FDA Announces Qualified Health Claims for EPA, DHA

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Silver Spring, MD—FDA announced in a press release that it “does not intend to object” to the use of qualified health claims stating that EPA and DHA omega-3 fatty acids may reduce the risk of hypertension and coronary heart disease.

FDA responded to a health claim petition submitted by the Global Organization for EPA and DHA Omega-3s (GOED) in a letter of enforcement discretion. FDA determined that the overall evidence did not meet the “significant scientific agreement” standard required for an authorized health claim but did meet the “credible evidence” standard for a qualified health claim in the labeling of conventional foods and dietary supplements, according to the release.

FDA reviewed the 717 publications cited by GOED, as well as other studies published after the petition was submitted and studies cited in public comments regarding the petition. It found that, while there is credible evidence suggesting that combined intake of EPA and DHA may reduce risk of hypertension, the evidence is “inconclusive and highly inconsistent.”

The claim can be written in any of the following ways:

  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.

  1. 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.

The full letter can be read here.

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