Omega-3 Petition Seeks Unqualified Blood Pressure, CHD Claims
This article was originally published in The Tan Sheet
The trade group Global Organization for EPA and DHA Omega-3 petitions FDA for an unqualified health claim related to reduced blood pressure as a surrogate marker for coronary heart disease risk.
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"The reality is that the FDA remains unwilling to rely upon a meta-analysis of only the highest quality studies in order to guide its final decision," GOED VP Harry Rice. "I think FDA has really lost sight of how the dietary supplement industry has changed," says attorney Charles Jolly.
Agency says "some credible evidence" suggests intake of EPA and DHA "may reduce the risk of hypertension by lowering blood pressure, this evidence is inconclusive and highly inconsistent" and does not support actual approval of a qualified health claim.
A citizen petition for omega-3 cardiovascular health claims is the first since the Institute of Medicine in 2010 recommended a framework to assess biomarkers for supplement health claims. The petition also will show whether FDA changed its thinking about supplement claims, says former FDA dietary supplement programs head Bill Frankos.