The Panel’s conclusions concerning the grape seed extract MegaNatural-BP, produced by US firm Polyphenolics, describes the submitted evidence as ‘insufficient to establish a cause and effect relationship between its consumption and maintenance of normal blood pressure.’
“The Panel also took into account that the evidence provided did not establish a plausible mechanism by which the food could exert the claimed effect in vivo in humans,” the Authority adds.
MegaNatural-BP is made of grapes containing total phenolics (90–93%), gallic acid (greater than or equal to 2%) and catechin and epicatechin (greater than or equal to 5%).
The distribution of phenolic compounds in the product is on average 9% monomers, 69% oligomers and 22% polymers.
The application published in the EFSA journal states the target population for the intended health claim is healthy adults with a quantity of 300 milligrams per day (mg/day) recommended.
International distributor
According to the applicant, Polyphenolics’ international distributor, Praline i Čokolada j.d.o.o, MegaNatural-BP’s main health effect relates to the ‘maintenance of normal blood pressure through endothelium dependent vasodilatation.'
"The outcome variables used to establish the claimed effect include multiple ambulatory measurements of systolic and diastolic blood pressure and elevation of oxidised LDL in serum," the Croatian firm adds.
Central to the application was the proposed mechanism of action, which stated the extract was able to cause endothelium-dependent relaxation of the blood vessels through antioxidant activity and inhibit endothelin-1 (ET-1) synthesis.
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August 17, 2021 at 12:00PM
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EFSA halts grape extract claim said to benefit blood pressure - NutraIngredients.com
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