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 colored 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.
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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 a failed bid by the FDA in 2011 for colored
graphic warnings, which 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 2019 directing the agency to publish a
proposed rule by August and issue a final rule in March 2020.
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