The proposed Food and Drug Administration (FDA) rule, "Tobacco Products, Required Warnings for Cigarette Packages and Advertisements" (84 FR 42754), would implement provisions of the 2009 Family Smoking Prevention and Tobacco Control Act (Public Law 111-31) by requiring warning labels on cigarette packages and advertisements to better reflect new evidence on health risks associated with tobacco consumption.
In the proposed rule, the FDA claims that the current Surgeon General’s warnings, which have not been updated since the 1984 Comprehensive Smoking Education Act (Public Law 98-474), no longer effectively capture the attention of the public or adequately convey the health risks known to be associated with smoking cigarettes.
Accordingly, the proposed FDA rule specifies thirteen new textual warnings, which seek to increase public awareness by highlighting lesser-known health risks associated with smoking, as required by the 2009 Tobacco Control Act. The warnings are based on evidence presented in the 2014 Surgeon General’s Report. Verbatim examples include:
- WARNING: Smoking reduces blood flow to the limbs, which can require amputation.
- WARNING: Smoking causes age-related macular degeneration, which can lead to blindness.
- WARNING: Smoking causes bladder cancer, which can lead to bloody urine.
As mandated in the Tobacco Control Act (at 15 U.S.C. 1333(d)), the proposed rule would also require manufacturers to include photorealistic color images depicting the respective negative health consequences alongside the new written warnings. Manufacturers would be responsible for establishing an FDA-approved schedule to rotate which labels are being printed on packages and advertisements each quarter and to ensure that all labels are equally represented.
In 2011, the FDA issued a similar final rule calling for color images to be displayed alongside the original nine warning labels currently in circulation. However, the rule was challenged by tobacco companies (RJ Reynolds Tobacco Co. v. FDA) for violating the First Amendment, and subsequently vacated by the US District Court for the District of Columbia in 2012. In March 2019, The US District Court for the District of Massachusetts ordered the FDA to finally carry out the mandates of the 2009 Tobacco Control Act and publish a proposed rule by August 2019.
The period for public comment on the current proposed rule ended on October 15, 2019 with 192 comments posted. The final rule is expected to be published by March 2020.