The undersigned public health and medical organizations submit these comments in response to the request for comments on FDA’s proposed rule to establish new required health warnings for cigarette packages and advertisements, “Tobacco Products; Required Warnings for Cigarette Packages and Advertisements,” 84 Fed. Reg. 42754 (August 16, 2019) (proposed rule).

It has been over ten years since the Family Smoking Prevention and Tobacco Control Act of 2009 (Tobacco Control Act or Act) required FDA to issue a final rule mandating color graphic health warnings on cigarette packages and ads. In enacting that landmark legislation, Congress determined that the current Surgeon General warnings on the sides of cigarette packages were largely ignored and utterly ineffective in communicating the health hazards of cigarettes to the public. Those warnings remain just as ineffective today.

Over 120 countries have adopted graphic health warnings; 81 in the ten years since enactment of the Tobacco Control Act. The evidence is overwhelming that such warnings substantially increase public understanding of the dangers of smoking. Yet, in the U.S., cigarette packages and advertising today remain devoid of effective health warnings. Given the length of time that the Congressional mandate of graphic health warnings has remained unfulfilled, and the strong support for the proposed warnings in the administrative record, FDA must ensure that a final rule is issued by the March 15, 2020 deadline established by order of the United States District Court for the District of Massachusetts in Am. Acad. of Pediatrics v. FDA, No. 1:16-cv-11985-IT, Dkt. No. 56 (March 5, 2019).

There is no question that the graphic warnings in the proposed rule would effectively promote greater public understanding of the negative health consequences of cigarette smoking. The administrative record supporting the proposed rule establishes (1) that the current Surgeon General’s warnings on cigarette packs are wholly inadequate because they are not noticed and fail to address many of the health harms of smoking of which the public has little knowledge; (2) research from across the globe demonstrates that large, pictorial health warnings enhance the effectiveness of textual warnings in increasing public understanding of the health harms of smoking; (3) the FDA’s own research supporting the development of the proposed textual and graphic elements in the proposed rule strongly supports the conclusion that the proposed warnings will lead to greater public understanding of the health harms of smoking; (4) the proposed rule and supporting justification are responsive to the First Amendment concerns that led the U.S. Court of Appeals, in R.J. Reynolds Tobacco Co. v. FDA, 696 F.3d 1205 (D.C. Cir. 2012) to strike down the final rule issued by FDA in June, 2011 (the 2011 rule) and remand the matter to the agency; and (5) the various textual and graphic elements in the proposed rule should be considered severable and workable on their own and, should portions of the rule be invalidated by the courts, the implementation of other portions would nevertheless promote greater public understanding of the health harms of smoking.

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