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FDA Seeks Comment on Ways to Manage Qualified Health Claims

The Food and Drug Administration (FDA) today announced it is issuing an advance notice of proposed rulemaking (ANPRM) to request public comment on several topics involving qualified health claims and other potential initiatives to help consumers choose a healthy diet. Qualified health claims are claims that are not supported by significant scientific agreement (SSA). Among other issues, the agency is requesting comments on alternatives for regulating qualified health claims and on the appropriateness and nature of dietary guidance statements in food labeling.

Today's action is a follow-up to the July 11, 2003, report of the Consumer Health Information for Better Nutrition Initiative Task Force (the Task Force). In addition to the Task Force report, FDA also made available two final guidance documents that provide: (1) interim procedures for qualified health claims in the labeling of conventional foods and dietary supplements, and (2) an interim evidence-based ranking system to systematically evaluate and rank the scientific evidence relevant to a qualified health claim. These interim procedures were implemented on September 1, 2003.

In the ANPRM, FDA is soliciting comments in three broad areas:

• Alternatives for regulating health claims that do not meet the significant scientific agreement standard, including three options presented as part of the Task Force report;
• Other issues related to health claims, including, for example, data and research on a substance/disease relationship, including how to provide incentives for manufacturers to develop the data needed to obtain significant scientific agreement; use of phrases such as "FDA authorized" in qualified and unqualified health claims; and consumer education about qualified health claims; and
• Dietary guidance statements on conventional food and dietary supplement labels.

Interested persons have 60 days to comment on the ANPRM. Comments may be submitted to the Division of Dockets Management, HFA-305, Food and Drug Administration, 5630 Fishers Lane, Rm 1061, Rockville, MD 20852. Comments may be submitted electronically after the Federal Notice is published on November 25, 2003, to www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm.

Federal Register notice
Federal Register notice [PDF]

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