Big Tobacco Scores a Win Against Graphic Warning Labels on Cigarette Packs

The AHA and others are undeterred, believing ultimately that these health warnings are truthful and comply with the law.

Big Tobacco Scores a Win Against Graphic Warning Labels on Cigarette Packs

Cigarette packaging in Germany comes with graphic warning labels.

The American Heart Association (AHA), along with several other professional organizations, is condemning a recent legal decision that allows tobacco companies to avoid putting graphic cigarette warnings on their packages.

Issued by the US District Court for the Eastern District of Texas, last week’s ruling blocks the implementation of graphic warnings mandated by the US Congress and ordered by the Food and Drug Administration. US District Judge J. Campbell Barker stated in his decision that the rule, which was to go into effect next October, violated the tobacco companies’ First Amendment rights.

R.J. Reynolds, which filed the lawsuit, argued that the graphic packaging was unconstitutional because it forced them to promote an anti-smoking message. 

The AHA and the American Academy of Pediatrics, the American Cancer Society, the American Cancer Society Action Network, the American Lung Association, the Campaign for Tobacco-Free Kids, and the Truth Initiative disagree with the court’s decision. The organizations say the legal ruling “is wrong on the law, inconsistent with decades of precedent, and harms public health.”

“Courts have long held that mandatory health warnings conveying truthful information about the risks of dangerous products do not violate the First Amendment,” they write in a statement. “According to the court’s ruling, however, the First Amendment permits only ineffective health warnings that do little to educate the public about the serious health risks of smoking.”

Nancy Brown, CEO of the AHA, said that while they are disappointed with the decision, they are confident it will be overturned by a higher court and are urging the Justice Department to appeal. “This is Big Tobacco, yet again, trying to manipulate the American people, and young people, by putting up roadblocks when they say they are trying to end smoking,” Brown told TCTMD.

For the FDA’s required warnings rule, depictions of the hazards of smoking—color photographs of diseased hearts and lungs, end-stage cancer patients, lesions typical of mouth and throat cancer, and amputated toes from peripheral vascular disease, among others, all coupled with textual warnings of the risk of disease—would be placed on the top half of the front and back of all cigarette packaging (and 20% of the top of cigarette ads). 

“Congress first mandated these graphic cigarette warning labels more than 10 years ago and we can’t afford more delays,” Brown continued. “Tobacco still kills half a million people in the United States, sickens millions more, and costs the nation more than $70 billion in healthcare expenses each year.”

Tobacco company Philip Morris is also challenging the FDA’s graphic warning labeling in court, filing their challenge in the US District Court for the District of Columbia.

Tortuous Legal Path

Graphic cigarette warnings, which have been adopted by more than 120 countries, were mandated by a large, bipartisan congressional majority as part of the 2009 Family Smoking Prevention and Tobacco Control Act.

Implementation, however, has been another story entirely, with the rule tied up in courts for more than a decade. 

Following the congressional mandate, the FDA issued the first comprehensive set of graphic warnings in 2011. Almost immediately, several tobacco companies filed suit in district court challenging the agency’s graphic packaging rule, ultimately winning as it was struck down as unconstitutional. The US Court of Appeals for the DC Circuit upheld the ruling and the federal government declined to appeal that decision to the US Supreme Court. 

This is Big Tobacco, yet again, trying to manipulate the American people, and young people, by putting up roadblocks when they say they are trying to end smoking. Nancy Brown

A separate ruling, however, upheld the FDA’s authority to require graphic warnings on cigarette packaging, leading the agency to say they would revise their requirements. After not issuing a proposal for several years, multiple organizations, including the AHA, took the FDA to federal court to force them to issue a final rule around graphic packaging. After the AHA and others won that lawsuit, the FDA issued new graphic warning labels in 2019 focusing on the risks of cigarette smoking.

The warning labels were scheduled to go into effect 15 months after the FDA decision, but this has since been tied up in legal challenges from R.J. Reynolds and Philip Morris in district court.

Brown said the US remains “behind the times” when it comes to implementing policy around graphic warning labels, lamenting that “it is more than unfortunate that in this country, Big Tobacco is able to have the influence it has to stop scientific-based things like graphic warning labels from coming to life.”

In the US, there have not been any changes to the text-only warning labels since 1984, which the AHA says have become stale and go unnoticed. When the Tobacco Control Act was passed in 2009, just 18 countries required graphic warning labels. In the 13 years the labelling proposal has been tied up in courts, more than 100 other countries have gotten on board, a statistic that shows just how far behind the US is when it comes to this issue, according to the AHA. 

One study estimated that had the US implemented the graphic warnings in 2012, it would have led to a reduction of between 5.3 and 8.6 million adult smokers. These warnings are also effective in young people, with studies from Canada, Australia, and Greece showing that the photographic labels are better than text-based warnings when it comes conveying the risks of smoking and preventing nonsmokers from starting.

“We know there is extensive scientific evidence showing that graphic warnings are most effective in increasing public understanding and reducing tobacco use,” said Brown.

The AHA and other groups are confident the FDA’s rule will be upheld by a higher court. “We’ve had disappointment after disappointment, and this most-recent one is really unacceptable,” said Brown. “We will stop at nothing at the AHA to make sure that no stone is unturned to implement into reality what already is law.”  

Another Fight Coming Soon

Earlier this year, the FDA proposed new regulations that would ban menthol cigarettes and flavored cigars in a bid to prevent more young people from starting smoking and to help adult smokers quit. Menthol is used by tobacco companies to make smoking more palatable, while flavored cigars, which come in strawberry, grape, fruit punch, and cocoa flavors, are aimed more at the youth market because they are easier on new smokers.

Not unlike the graphic-packaging rule, the tobacco companies are fighting legislation every step of the way, according to the AHA.

In California, for example, the industry spent more than $20 million initiating a referendum to challenge a 2020 state law banning the sale of most flavored tobacco products. California voted to uphold the law in the November 8, 2022, referendum, giving anti-tobacco advocates a win at the ballot box. R.J. Reynolds asked the Supreme Court to strike down the law, but the court declined, paving the way for the law to go into effect next week.    

Despite the success in California, the AHA is anticipating legal challenges to the proposed ban on menthol cigarettes and flavored cigars, so much so that they’ve gone on the offensive with a massive report laying out the manipulative marketing tactics of the tobacco companies. Using the companies’ own internal communications, the report shows that these flavored products were specifically created to capture young people, women, and Black Americans.  

Michael O’Riordan is the Managing Editor for TCTMD. He completed his undergraduate degrees at Queen’s University in Kingston, ON, and…

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  • Brown reports no relevant conflicts of interest.

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