Bread, dairy products, cereals and nutrition bars — and omega-3 suppliers — will be the initial winners of the Food & Drug Administration?s qualified health claim for DHA, EPA and cardiovascular health. But many believe the claim doesn?t go far enough.
They say evidence is sufficient for an unqualified health claim and the lack of a minimum requirement per serving is problematic. And the FDA suggestion that supplements should provide only two out of the three grams per day maximum is unnecessary because supplements are equally bioavailable as food-source EPA and DHA.
?The science is strong enough to warrant an unqualified health claim,? says Annette Dickinson, PhD, president of the Council for Responsible Nutrition.
Martek Biosciences, the US market leader in algae-source DHA, supplied the FDA with 12 studies to support the proposed health claim.
?Certainly we would have liked an unqualified health claim, but obviously the FDA isn?t quite ready to go there yet,? said Angela Tsetsis, executive director of business development at Martek. ?We?re not disappointed in the outcome at all — it opens doors that we?ve been trying to open all along. We see this as one step.?
Martek?s main business is in infant formulas — hardly a target for a cardiovascular health claim. But it has other interests in DHA-rich eggs and sees ?a real boost? ahead. ?Dairy is a great category, and bakery-type items and nutrition bars are a natural fit,? observed Tsetsis.
Ocean Nutrition Canada had similar sentiments. ?With all the evidence to support it, it?s disappointing to not have a full claim like soy products,? said Ian Lucas, vice president of marketing. ?But this opens up a whole new market for food manufacturers.?
Both Tsetsis and Lucas noted the claim is only for the omega-3s of DHA and EPA — which effectively keeps flax at bay. Flax is an omega-3 source, but the conversion rate of alpha-linolenic acid (ALA) to EPA and DHA is only about 10 per cent.
?In a couple of years that health claim will come for flax. It?s a funding issue — there are large players in the fish oil side,? said Michael Langenborg, vice president of marketing for Spectrum Organic Products in California. ?We don?t see it as a problem because there?s a huge vegetarian population out there. Plus, ALA has other benefits other than cardiovascular.?
EPA and DHA suppliers are disappointed no minimum quantities have been determined by the FDA. ?It would be nicer to have quantity because it?s more directional for consumers, and for businesses in labelling,? said Lucas.
?It will do consumers a disservice if foods with insignificant amounts of these fatty acids carry the claim,? said Dickinson.
The FDA said the evidence was not adequate to establish minimum quantities. It also recommended against ingesting excessive amounts of omega-3s because high amounts can slow blood clotting.
The qualified claim should read: ?Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease. One serving of [name of food] provides [x] grams of EPA and DHA omega-3 fatty acids. [See nutrition information for total fat, saturated fat and cholesterol content.]?
In 2000, the FDA announced a similar qualified health claim for supplements containing EPA and DHA with reduced risk of heart disease.