Barring another failed court battle, the FDA will move ahead with requiring new graphic warnings for cigarette packaging that depict the serious diseases and health effects associated with smoking.
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. Each picture is accompanied by text such as: “WARNING: Smoking can cause heart disease and strokes by clogging arteries.”
The move comes 9 years after U.S. tobacco companies sued the agency and were successful in blocking an earlier set of proposed graphic warnings on First Amendment grounds. Last September, a federal judge ordered the FDA to speed up development of new warnings as required by law.
In a briefing on Thursday, Acting FDA Commissioner Ned Sharpless, MD, said the goal of these warnings is to address substantial knowledge gaps and misinformation about the potential harms of smoking tobacco.
“While most people assume in this day in age that the harms of cigarette smoking are pretty well understood by the public, this is not true,” Sharpless said. He added that the outdated content, small size, and location of current warning labels are practically invisible and ineffectively inform the public about the product’s potential risks.
Proposed warnings would occupy the top half of the front and rear panels of cigarette packages, and cover at least 20% of the area at the top of advertisements. The proposed rule will be open for public comment for a 2-month period.
“With these new proposed cigarette health warnings, we have an enormous public health opportunity to increase the public’s understanding of the full scope of the serious negative health consequences of cigarette smoking,” Sharpless said.
Finalization of the rule would mark the first major change to cigarette labeling in more than 35 years. It would require the warnings to show up on all packaging and advertisements 15 months after the final rule, expected in March 2020, is issued.
In 2009, a provision of the Family Smoking Prevention and Tobacco Control Act granted the FDA powers to regulate tobacco products. At the time, the agency was given until June 2011 to issue a final rule requiring graphic warnings on cigarette packaging.
While the FDA met this initial deadline, tobacco companies filed lawsuits and the graphic warnings were struck down 2-1 in 2012 by a three-judge panel of the U.S. Court of Appeals for the D.C. Circuit, which ruled that the specific proposed warnings violated the First Amendment. The majority determined that the FDA hadn’t adequately established that the particular warnings were truthful and necessary to protect public health. At the same time, however, the court didn’t strike down the law under which the FDA was acting, and a separate appeals court specifically upheld the law. The FDA was therefore obliged to come up with new warnings that would pass constitutional muster.
“The statute says that we have a mandate, an obligation, to improve the public’s understanding of the negative health consequences of cigarette smoking,” said Mitch Zeller, JD, director of the Center for Tobacco Products at the FDA. “That is the governmental interest here.”
In the proposed rule released Thursday, the FDA said the new warnings should “pass a First Amendment analysis” because they are factual, backed by “robust scientific evidence,” and advance the government’s interest of informing the public about smoking’s consequences. The agency added that the warnings “are not unduly burdensome.”
But tobacco companies signaled they may again fight the agency’s proposed warnings on Constitutional grounds. In a statement to CNN, an R.J. Reynolds Tobacco Company spokesperson said the firm was reviewing the rule, and commented that “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.”
In preparing for the new proposed rule, the agency conducted a consumer research study to evaluate public perception of health warnings. Participants in the study said the 13 new warnings provided new information about tobacco use, and they learned something when comparing the proposed warnings to the current Surgeon General’s warnings.
“The ads are intended to be compelling and educational in a way that will increase the public understanding,” Sharpless said.
Previous research on graphic warnings on cigarette packaging has also shown that shocking images can prompt more attempts to quit in tobacco-users.
According to the FDA, about 34.3 million adults and almost 1.4 million youth in the U.S. smoke cigarettes. Tobacco use, which is the leading cause of preventable disease and death in the nation, currently kills around 480,000 Americans each year.
Source: MedicalNewsToday.com
