Tag: Graphic Health Warnings

  • Health Labels Planned for October 2021

    Health Labels Planned for October 2021

    Image: FDA

    The U.S. Food and Drug Administration (FDA) has set Oct. 16, 2021, as the new effective date for graphic health warning labels for combustible cigarettes.

    The FDA signed off March 18 on a new set of 11 graphic warning labels for traditional cigarettes that are toned down considerably from its first attempt in 2012, which was abandoned after an industry legal challenge.

    The new set of warnings contains images of diseased lungs, a man experiencing erectile dysfunction, a man with surgical stitches from heart or lung surgery and a child with an oxygen mask. But there is no smoke coming out of a tracheal hole, no cadaver and no photo of a man who appears deathly ill, as the FDA proposed.

    The labels 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. The messages must be randomly and equally displayed and distributed on cigarette packages and rotated quarterly in cigarette advertisements.

    The warnings were mandated by a federal judge for cigarette packaging and marketing. The ruling does not affect other tobacco products, such as electronic cigarettes.

    Initially, the agency set a deadline for June 18, 2021. However, on April 3, Philip Morris USA, R.J. Reynolds Tobacco Co., ITG Brands and Liggett Group filed a joint motion requesting a preliminary injunction on implementing the labels and a ruling to prohibit enforcement. The manufacturers insist that the labels violate the First Amendment of the U.S. Constitution, which guarantees free speech.

    On May 8, the FDA and the manufacturers filed a joint motion to extend the deadline by 120 days. The manufacturers said the pandemic has complicated their ability to meet the June 18, 2021, deadline.

    Despite the postponement of the deadline, the FDA urged manufacturers to submit plans for compliance as soon as possible.

    “Early submission will facilitate timely FDA review of plans prior to the effective date of the required warnings, encourage dialogue with entities regarding any implementation concerns, and provide time to consider proposals by entities in a timely manner,” the FDA said.

  • Philip Morris Challenges Health Warnings

    Philip Morris Challenges Health Warnings

    Image by jessica45 from Pixabay

    Philip Morris USA filed a lawsuit on May 6 in the U.S. District Court for the District of Columbia to block the graphic cigarette warnings that tobacco companies will be required to print on their products in the United States starting June 18, 2021.

    It follows a similar lawsuit filed last month by other tobacco companies in the U.S. District Court for the Eastern District of Texas.

    This is the Food and Drug Administration’s (FDA) 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. The plaintiffs in Texas case state that this version of the FDA’s rule is no improvement and urge the court to strike down both the rule and the Tobacco Control Act’s graphic-warnings requirement as violations of the First Amendment.

    The companies allege that FDA’s required warnings force plaintiffs to become a “mouthpiece for the government’s anti-smoking advocacy” and are “precisely the type of compelled speech that the First Amendment prohibits.”

    The new rule includes 11 graphic images paired with textual warnings. Among other smoking-related afflictions, the images depict a person with neck cancer, ill children and bloody urine

    Also on May 6, the plaintiffs and the government in the Texas case jointly proposed to delay the implementation date for the graphic warnings for four months, from June 18, 2021, to Oct. 16, 2021. 

    Public health advocates expressed outrage at the legal challenge. “It is truly shameless for tobacco companies to file these lawsuits at a time when there is clear evidence that smoking can increase risk of severe complications and even death from Covid-19,” said Matthew L. Myers, president of the Campaign for Tobacco-Free Kids.

    “We urge the Administration to vigorously defend these warnings in court and urge the court to reject the proposed four-month delay.”

  • FDA Wants to Delay Graphic Warnings

    FDA Wants to Delay Graphic Warnings

    The U.S. Food and Drug Administration (FDA) has asked a federal judge in Texas to delay the effective date of a rule requiring graphic health warnings on cigarette packages due to the outbreak of Covid-19, reports Reuters.

    The FDA and tobacco companies that are suing the agency have asked the court to delay the effective date from June 18, 2021, to Oct. 16, 2021.

  • Coming to America

    Coming to America

    The U.S. Food and Drug Administration has issued a final rule to require new health warnings on cigarette packages and in cigarette advertisements. The warnings feature textual statements with photo-realistic color images depicting some of the lesser-known, but serious health risks of cigarette smoking, including impact to fetal growth, cardiac disease, diabetes and more.

    “The 11 finalized cigarette health warnings represent the most significant change to cigarette labels in more than 35 years and will considerably increase public awareness of lesser-known, but serious negative health consequences of cigarette smoking,” said Mitch Zeller, director of FDA’s Center for Tobacco Products.

    “Research shows that the current warnings on cigarettes, which have not changed since 1984, have become virtually invisible to both smokers and nonsmokers, in part because of their small size, location and lack of an image.

    “Additionally, research shows substantial gaps remain in the public’s knowledge of the harms of cigarette smoking, and smokers have misinformation about cigarettes and their negative health effects.”

    Beginning June 18, 2021, these new cigarette health warnings will be required to appear prominently on cigarette packages and in advertisements, occupying the top 50 percent of the area of the front and rear panels of cigarette packages and at least 20 percent of the area at the top of cigarette advertisements.”

     

     

     

  • Warnings on hold

    Health warnings photo
    Photo by Mikael Colville-Andersen

    Pakistan’s Coalition for Tobacco Control is calling on the government to enforce regulations requiring cigarette packs to carry graphic health warnings taking up 85 percent of both the front and back panels, according to a story in the Pakistan Observer.

    The regulations appear to be two years old.

    The national co-ordinator of the coalition, Khurram Hashmi, said on Sunday that the Ministry of National Health Services, Regulation and Co-ordination (NHSRC), had demonstrated exemplary leadership by introducing in January 2015 graphic warnings increased from 40 percent to 85 percent on the front and back of cigarette packs.

    He said this government initiative had set an example within the Asia region and demonstrated that Pakistan was one of the few countries that prioritized the health of its citizens over corporate interests.

    After the government’s announcement, India had been encouraged to enforce a similar policy of enhanced graphic warnings on cigarette packs, he said, and, as of June 2016, those warnings had started to appear on cigarette packs in India.

    However, Hashmi said, despite government efforts, there had been a delay in the implementation of the enhanced graphic warnings in Pakistan that had resulted in a major set-back for tobacco control efforts by the government.

    Meanwhile, Dr. Sobia Faisal, a public health expert, said that Pakistan had about 19.1 million tobacco users, made up of 31.8 percent of the country’s men and 5.8 percent of its women.

    Tobacco she said harmed people’s health, the treasury, and the spirit of citizens. The tobacco epidemic in Pakistan required urgent attention.

    Faisal said that tobacco companies used packaging as their major marketing tool to make tobacco appear appealing, while distracting consumers from the reality of how tobacco destroyed health.

    Graphic warnings were a low-cost method of warning tobacco users and non-users about the harms of tobacco, and they were effective in motivating smokers to quit.

  • Thai court approves bigger warnings

    Thai cigarette manufacturers will have to print even larger pictorial health warnings by Sept. 23, now that the Supreme Administrative Court has ruled in support of a new regulation by the Public Health Ministry, according to a report in The Nation.

    In line with the regulation, pictorial warnings must now cover at least 85 percent of space on the two largest sides of each package.

    Earlier, the tobacco industry had secured an injunction from the Central Administrative Court.

    The Supreme Administrative Court, however, decided to scrap the injunction on the grounds that the Public Health Ministry has proceeded with proper procedures and introduced the regulation to protect people’s health.

    There will be a 90-day grace period for retailers to clear their existing stock of cigarettes, according to the Disease Control Department.

    Currently, cigarette packages have pictorial warnings that cover about 55 percent of packets. After the grace period, companies that fail to abide by the new regulation will face a fine.

  • Low compliance with health warnings requirement

    The majority of cigarette packs in Indonesia do not comply with the country’s new graphic health warning requirements, according to a report in The Jakarta Post.

    The Drug and Food Monitoring Agency (DFMA) said only 13.44 percent of cigarette packages circulating in the market bear the pictorial warnings that became mandatory on June 24.

    Under a presidential regulation on tobacco control issued last year, cigarette makers must allocate 40 percent of cigarette packaging for text and pictorial warnings about the health effects of smoking.

    The DFMA and regional food and drug offices in 31 regions monitored the implementation of the new tobacco-control rules during the two days following their enactment.

    Of the 2,270 cigarette packages monitored, only 305 or had pictorial warnings. There are 3,363 cigarette brands, produced by 672 companies, registered with Indonesia’s Customs and Excise Directorate.

    Health Minister Nafsiah Mboi said that cigarette makers should recall all products that did not display the pictorial warnings.

    The ministry said that there would be penalties for companies that failed to comply with the new policy, ranging from written warnings and reprimands to the revocation of their business licenses.

    Nafsiah said companies that missed the deadline would be issued warnings, and those that failed to comply could eventually be fined up to $42,000. Their executives could face up to five years in prison.

    The country’s biggest cigarette producer, Philip Morris-owned Sampoerna, said it began distributing products with the new warnings on June 23, but it needed more time to clear out existing stock.

    A national survey in 2012 found that 67 percent of all Indonesian males over age 15 smoked—the world’s highest rate—while 35 percent of the total population lit up; a figure surpassed only by Russia.

     

  • Deadline nears for Indonesian health warnings

    Indonesia’s Food and Drug Monitoring Agency (FDMA) has told tobacco companies to comply with a government regulation requiring pictorial health warnings on cigarette packs by June 24, reports The Jakarta Post.

    Indonesian tobacco companies produced 3,392 cigarette brands as of April, according to Indonesia’s taxation directorate general. Of those companies, only Bentoel, Sampoerna, Djarum and Gudang Garam had registered their cigarette packaging designs with pictorial health warnings, said Sri Utami Ekaningtyas, the FDMA’s addictive substances monitoring director.

    “They have sent their pictorial health warnings and shown a commitment to launch these cigarette packs on 24 June. We are optimistic that other companies will follow,” Sri added.

    According to the government regulation, tobacco companies should print five pictorial health warnings on their cigarette packs, covering at least 40 percent of a pack’s overall size.

    These warnings show scary images of tobacco-related diseases such as mouth cancer, throat cancer and lung cancer.

  • Kazakhstan to go graphic

    Kazakhstan will start requiring pictorial health warnings on cigarette packs from July, according to Azhar Tulegaliyeva, director of the Medical Care Organization Department. The country will be the first nation in the Commonwealth of Independent States to mandate graphic warnings in line with the World Health Organization’s Framework Convention on Tobacco Control, which Kazakhstan ratified in 2007.

    Under the new law, cigarette packs will contain smoking-related diseases such as stroke and heart attack, and show the threat of miscarriage among pregnant women and the impact of smoking on premature aging of the skin.

  • Cigarette manufacturers prevail in graphic warnings suit

    Cigarette manufacturers prevail in graphic warnings suit

    The U.S. Court of Appeals for the D.C. Circuit today held unconstitutional a regulation by the U.S. Food and Drug Administration (FDA) that would have forced cigarette makers to place nine graphic health warnings on all cigarette packaging and advertising.

    Agreeing with arguments made by four tobacco manufacturers, the Court held that the proposed warnings violated the First Amendment because the FDA did not provide evidence that the graphic warnings would “‘directly advance” its interest in reducing the number of Americans who smoke.”

    “We are pleased that the Court of Appeals agreed with Reynolds that consumers can and should be fully informed about the risks of tobacco use in a manner consistent with the U.S. Constitution,” said Martin L. Holton III, executive vice president and general counsel for R.J. Reynolds, which was one of the plaintiffs.

    “Reynolds is committed to providing tobacco consumers with accurate information about the various health risks associated with smoking.”

    The Court of Appeals noted that the government can require companies to make “purely factual and uncontroversial” disclosures about the risks of their products in order to prevent consumer deception, but stated that the graphic warnings crossed into unconstitutional territory:

    “These inflammatory images and the provocatively-named hotline cannot rationally be viewed as pure attempts to convey information to consumers. They are unabashed attempts to evoke emotion (and perhaps embarrassment) and browbeat consumers into quitting.”

    The Court relied on data included in FDA’s regulation that showed the graphic warnings would have little to no effect in reducing tobacco use. In particular, FDA’s analysis of the regulation estimated that the warnings would likely cause no statistically significant change in U.S. smoking rates.