In a statement accompanying the recently enacted omnibus appropriations act for fiscal year 2008, Congress questioned the authority of the FOOD AND DRUG ADMINISTRATION (FDA) to authorize qualified health claims, according to FI Counsel, OLSSON, FRANK, WEEDA, TERMAN, BODE & MATZ.
The Consolidated Appropriations Act of 2008 (the State, Foreign Operations, and Related Programs Appropriations Act, 2008), signed by President Bush on Dec. 26, provides fiscal year (FY) 2008 appropriations for all federal agencies and departments, except the Department of Defense. In the Joint Explanatory Statement to the appropriations act, Congress cast doubt on whether FDA has the statutory authority to allow qualified health claims in food labeling:
The [House and Senate Appropriations] Committees are concerned that FDA may have exceeded its statutory authority when the agency decided to begin allowing the use of qualified health claims for conventional foods in 2003. Such claims are not based on the standard of 'significant scientific agreement' set forth in the Nutrition Labeling and Education Act [NLEA]. The agency has devoted literally thousands of hours of staff work to this undertaking at a time when the agency's ability to carry out its public health responsibilities are severely stretched.
While the consumer group CENTER FOR SCIENCE IN THE PUBLIC INTEREST has alleged in a lawsuit that FDA's policy on qualified health claims violates the NLEA and the Administrative Procedures Act, this is the first time that Congress has suggested that FDA may have exceeded its legislative authority in approving qualified health claims.
The Congressional statement requests that the Government Accountability Office (GAO) prepare a report on qualified health claims, including their usefulness and their impact on public perceptions of conventional foods. Moreover, the statement 'urges' FDA not to use any FY 2008 appropriated funds to review petitions for qualified health claims or to issue letters of enforcement discretion allowing such claims until the GAO report is completed.
In a related development, FDA has announced its intent to reevaluate, in light of new information, the scientific basis for four health claims, including two qualified health claims for dietary supplements (i.e., antioxidant vitamins and certain cancers, selenium and certain cancers). 72 Fed. Reg. 72,738 (Dec. 21, 2007).
Qualified health claims are health claims about the relationship between a substance and a disease or health-related condition where there is emerging scientific evidence in support of a relationship but such evidence does not rise to the level of 'significant scientific agreement.' FDA implemented its policy to permit qualified health claims (as part of its Better Nutrition Information for Consumer Health Initiative) pursuant to the decision in Pearson v. Shalala, 164 F.3d 650 (D.C. Cir.1999), in which the court held that the First Amendment does not permit FDA to reject health claims that the agency determines to be potentially misleading unless the agency also reasonably determines that no disclaimer would eliminate the potential deception.
The Joint Explanatory Statement to the Consolidated Appropriations Act is available at http://appropriations.senate. gov/amendment.cfm
