CVI occurs when veins do not properly pump blood around the body, due to valve damage. It is a consequence of hypertension in the veins and can lead to symptoms such as varicose veins, calf tenderness, pigmentation of the skin and ulceration.
The Article 14 application, submitted by GP International Holding B.V., claimed that a branded blend of oligomeric procyanidins (OPC) could help reduce the risk of CVI by increasing microcirculation.
The claimed effect was: “alterations in the venous microcirculation are the main risk factors in chronic venous insufficiency (CVI). The beneficial effects of OPC improve the microcirculation and increase the capillary resistance and therefore may reduce the risk of CVI”.
However, EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) said that “alterations” in the venous microcirculation is a consequence rather than a cause of –or a risk factor for – CVI.
“The Panel considers that the evidence provided does not establish that improving the “alterations in the venous microcirculation” is a beneficial physiological effect by reducing the risk of chronic venous insufficiency,” noted the panel.
OPC from grape seeds
The product subject to the health claim was OPC Plus, a supplement containing 40mg OPC as the active ingredient, as well as 40mg berry-blend, 338mg inulin and 2mg magnesium stearate.
OPC is extracted from grape (Vitis vinifera L.) seeds and contains procyanidins and other phenolics including epicatechin-3-O-gallate and phenolic acids.
The health claim application included 20 references as being pertinent to the claimed effect, however EFSA noted that no details concerning the search strategy were provided. The panel also said that no human intervention studies using the constituent OPC extracted from grape seeds were provided.
Although the product was deemed to be sufficiently characterised, the evidence provided did not establish a beneficial physiological effect.
“A cause and effect relationship has not been established between the consumption of OPC Plus and reducing the risk of chronic venous insufficiency by increasing microcirculation,” concluded the panel.
The opinion can be accessed here.