FDA Decides on EFA Nutrient Content Claims

WASHINGTONFDA has preliminarily rejected three nutrient content claim filings for omega-3 fatty acids and food labels, saying the notifications submitted did not meet requirements. In the published proposed rule, FDA stated: certain nutrient content claims for foods, including conventional foods and dietary supplements, that contain omega-3 fatty acids, do not meet the requirements of the Federal Food, Drug, and Cosmetic Act and may not appear in food labeling. The rule was in response to three notifications: one for docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA), submitted by Ocean Nutrition Canada ONC); one for alpha-linolenic acid (ALA), DHA and EPA, submitted collectively by Alaska General Seafoods, Ocean Beauty Seafoods Inc. and Trans-Ocean Products; and one for ALA, DHA and EPA, submitted by Martek Biosciences Corp.

On the DHA/EPA filing by ONC, FDA proposed the filing is not based on an authoritative statement that identifies a nutrient level to which the claims refer, as is required by the act. The agency stated the ALA filing by the seafood companies should also be rejected, but for basing the claim on a daily value (DV) that was determined by a different method than DVs already established for other nutrients, which would confuse the public. However, FDA suggested no action on the Martek claim, essentially allowing its use on nutrient labels, if the proposed rule becomes final.

In response to the suggested rejection of the DHA/EPA claim filed by ONC, the Global Organization for EPA and DHA Omega-3s (GOED) urged FDA and/or the Institute of Medicine (IOM) to review the clinical science on omega-3s and make an authoritative statement on a recommended intake for EPA and DHA. The proposed rule would ban this claim on the basis that the IOM has made no authoritative statement identifying a daily required or recommended nutrient level for EPA and DHA. IOMs last such review of these fatty acids involved research through only 2001, but there have been 260 randomized, controlled clinical trials on humans and 347 reviews and meta-analyses published since 2002 not yet assessed as part of the IOMs body of evidence.

Rather than prohibiting nutrient content claims on EPA and DHA because an old review of the science set no daily requirement, we believe there should be a proper examination of the current clinical science to set a level for EPA and DHA as vital nutrients for chronic disease prevention and nutrient deficiencies, said Adam Ismail, executive director of GOED.

Comments on the proposed rule must be submitted by Feb. 11, 2008. Electronic submission of comments can be completed at the FDA Web site or the federal regulations site (Docket # FDA-2007-0601).