FDA Approves Qualified Health Claim for Omega-3 Fatty Acids

Omega-3 fatty acids just received a stamp of approval from FDA for their ability to reduce the risk of hypertension and heart disease. The agency approved a qualified-health claim for Omega 3 fatty acids recently, which means they will not object to the use of certain claims on dietary supplements and foods, 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. The industry is optimistic that the qualified claim will improve awareness about the safety of higher dosages of Omega-3 fatty acids.

The Global Organization for EPA and DHA Omega-3 (GOED) played a significant role in providing peer-reviewed scientific support for the decision. “GOED is happy to finally see this decision made by the FDA. While we would have liked less qualifying language, we are glad to have acknowledgement of the connection between omega-3s and important cardiovascular outcomes like lowering blood pressure and reducing the risk of coronary heart disease,” said Ellen Shutt, Executive Director, GOED.

The FDA also changed the upper limit, per recommendations from the stakeholders, based on supportive evidence.  “Also important for practitioners is the updated upper limit — from 3 g/day to 5 g/day — that FDA included in its decision. GOED has long advocated for the safety of omega-3s and this scientifically-based upper limit will help patients feel comfortable consuming therapeutic doses,” said Shutt.

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 lower-tier, qualified-health claim in the labeling of conventional foods and dietary supplements.

“We have great respect for the FDA and appreciate their review of the evidence supplied by GOED,” says Denis DeLuca, President, Biotics Research Corp. “While we are disappointed that this review did not result in an authorized-health claim, we are excited to utilize the qualified health claim to further educate on the importance of omega-3 fatty acids. Biotics Research is a proud member of GOED and appreciate their role in petitioning the FDA for further recognition of the role omega-3s play in cardiovascular health.” Biotics Research Corp. was the first professional supplement brand in the United States to join the ranks of GOED membership. For more on scientific summaries on Omega-3s click here.

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.