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Judge orders FDA to speed up graphic warnings requirements for cigarettes :

September 5, 2018

Federal authorities cannot continue delaying guidance on requiring cigarette packs to carry graphic health warnings, a judge ruled today.

The decision is a victory for the Academy and other health groups that filed suit against the Food and Drug Administration (FDA) in 2016, asking that warnings be implemented.

Studies around the world have shown that graphic warnings are most effective at informing consumers about the health risks of smoking, preventing children and other nonsmokers from starting to smoke, and motivating smokers to quit,” the groups said in a statement. “Requiring graphic cigarette warnings in the U.S. will protect kids, save lives and reduce tobacco-related health care costs, which total $170 billion a year.”

The 2009 Family Smoking Prevention and Tobacco Control Act requires graphic warnings on the front and back of cigarette packs and 20% of cigarette advertising. However, when the FDA released the images to be used in 2011, they were challenged in court by tobacco companies.

In two 2012 cases, U.S. Court of Appeals judges struck down those specific images while another panel upheld the FDA’s legal obligation to implement some type of graphic warnings.

Four years later, the FDA still had not issued the new images and the Academy, its Massachusetts chapter, three AAP members, the American Cancer Society, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids and Truth Initiative filed a lawsuit.

The FDA told U.S. District Judge Indira Talwani it would finalize new warning labels by November 2021, but the judge pointed out the proposed date is a decade after the original deadline and ruled the FDA had “unreasonably delayed” action. She said the agency must present her with an expedited schedule by Sept. 26.

Smoking causes an array of serious health issues, and more than 480,000 Americans die each year from tobacco-related illnesses, according to the Centers for Disease Control and Prevention.

The health groups argue cigarette packs have had text warnings since the 1960s and they have not been updated for 30 years, so they often go unnoticed. Graphic warnings, which are required in more than 122 countries, have been shown to prevent people from starting to smoke and encourage others to quit.

In a 2013 study, researchers found if such warnings had been adopted in the U.S. in 2012, the number of adult smokers would have decreased by 5.3 million to 8.6 million the following year.

Lynda M. Young, M.D., FAAP, a plaintiff in the lawsuit who chairs both the AAP Committee on Federal Government Affairs and Tobacco Free Mass, said it will take some time for the FDA to create a final rule, but the judge's order is "a wake-up call."

"There is plenty of evidence that graphic warnings deter people from smoking, especially youth," she said via email. "Our coalition won’t give up until this is done!"

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