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 that contain 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 (Volume 72, No. 227). 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 in total: 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 processors, refiners, manufacturers, distributors, marketers and supporters 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.
"With respect to the claims for A.L.A. in the seafood processors notification, F.D.A. proposes to prohibit those claims because they are based on a population-weighted average of the AIs for A.L.A.," the F.D.A. said.
The F.D.A. received a notification from Martek Biosciences on Jan. 21, 2005. It proposed "high," "good source" and "more claims for A.L.A. and "high" claims for DHA. It set 1.6 grams as a daily value for A.L.A.
"The inconsistency between the population-weighted average method used to set the daily value for A.L.A. 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. "Such inconsistencies make meaningful product-to-product comparisons of A.L.A. content based on label claims impossible."
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 cited an I.O.M. report from 2005, which did not establish a recommended daily allowance (R.D.A.) for A.L.A. 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."
The F.D.A. gave the example of a food label or dietary supplement label lawfully claiming, "Contains x mg of EPA and DHA omega-3 fatty acids per serving."