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F.D.A. issues formal approval for omega-3 health claim
Source: Bakingbusiness.com, September 8, 2004
by Lyle Niedens
WASHINGTON - Formalizing a practice it essentially approved earlier this year, the Food and Drug Administration announced Wednesday it will allow manufacturers to attach a qualified health claim to food products containing omega-3 fatty acids.
Typically found in oily fish but also added to a variety of foods, omega-3 fatty acids have shown evidence of warding off cardiovascular disease and other heart ailments. But the F.D.A.'s decision to keep the claim "qualified" means that although such research has proved credible, it has yet to prove conclusive.
"While the F.D.A. has concluded these fatty acids are not essential to a healthy diet, they may be beneficial in reducing coronary heart disease," said Lester Crawford, acting commissioner of the F.D.A.
As a result, allowing food companies to tout the presence of omega-3 fatty acids could help consumers reduce coronary heart disease, blamed for 500,000 deaths annually in the United States, Dr. Crawford said.
"This new qualified health claim for omega-3 fatty acids should help consumers as they work to improve their health by identifying foods that contain these important compounds," Dr. Crawford said.
The F.D.A. actually began allowing qualified claims for omega-3 in mid-May after it did not object to a nutrient content claim notification filed in January by three seafood companies.
Because the agency did not respond to that notification within a 120-day time frame, U.S. food manufacturers essentially received the right to use qualified health claims for omega-3 almost four months before last week's formal announcement.
The formal claim unveiled Wednesday covers foods containing eiscosapentaenoic acid (E.P.A.) and/or docosahexaenoic acid (D.H.A.). Its language states that, "Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease."
Dr. Kathy Ellwood, division director of nutrition programs and labeling in the Office of Nutritional Products, Labeling and Dietary Supplements in the F.D.A.'s Center for Food Safety and Applied Nutrition, said the claim covers foods naturally containing omega-3 fatty acids and foods artificially injected with omega-3 compounds.
However, foods such as health bars or snack products that contain omega-3 have "disqualifying" levels that will prevent them from using the claim if they contain too much saturated fat and/or cholesterol, Ms. Ellwood said.
She added the claim doesn't specifically cover soy ingredients, which tend to contain higher levels of omega-6 fatty acids. However, it does cover grain-based foods products and soy-based products that contain omega-3 additives.
The claim does not fall under the purview of the F.D.A.'s proposed plan, unveiled last year, for evaluating health claims using a letter-grade system.
Instead, it constitutes the second qualified health claim the agency has issued for conventional food since pledging last year to allow food processors to expand their use of health claims on product packaging. The agency also has approved a qualified heart-health claim for whole and chopped walnuts.
The omega-3 claim also mirrors a similar qualified claim the agency has allowed since 2000 for dietary supplements with omega-3 additives.
Dr. Ellwood cautioned, though, that consuming massive amounts of omega-3 fatty acids can do more harm than good.
That's why the F.D.A. will continue recommending that consumption of omega-3 fatty acids not exceed a total of 3 grams per day of E.P.A. and D.H.A., with no more than 2 grams per day coming from a dietary supplements.
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