On August 9, EFSA published an evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006: MegaNatural‐BP grape seed extract and maintenance of normal blood pressure.
The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence. MegaNatural®‐BP, a grape seed extract standardised for total phenolics, gallic acid and the catechin and epicatechin content, is sufficiently characterised. The proposed claimed effect, maintenance of normal blood pressure (BP), is a beneficial physiological effect. Among the two human intervention studies provided from which conclusions could be drawn, one showed an effect of MegaNatural®‐BP (300 mg/day) on BP in adults with normal and high normal BP when consumed daily for 6 weeks, whereas the second study did not show an effect of MegaNatural®‐BP at the same daily dose consumed for 8 weeks in adults with normal and high normal blood pressure or stage 1 hypertension. The evidence provided did not establish a plausible mechanism by which the food could exert the claimed effect in vivo in humans. The evidence provided is insufficient to establish a cause and effect relationship between the consumption of MegaNatural®‐BP and maintenance of normal blood pressure.
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