Graphic tobacco warnings coming to US after courts forced FDA action

After over a decade of legal and political battles, the US Food and Drug Administration (FDA) has finally issued a conclusive new ruling regarding health warnings on cigarette packs and advertisements. The 11 new warnings will fill 50 percent of the package with text and graphic imagery depicting the health consequences of smoking.

Back in 2009 the US Congress passed the Family Smoking Prevention and Tobacco Control Act, designed primarily to establish a legal framework by which the FDA had clear regulatory authority over tobacco products. One of the fundamental elements of the new law was the requirement for all tobacco products to receive new graphic labeling to cover the top 50 percent of the front and back of cigarette packets.

By mid-2011 the FDA fulfilled its initial part of the process by releasing the nine prospective warning labels. Within weeks a number of tobacco companies had filed lawsuits claiming the warnings were unconstitutional and violated their First Amendment rights.

After nearly another whole year of legal battles a Court of Appeals ultimately agreed with the tobacco companies, ruling the specific images in the FDA’s initial prospective warnings were indeed unconstitutional. However, a different lawsuit upheld the constitutionality of the Act itself, claiming large graphic warnings, “are reasonably related to the government’s interest in preventing consumer deception and are therefore constitutional.”

Tobacco companies appealed this decision, however, the US Supreme Court declined to review the case. And so, the constitutionality of the 2009 Tobacco Act still held, as did the FDA’s requirement to review and resubmit different graphic warnings for cigarette packets.

Years passed, and the FDA’s inaction ultimately resulted in a lawsuit being filed to compel it to comply with the Act. The lawsuit was filed in 2016 by a number of health organizations, including the American Heart Association, the American Cancer Society and the American Lung Association.

Fast forward through another two years of onerous legal battles and in late 2018 a judge for the U.S. District Court for the District of Massachusetts ultimately ordered the FDA to issue new cigarette warnings, setting specific dates for proposed and final rules to be delivered. The judge noted while issuing the ruling that the FDA “unlawfully withheld” and “unreasonably delayed” actions necessary to comply with the Act.

The judge ordered the FDA to present its initial proposed rule by August 15, 2019, and a final rule by March 15, 2020.

The FDA subsequently hit both those deadlines … barely.

On March 17 2020, the FDA revealed its final ruling, presenting 11 health warnings it claims will need to be prominently displayed on cigarette packets and in advertising from June 18, 2021.

“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,” says Mitch Zeller, director of FDA’s Center for Tobacco Products.

These new warnings are undeniably milder than the warnings presented in 2011. The 2011 warnings included statements such as, “Smoking can kill you” and “Cigarettes are addictive." The new warnings are much more medically specific, with statements including, “Smoking causes COPD, a lung disease that can be fatal”, “Smoking causes cataracts, which can lead to blindness”, and “Smoking causes type 2 diabetes, which raises blood sugar.”

In a statement from the American Heart Association, in conjunction with the partner organizations behind the 2016 lawsuit, the new graphic warnings are called “a dramatic improvement” over current labels. However, the statement also urges the FDA to ensure these warnings are effectively implemented by tobacco companies who will clearly try to push back.

“By law, the new warnings are required to appear on cigarette packs and ads 15 months after a final rule is issued (June 18, 2021),” the statement reads. “The FDA must now ensure these warnings are fully implemented and vigorously defended against likely legal challenges by the tobacco industry.”

Source: FDA, American Heart Association