The regulatory body ruled that the extract Xerme, produced by French-based firm Xan, did not have the scientific backing to prove the extract could “help maintain the integrity of DNA and protect against oxidative damage in the cells of the body”.
EFSA concluded that a cause and effect relationship could not be established between xanthohumol consumption and DNA protection from oxidative damage.
The decision comes as a blow to Xan, who started the regulatory process in September of last year.
Under Article 13(5) of Regulation (EC) No 1924/2006, the scope of the application fell under a health claim based on newly developed scientific evidence.
The NDA Panel requested additional evidence later that year with a meeting in February, where the Panel reached its conclusions.
Key to the decision was the existence of one unpublished human study submitted, which was unable to show an effect of xanthohumol in XERME on the protection of DNA from oxidative damage.
Studies not considered
“In the absence of evidence for an effect of xanthohumol in XERME, the studies provided by the applicant on the proposed mechanisms by which the food/constituent could exert the claimed effect were not considered by the Panel for the scientific substantiation of the claim,” the ruling said.
Xanthohumol is considered to be the bioactive ingredient in the product, where it is combined with a roasted malt extract to enhance bioavailability and solubility of the xanthohumol.
The blend also serves to stabilise the xanthohumol by suppressing the transformation of xanthohumol to iso-xanthohumol.
Xan added that Xanthohumol enriched roasted malt extract was a product that could be added to other foods, beverages and dietary supplements as a functional food ingredient.
The firm added that the target population for the intended health claim was “healthy adults over 18 years of age who wish to maintain their overall health status”.
“Daily consumption of 12mg of xanthohumol taken as a beverage containing the xanthohumol-enriched roasted malt extract (in up to 3 divided applications) has been shown to lead to a reduction in oxidative DNA damage,” the Monaco-based firm claimed.
Hop to it
Hops, which contain the flavonoid xanthohumol, has a long history of use in herbal medicine but are best known as a flavouring and stability agent in beer. Xanthohumol is also readily available in supplement form.
Although some brewers are now marketing products enriched in the compound there is scepticism that beer can provide enough of xanthohumol to have much of an effect.
Conventional brewing process do not retain much of the xanthohumol with commercially available beers containing less than 0.2 mg xanthohumol per litre.
According to Xan, xanthohumol has a wide range of health benefits from fighting oxidative stress, regulating fat metabolism, helping maintain healthy glucose and cholesterol levels, eliminating toxins, modulating hormone levels and supporting eye health.