It's the latest blow to federal efforts to strengthen tobacco warnings
- Philip Morris wins court fight to block new cigarette warning labels and ads
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Judge says FDA failed to disclose raw study data during rulemaking process
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Ruling is latest blow to government efforts to strengthen tobacco warnings
A federal judge has struck down the Food and Drug Administrations rules requiring new graphic warnings on cigarette packages and advertisements, siding with Philip Morris USA and other plaintiffs in a closely watched case.
In an Aug. 29 order, Judge Lisa G. Wood of the U.S. District Court for the Southern District of Georgia said the FDA failed to disclose the raw data from studies it relied on to design the labels. That, she wrote, prejudiced cigarette makers and convenience store operators who challenged the rules.
The Georgia plaintiffs, including the Georgia Association of Convenience Stores, argued the rule would cost millions, force retailers to speak against their own products, and deter customers by making convenience stores "unwelcoming." accoring to TobaccoReporter.com.It said the FDA arbitrarily focused on certain smoking-related risks over others without explanation, and claimed it ignored countless red flags in its studies. The FDA defended its process, noting the warnings aimed to better inform consumers of smoking risks.
Yet another setback
The ruling marks another setback for regulators trying to enforce tougher health warnings. The 2009 Family Smoking Prevention and Tobacco Control Act directed the FDA to require graphic warnings alongside text statements about the dangers of smoking. The agencys first attempt in 2011 was vacated by a federal appeals court for violating the First Amendment.
In 2020, the FDA issued a new rule with 11 graphic warnings tied to smoking-related diseases, supported by agency studies it said would promote public understanding of health risks. But Philip Morris and its co-plaintiffs argued the process violated both the tobacco law and the Administrative Procedure Act.
Earlier this year, a Texas judge temporarily blocked enforcement of the rules, finding the FDA likely violated procedure. Fridays Georgia ruling goes further, granting summary judgment to the tobacco companies and striking the rules down altogether.
The government has defended its approach, noting the need to update warning labels after decades without changes. But the latest ruling underscores the steep legal hurdles regulators face in forcing the industry to adopt stronger labels.
Still lethal after all these years
Tobacco remains the leading cause of preventable death in the U.S., responsible for nearly one in five deaths annually.
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The Centers for Disease Control and Prevention (CDC) states that cigarette smoking and exposure to secondhand smoke cause more than 480,000 deaths each year nearly 20% of all U.S. deaths.
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The American Lung Association also reports that smoking tops the list of preventable death causes, resulting in around half a million deaths annually in the country.
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Although smoking rates have dropped dramatically from about 42% of U.S. adults in 1965 to 1112% by 2022 the health impact remains significant.
What you need to know
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Philip Morris and others prevailed in court, with a judge invalidating FDAs graphic warning label rules.
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Why it matters: The decision delays updated health warnings Congress called for in 2009.
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Whats next: The government can appeal, but legal challenges have repeatedly stalled tobacco labeling efforts for more than a decade.
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A federal judge in South Georgia struck down the U.S. Food and Drug Administrations (FDA) rule requiring graphic health warnings on cigarette packs and ads, siding with Philip Morris USA and Georgia retailers, according to The Atlanta Journal-Constitution. U.S. District Judge Lisa Wood ruled that the FDA failed to disclose all raw data used in developing the 2020 rule, preventing stakeholders from offering meaningful feedback. While Wood rejected most of the plaintiffs arguments, she vacated the rule, citing a violation of the Administrative Procedures Act.
The Georgia plaintiffs, including the Georgia Association of Convenience Stores, argued the rule would cost millions, force retailers to speak against their own products, and deter customers by making convenience stores unwelcoming. It said the FDA arbitrarily focused on certain smoking-related risks over others without explanation, and claimed it ignored countless red flags in its studies. The FDA defended its process, noting the warnings aimed to better inform consumers of smoking risks.
The decision marks another setback in the FDAs long-running effort to implement graphic warnings under the 2009 Family Smoking Prevention and Tobacco Control Act. A similar case is pending in Texas, where a judge has already blocked enforcement until appeals are resolved.
Posted: 2025-09-03 14:57:37
