A request for a claim on grape seed extract for blood pressure: a rejection from EFSA
A health claim application, submitted by Praline I Cokolada j.d.o.o. (Croatia), and related to the effects of a grape seed extract (MegaNatural®-BP) and the maintenance of normal blood pressure, has been recently evaluated by EFSA. The ingredient is a grape seed extract standardized for total phenolics (90-93%), gallic acid (≥ 2%) and the sum of catechin and epicatechin content (≥ 5%). The applicant requested the use of the claim for products providing 300 mg/day of the ingredient. The target population was healthy adults.
Among the studies provided in the application, four trials assessed the effects of MegaNatural®-BP, one in individuals with metabolic syndrome, and three in subjects with normal, high blood pressure (prehypertension) or untreated stage 1 hypertension. Among these four studies, EFSA considered that only two studies were pertinent for the substantiation of the claimed effect, one showing a reduction in blood pressure after the consumption of 300 mg/day of the ingredient for 6 weeks, whereas the second study did not show an effect at the same dosage over 8 weeks. No plausible mechanism of action has been proposed by the applicant to explain how the ingredient could exert the claimed effect in humans.
EFSA considered that the available evidences were not sufficient to establish a cause-and-effect relationship between the ingredient and the claimed effect, and rejected consequently the application.
EFSA NDA Panel (EFSA Panel on Nutrition, Novel Foods and Food allergen), 2021. Scientific Opinion on MegaNatural®-BP grape seed extract and maintenance of normal blood pressure: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006. EFSA Journal 2021;19(8):6776.