Tag: Graphic Health Warnings

  • New Tobacco Health Warnings in India

    New Tobacco Health Warnings in India

    Photo: Tobacco Reporter archive

    Tobacco manufacturers selling in India will have to print a new health warning on their products starting Dec. 1, reports Mint.

    The Union Health Ministry has specified two sets of warning messages and images to be used on both sides of the pack. The first, “Tobacco causes painful death,” must be printed with an image on one side of a pack, and the message “Tobacco users die young” must be displayed with an image on the other side of a pack.

    The packs must also display a toll-free helpline for smokers wishing to quit.

    Health activists welcomed the new warnings.

    “It’s a proven fact that the lives of tobacco users are shortened by up to 10 years as compared to nontobacco users,” said S.K. Arora, medical superintendent of the Sanjay Gandhi Memorial Hospital and renowned tobacco control expert. “The warnings play a significant role in helping tobacco users quit the habit.”

    In the second round of the Global Adult Tobacco Survey, 61.9 percent of cigarette smokers, 53.8 percent of bidi smokers and 46.2 percent of smokeless tobacco users were considering quitting due to the warning label on packets. The number is significantly higher compared to the 2009–2010 figures.

    According to government data, tobacco use causes more than 1.3 million deaths every year

  • Study: Graphic Warnings Boost Pack Hiding

    Study: Graphic Warnings Boost Pack Hiding

    Illustration: FDA

    The presence of graphic health warnings encouraged smokers to hide their packs but did not change smoking behavior among participants in a recent study published in Jama Network Open.

    As part of their tobacco-control policies, many countries require cigarette manufacturers to print images of smoking-related diseases on their cigarette packs. A similar rule is pending in the U.S., but the measure has been repeatedly postponed due to industry litigation and the Covid-19 pandemic.

    A group of public health experts at the University of California in San Diego wanted to find out how graphic health warnings would affect the behavior of U.S. smokers.

    They asked smokers to purchase their preferred brand of cigarettes from a study website. Participants were randomized to receive their cigarettes in one of three pack designs: a package with a graphic warning label, with a blank pack, or in a standard commercially available U.S. pack. Approximately 19,000 packs were delivered to participants.

    The researchers found that smokers given packets stamped with images of diseased feet, ill children and throat cancer continued to puff on about 10 cigarettes daily up to a year after receiving them. But six in ten admitted to concealing the packets at least some of the time due to the images, which was up 40 percent from before the study began.

    More than 120 countries already force tobacco companies to put warnings over the side-effects of smoking on their packets.

    But a growing body of studies suggest that the warnings are becoming less effective as smokers are becoming too used to them.

    One paper from 2019 found that about 36 percent of smokers in Canada—which has had graphic health warnings for many years—found them “not at all” or “minimally” effective in prompting them to quit.

  • Cigarette Health Warnings Effective Date Postponed Again

    Cigarette Health Warnings Effective Date Postponed Again

    Photo: Tobacco Reporter Archive

    On May 10, 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., No. 6:20-cv-00176 to postpone the effective date of the “Required Warnings for Cigarette Packages and Advertisements” final rule.

    The new effective date of the final rule is July 8, 2023. Pursuant to the court order, any obligation to comply with a deadline tied to the effective date is similarly postponed. For example, the FDA strongly encourages entities to submit cigarette plans as soon as possible but no later than Sept. 8, 2022.

    This is not the first time the new health warnings have been delayed. The rule was most recently delayed to April 9, 2023, after being postponed multiple times before this over the past few years. The rule was originally supposed to go into effect in 2021.

    Additional details on the rule, as well as the new effective date and recommended date for submission of cigarette plans, can be found on the FDA’s website.

  • Thailand: New Graphic Health Warnings

    Thailand: New Graphic Health Warnings

    Photo: kikujungboy

    Retailers and wholesalers in Thailand will have to sell cigarette packs with newly designed warning labels beginning April 11, reports The Bangkok Post.

    The new packs must have text warnings and newly designed pictorial warnings showing graphic details of the consequences of smoking, according to Khachornsak Kaewcharas, deputy director-general of the Department of Disease Control.

    “Violators who still sell cigarette packets with the old pictorial warnings are liable to a fine of no more than THB40,000 [$1,197],” he said.

  • Graphic Health Warnings Postponed Again

    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.

  • New Tobacco Health Warnings in Cambodia

    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.”

  • U.S. Pictorial Health Warnings Postponed Again

    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.

  • Report: Plain Packaging Gaining Momentum

    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.

    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.

  • Study: Graphic Warnings Could Have Prevented Many U.S. Deaths

    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.

  • U.S. Warnings Delayed to Oct. 11, 2022

    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.