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FDA to allow qualified health claims for EPA and DHA

July 05, 2019

The US Food and Drug Administration (FDA) has announced that it will not object to the use of certain qualified health claims claiming that consuming eicosapentaenoic (EPA) and docosahexaenoic (DHA) omega 3 fatty acids in food or dietary supplement may reduce the risk of hypertension and coronary heart disease.

, FDA to allow qualified health claims for EPA and DHA

The FDA said on 19 June that it was responding specifically to a health claim petition filed in August 2014 by The Global Organization for EPA and DHA Omega-3s (GOED).

It said EPA and DHA omega 3 fatty acids were found primarily in some fatty fish, fish oils and dietary supplements.

“While there is some credible evidence suggesting that combined intake of EPA and DHA from conventional foods and dietary supplements may reduce the risk of hypertension by lowering blood pressure, this evidence is inconclusive and highly inconsistent,” it said.

The agency found that the overall evidence did not meet the ‘significant scientific agreement’ standard required for an authorised health claim but did meet the ‘credible evidence’ standard for a qualified health claim.

To prevent consumer deception, the FDA said the qualified health claim had to be accompanied by a disclaimer, such as “Consuming EPA and DHA combined may help lower blood pressure in the general population and reduce the risk of hypertension. However, FDA has concluded that the evidence is inconsistent and inconclusive”.


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