US FDA to Ban Certain Nutrient Content Claims for Omega-3 Fatty Acids

The US FDA will prohibit DHA and EPA nutrient content claims on food and dietary supplement labels, unless certain requirements are met.

The United States Food and Drug Administration (USFDA) published a final rule prohibiting certain nutrient content labeling claims for docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA) and alpha-linolenic acid (ALA) omega-3 fatty acids.

The final rule is not substantially different than the proposal published in 2007.

The US FDA will prohibit DHA and EPA nutrient content claims such as “high in”, “rich in” and “excellent source of” and other similar claims on food and dietary supplement labels. It is prohibiting some such claims for ALA, but at this time will continue to allow the claims noted in Table 1 to remain on labels in the market providing the conditions are met. The US FDA will allow product claims if certain requirements are met, such nutrient levels can be based on authoritative statements published by certain types of scientific bodies, such as the Institute of Medicine of the National Academies (IOM).

Nutrient content claim and related conditions for making the claim are summarized within the latest SafeGuardS bulletin. The claims listed in Table 1 are being allowed by the US FDA because they are authoritative statements from a scientific body recognized by the US FDA.




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