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FDA approves expanded health claims for omega-3 fatty acids

Dec 16, 2019

For those who rely on government edicts to know when a nutrient is beneficial, 2019 is the year you can finally be assured the government officially recognizes the heart health benefits of omega-3 fatty acids.

The caveat is that the approval is somewhat tacit, and the FDA still requires that the health claims include specific “qualifying” words.

Still, it is a milestone achievement for the Global Organziation for EPA and DHA Omega-3s (GOED), the organization that worked with the FDA for five years to gain the recognition.

Most health-conscious consumers had already ascertained the benefits of omega-3s more than a decade ago. After all, there exists literally thousands of studies supporting the benefits of omega-3s. And that includes health benefits that extend far beyond the heart—including brain, skin, eyes, hormones and more.

A five year effort

Even in the face of all the evidence, the claims previously allowed by the FDA were extremely limited in scope. This is why GOED submitted a petition to get the FDA in 2014 to officially recognize the heart benefits of omega-3s.

To back up their petition GOED also provided 717 studies linking omega-3s with heart health benefits.

It took five years for the lethargic bureaucracy of the FDA to respond, but in the end it agreed the evidence was indeed persuasive. In light of this the agency agreed to “allow” new health claims.

The new health claims that can be made are relative to blood pressure, hypertension and heart disease. In June the FDA provided the specific wording that can be made for five different officially-approved health claims.

[See graphic below article for exact wording.]

The government’s approval of legal health claims can be a complicated maze of legal jargon that often takes a lawsuit and teams of lawyers to qualify.

This leaves food and supplement manufacturers frequently confused about what can and cannot be said in their advertising and labels.

More often than not, wording that could be potentially helpful to the consumer is left off because a company is fearful of coming down on the wrong side of the law.

In a very generalized simplification, the FDA’s approved health-claim wording can be broken down to three levels:

1. Supportive, but not conclusive research (lowest level)
2. Credible evidence
3. Significant scientific agreement.

It is with regards to these categories that omega-3 claims have now moved up a notch—from supportive to credible.

This may seem like a minor difference to many; however, it greatly expands the claims that can now be made with regards to omega-3s.

It also lets the potential food and supplement consumers know that the research has been reviewed and approved by the FDA.

Some recognition better than no recognition

When GOED first petitioned the FDA they were requesting that the health benefits be approved for the higher “significant scientific agreement” approval; however, that approval wasn’t achieved.

Regardless, the official recognition at a lower level was still a welcome step forward. “At least the FDA is willing to acknowledge that there is something there,” said omega-3s expert William Harris, PhD of the Sanford School of Medicine at the University of South Dakota.

“I think the approval of the health claims is a welcome step forward in the recognition of the multiple health benefits of omega-3 fatty acids. It’s not just about their effects on blood lipids, like triglycerides,” said Harris. “The do affect other risk factors, like blood pressure and endothelial function.”

If you’re convinced of the benefits of essential fatty acids, including omega-3s, check out Optimal E.F.A from Optimal Health Systems.

Optimal E.F.A provides potent essential fatty acids via all-vegetarian sources—and provides them in the correct ratio of omega-3s and omega-6s.

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Sources: Regulations.gov, NutraIngredients.com, GOEDomega3.com.