FDA Holds Line On Omega-3 Claims, But Gives Enforcement Discretion For More
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.
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AF events occurred in 469 (3.7%) of subjects receiving EPA and DHA supplements compared to 431 (3.4%) of participants receiving placebos. In vitamin D3 and placebo comparison, AF events occurred in 469 (3.7%) versus 431 (3.4%).
Results of Study to Assess Statin Residual Risk with Epanova in High Cardiovascular Risk Patients with Hypertriglyceridemia “should prompt reconsideration of [OTC] mixed omega-3 fatty acid products for [atherosclerotic cardiovascular disease] prevention,” say cardiologists in an editorial published with JAMA study.
FDA intends to exercise enforcement discretion regarding QHCs about the association between reduced risk of recurrent UTI and use of supplements with at least 500 mg cranberry fruit powder and of cranberry juice beverages containing at least 27% cranberry juice.