15 May 2014
US FDA Prohibits Some Labelling Claims for Omega-3 Fatty Acids (DHA, EPA and ALA)
On 28 April 2014 the United States Food and Drug Administration (US FDA) 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. This final rule is not substantially different then the proposal published in 2007.1
Certain Nutrient Content Claims Prohibited for DHA, EPA and ALA2
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. The US FDA is prohibiting some such claims for ALA but at this time will continue to allow the claims noted in the following table to remain on labels in the market providing the conditions are met.
|Nutrient Content Claim for ALA||Conditions For Making the Claim1|
≥ 320 mg of ALA per RACC
≥ 160 mg of ALA per RACC
≥ 160 mg of ALA more per RACC than an appropriate reference food
US FDA is prohibiting these claims because they have not established nutrient content levels by regulations. 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). The claims listed in the above table are being allowed by the US FDA because they are authoritative statements from a scientific body recognized by the US FDA.
Effective date of this rule is January 1, 2016.
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