over the
current text-only warnings, which haven’t been updated since 1984 and are now
barely noticed by smokers or kids thinking about smoking. They are supported by
scientific evidence showing that graphic warnings
are far more effective at communicating the health risks of smoking than
text-only warnings. And they will help the United States catch up to the 120+ countries that have adopted graphic cigarette warnings. Prior to
2009, when Congress passed the Tobacco Control Act, only 18 countries required
graphic warnings, showing how far behind the rest of the world the U.S. has
fallen over the past 10 years.
The 2009 Tobacco Control Act required graphic warnings
covering the top half of the front and back of cigarette packs and 20 percent
of cigarette advertising and gave the FDA until June 22, 2011, to issue a final
rule requiring such warnings. While the FDA met that deadline, the specific
graphic warnings required by the FDA were struck down in August 2012 by a
three-judge panel of the U.S. Court of Appeals for the D.C. Circuit, which
ruled 2-1 that the proposed warnings violated the First Amendment. That ruling
only applied to the specific images proposed by the FDA and did not address the
law’s underlying requirement.
Ruling in a separate case in March 2012, the U.S. Court
of Appeals for the Sixth Circuit upheld the law’s requirement for graphic
warnings, finding that this provision did not violate the First Amendment. That
court found the graphic warnings “are reasonably related to the government’s
interest in preventing consumer deception and are therefore constitutional.”
The U.S. Supreme Court declined to hear a tobacco industry appeal of this
Taken together, these federal court decisions mean the
FDA is still legally obligated to require graphic health warnings, and the
agency is free to use different images than those struck down by the D.C.
Circuit in 2012.
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