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FDA Announces Qualified Health Claim for Omega-3 Fatty Acids!!
Now, foods containing any level of EPA and DHA, which meet the qualifying criteria, are able to carry the 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. One serving of [name of food] provides [X] grams of EPA and DHA omega-3 fatty acids. [See nutrition information for total fat, saturated fat and cholesterol content.]"
An individual food product must meet ALL the following criteria in order to use the health claim on its package. Here is the link to FDA Health Claim Criteria, Docket #2003Q-0401.
10% of Daily Value for the six nutrients:
| Vitamin A |
500 IU |
Calcium |
100 mg |
| Vitamin C |
6 mg |
Protein |
5 g |
| Iron |
1.8 mg |
Fiber |
2.5 g |
At this time no minimum levels for EPA and DHA have been established in order to use the health claim. However, both EPA and DHA must be present and their total amount per serving must be listed within the context of the health claim itself.
The FDA advises to consume no more than 3g of EPA and DHA per person per day, with no more than 2 g of EPA and DHA coming from dietary supplements.
For complete information regarding the use of the DHA omega-3 and EPA omega-3 health claim please visit: http://www.cfsan.fda.gov/~dms/ds-ltr38.html.
If a product fails to meet all the requirements for usage of the DHA omega-3 and EPA omega-3 qualified health claim it is possible to make a Nutrient Content Claim.
The requirements for usage of the nutrient content claim are as follows:
| Individual Food |
*Maximum Level |
Meal |
*Maximum Level |
Main Dish |
*Maximum Level |
| Fat |
13 g |
Fat |
26 g |
Fat |
19.5 g |
| Saturated Fat |
4 g |
Saturated Fat |
8 g |
Saturated Fat |
6 g |
| Cholesterol |
60 mg |
Cholesterol |
120 mg |
Cholesterol |
90 mg |
| Sodium |
480 mg |
Sodium |
960 mg |
Sodium |
720 mg |
* Maximum level of the nutrient must be examined per reference amount customarily consumed (RACC) and per labeled serving size. Nutrient levels must be examined "per 50g" for "foods with reference comments customarily consumed at 30g or less or tablespoons or less".
If a food or food product surpasses any of the above levels it is still possible to make a nutrient content claim, however, a disclosure statement would be required.
The available nutrient content claim for DHA omega-3 and EPA omega-3 are as follows:
| Nutrient Content Claim |
EPA omega-3 |
DHA omega-3 |
| High in/Excellent Source/Rich in |
130 mg/RACC |
130 mg/RACC |
"High"-type claims about EPA and/or DHA must be accompanied by one of the following statements:
Contains ___ mg of [EPA/DHA] per serving, which is ___% of the Daily Value for [{EPA/DHA} (130 mg)].
Contains ___% of the Daily Value for [EPA/DHA] per serving. The Daily Value for [EPA/DHA] is 130 mg.
The label cannot refer to EPA and/or DHA as omega-3’s or omega-3 fatty acids alone but can state:
DHA omega-3, EPA omega-3 or DHA omega-3
For complete information regarding the use of a nutrient content claim please visit: http://www.cfsan.fda.gov/~dms/flg-toc.html.
Structure/Function claims for omega-3 fatty acids are also available. Structure/function claims describe the role of a nutrient or dietary ingredient intended to affect normal structure or function in humans.
There is no minimum level of omega-3 fatty acids required to make a structure/function claim.
Examples of some structure/function claims for omega-3 fatty acids:
- Omega-3’s support cardiovascular health
- Omega-3’s support healthy brain function
- Omega-3’s support healthy brain and eye development
- Omega-3’s support a healthy immune system
- Omega-3’s are beneficial for health maintenance
In using a structure/function claim the manufacturer must substantiate the accuracy and truthfulness of the claims; the FDA does not pre-approve the claims, however, they must be truthful and not misleading.
FDA generally must be notified of all such claims within 30 days of first marketing a dietary supplement.
For complete information regarding the use and restrictions of structure/function claims please visit: http://www.cfsan.fda.gov/~dms/labstruc.html.
The information provided herein is a compilation of known or suspected information from various sources and is offered for the benefit and convenience of customers. The information is SPECIFICALLY NOT WARRANTED by Omega Protein Corporation either to its comprehensiveness, correctness, sufficiency, or scientific accuracy.
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