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.

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).