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GOED Submits Authorized Health Claim Petition to FDA

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By: Sean Moloughney

Editor, Nutraceuticals World

The Global Organization for EPA and DHA Omega-3s (GOED), Salt Lake City, UT, has submitted its petition to the U.S. FDA for an authorized health claim for Eicosapentaenoic and Docosahexaenoic Acids and Reduction of Blood Pressure in the General Population.

The basis for the GOED petition is a comprehensive meta-analysis of 70 randomized controlled trials, pertaining to EPA+DHA and blood pressure reduction, according to the organization. Collectively, the totality of evidence indicates that provision of EPA+DHA significantly reduces both systolic blood pressure and diastolic blood pressure among study participants representative of the general population. The data across all studies are overwhelmingly consistent, GOED said, suggesting an independent causal relationship.

It has been more than nine years since the FDA announced it would allow the following claim to be used on foods and dietary supplements with EPA and DHA: “Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease.”

In 2004, when FDA responded to the health claim petitions, high blood pressure was recognized as a surrogate endpoint for coronary heart disease (CHD). More recently, on August 1st of this year, GOED, along with its consultants from Exponent Inc. Health Sciences and Van Elswyk Consulting Inc., visited the FDA and the agency’s position was confirmed.     

The review process will likely be lengthy, according to GOED, particularly given the number of studies included in the meta-analysis. The FDA was clear when GOED met with the agency in August that each study included in the meta-analysis will need to be reviewed. 

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