Category: Packaging

Graphic Health Warnings Postponed Again

Image: FDA
The U.S. Food and Drug Administration has postponed the effective date of its “Required Warnings for Cigarette Packages and Advertisements” final rule to April 9, 2023, following a Feb. 10, 2022, ruling by the U.S. District Court for the Eastern District of Texas.
The move marks at least the fifth delay for graphic warning health warnings in the United States when counting previously set launch dates of June 18, 2021, Oct. 16, 2021, Jan. 14, 2022, April 14, 2022, and July 13, 2022.
The FDA released its final rule requiring new graphic warnings for cigarettes in March 2020. The rule calls for labels that feature some of the lesser known health risks of smoking, such as diabetes. The graphic warnings must cover the top 50 percent of the front and rear panels of packages as well as at least 20 percent of the top of advertisements.
In April and May 2020, cigarette manufacturers and retailers sued the FDA, arguing that the graphic warning requirements amount to governmental anti-smoking advocacy because the government has never forced makers of a legal product to use their own advertising to spread an emotionally charged message urging adults not to use their products.
In a more recent challenge, tobacco companies argued that the deadline was too onerous due to the impact of the Covid-19 pandemic. They also pointed to the risk that they would lose their investments in new packaging if the graphic health warning requirement were to be thrown out in court.
In March 2021, the Texas District Court granted a motion by the plaintiffs to postpone the effective date of the final rule to April 14, 2022. The move was followed by additional postponements.
This is the FDA’s second attempt to enact graphic health warnings under the 2009 Family Smoking Prevention and Tobacco Control Act. The first rule was struck down by the federal court in the District of Columbia as a violation of the First Amendment.
Pursuant to the Feb. 10, 2022, court order, any obligation to comply with a deadline tied to the effective date is similarly postponed. The FDA encourages entities to submit cigarette plans as soon as possible, and in any event by June 10, 2022.
February 16, 2022
Cote d’Ivoire Mandates Plain Tobacco Packs

Photo: alexlmx
Cote d’Ivoire has become the first country in Africa to require plain packaging on tobacco products, according to the Campaign for Tobacco-Free Kids (CTFK).
Pioneered in Australia, plain packaging legislation requires that cigarettes be sold in generic, uniform packaging free of colorful branding or designs. When implemented in concert with smoke-free public places, restrictions on tobacco advertising, increased tobacco taxes and warning labels on tobacco products, plain packaging is a powerful public health tool, according to anti-smoking activists.
To reduce the appeal of tobacco products, more than 20 countries have adopted plain packaging as part of a suite of tobacco control measures aimed at driving down smoking rates and preventing young people from starting to smoke.
In 2015, Bloomberg Philanthropies and the Bill and Melinda Gates Foundation announced the creation of the Anti-Tobacco Trade Litigation Fund, which provides on-request support to low-income and middle-income countries that have been sued by tobacco companies opposed to plain packaging laws.
“The Campaign for Tobacco-Free Kids congratulates Cote d’Ivoire on bringing plain packaging to Africa where strong action is needed to prevent a tobacco epidemic—and stands ready to support this life-saving public health measure,” wrote Bintou Camara Biyeki, director of Africa programs at the CTFK.
January 31, 2022
New Tobacco Health Warnings in Cambodia

Image: ATIC
New tobacco health warning requirements took effect in Cambodia today, according to The Phnom Penh Post.
The amended rules require cigarette manufacturers to print textual and pictorial messages on 55 percent of each tobacco product pack warning consumers that smoking can lead to heart disease and fatal emphysema.
Retailers may continue to sell existing legally compliant and tax-paid tobacco products until they are depleted in the marketplace.
In the runup to the directive, the Association of Tobacco Industry in Cambodia (ATIC) produced and distributed an informational poster about the new rules to more than 20,000 retail outlets across the Kingdom.
“Our members have printed the new textual and graphic health warning on our product packs,” said ATIC President Roy Manalili. “The association is pleased to follow and support the authorities in this process to promote public health and strengthen fair competition.”
A Kantar study on illicit tobacco trade across Cambodia last year found 3.4 million out of 4.7 million packs complied with the then-prevailing health warning requirements.
Eighteen percent of noncompliant packs were identified as illicit product.
“It was believed that the ministry’s prioritized action to enforce and strengthen the existing regulations on the tobacco products with no pictorial health warning would be a much more important step than releasing new pictorial health warning or enlarging it,” said Manalili.
“Better enforcement would increase the level playing field in the market for a transparent business environment in line with the latest government’s policy reform.”
December 1, 2021
U.S. Pictorial Health Warnings Postponed Again

Image: FDA
The new effective date for the FDA’s final rule on health warnings is Jan. 9, 2023, after the U.S. District Court for the Eastern District of Texas ruled to extend the date in R.J. Reynolds Tobacco Co. et al. v. United States Food and Drug Administration et al.
Deadlines tied to the effective date have also shifted. For instance, while the FDA strongly encourages entities to submit cigarette plans as soon as possible, the deadline for submission is now March 12, 2022.
The Family Smoking Prevention and Tobacco Control Act (TCA) of 2009 directed the FDA to issue regulations requiring color graphics depicting the negative health consequences of smoking to accompany new textual warning statements.
In March 2020, the FDA finalized the “Required Warnings for Cigarette Packages and Advertisements” rule, establishing 11 new cigarette health warnings consisting of textual warning statements accompanied by color graphics, in the form of photorealistic images, depicting the negative health consequences of cigarette smoking.
The new graphic warnings, which depict some of the lesser known health risks of smoking, such as diabetes, must cover at least the top 50 percent of the front and rear panels of packages as well as at least 20 percent of the top of advertisements.
In April and May 2020, cigarette manufacturers and retailers sued the FDA, arguing that the graphic warning requirements amount to governmental anti-smoking advocacy because the government has never forced makers of a legal product to use their own advertising to spread an emotionally charged message urging adults not to use their products.
In a more recent challenge, tobacco companies argued that the deadline was too onerous due to the impact of the Covid-19 pandemic. They also pointed to the risk that they would lose their investments in new packaging if the graphic health warning requirement were ultimately thrown out in court.
The industry won several postponements of the new health warnings’ effective date in court.
This is the FDA’s second attempt to enact graphic health warnings under the TCA. The first rule was struck down by the federal court in the District of Columbia as a violation of the First Amendment.
November 19, 2021
Report: Plain Packaging Gaining Momentum

Image: CCS
Tobacco plain packaging continues to gain momentum worldwide, according to a new report released by the Canadian Cancer Society (CCS) in conjunction with the ninth session of the Conference of the Parties to the World Health Organization Framework Convention on Tobacco Control, Nov. 8–13. The FCTC recommends member states to consider plain packaging.
Titled Cigarette Package Health Warnings: International Status Report, the CCS study reveals that 21 countries and territories have currently adopted plain packaging compared with nine in 2018. An additional 14 countries are working to implement the measure.
“There is a strong, unstoppable global trend for countries to implement plain packaging,” says Rob Cunningham, senior policy analyst at CCS, in a statement. “Australia was the first country to implement plain packaging in 2012, and now the pace of implementation is accelerating. These developments are very encouraging as plain packaging is a key measure to protect youth and to reduce tobacco use.”
Plain packaging includes health warnings on packages and prohibits tobacco company branding such as colors, logos and design elements. It also requires the brand name to be a standard font size, style and location on the package and the brand portion of each package to be the same color, such as an unattractive brown. Finally, the package format is standardized. Plain packaging regulations put an end to packaging being used for product promotion, increase the effectiveness of package warnings, curb package deception and decrease tobacco use.
Plain packaging has been implemented in Australia (2012), France (2016), the United Kingdom (2016), Norway (2017), Ireland (2017), New Zealand (2018), Saudi Arabia (2019), Turkey (2019), Thailand (2019), Canada (2019), Uruguay (2019), Slovenia (2020), Belgium (2020), Israel (2020), Singapore (2020), the Netherlands (2020), Denmark (2021) and Guernsey (2021) and will be implemented in Hungary (2022), Jersey (2022) and Myanmar (2022).
Plain packaging has been implemented in practice in three countries where packages are imported from a country with plain packaging: Monaco (from France), Cook Islands (from New Zealand) and Niue (from Australia). Plain packaging is under formal consideration in at least 14 countries: Armenia, Chile, Costa Rica, Finland, Georgia, Iran, Malaysia, Mauritius, Mexico, Nepal, South Korea, South Africa, Spain and Sri Lanka.
The number of countries requiring plain packaging is expected to increase even further because of the World Trade Organization (WTO) appeal decision on June 9, 2020, that Australia’s plain packaging requirements are consistent with the WTO’s international trade agreements.
The case followed an unsuccessful legal challenge to plain packaging by the tobacco industry.
There is a strong, unstoppable global trend for countries to implement plain packaging.
Rob Cunningham, senior policy analyst, Canadian Cancer Society
The CCS report also reveals growing momentum for graphic health warnings. It found that 134 countries and territories now require pictorial health warnings on cigarette packages, up from 117 in 2018. This represents 70 percent of the world’s population. Canada was the first country to require pictorial health warnings in 2001.
“There is unrelenting international momentum for countries to use graphic pictures on cigarette packages to show the lethal health effects of smoking,” says Cunningham. “It is extremely positive for global public health that more than 130 countries and territories have required picture health warnings and have increased warning size and that so many are moving toward plain packaging,” says Cunningham. “The international trend will reduce global tobacco industry sales and will save lives lost to cancer and other tobacco-related diseases.”
In total, 122 countries and territories have required warnings to cover at least 50 percent of the package front and back (on average), up from 107 in 2018 and 24 in 2008. There are now 71 countries and territories with a size of at least 65 percent (on average) of the package front and back, and 10 with at least 85 percent.
November 10, 2021
Study: Graphic Warnings Could Have Prevented Many U.S. Deaths

Image: FDA
Warning labels with graphic depictions of the negative health consequences of smoking could have averted thousands of smoking-related deaths if approved as originally planned in 2012, according to a new analysis by University of Michigan (U-M) researchers and colleagues from the Cancer Intervention and Surveillance Modeling network (CISNET) Lung Group.
If the U.S. Food and Drug Administration requires tobacco companies to include the graphic warning labels on cigarette packages in October 2022, as it’s expected to do, between 275,000 and 794,000 smoking-attributable deaths could be averted by 2100, and between 4 million to 11.6 million life-years could be gained during that period.
While the FDA had planned to implement the graphic warning labels nine years ago, it has been entangled in litigation with the tobacco industry over the issue. The rules to add the labels include textual warnings and color graphics with photorealistic images depicting the negative health consequences of cigarette smoking, such as warnings that smoking can cause erectile dysfunction or head and neck cancer and can lead to COPD.
“Industry litigation and delays to implementing tobacco regulations have high costs to public health,” said Rafael Meza, professor of epidemiology and global public health at U-M’s School of Public Health and senior author of the study published in JAMA Health Forum. “This research shows that we must move forward with implementation to maximize the benefits of adding graphic health warnings to cigarette’s packaging.”
For their study, researchers simulated smoking and mortality outcomes associated with the health warnings using the CISNET Smoking History Generator Population Model and previously published research of the expected impacts of graphic health warnings on smoking prevalence and cessation. The assumptions in the model are based in part on what has been seen in other countries like Canada and Australia that have already rolled out these graphic warnings.
All CISNET lung cancer models are based on inputs from the Smoking History Generator, which simulates detailed individual-level life and smoking histories: birth, probabilities of smoking initiation, smoking cessation and death. Because graphic health warnings have never been implemented in the United States, researchers could not perform external validation of the policy scenarios.
The researchers acknowledge that while literature on graphic health warnings demonstrates their public health benefit, uncertainty remains about the true magnitude of their effect on smoking behavior, especially with regard to smoking initiation.
Researchers first modeled a baseline scenario with the current status quo and then calculated smoking attributable deaths under different graphic health warnings scenarios. The team varied the time of implementation of the warnings and their impact on smoking initiation and cessation to more accurately capture the uncertainty in the actual effects that health warnings could have on smoking behaviors and outcomes.
In the baseline scenario, smoking prevalence is projected to decline from 20 percent in 2012 to 13.6 percent in 2022 and 4.6 percent in 2100. In the scenarios with graphic health warnings implemented in 2022, the model estimated that smoking prevalence would decrease from 13.6 percent in 2022 to between 4 percent and 4.4 percent in 2100.
If the warnings had been implemented in 2012, researchers estimate about 365,000 to 1,060,000 deaths might have been prevented, and 5.7 million to 16.6 million life-years could have been gained, roughly 40 percent higher. The upcoming policy and its simulated impacts on population health can be explored in more detail online through the Tobacco Control Policy Tool.
“This shows the health costs of delaying implementation of this regulation by 10 years due to industry litigation and procedural delays,” said Meza, who is also the principal investigator of the CISNET Lung Cancer Working Group and the Center for the Assessment of Tobacco Regulations.
More than 120 countries have required graphic health warnings on cigarette packs and saved lives by doing so, said the study’s first author, Jamie Tam, an assistant professor at the Yale School of Public Health.
“The U.S. has been lagging behind the rest of the world when it comes to this issue, so we are long overdue,” she said.
In addition to Meza and Tam, authors include Jihyoun Jeon of the Department of Epidemiology at U-M’s School of Public Health; Theodore Holford of Yale University School of Public Health; James Thrasher of the University of South Carolina’s Arnold School of Public Health; David Hammond of the University of Waterloo, Canada; and David Levy of the Lombardi Comprehensive Cancer Center at Georgetown University Medical Center.
September 24, 2021
U.S. Warnings Delayed to Oct. 11, 2022

Images: FDA
The U.S. Food and Drug Administration has postponed the deadline by which cigarette manufacturers must print new health warnings on their products to Oct. 11, 2022, the agency announced on its website. The FDA encourages companies to submit their plans for compliance before Dec. 12, 2021.
The Family Smoking Prevention and Tobacco Control Act (TCA) of 2009 directed the FDA to issue regulations requiring color graphics depicting the negative health consequences of smoking to accompany new textual warning statements.
In March 2020, the FDA finalized the “Required Warnings for Cigarette Packages and Advertisements” rule, establishing 11 new cigarette health warnings consisting of textual warning statements accompanied by color graphics, in the form of photorealistic images, depicting the negative health consequences of cigarette smoking.
The new graphic warnings, which depict some of the lesser known health risks of smoking, such as diabetes, must cover at least the top 50 percent of the front and rear panels of packages as well as at least 20 percent of the top of advertisements.
In April and May 2020, cigarette manufacturers and retailers sued the FDA, arguing that the graphic warning requirements amount to governmental anti-smoking advocacy because the government has never forced makers of a legal product to use their own advertising to spread an emotionally charged message urging adults not to use their products.
In a more recent challenge, tobacco companies argued that the deadline was too onerous due to the impact of the Covid-19 pandemic. They also pointed to the risk that they would lose their investments in new packaging if the graphic health warning requirement were ultimately thrown out in court.
The industry won several postponements of the new health warnings’ effective date in court, most recently, on Aug. 18, 2021, when the U.S. District Court for the Eastern District of Texas issued an order in the case of R.J. Reynolds Tobacco Co. et al. v. United States Food and Drug Administration et al.
This is the FDA’s second attempt to enact graphic health warnings under the TCA. The first rule was struck down by the federal court in the District of Columbia as a violation of the First Amendment.
August 25, 2021
Study: Graphic Health Warnings May Work

Image: Tobacco Reporter archive
Graphic health warnings on cigarette packs do indeed scare smokers, but they should be combined with other anti-smoking measures, reports HealthDay, citing new research published by Jama Network Open.
For the study, David Strong, professor in the School of Public Health and Human Longevity Science at the University of California, San Diego, assessed how 357 smokers in San Diego responded to graphic warning labels used on cigarettes sold in Australia.
Participants in the study received one of three types of cigarette packs: a pack with a graphic warning label; a blank pack; or a standard commercially available U.S. pack.
Those who received cigarettes in the standard pack or a blank pack had no change in their positive views of cigarettes, but there was a decline among those who received a pack with a graphic warning label, the investigators found.
Health concerns increased in all three groups, likely because they were forced to think about the health consequences of smoking more often, the study authors noted.
“While these labels make smokers more likely to think about quitting, it did not make them more likely to make a serious quit attempt nor was it sufficient to help them quit their nicotine addiction,” said study senior author Karen Messer.
“Thus, graphic warning labels are an integral component of tobacco control strategies, but they are only one tool for governments to reduce the societal costs from the death and disease caused by tobacco smoking,” Messer said in a university news release.
According to Strong, graphic warning labels are used in more than 120 countries to counter marketing that promotes cigarette smoking. U.S. lawmakers approved graphic health warnings in 2009, but implementation has been stalled until legal challenges to the law by the tobacco industry are resolved.
August 10, 2021
Plain Packaging Impacted Smoking

Photo: Taco Tuinstra
Plain packaging has had a measurable impact on smoking rates in Australia, according to Melanie Wakefield, who heads the Center for Behavioral Research at the Cancer Council of Victoria and was also on the advisory group to government on plain packaging implementation.
Data from the National Drug Strategy Household Survey estimated about 11.6 percent of Australian adults smoke daily, down from 12.8 percent in 2016 and more than half the 25 percent who smoked in 1991.
Plain packaging was not the only reform introduced to help bring down the rate, however. Taxes on tobacco were upped by 25 percent in 2010 and then increased by 12.5 percent each year from 2013 to 2020.
Nonetheless, speaking with The Sydney Morning Herald, Wakefield estimates that plain packaging accounted for about a quarter of the total decline in smoking prevalence in three years after plain packaging, leaving Australia with about 100,000 fewer smokers as a result.
Importantly, she says, it has also had an impact on youth smoking rates.
“In the last national survey, only 5 percent of secondary school students had smoked in the last week, and that was down by a third from before plain packaging.”
In December 2012, Australia became the first country to require tobacco companies to sell their products in drab olive-brown boxes stripped of branding but featuring large pictures of smoking-related diseases.
Tobacco companies challenged the move in various courts, saying it not only breached trademark laws and intellectual property rights but would also boost black market sales. Libertarians characterized plain packaging as a “nanny state” measure.
Now, 20 countries, including the U.K., Turkey, France, Sweden, Belgium, the Netherlands and Ukraine, have brought in their own versions of plain packaging legislation.
July 13, 2021
Graphic Warnings Postponed to July 2022

Images: FDA
The U.S. Food and Drug Administration has delayed the effective date by which cigarette manufacturers will be required to print graphic health warnings on their products by three months to July 13, 2022, reports The Winston-Salem Journal.
It is at least the fourth delay for the graphic warning labels when counting previously set launch dates of June 18, 2021, Oct. 16, 2021, Jan. 14, 2022, and April 14, 2022.
The FDA released its final rule requiring new graphic warnings for cigarettes in March 2020. The rule calls for labels that feature some of the lesser known health risks of smoking, such as diabetes. The graphic warnings must cover the top 50 percent of the front and rear panels of packages as well as at least 20 percent of the top of advertisements.
In April and May 2020, cigarette manufacturers and retailers sued the FDA, arguing that the graphic warning requirements amount to governmental anti-smoking advocacy because the government has never forced makers of a legal product to use their own advertising to spread an emotionally charged message urging adults not to use their products.
In a more recent challenge, tobacco companies argued that the deadline was too onerous due to the impact of the Covid-19 pandemic. They also pointed to the risk that they would lose their investments in new packaging if the graphic health warning requirement were to be thrown out in court.
“These expenditures of resources for the purpose of meeting the rule’s requirements constitute irreparable harm because plaintiffs cannot recover money damages should the rule and/or the graphic warning requirement in the Tobacco Control Act be invalidated,” the companies said in a legal filing.
In March 2021, a district court judge in Texas granted a motion by the plaintiffs to postpone the effective date of the final rule to April 14, 2022. In May 2021, the court pushed back the final rule by an additional 90 days.
This is the Food and Drug Administration’s second attempt to enact graphic health warnings under the 2009 Family Smoking Prevention and Tobacco Control Act. The first rule was struck down by the federal court in the District of Columbia as a violation of the First Amendment.
July 11, 2021