EFSA comment rebuttal shows product-specific claims are not the way to go, says expert
The recently published European Food Safety Agency (EFSA) response to comments on Vivatech's positive health claim opinion - initially published in October 2013 - demonstrate that product-specific health claims "remain the way not to go," warned Italian-based botanicals expert Luca Bucchini, PhD.
The response to comments - found here - comes after Vivatech responded to its landmark claim approval with comments suggesting that, although the claim was approved, the NDA panel approval was based on one component of the product (hydroxyanthracene derivatives) rather than the whole product (Transitech).
"The applicant argued that the Panel failed to recognise the effect on bowel function of the specific combination of ingredients contained in Transitech, even though an effect on bowel function was observed in a human intervention study performed with Transitech and submitted by the applicant for the scientific substantiation of the claim," noted EFSA of Vivatech's appeal.
However EFSA's Panel on Dietetic Products, Nutrition and Allergies (NDA) dismissed the suggestion that the positive opinion should have been related to the specific product rather than the hydroxyanthracene derivatives contained in the supplement.
"The applicant claimed that the constituents in Transitech responsible for the claimed effect were hydroxyanthracene derivatives derived from Rheum palmatum L. and/or Rheum officinale Baillon and/or their hybrids, and fructo-oligosaccharides derived from Althaea officinalis L. and Cynara scolymus L," noted the NDA. "The applicant also indicated that other ingredients in Transitech were added in order to prevent bloating, flatulence and spasms."
"As detailed in the opinion, the human intervention study which investigated the effect of Transitech on bowel function was not designed to establish whether the combination of ingredients in Transitech exerts an effect on bowel function beyond the well-established effect of hydroxyanthracene derivatives or whether the use of Transitech would lead to a lower incidence of untoward effects of hydroxyanthracene derivatives," the response stated.
Product-specific claims will not wash
Commenting on the fall-out, Bucchini said that the EFSA response to comments offers some 'interesting' learning points - the first being that product-specific claims are still not the way to go.
"The European Commission has said clearly - and EFSA seems to take the same view - that there is a preference for health claims linked to substances or foods, and not to specific products," explained Bucchini, who is managing director of Rome-based Hylobates Consulting. "This is a policy choice, of course, as the NHCR does not preclude product-specific health claims; yet it is a clearly affirmed choice."
"Also, from a scientific standpoint, understandably, the NDA Panel prefers to look at several sources of evidence for a substance, not only the studies provided by the applicant on a product, which also does not help with product specific claims."
He added that a 'massive' amount of scientific evidence could change this situation but noted that, "Transitech was backed by a few adequate studies, not a massive amount of evidence."
"Though EFSA is often chided for mistaking foods for drugs, in fact the NDA Panel is not looking at new molecules, as in the case of medicines, but mostly to well-known food substances, so it's perfectly rational for them to focus on existing evidence rather than on the new studies for single products."
In conclusion, he added that while Vivatech's comments on this and other issues discussed in the document were 'appropriate', such details will not sway the EFSA Panel no matter how 'frustrating' that may be for applicants.
Warned Bucchini. "One would need to spot obvious mistakes, and EFSA is careful not to make them."