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FDA to allow broader omega-3 health claims

Decision is a 'breakthrough' for companies marketing the connection between seafood and healthy omega-3s, top nutrition expert tells IntraFish.

The US Food and Drug Administration on Wednesday said it will allow the use of new 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.

The FDA determined that while the overall evidence of omega-3s benefits on health did not meet the “significant scientific agreement” standard required for an authorized health claim, it did meet the “credible evidence” standard for a qualified health claim in the labeling of conventional foods and dietary supplements.

The announcement is a step forward for seafood companies and supplement makers wanting to cement the link between omega-3s and health benefits, specifically heart health. Linda Cornish, founder and president of the Seafood Nutrition Partnership, hailed the decision as a "breakthrough."

"This is very good news for the seafood industry as well as the omega 3 supplementation industry," she said.

FDA previously ruled that the daily upper limit for dietary supplements should be 3g of EPA and DHA but has lifted that to 5g, Cornish observed.

In 2004, the FDA allowed food manufacturers to use a qualified health claim for omega-3s with the language "Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease."

Wednesday's FDA announcement was in response 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 the FDA does not intend to object to the claim if it is used consistent with the factors described in the letter.

The FDA scrutinized 717 publications cited by GOED in making its decision to not object to certain health claims. 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.

Specifically, GOED requested that the following labeling claims be allowed:

  • EPA and DHA help lower blood pressure in the general population
  • EPA and DHA reduce BP, a risk factor for CHD (coronary heart disease)
  • EPA and DHA reduce the risk of CHD
  • Research shows that EPA and DHA may be beneficial for moderating BP, a risk factor for CHD
  • Convincing scientific evidence indicates that EPA and DHA help lower blood pressure in the general population, with comparable reductions to those achieved with other diet and lifestyle interventions
The FDA largely accepted GOED's language recommendations, with caveats about the evidence. Specifically, the FDA said it would not object to the following labeling claims:
  • 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.
  • 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.
  • 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.
  • 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 48 inconsistent and inconclusive. One serving of [name of the food or dietary supplement] provides [ ] gram(s) of EPA and DHA.
  • 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.

Under FDA’s health claim regulations, foods and dietary supplements that bear a health claim must meet requirements regarding levels of certain nutrients. To use the qualified omega-3 claims, the foods or supplements making the statement must contain at least 0.8 grams of 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 notes.

Cornish said it is unclear when companies can now start using these claims.

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