The U.S. Food and Drug Administration (FDA) has issued a proposed rule to require new health warnings on cigarette packages and in advertisements, which the agency says would "represent the most significant change to cigarette labels in more than 35 years".
A tobacco product manufacturer/importer, distributor or retailer would be required to submit a plan to the FDA for the random and equal display and distribution of required warnings on packages and a quarterly rotation of required warnings for advertisements for approval by the FDA.
"Given that tobacco use is still the leading cause of preventable disease and death in the USA, there's a lot at stake to ensure the public understands these risks", Sharpless said. In fact, smoking kills more people each year than alcohol, HIV, auto accidents, illegal drugs, murders and suicides combined, and over 16 million Americans alive today live with disease caused by cigarette smoking.
Other color illustrations would warn smokers that cigarettes can cause heart disease, impotence and diabetes.
"Given that tobacco use is still the leading cause of preventable disease and death in the US, there's a lot at stake to ensure the public understands these risks", Sharpless said. Several tobacco companies challenged the warnings in court and a year later the U.S. Court of Appeals of the District of Columbia ruled that the information violated the First Amendment.
The new warnings would be accompanied by a color image demonstrating the health risk.
The proposed rule will be open for a 60-day public comment period.
One warning label features a photo of a woman with a large lump on her neck next to text that reads "WARNING: Smoking causes head and neck cancer".
Pictorial warning labels on cigarette packs could reduce smoking prevalence by 5% in the short term and 10% over the long term in the United States, according to a study published in the journal Tobacco Control in 2016.
Nearly 1.4 million young people and 34.3 million adults in the US now smoke cigarettes, and nearly 480,000 people die from tobacco use each year. The labels are expected to begin appearing on cigarette packaging in 2021.
Another image shows a pair of feet with missing toes, with the message "WARNING: Smoking reduces blood flow to the limbs, which can require amputation".
"Given the extreme risks cigarette smoking poses to the public health", said Mitch Zeller, who runs the Center for Tobacco Products at the FDA, "new proposed warnings of this type are critical to promote greater public understanding of the risks associated with cigarette smoking".
This isn't the first time the FDA has tried to implement more visceral cigarette warnings.
"[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 unsafe, which the public already understands", Hollon added. These warnings "go unnoticed" and are effectively "invisible", the FDA said in its announcement. That requirement, however, was challenged by tobacco companies and ultimately vacated. "We are especially encouraged that the research we conducted on these new proposed warnings demonstrated they would lead to improved understanding among both youth and adults, smokers and nonsmokers".
"We firmly support public awareness of the harms of smoking cigarettes, but the manner in which those messages are delivered to the public can not run afoul of the First Amendment protections that apply to all speakers, including cigarette manufacturers", the spokesperson said (Hellmann, The Hill, 8/15; Siddons, Roll Call, 8/15; Bever, Washington Post, 8/15; Kaplan, New York Times, 8/15; FDA proposal, Federal Register, 8/16).