Omega-3 blood pressure qualified health claim gets FDA nod

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FDA today signaled that it will allow the use of a qualified health claim linking omega-3 fatty acids EPA and DHA with blood pressure benefits. The decision is a response to a petition filed back in August 2014 by omega-3 association the Global Organization for EPA and DHA Omega-3s (GOED; Salt Lake City, UT).

Initially, GOED had petitioned FDA for an authorized health claim, but was soon after notified that FDA would be instead reviewing the claim as a qualified health claim rather than an authorized health claim. A qualified health claim does not carry the full weight of an authorized health claim. FDA says: “Qualified health claims (QHCs) are supported by scientific evidence, but do not meet the more rigorous ‘significant scientific agreement’ standard required for an authorized health claim. To ensure that these claims are not misleading, they must be accompanied by a disclaimer or other qualifying language to accurately communicate to consumers the level of scientific evidence supporting the claim.”

Nonetheless, the qualified health claim is a landmark achievement for GOED and one that will benefit the entire omega-3 industry. At press time, GOED noted that it is reviewing FDA’s response in full.

FDA noted that it will exercise its enforcement discretion to allow use of the following qualified health claims indicating that these omega-3 fatty acids may help lower blood pressure, reduce the risk of hypertension, and reduce the risk of coronary heart disease:

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.

3a. 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.

3b. 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.

Food and dietary supplements are now allowed to use these claims for their omega-3 products. FDA has also indicated the minimum and maximum usage levels of EPA/DHA required to carry this claim.

In order to use the claim, foods or dietary supplements must contain a minimum of 0.8 g EPA and DHA (combined total). At the other end, FDA limits the claim’s usage to products that provide no more than 5 g/day EPA and DHA, noting that “Due to the lack of scientific evidence about risk of excessive bleeding at intakes of more than 5 g/day, however, we are unable to determine whether these products are safe within the meaning of the ‘safe and lawful’ requirement for conventional foods and dietary supplement to bear a health claim (21 CFR 101.14(b)(3)(ii)).”