The United States Food and Drug Administration (FDA) has proposed that cigarette packs carry graphic new health warnings including pictures – along with text outlining not only the dangers of lung cancer, but the lesser-known risks of smoking such as bladder cancer and diabetes.
The FDA said the proposed changes, which also drastically increase the size of the warnings, could be the most significant to cigarette labels in more than 35 years.
The proposal also applies to cigarette advertisements and would add 13 new warnings, along with coloured pictures that outline the risk of diseases associated with smoking.
“While most people assume the public knows all they need to understand about the harms of cigarette smoking, there’s a surprising number of lesser-known risks that both youth and adult smokers and nonsmokers may simply not be aware of,” Ned Sharpless, the FDA’s acting commissioner, said in a statement.
Research has shown that the current warnings on cigarette packages are “virtually invisible to both smokers and non-smokers”, the FDA said.
The new proposal follows the FDA’s failed attempt in 2011 to get coloured graphic warnings – a bid that was challenged in court by tobacco companies and ultimately declined in 2012.
Following a lawsuit filed by several public health groups, a judge issued an order in March of this year directing the agency to publish a proposed rule by August and issue a final rule in March 2020.
“We learned a lot from what happened the last time around, and took the time through the research to get this right,” said Mitch Zeller, the director of the FDA’s Center for Tobacco Products, on a call with the media.
“If we are sued after we issue a final rule, we strongly believe this will hold up under any legal challenges,” he said.
The impact of graphic warning labels on cigarette-sales volumes is unclear, as markets such as Australia and the United Kingdom – where such labels have been in use for a few years – have not necessarily had a material negative impact, Wells Fargo analyst Bonnie Herzog wrote in a client note.
Shares of tobacco companies were unaffected in morning trade, with Philip Morris International Inc’s shares up about one percent and Altria Group Inc’s shares also marginally higher.
Tobacco use is the leading cause of preventable death in the US, killing about 480,000 Americans a year.
The latest proposal is open to public comment for 60 days through October 15, the FDA said.