Tag: Graphic Health Warnings

FDA Halts Packaging Enforcement for 15 Months

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The U.S. Food and Drug Administration has provided guidance on the “Tobacco Products; Required Warnings for Cigarette Packages and Advertisements” final rule that established new required health warnings for cigarette packages and advertisements.
Specifically, the FDA has issued guidance to the tobacco industry that describes the agency’s enforcement policy for the final rule. The final rule was issued in March 2020 and was challenged in the U.S. District Court for the Eastern District of Texas. In December 2022, the District Court struck down the rule.
The government appealed the decision and in May of 2024, the U.S. Court of Appeals for the 5th Circuit reversed the District Court’s decision. This reinstated the final rule, causing the rule to now be in effect. The plaintiffs’ petition for a review by the Supreme Court review is pending.
“The new guidance for the agency’s enforcement policy states that the FDA intends to exercise enforcement discretion and generally not enforce requirements of the final rule for 15 months, or until December 12, 2025,” an FDA release states. “With respect to products manufactured before December 12, 2025, the FDA also intends to exercise enforcement discretion and generally not enforce the rule’s requirements for these products for an additional 30-day period, or until January 12, 2026.”
The pause aligns with the 15-month compliance period originally contemplated by the Family Smoking Prevention and Tobacco Control Act.
The FDA chose 15 months to provide an orderly transition period; this aligns with the 15-month compliance period originally contemplated by the Family Smoking Prevention and Tobacco Control Act, before that timing was disrupted by litigation.
The final rule also requires the industry to submit a plan and obtain FDA approval for the random and equal display and distribution of required warnings on cigarette packages and the quarterly rotation of required warnings in cigarette advertisements.
The agency’s guidance recommends that entities that do not already have approved cigarette health warning plans submit such plans as soon as possible, but in any event, within five months or by February 10, 2025. Entities that previously submitted cigarette plans to the FDA do not need to resubmit their plans unless they wish to make changes.
The public can provide comment on the guidance in the docket at regulations.gov.
September 12, 2024
Top Court Urged to Review Graphic Labels

Images: FDA
Cigarette manufacturers have asked the U.S. Supreme Court to review a lower court ruling affirming a Food and Drug Administration rule mandating graphic health warnings on cigarette packaging and advertisements, reports Law360.
In March, the U.S. 5th Circuit Court of Appeals rejected industry arguments that FDA’s plans violates companies’ free speech rights and that the requirement overpowers branding and messaging on packages and advertisements due to the size of the images and lettering.
Earlier, a district court had found that the new labels were provocative, value-laden messages that burdened tobacco companies’ free speech, but the Fifth Circuit disagreed, concluding that the warnings are undisputedly factual and the images “are no different from those a medical student might see in a textbook.”
On Aug. 19, R.J. Reynolds Tobacco Co., ITG Brands and other tobacco companies urged the nation’s top court to review the appeals court’s decision, arguing that the proposed warnings are “massive, provocative and misleading.”
They also noted that the Fifth Circuit’s finding are at odds with other court rulings that found “far smaller warnings were unduly burdensome.”
“The Fifth Circuit’s opinion, if permitted to stand, would authorize the government to require similar massive and grotesque admonitions on virtually any disfavored consumer product—from fast food, candy and wine to plastic straws, firearms and gas stoves,” the petition said.
The FDA released the final rule in March 2020 requiring new graphic warnings for cigarettes that feature some of the lesser-known but still serious health risks of smoking, such as diabetes, on the top half of the front and back of cigarette packages and at least 20 percent of the area on the top of cigarette advertisements.
August 22, 2024
New Zealand Warnings Losing Bite: Study

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Research out of New Zealand has found that graphic health warnings on tobacco packages are no longer motivating smokers to quit, reports RNZ.
According to Lani Teddy, University of Otago research fellow, the warnings have not been refreshed since 2018 and have lost their impact.
“For example, many on-pack warnings feature diseased organs that participants found difficult to recognize. They felt messages that recognized them as whole people would create greater empathy and do more to encourage them to quit,” Teddy said in a statement.
The study found that consumers were avoiding looking at the health warnings and did not feel that they would be personally harmed by using the products. According to Teddy, smokers were more likely to care about cost, stress of addiction and how their smoking affected their loved ones.
“Other countries are moving ahead with additional product design policies,” said Janet Hoek, research co-leader. “Canada has introduced warnings on individual cigarettes, a move that Australia is also considering. Australia has brought in new regulations that allow for filter regulations and is banning the use of flavor capsules, which make smoking more appealing to young people.”
Hoek said the packaging should include details on how to quit smoking.
“The repeal of the Smokefree Environments and Regulated Products (Smoked Tobacco) Amendment Act 2023 has left a policy vacuum,” Hoek said. “The government should demonstrate its commitment to the Smoke-Free 2025 goal by adopting international best practice in both tobacco product and packaging measures.
“At the very least, the government should maximize the impact that existing measures, such as on-pack warnings, could have and complement these with advice that will help people quit.”
June 12, 2024
Court Refuses to Hear Health Label Challenge

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The U.S. Court of Appeals for the 5th Circuit has refused to hear the tobacco industry’s challenge to graphic health warnings required by a 2020 Food and Drug Administration rule.
In March, a three-judge panel of the same court ruled that the federal requirement for cigarette packs and advertising, which includes graphic images of the effects of smoking, including images of smoke-damaged lungs and blackened feet, does not violate the First Amendment of the Constitution, reports AP News.
The March ruling affirmed that the FDA’s graphic cigarette warnings are both scientifically and legally sound. Proponents say these graphic warnings are critically needed as the current text-only warnings have become stale and unnoticed since they were last updated in 1984.
The three-judge panel ruling overturned a lower court order from a Texas federal district court, which ruled that the requirements violate the First Amendment.
Congress first mandated the graphic health warnings as part of the 2009 Family Smoking Prevention and Tobacco Control Act, which required graphic warnings covering the top half of the front and back of cigarette packs and 20 percent of cigarette advertisements.
Anti-smoking activists welcomed the appeals court’s refusal to hear the industry’s challenge.
“Because of the tobacco industry’s repeated legal challenges, the U.S. currently ranks last in the world in the size of its cigarette warnings and has fallen behind the rest of the world in implementing graphic warnings, which are now required by 138 countries and territories,” said Yolonda C. Richardson, president and CEO of the Campaign for Tobacco-Free Kids, in a statement.
“It is time for the U.S. to catch up with the rest of the world in implementing this best-practice policy to reduce tobacco use and save lives.”
May 22, 2024
Industry Insists on Risk-Appropriate Warnings

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The tobacco industry is asking the government of Kenya to distinguish between traditional cigarettes and tobacco-free alternatives, such as vapes and nicotine pouches, when crafting health warning labels, reports The Star.
Kenya’s health ministry is currently gathering public feedback on a proposal that would require cigarette manufacturers to print new graphic health warnings on packs of nicotine products. The consultation ends May 15.
The industry says that most of the proposed images do not correlate with the products for which they are proposed.
“We are looking at information that does not mislead the user, is factual and evidence-based,” said BAT Kenya’s scientific engagement manager, Douglas Weru, during a public participation workshop hosted by the Ministry of Health. “The message coming through from stakeholders in this public participation sessions, and which we agree with, is that the images should correlate to the risk associated with the product,” said Weru.
The Retail Trade Association of Kenya (Retrak) said the proposed warnings require an amendment to the 2007 Tobacco Control Act, given that many of the new products were not widely available when the law was written.
May 11, 2024
Kenya Gathering Input on Graphic Warnings

Photo: Vitaliy Sova
Kenya’s health ministry is gathering public feedback on a proposal that would require cigarette manufacturers to print new graphic health warnings on packs of nicotine products, reports The Standard.
The new rules will require tobacco manufacturers to display labels covering 80 percent of the packaging of cigarettes, nicotine pouches and e-cigarettes.
“The objectives of the graphic health warnings are to increase knowledge about risks associated with tobacco use, to deter initiation to tobacco, to reduce tobacco consumption and persuade tobacco users to quit and to break the challenges of languages and the inability to read text-only messages,” said the Ministry of Health in a public notice.
Some 8.6 percent of Kenyans smoked in 2020, according to World Health Organization data. The government wants to reduce this figure to less than 5 percent by 2025.
Tobacco industry representatives contend that the proposed measure does not appropriately distinguish between cigarettes and smoke-free nicotine products, such as nicotine pouches, which they tout as less hazardous than cigarettes.
“There is a need for legislation in Kenya to separate tobacco products from nicotine products and for an appreciation of the role played by alternative nicotine-delivery products,” an unnamed official was quoted as saying. “The current graphic health warnings campaign does not distinguish between the two products.”
May 6, 2024
Vape Companies Urged to Implement Graphic Warnings

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The Philippines’s Department of Health (DOH) is urging businesses, distributors and importers to start printing graphic health warnings (GHW) on vaporized products, reports Tribune.
The first set of GHW templates for vape products is set to take effect on May 12.
Under Republic Act No. 11900, also known as the Vape Law,
Operators who fail to comply with the new rules risk fines of between PHP2 million and PHP5 million and imprisonment of up to six years.
Manufacturers, importers, distributors and sellers may also face revocation or cancellation of permits and licenses as well as immediate recall, ban, or confiscation of products at the direction of the Bureau of Internal Revenue.
In addition, foreign individuals found in violation risk deportation.
April 26, 2024
Kenya to Consult on New Health Warnings

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Kenya’s Ministry of Health has invited the public to comment on 13 proposed large graphic warnings for tobacco products, reports The Star.
If the changes are approved, graphic warning depicting impotence, cancerous growths and sick fetuses will also be printed on new tobacco and nicotine products sold in Kenya. Currently, only cigarette packets are required to display such warnings. The law requires a combined picture and text health warning to occupy at least 30 percent of the front and 50 percent of the back of smoked tobacco products. Among the proposed labels is also a message indicating that nicotine pouches are not a safe alternative.
“These warnings are very important because they speak even to those who can’t read and they attract attention. They also scare people and pass information more clearly and immediately compared to text,” said Joel Gitali, head of the Kenya Tobacco Control Alliance.
Health warnings were introduced in Kenya as part of the 2007 Tobacco Control Act, which came into force in July 2008 and included requirements for 13 rotating text-only health warnings in Kiswahili and English.
In 2014, the government introduced 15 new images for smoked and smokeless tobacco packages. The regulations were to be implemented in June 2015 but were delayed due to a legal challenge by cigarette manufacturers, who lost the case at the Supreme Court. The images were introduced beginning September 2016.
The 2014 regulations require tobacco manufacturers to rotate the picture and text warnings in a 12-month period.
However, the law does not state how frequently the health minister must update the warnings. The World Health Organization advises governments to change tobacco health warnings every 12 to 36 months.
April 23, 2024
South Korea to ‘Refresh’ Graphic Warnings

Photo: KT&G
In December 2024, South Korea will mandate new graphic health warnings on cigarette packs, reports mk.co.kr .
The new warning pictures and phrases, the fifth approved set under the National Health Promotion Act, will be applied Dec. 23, 2024, through Dec. 22, 2026. The fourth approved set of warnings expires on Dec. 22, 2024.
The new warnings replace two out of 10 types of pictures on cigarette packs, increasing the proportion of the disease depicted, and the phrase changes from a word to a sentence.
For e-cigarettes, the subject of the warning pictures will increase from one to two, but the warning phrases will remain the same.
“The fifth warning picture and phrase comprehensively considered the analysis of domestic and foreign policy studies, public surveys and opinions of related experts,” said Jeong Yeon-hee, head of the Health Promotion Division at the Ministry of Health and Welfare. “We set it as an effective plan to prevent smoking and induce smoking cessation by utilizing the purpose of introducing the cigarette pack health warning notation system.”
April 4, 2024
Warnings Don’t Violate First Amendment: Court

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The U.S. 5th Circuit Court of Appeals ruled that the federal requirement for cigarette packs and advertising include graphic images of the effects of smoking, including images of smoke-damaged lungs and blackened feet, does not violate the First Amendment of the Constitution, reports AP News.
The ruling came from a three-judge panel, consisting of Jerry Smith, Jennifer Walker Elrod and James Graves, that also kept alive a tobacco industry challenge of the rule, stating that a lower court should review whether the rule was adopted in accordance with the federal Administrative Procedure Act, which governs the development of regulations.
The panel rejected the argument from the tobacco industry that the rule violates free speech rights and that the requirement overcomes branding and messaging on packages and advertisements due to the size of the images and lettering.
This latest ruling overturns a lower court order from a Texas federal district court, which ruled that the requirements violate the First Amendment.
“We disagree,” Smith wrote for the 5th Circuit panel. “The warnings are both factual and uncontroversial.”
The U.S. is among about 120 countries globally that have adopted larger graphic health warnings. Studies from other countries suggest that the image-based labels are more effective than text warnings.
March 22, 2024