ULTIMATE™ ESSENTIAL FATTY ACID (E.F.A.)™
FDA AMENDS OMEGA-3 FATTY
ACIDS/CORONARY HEART DISEASE QUALIFIED HEALTH CLAIM AND EXTENDS CLAIM FOR USE ON CONVENTIONAL FOODS Dated: September 8, 2004 Contact: Jonathan W. Emord Emord & Associates, P.C. (202) 466-6937 Washington, D.C. - Today the Food and Drug Administration (FDA) authorized a qualified health claim linking consumption of omega-3 fatty acids with a reduced risk of coronary heart disease (CHD): "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 far and cholesterol content.] The announcement follows FDA consideration of a health claim petition filed by American Longevity and Life Extension Foundation Buyers Club seeking to amend the agency’s previously authorized health claim for omega-3 fatty acids and CHD. Today’s decision dramatically widens FDA’s former position regarding the relationship between dietary supplements containing omega-3 fatty acids and the resulting reduced risk of CHD. The former qualified health claim contained a substantively limiting disclaimer that failed to adequately assess the benefits of omega-3 fatty acids in reducing the risk of CHD. FDA’s current qualified health claim more accurately describes the current state of the scientific evidence on the benefits of omega-3 fatty acids and extends use of the health claim to both dietary supplements and conventional foods. *A copy of the FDA letter allowing use of the claim may be obtained from Cynthia Lewis at Emord & Associates (202) 466-6937. |