10.01.04
FDA in early September finally approved a qualified health claim for a reduced risk of coronary heart disease (CHD) on conventional foods that contain eiscosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) omega 3 fatty acids. This move was made, according to the agency, to improve consumers’ understanding of the health benefits of omega 3 fatty acids contained in oily fish such as salmon, lake trout, tuna and herring. FDA said while these fatty acids are not essential to the diet, scientific evidence indicates that they may be beneficial in reducing CHD. As this research is not conclusive, FDA intends to exercise its enforcement discretion with respect to the following qualified health claim: “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, FDA announced a similar qualified health claim for dietary supplements containing EPA and DHA omega 3 fatty acids and the reduced risk of CHD. FDA recommends that consumers not exceed more than a total of 3 grams per day of EPA and DHA omega 3 fatty acids, with no more than 2 grams per day from a dietary supplement. In response to FDA’s action, CRN commended the agency but said it fell short of recommending what the science supports in two areas. First, CRN said that it believes the science is strong enough to warrant an unqualified health claim for omega 3 EPA/DHA. Second, it feels that FDA should have established a minimum requirement for the amount of omega 3 EPA/DHA that a conventional food must contain in order to use the qualified health claim. In not doing so, CRN said the claim will do consumers a disservice if foods with insignificant amounts of these fatty acids carry the claim.