Food and Drug Administration

The Food and Drug Administration (FDA) in 1996 published a final rule banning the sales of cigarettes and smokeless tobacco to minors and restricting the advertising of these products. GAO was unsuccessful in obtaining internal FDA memorandums, notes from meeting and conversations, and other documents that would shed light on how FDA arrived at its proposal. GAO was only able to examine documents on the public record. In withholding this material from GAO, FDA cited the integrity of the deliberative process, the sensitivity of ongoing litigation, and the need to protect the confidentiality of sources.

GAO noted that: (1) its efforts to obtain information that would enable it to adequately describe the activities that led to FDA's proposal to regulate tobacco products were obstructed by FDA's and HHS' refusals to provide many of the documents requested by Congress and by GAO; (2) through interviews with FDA officials and staff, GAO obtained testimonial evidence on some FDA actions prior to the publication of the final rule and jurisdictional determination, but without the documents requested, it could not verify this information; (3) FDA and HHS officials refused most of GAO's requests for tobacco-related documents in the possession of agency officials that were not included on either the public or confidential record or an index of these documents; (4) they cited several reasons for declining GAO's requests: (a) the proposed tobacco regulation was part of an ongoing rulemaking and release of the requested information would jeopardize the integrity of this deliberative process; (b) releasing the requested information and communications with officials employed by the Department of Justice would negatively affect the government's position in ongoing litigation; (c) the requested information was obtained from confidential sources and its disclosure could undermine pledges of confidentiality; and (d) communications with officials employed by the White House are subject to a possible claim by the President of executive privilege, which only he can waive; (5) although GAO informed FDA and HHS that these factors do not limit its statutory right of access to the information, officials were unwilling to be forthcoming; (6) since FDA refused to provide GAO many of the documents that it requested, the information GAO obtained about FDA's tobacco regulation activities came primarily from interviews with key FDA staff who participated in FDA tobacco-related investigations, developed regulatory options, and assessed FDA's jurisdiction to regulate tobacco FDA officials would not discuss the specific regulatory approaches they considered prior to the rule's publication nor would they provide internal documents addressing the options they considered and their internal analyses of FDA's jurisdiction; and (7) according to FDA staff, FDA's investigation culminated with its issuance of the proposed rule and accompanying analysis regarding the agency's jurisdiction over nicotine-containing cigarettes and smokeless tobacco products and its proposal to regulate the sale and marketing of tobacco products to children and adolescents.