Questions and Answers
Qualified Health Claim for Omega-3 Fatty Acids,
Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA)

1. What action has FDA taken today?
2. What is the difference between a qualified health claim and an unqualified health claim?
3. What products can use the qualified health claim?
4. Are omega-3 fatty acids essential to a healthy diet?
5. What foods contain omega-3 fatty acids?
6. What are the benefits of omega-3 fatty acids?
7. How much omega-3 fatty acids should I consume in my diet?
8. What happens if I consume more the recommend amounts of omega-3 fatty acids?
9. Since FDA is announcing this claim, does this mean that FDA has scientific evidence that consumption of omega-3 fatty acids reduces the risk of coronary heart disease?
10. FDA has warned consumers about tuna and mercury. Doesn't this qualified health claim contradict this warning?
11. Can all fish use this qualified health claim?
12. Since fresh fish is not labeled, how will consumer know which fish have these fatty acids?

1. Q: What action has FDA taken today?

   A: FDA announced a qualified health claim for the use of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) omega-3 fatty acids for conventional foods and dietary supplements.

2. Q: What is the difference between a qualified health claim and an unqualified health claim?

   A: Both types of health claims characterize a relationship between a substance (specific food component or a specific food) and a disease or health-related condition, and are supported by scientific evidence. All health claims must undergo review by FDA through a petition process. All unqualified health claims must meet the Significant Scientific Agreement standard as provided for by Congress in 1990. Court decisions resulting in qualified health claims focused on a manufacturer's right to make statements about diet/disease relationships when the science supporting the claim did not meet the Significant Scientific Agreement standard, provided that the claim about the relationship was stated or "qualified" in such a way as to not mislead consumers. Thus, qualified health claims differ from unqualified ones in the level of scientific support and in that they must be accompanied by a disclaimer or otherwise qualified.

3. Q: What products can use the qualified health claim?

   A: FDA will consider its enforcement discretion, effective immediately, for food products labeled with the qualified health claim. Food products labeled with the qualified health claim must contain both EPA and DHA omega-3 fatty acids.

4. Q: Are omega-3 fatty acids essential to a healthy diet?

   A: Alpha-linolenic acid is the only essential omega-3 fatty acid and is found in vegetable oil, e.g. flax seed. EPA and DHA omega-3 fatty acids are synthesized in the body and are not essential although there is supportive but not conclusive research to show that these fatty acids are beneficial in reducing the risk of coronary heart disease.

5. Q: What foods contain omega-3 fatty acids?

   A: Foods that contain omega-3 fatty acids include fatty fish such as salmon, lake trout, tuna, and herring.

6. Q: What are the benefits of omega-3 fatty acids?

   A: Supportive but not conclusive research has shown that EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease.

7. Q: How much omega-3 fatty acids should I consume in my diet?

   A: FDA recommends that consumers not exceed more than a total of 3 grams per day, with no more than 2 grams per day from a dietary supplement.

8. Q: What happens if I consume more the recommend amounts of omega-3 fatty acids?

   A: Some scientific studies show that consumption levels well over 3 grams per day may lead to excessive bleeding. Therefore, FDA recommends that consumption not exceed 3 grams per day from all food sources.

9. Q: Since FDA is announcing this claim, does this mean that FDA has scientific evidence that consumption of omega-3 fatty acids reduces the risk of coronary heart disease?

   A: FDA has determined that there is supportive, but not conclusive, scientific evidence that suggests a reduction in coronary heart disease as a result of eating foods rich in omega-3 fatty acids. This important health benefit will help consumers as they work to improve their diets by selecting foods that will benefit their health.

10. Q: FDA has warned consumers about tuna and mercury. Doesn't this qualified health claim contradict this warning?

    A: FDA's fish advisory is directed to a specific population--women of childbearing age, pregnant women, nursing mothers and young children. This qualified health claim does not contradict the advisory; instead it makes consumers aware of the benefits of consuming fish. The advisory addresses the issue of the types and amounts of fish to consume for the specific subpopulation (women of childbearing age, pregnant women, nursing mothers and young children) to reduce their exposures to the harmful effects of mercury.

11. Q: Can all fish use this qualified health claim?

    A: FDA will consider its enforcement discretion for the use of the qualified claim for fish that contain EPA and DHA omega-3 fatty acids such as salmon, lake trout, tuna, and herring.

12. Q: Since fresh fish is not labeled, how will consumers know which fish have these fatty acids?

    A: As part of the qualified health claim language, products that bear the qualified health claim will say how much EPA and DHA omega-3 fatty acid will be present in a serving.

    If a product bears a qualified health claim, consumers may find information on the amount of EPA and DHA omega-3 fatty acid on labels affixed to the food or through other labeling including shelf labels, signs, posters, brochures that are readily available and in close proximity to the fish.

FDA Announces Qualified Health Claims for Omega-3 Fatty Acids September 8, 2004