"The EFSA NDA opinion is a significant change – potentially a sea change – in the panel's attitude to botanicals,” said Luca Bucchini, PhD, the managing director of Italian firm, Hylobates Consulting.
Bucchini said the claim from French company Vivatech was originally rejected but accepted a second time with a method more commonly associated with vitamin and mineral approvals.
“Originally the panel said that although one of the proprietary studies was scientifically valid, it did not contribute to establishing the final claim, ‘Hydroxyanthracene derivatives improve bowel function’,” he said.
“In fact, the claim was given a positive evaluation based on well-established authoritative sources, an approach that was hitherto used only for vitamins, minerals and few other nutrients.”
Bucchini said the European Food Safety Authority’s (EFSA) Panel on Dietetic Products, Nutrition and Allergies (NDA) had looked to medicines law in the opinion.
“Strikingly EFSA has relied on the European Medicines Agency (EMA) assessment of herbal medicines, as well as World Health Organization (WHO) monographs.”
“While it is true that EMA has relied on human studies in the case of Cassia senna, in all other cases EMA granted well-established use in the absence of human studies, or with very limited human studies.”
In its article 13.5 opinion, the NDA said there was sound scientific data to demonstrate short-term constipation alleviation from hydroxyanthracene root and rhizome derivatives in the Vivatech food supplement, Transitech
The panel said the mechanism of action was demonstrated by stimulation of colonic motility, inhibition of absorption of water and electrolytes, and stimulation of secretion of water and electrolytes into the lumen of the colon resulting in enhanced concentrations of fluid and electrolytes in the lumen of the colon
Sea change?
Bucchini wondered if the opinion meant an opening of doors to tradition-of-use data that so far has not met with much acceptance by the NDA.
“Will this panel accept all claims based on what EMA has regarded as well-established use? In any case, many will see this as a positive step forward which is, in effect, reducing the gap in treatment between herbal medicines and botanical food supplements.”
“It is however unclear what could happen when EMA has only been able to confirm traditional use, and not well-established use, implicating that little scientific evidence is available.”
He opined that the general style of the proposed NDA claim for ‘bowel function’ was encouraging to the botanicals sector.
“It is a far cry from the very specific formulations that the panel had so far approved for bowel function or laxative-related claims,” he said.
“Those who are very careful with the medicine/food demarcation will be surprised by the panel's suggestion to adopt restrictions and conditions used for herbal medicines - not an absolute first, but still remarkable.”
He added: “This may create an issue down the line and confusion in the single market, as EU member states are already nervous with EFSA-backed health claims on substances they regard as solely medicinal.”
“On the other hand, the panel confirmed its focus on compounds in plants, rather than on botanicals themselves."