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FDA qualifies new health claims for EPA & DHA

Posted by Daniel Patrick on

An industry organization known as The Global Organization for EPA and DHA Omega-3s petitioned the FDA to allow a certain health claims on foods containing those ingredients.

The FDA reviewed 717 publications cited in the petition. They concluded the following.

The FDA intends to exercise enforcement discretion for the following qualified health claims regarding EPA and DHA when the claims are used in the labeling of conventional foods and dietary supplements consistent with the letter of enforcement discretion:

1. 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. One serving of [name of the food or dietary supplement] provides [  ] gram(s) of EPA and DHA.

2. Consuming EPA and DHA combined may reduce blood pressure and reduce the risk of hypertension, a risk factor for CHD (coronary heart disease). However, FDA has concluded that the evidence is inconsistent and inconclusive. One serving of [name of the food or dietary supplement] provides [  ] gram(s) of EPA and DHA.

3.a. Consuming EPA and DHA combined may reduce the risk of CHD (coronary heart disease) by lowering blood pressure. However, FDA has concluded that the evidence is inconsistent and inconclusive. One serving of [name of the food or dietary supplement] provides [  ] gram(s) of EPA and DHA.

3.b. Consuming EPA and DHA combined may reduce the risk of CHD (coronary heart disease) by reducing the risk of hypertension. However, FDA has concluded that the evidence is inconsistent and inconclusive. One serving of [name of the food or dietary supplement] provides [  ] gram(s) of EPA and DHA.

4. Research shows that consuming EPA and DHA combined may be beneficial for moderating blood pressure, a risk factor for CHD (coronary heart disease). However, FDA has concluded that the evidence is inconsistent and inconclusive. One serving of [name of the food or dietary supplement] provides [  ] gram(s) of EPA and DHA.

In addition to the qualified health claims announced today, since 2004 the FDA has exercised enforcement discretion for the 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” under certain circumstances.


Reference: 

https://www.fda.gov/food/cfsan-constituent-updates/fda-announces-new-qualified-health-claims-epa-and-dha-omega-3-consumption-and-risk-hypertension-and

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