On Dec. 5, 2012, the U.S. Food & Drug Administration (FDA) published a notice in the Federal Register requesting the Federal Office of Management and Budget approve the reinstatement of the FDA's web-based survey to evaluate the effectiveness of various graphic health warnings on cigarette packages. The reinstatement is being sought to aid in the FDA's "efforts to implement the mandatory graphic warnings required by the Tobacco Control Act."
Specifically, the FDA states that the purpose of conducting this annual study is to (1) convey information about various health risks of smoking, (2) encourage cessation of smoking among current smokers, and (3) discourage initiation of smoking among youth and former smokers. The study seeks to collect information from current smokers aged 13 years and older, former smokers aged 13 years and older, and non-smokers aged between 13 and 25 years who may be susceptible to initiation of smoking.
The prior OMB approval for the FDA to conduct this web-based annual survey expired on Oct. 31, 2012, and the FDA is now seeking reinstatement by surveying these three groups of individuals. The goals of continuing the survey are to: "(1) Measure consumer attitudes, beliefs, and intended behaviors related to cigarette smoking in response to graphic labels; (2) determine whether consumer responses to graphic warning labels differ across various groups based on smoking status, age, or other demographic variables; and (3) evaluate the relative effectiveness of various graphic images associated with each of the nine warning statements specified in the Tobacco Control Act for achieving each of the communication goals."
The notice also states that "FDA expects that the information that FDA proposes to collect will be relevant to FDA's regulation of cigarette warnings no matter the final outcome of the current litigation." This statement is in reference to the two pending federal lawsuits challenging the graphic cigarette health warning labels for cigarette packages and advertisements. The U.S. Circuit Court of Appeals for the Sixth Circuit ruled in the first lawsuit that the graphic health warnings were constitutional while the U.S. Circuit Court of Appeals for the District of Columbia Circuit ruled in a second lawsuit that the graphic health warning labels were unconstitutional.
The FDA estimates that 5,400 individuals will complete the survey. Public comments on this request for reinstatement may be submitted via fax to the OMB by Jan. 4, 2013. NATO will be drafting and submitting a set of comments to the OMB regarding this request for reinstatement. A copy of the notice published by the FDA in the Federal Register accompanies this Tobacco E-News article.