WASHINGTON — The Food and Drug Administration does not intend to object to certain qualified health claims stating that consuming two forms of omega-3 fatty acids in food or dietary supplements may reduce the risk of hypertension and coronary heart disease. The two forms are eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), which are found in some fatty fish, fish oils and dietary supplements.

The dietary supplements and conventional foods labeled with the qualified health claim must contain a total of at least 0.8 grams of EPA and DHA combined per serving. The qualified health claim also must be accompanied by a disclaimer or other qualified language that describes the level of scientific evidence supporting the qualified health claim.

The F.D.A. in the June 19 ruling responded to a health claim petition originally submitted in 2014 by The Global Organization for EPA and DHA Omega-3. The F.D.A. reviewed the 717 publications cited in the petition and other studies published after the petition was submitted. The F.D.A. then ruled the evidence did not meet the “significant scientific agreement” standard needed for an authorized health claim, but it met the “credible evidence” standard for a qualified health claim in the labeling of conventional foods and dietary supplements.

The F.D.A. gave several examples of acceptable qualified health claims:

  • “Consuming EPA and DHA combined may help lower blood pressure in the general population and reduce the risk of hypertension. However, F.D.A. 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.”
  • “Consuming EPA and DHA combined may reduce blood pressure and reduce the risk of hypertension, a risk factor for C.H.D. (coronary heart disease). However, F.D.A. 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.”
  • “Consuming EPA and DHA combined may reduce the risk of C.H.D. (coronary heart disease) by lowering blood pressure. However, F.D.A. 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.”
  • “Consuming EPA and DHA combined may reduce the risk of C.H.D. (coronary heart disease) by reducing the risk of hypertension. However, F.D.A. 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.”
  • “Research shows that consuming EPA and DHA combined may be beneficial for moderating blood pressure, a risk factor for C.H.D. (coronary heart disease). However, F.D.A. 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.”

Since 2004, the F.D.A. has allowed the use of another qualified health claim saying, “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.