06.19.19
The U.S. Food and Drug Administration said it does not intend to object to the use of certain qualified health claims stating that consuming eicosapentaenoic acid (EPA) and docosahexaenoic (DHA) omega-3 fatty acids in food or dietary supplements may reduce the risk of hypertension and coronary heart disease.
Specifically, the 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. Enforcement discretion means that FDA does not intend to object to the claim if it is used consistent with the factors described in the letter of enforcement discretion. The 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.
The agency found that 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. EPA and DHA omega-3 fatty acids are found primarily in some fatty fish, fish oils, and dietary supplements.
The FDA thoroughly reviewed the 717 publications cited by the petitioner. The FDA also considered other written data and information, including studies published after the petition was submitted and studies cited in public comments about the petition. The FDA posted the petition for comment and received 22 comments in response to the petition.
Under FDA’s health claim regulations, foods and dietary supplements that bear a health claim must meet requirements regarding levels of certain nutrients. These requirements and the enforcement discretion factors FDA intends to consider for the use of this qualified health claim are described in detail in the letter of enforcement discretion issued to the petitioner. One of these enforcement discretion factors is that dietary supplements and conventional foods labeled with the qualified health claim contain at least 0.8 g EPA and DHA (combined total) per serving. To prevent consumer deception about the strength of the science underlying the new claim, the qualified health claim must be accompanied by a disclaimer or other qualifying language that accurately describes the level of scientific evidence supporting the claim. 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.
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.
In addition to the new qualified health claims, 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.
Specifically, the 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. Enforcement discretion means that FDA does not intend to object to the claim if it is used consistent with the factors described in the letter of enforcement discretion. The 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.
The agency found that 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. EPA and DHA omega-3 fatty acids are found primarily in some fatty fish, fish oils, and dietary supplements.
The FDA thoroughly reviewed the 717 publications cited by the petitioner. The FDA also considered other written data and information, including studies published after the petition was submitted and studies cited in public comments about the petition. The FDA posted the petition for comment and received 22 comments in response to the petition.
Under FDA’s health claim regulations, foods and dietary supplements that bear a health claim must meet requirements regarding levels of certain nutrients. These requirements and the enforcement discretion factors FDA intends to consider for the use of this qualified health claim are described in detail in the letter of enforcement discretion issued to the petitioner. One of these enforcement discretion factors is that dietary supplements and conventional foods labeled with the qualified health claim contain at least 0.8 g EPA and DHA (combined total) per serving. To prevent consumer deception about the strength of the science underlying the new claim, the qualified health claim must be accompanied by a disclaimer or other qualifying language that accurately describes the level of scientific evidence supporting the claim. 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.
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.
In addition to the new qualified health claims, 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.
