International omega-3s ?trade group, Global Organization for EPA and DHA Omega-3s, has responded to a US Food and Drug Administration threat to prohibit Eicosapentaenoic Acid, and Docosahexaenoic Acid claims by urging the FDA to scrutinise omega-3 clinical data that has come to light since the last major review in 2001.
GOED said the FDA or the Institute of Medicine should "review the clinical science on omega-3s and make an authoritative statement on a recommended intake for EPA and DHA." These included hundreds of clinical trials, reviews and meta analyses.
The FDA has intimated it would prohibit claims stemming from three separate submissions. It would ban "the nutrient content claims for DHA and EPA set forth in the three notifications because they are not based on an authoritative statement that identifies a nutrient level to which the claims refer, as required by the controlling statutory authority."
The problem is that the "authoritative statement" does not exist because the IOM has not established one nor has any other official US body. A figure of 450mg of EPA/DHA per day for adults was arrived at by UK scientists some years ago but has not been ratified in the European Union or even in the UK.
"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, which has commissioned a workshop to look into the matter in early 2008.
Two of the three submissions also contained Alpha Linolenic claims. FDA said it would prohibit one of the ALA claims because of a discrepancy over recommended daily intakes between the submission and established levels. The other, submitted by Martek, it had no issue with. "Therefore, if this proposed rule is finalised without change, these claims will be allowed to remain on the market," FDA said.
Other companies involved in the submissions to the FDA were Alaska General Seafoods, Ocean Beauty Seafoods, Inc., and Trans-Ocean Products, Inc. (jointly) and Ocean Nutrition Canada.According to Nutrition Business Journal, the US market for dietary supplements with EPA and DHA has grown from $100 million in 2001 to $489 million in 2006, while market researcher Packaged Facts estimates the US market for food products fortified with EPA and DHA has grown from nothing in 2001 to $600 million in 2006.
More information: www.goedomega3.com or contact Lindsay Wright at +1 801 746-1413