SALT LAKE CITY — Even though the Food and Drug Administration ruled that, effective Jan. 1, 2016, certain nutrient content claims will not be allowed for foods that contain certain omega-3 fatty acids, manufacturers still have various ways of promoting the ingredients.
“Whether fish or fish oil or some other omega-3 rich product, (consumption) really is important, and it is important at all life stages,” said Harry B. Rice, Ph.D., vice-president of regulatory and scientific affairs for the Global Organization for EPA and DHA Omega-3s (GOED), which is based in Salt Lake City.
He said manufacturers still may say a product contains “x” amount, such as mg, of omega-3 fatty acids per serving. Also, a qualified health claim from the F.D.A. states, “Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease.”
The Dietary Guidelines for Americans 2010 states, “Moderate evidence shows that consumption of about 8 oz per week of a variety of seafood, which provide an average consumption of 250 mg per day of EPA and DHA, is associated with reduced cardiac deaths among individuals with and without pre-existing cardiovascular disease.”
Dr. Rice said in America the mean intake of EPA and DHA from food and dietary supplements combined is about 113 mg per day.
The F.D.A. published a final rule in the April 28 Federal Register. The rule prohibits statements on the labels of food products, including dietary supplements, claiming the products are “high” in DHA (docosahexaenoic acid) and EPA (eicosapentaenoic acid). Synonyms such as “rich in” and “excellent source of” also are prohibited.
In regard to similar claims for alpha-linolenic acid (ALA), another omega-3 fatty acid, the F.D.A. said it will take no regulatory action at this time on one set of nutrient content claims, but it will prohibit another set of nutrient content claims.
The final rules said that under the Federal Food, Drug and Cosmetic Act, nutrient content claims such as “high in” are allowed only for nutrients for which the claim refers has been set. The F.D.A. has not established nutrient levels that serve as the basis for nutrient content claims for DHA, EPA or ALA.
Dr. Rice said EPA and DHA last year were nominated as nutrients for review. The Institute of Medicine would undertake any possible review. The findings of such a review might increase the chances of the F.D.A. establishing nutrient levels for EPA and DHA.
