As part of its continuing Consumer Health Information for Better Nutrition initiative, the Food and Drug Administration (FDA) announced the release of the initiative's task force report on July 10, unveiling a review process for qualified health claims on foods.
FDA issued guidance on a process for evaluating and ranking the scientific evidence for a qualified health claim. The ranking system categorizes the quality and strength of the scientific evidence, through an A, B, C, or D grading system for proposed qualified health claims. An unqualified health claim, (a grade of "A") meets the standards of significant scientific agreement achieved by previously approved health claims such as calcium to reduce risk of osteoporosis. FDA will also conduct consumer research to make sure that the language used is easily and accurately interpreted by consumers.
In a second piece of guidance, FDA explains how applicants can seek a qualified health claim for foods or dietary supplements and describes how FDA will prioritize the review of such petitions.
The report highlights the key areas in which FDA intends to focus its efforts in the coming months:
- Consumption of omega-3 fatty acids for reducing the risk of heart disease.
- Consumption of fruits and vegetables for reducing the risk of some cancers and other chronic illnesses.
- Replacing solid fats that are high in saturated and trans fats with vegetable oils containing unsaturated fats for reducing the risk of heart disease.
- Substituting nuts for other sources of saturated-fat-containing protein for reducing the risk of heart disease on July 15, 2003, the FDA issued a decision to allow a qualified health claim for some nuts.)
In addition to the task force findings, FDA issued a report detailing enforcement actions that will be taken against misleading claims by some manufacturers of dietary supplements.
Additional information about the FDA's "Consumer Health Information for Better Nutrition" initiative is available at: http://www.fda.gov/oc/mcclellan/chbn.html.
