The Food and Drug Administration has released a new set of 13 graphic warning labels for traditional cigarettes that are toned down considerably for its first attempt in 2012.

The warnings have been mandated by a federal judge to be in place by March for cigarette packaging and marketing. The ruling does not affect other tobacco products, such as electronic cigarettes.

By July 2021, the labels would be required to cover the top 50% of the front and rear panels of cigarette packages, as well as at least 20% of the top of cigarette advertisements.

The new set contains images of diseased lungs, 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, the FDA previously proposed.

Instead, the FDA said the new images “depict some of the lesser-known, but serious health risks of cigarette smoking,” such as risk of blindness, lower blood flow to the extremities, type 2 diabetes and erectile dysfunction.

Friday begins the FDA’s two-month public-comment period on the images before a final ruling.

Mitch Zeller, director of the FDA’s Center for Tobacco Products, said the agency “undertook a comprehensive, science-based research and development process to get these proposed warnings right by developing distinct and clear messages about the risks associated with cigarette smoking and exposure to secondhand smoke.”

Reynolds American spokeswoman Kaelan Hollon said the manufacturer is “carefully reviewing FDA’s latest proposal for graphic warnings on cigarettes.”

“We firmly support public awareness of the harms of smoking cigarettes, but the manner in which those messages are delivered to the public cannot run afoul of the First Amendment protections that apply to all speakers, including cigarette manufacturers.”

Legal roadblocks

In June 2011, the FDA chose nine labels that were scheduled to debut in September 2012.

However, tobacco manufacturers, including Reynolds, were able to get a federal judge in the D.C. District to halt the effort.

In August 2012, a panel of the U.S. Court of Appeals for the D.C. Circuit voted 2-1 that the proposed specific warning labels violated the First Amendment.

A federal appeals court ruled in 2013 that the FDA failed to prove that the proposed graphic warnings “will accomplish the agency’s stated objective of reducing smoking rates.” The FDA told the U.S. attorney general in 2013 that it would undertake a new review of graphic warning labels.

A coalition of anti-tobacco and public-health groups sued the FDA in October 2016, saying it “unlawfully withheld” or “unreasonably delayed” issuing its final rule.

“The current U.S. cigarette warnings, which are printed on the side of cigarette packs and haven’t been updated since 1984, are stale, unnoticed and fail to contribute to greater progress in reducing cigarette smoking,” according to the coalition.

The coalition said Thursday that “the new graphic warnings are a dramatic improvement over the current text-only warnings ... they are supported by extensive scientific evidence.”

Hollon said Reynolds expects the FDA, as part of the graphic warning strategy, “to publicize the comparative risks of other tobacco products to the public so that adults who wish to continue to use them can make fully informed decisions between product options in the tobacco category.”

“For this mission to succeed, it is important for FDA to focus on providing information that can produce health benefits for the public, not merely reiterating well-known messages that smoking is dangerous, which the public already understands,” Hollon said.

Are labels working?

The governments of more than 120 countries require similar graphic warning labels. Australia, which was among the first to introduce the labels and has some of the most graphic images, is perhaps the most noteworthy.

The public health advocacy coalition says that 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.”

“They will help the United States catch up to the 120-plus countries that have adopted this best-practice strategy to reduce tobacco use and save lives,” the coalitions said.

However, the effectiveness of a similar strategy in the U.S. is questioned.

A local survey of smokers for the initial set of images in 2012 found many saying they would just buy a holder to place their cigarettes in so they would not have to see the graphics.

Several published studies have found mixed smoker reactions to the initial nine proposed labels.

In December 2010, an FDA study found putting graphic-warning labels on cigarette packs may stir emotions but not lead to quitting.

UNC Chapel Hill researchers said in June 2016 that 40% of participants in their study said they were more likely to consider quitting after exposure to the graphic images, compared with 34% with the text warning.

A February 2016 study published by University of Illinois researchers in the journal Communication Research suggests graphic images strike some people as manipulative, a reaction that could backfire on the attempt to steer individuals away from smoking.

The ultimate impact of the proposed warning labels on cigarette consumption is unclear, Wells Fargo Securities analyst Bonnie Herzog said, given evidence in other markets, such as Australia and U.K., where graphic warning labels have been present for a few years and “have not necessarily had a material negative impact on cigarette volumes.”

Herzog said the mid-2021 implementation goal is likely to be delayed by expected tobacco manufacturers’ legal actions.

“We believe this is yet again another manageable risk for the industry and, as such, we see limited downside risk to tobacco stocks,” Herzog said.

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