FDA Issues Proposed Rule Requiring Health Warnings With Images on Cigarette Packages

The FDA is rolling out a new effort to raise awareness of the negative consequences of smoking that it’s calling the most significant change to cigarette labels in more than 35 years.

Under a proposed rule released today, the agency would require new health warnings on cigarette packages and advertisements, which would feature pictures and images depicting some of the lesser-known health risks of smoking cigarettes, including bladder cancer and heart disease. The warnings would take up the top half of the front and back of the cigarette packages and at least 20% of the area at the top of the package. The proposed rule will be open for public comment until October 15. Once finalized, the rule will go into effect in 15 months.

“With these new proposed cigarette health warnings, we have an enormous public health opportunity to fulfill our statutory mandate and increase the public’s understanding of the full scope of serious negative health consequences of cigarette smoking,” said Acting FDA Commissioner Ned Sharpless, MD, in a statement.

To address gaps in knowledge of the risks of smoking cigarettes, the FDA held a consumer research study in which participants reported being unaware of 13 health warnings, including that smoking can harm children, cause fatal lung diseases in nonsmokers, cause head and neck cancer, cause heart disease and strokes by clogging arteries, cause type 2 diabetes, and reduce blood flow to the limbs, which can require amputation.

“The FDA undertook a comprehensive, science-based research and development process, and took the necessary time to get these new proposed warnings right by developing distinct and clear messages about the negative health consequences of smoking,” said Mitch Zeller, JD, director of the FDA’s Center for Tobacco Products, in the statement. “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.”

The rule follows several other initiatives rolled out by the FDA to curb smoking of both tobacco- and nicotine-containing products and, when finalized, will comply with a requirement under the Family Smoking Prevention and Tobacco Control Act. The act requires the agency to include new warning labels specifically on cigarette packages and in advertisements. The FDA in 2011 published a final rule fulfilling the requirement; however, the rule was challenged in court by tobacco companies. The US Court of Appeals of the District of Columbia in August 2012 ruled that the rule violated the First Amendment and the rule was vacated.

Energy and Commerce Committee Chairman Frank Pallone Jr, D-New Jersey, praised today’s proposed rule in a statement, saying, “I am pleased to see FDA proposing a rule that follows through on the requirement to update health warning labels on cigarette packages and advertisements that I believe will promote greater understanding of the health risks associated with smoking. This update is long overdue.”