WASHINGTON — The Food and Drug Administration has proposed a rule that certain nutrient content claims may not appear on labels for foods or dietary supplements containing omega-3 fatty acids because the claims do not meet the requirements of the Federal Food, Drug and Cosmetic Act. The proposed rule appeared in the Nov. 27 Federal Register. The F.D.A. will accept comments until Feb. 11, 2008.
The F.D.A. proposal came in response to three notifications submitted to the F.D.A. that sought claims for three omega-3 fatty acids: alpha-linolenic acid (ALA), docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA). The F.D.A. proposed to prohibit the claims in the three notifications because they are not based on an authoritative statement.
The Global Organization for EPA and DHA Omega-3s (G.O.E.D.) has urged the F.D.A. and the Institute of Medicine (I.O.M.) to make such a statement after first reviewing the clinical science on omega-3 fatty acids. "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 the G.O.E.D.
According to the G.O.E.D., the I.O.M.’s last review of EPA and DHA for the establishment of dietary reference intakes involved clinical studies and reviews through 2001. Since 2002, there have been 260 randomized, controlled clinical trials on humans and 347 reviews and meta-analyses published on EPA and DHA, according to the G.O.E.D.
The G.O.E.D. is an association of companies involved in the manufacture and marketing of products containing EPA and DHA.
The F.D.A. received notifications for omega-3 fatty acid claims from a group of seafood processors; Martek Biosciences Corp., an omega-3 ingredient supplier based in Columbia, Md.; and Ocean Nutrition Canada, an omega-3 ingredient supplier based in Dartmouth, N.S.
The F.D.A. received a notification from the seafood processors on Jan. 16, 2004. It proposed "high," "good source," and "more" claims for A.L.A. along with "high" claims for DHA and EPA. It set 1.3 grams as a daily value for A.L.A.
The F.D.A. received a notification from Martek Biosciences on Jan. 21, 2005. It proposed "high," "good source" and "more" claims for ALA and "high" claims for DHA. It set 1.6 grams as a daily value for ALA.
"The inconsistency between the population-weighted average method used to set the daily value for ALA in the seafood processors notification and the population coverage method used for that purpose in the Martek notification is likely to result in inconsistent and conflicting nutrient content claims on food labels," the F.D.A. said.
The F.D.A. received a notification from Ocean Nutrition Canada on Dec. 9, 2005. It proposed "high" claims for the combined amount of EPA and DHA.
The F.D.A. proposed to conclude the statements do not identify a nutrient level, or reference value, for EPA and/or DHA. The F.D.A. would need the nutrient level, or reference value, to establish by regulation a label reference value for use in nutrition labeling. The F.D.A. also proposed to conclude the statements do not identify a nutrient level, or reference value, for EPA and/or DHA. The F.D.A. would need the nutrient level, or reference value, to establish by regulation a label reference value for use in nutrition labeling.
"F.D.A. recognizes that consumption of EPA and/or DHA may provide health benefits and that industry may wish to alert consumers to those benefits," the F.D.A. said. "There are numerous lawful means of doing so."