FDA allows qualified health claims for omega-3 fatty acids
Calls evidence suggestive,’ not conclusive
The U.S. Food and Drug Administration (FDA) announced it will permit qualified health claims for cardioprotective qualities of supplements containing two long-chain omega-3 fatty acid components.
Both components, EPA (eicosapentaenoic acid, from which the body manufactures prostaglandin) and DHA (docosahexaenoic acid), are found in rich concentrations in cold water fish.
In a paper issued on Oct. 31, 2000, the qualified health claim stated, "The scientific evidence about whether omega-3 fatty acids may reduce the risk of coronary heart disease (CHD) is suggestive, but not conclusive." Expanding on its qualified endorsement, the FDA talk paper said, "there is suggestive evidence that the benefit on CHD reported in diseased populations will carry over to the general population.
"The evidence from intervention trials with CHD as an endpoint is strongly favorable in a diseased population showing that omega-3 fatty acid intake is related to reduced risk of CHD."
The letter specifically permits the health claim for long-chain omega-3 fatty acids derived from fish or algae sources and not to the short-chain omega-3s, such as flax or canola.
The FDA said it was using its enforcement discretion to allow the qualified health claim for use in labeling supplements containing EPA and DHA provided that the labels do not recommend daily intakes exceeding 2 g.
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