The FDA’s New EPA/DHA Health Claim

Jessica Levings wrote . . . . . . . . .

Fish and seafood packaging may now boast qualified health claims stating that omega-3s can help reduce risk of hypertension and coronary heart disease and lower blood pressure.

In June, the FDA approved the use of certain qualified health claims on foods and dietary supplements containing the omega-3 fatty acids EPA and DHA relating to their ability to reduce the risk of hypertension and coronary heart disease, as well as lower blood pressure. The decision was in response to a 2014 petition submitted by the Global Organization for EPA and DHA Omega-3 (GOED).

According to Harry Rice, PhD, GOED’s vice president of regulatory and scientific affairs, who spearheaded the health claim petition on behalf of the organization and its members, “The new qualified health claims provide what many, including GOED, consider to be long overdue acknowledgement from the FDA about the blood pressure–lowering benefits associated with EPA/DHA, the primary long-chain omega-3 fatty acids found in fatty fish. Linking EPA/DHA intake to blood pressure reduction provides consumers a benefit to which they can relate.”

Before the announcement of the new qualified health claims, since 2004 the FDA has allowed the following qualified health claim on certain foods and supplements: “Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease.”

Following are the new qualified health claims the FDA announced, which manufacturers may voluntarily use on labels of seafood and other qualifying foods and supplements:

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.

Dietary supplements and conventional foods bearing any of the above claims must contain at least 0.8 g EPA and DHA (combined total) per serving and meet certain other nutrient content criteria. Importantly, the requirement of 0.8 g per serving isn’t a recommended intake level but rather a level of intake the FDA observed to lower blood pressure in limited studies.

Under general health claim requirements, individual foods can’t bear a health claim if they exceed 13 g total fat, 4 g saturated fat, 60 mg cholesterol, and 480 mg sodium per reference amount customarily consumed (RACC), per labeled serving size, and per 50 g if the RACC is 30 g or less or two tablespoons or less. Furthermore, to bear a health claim, individual foods also must contain, before any nutrient addition, at least 10% DV for vitamin A, vitamin C, iron, calcium, protein (5 g), or dietary fiber per RACC.

Evidence Base for the EPA/DHA Health Claim

The FDA determined that the overall evidence relating to EPA/DHA intake and blood pressure didn’t meet the “significant scientific agreement” standard required for an authorized health claim, but it did meet the “credible evidence” standard for a qualified health claim.

To assess whether a beneficial link exists between consuming EPA and DHA together and lowering blood pressure, the FDA evaluated 104 intervention studies analyzing the effect of EPA and DHA from conventional foods, dietary supplements, and prescription drugs on blood pressure in both normotensive and hypertensive people. Only 36 of the 104 studies showed a statistically significant benefit, with durations ranging from four weeks to one year, and combined doses of EPA and DHA ranging from 390 mg per day to 15 g per day.

Based on its findings, the FDA concluded there’s “some credible evidence suggesting a relationship between the combined intake of EPA and DHA from conventional foods, dietary supplements, and prescription drugs and blood pressure reduction. However, this evidence is highly inconsistent.”

Sources of EPA and DHA, Average Intake

EPA and DHA are added to certain supplements and are naturally found or fortified in some conventional foods, including fatty fish (eg, salmon, mackerel, sardines), fish oils, seaweed, and algal oils. Studies have found that food contributes a small amount of DHA and EPA to total daily omega-3 intakes; the National Institutes of Health estimates the amounts at 40 mg in children and teenagers and about 90 mg in adults.

Dietary supplements containing omega-3s also contribute to total omega-3 intake, with fish oil as one of the most commonly used sources. According to 2012 data, 7.8% of US adults and 1.1% of US children reported taking supplements containing fish oil, omega-3s, and/or DHA or EPA. According to 2003–2008 National Health and Nutrition Examination Survey (NHANES) data, supplements add about 10 mg to average DHA intakes, and 20 mg to average EPA intakes in adults. Data from the FDA and NHANES indicate that the current average intake of EPA and DHA in the United States is only about 77 mg per day from all sources for people aged 4 and older.

Currently, there’s no recommended intake level in the United States for EPA or DHA. However, to help improve heart health, the 2015–2020 Dietary Guidelines for Americans (DGA) recommend individuals in the general population to consume about 8 oz per week of a variety of seafood, providing about 250 mg per day of EPA and DHA. Importantly, the DGA note that this recommendation is for the total package of nutrients seafood provides, including its EPA and DHA content.

Use of the EPA/DHA Health Claim on Fish

For items sold at seafood counters in supermarkets, nutrition labeling of fresh fish and packaged single-ingredient fish is voluntary unless nutrient content or a health claim is made. Fish and packaged seafood may bear the claim if they meet all the required criteria for its use.

The FDA defines fish as “fresh or saltwater finfish, crustaceans, other forms of aquatic animal life (including, but not limited to, alligator, frog, aquatic turtle, jellyfish, sea cucumber, and sea urchin, and the roe of such animals) other than birds or mammals, and all mollusks, where such animal life is intended for human consumption.” With regard for labeling these products with the EPA/DHA qualified health claims, the FDA considers “products that are essentially all fish” to be those without any added ingredients and with an “insignificant amount” of added fat or carbohydrate. Examples of products considered all fish include raw, boiled, and broiled fish.

Source: Today’s Dietitian