The 2009 Tobacco Control Act required graphic warnings covering the top half of the front and back of cigarette packs and 20 percent of cigarette advertising and gave the FDA until June 22, 2011, to issue a final rule requiring such warnings.
Instead of warning consumers about specific health risks, the first round of FDA graphics were seen as a mere "shock and awe" tactic, and not a reasonable infringement upon tobacco companies' free speech.
The Food and Drug Administration on Thursday rolled out a proposed rule to require tobacco companies to include graphic warnings on cigarette packages and tobacco ads with the aim of promoting "greater public understanding of the negative health consequences of smoking", the agency said in a statement.
Though WHO notes that the U.S. has mandated "large warnings" covering at least 50% of cigarette packaging, they fail to meet the WHO's standards for best practices.
Meanwhile, tobacco companies say they are looking into the FDA's proposed rule.
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In 2000, Canada became the first country to put graphic warnings on cigarettes.
The FDA has shared images showing the types of labels that may be featured on cigarette packages under this proposed rule, including one showing someone's chest after having open heart surgery, another showing a pale child with an oxygen mask, and another showing a container containing bloody urine meant to represent bladder cancer.
"There absolutely can be graphic warnings that meet constitutional muster", she said.
The US has made considerable progress in reducing smoking among adults and teenagers, yet the agency says almost half a million people die annually in the country as a direct outcome of tobacco use.
"While there are other important actions Congress and the FDA must take to address tobacco, including regulation of flavors and effective regulation of e-cigarettes, moving forward with graphic warning labels will have a big impact on reducing youth tobacco use", said Dr. Michele Eakin, chair of the ATS Tobacco Action Committee. In the end, the federal court determined that the agency's rule violated the first amendment.
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Although health warnings were updated in 1984 with the Surgeon General's warnings, research shows that smokers are misinformed regarding cigarettes and its negative health effects, the FDA said in a press release.
In a proposed rule from the agency, the 13 new graphic warnings would call needed attention to the lesser-known health risks of cigarette smoking, such as head and neck cancer, erectile dysfunction, and diabetes.
Among young smokers in the United States, 5.6 million people under age 18 in the United States will die later in life from smoking-related illnesses, according to the Centers for Disease Control and Prevention.
Visit the American Lung Association for more on kicking the smoking habit.
Jonathan Havens, a former FDA lawyer who worked with the agency's then newly-established Center for Tobacco Products, says the First Amendment is the primary obstacle separating the U.S. from other countries. The FDA stated in March 2013 that it planned to issue a new rule requiring graphic warnings, but failed to do so before today. Prior to 2009, when Congress passed the Tobacco Control Act, only 18 countries required graphic warnings, showing how far behind the rest of the world the US has fallen over the past 10 years. But that momentary reprieve before lighting up may only last a few more years. Reynolds Tobacco Company, which was part of the 2011 lawsuit against FDA, said the company is "carefully reviewing" the latest proposal.
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"We firmly support the public awareness of the harms of smoking cigarettes", she said in a statement.