ICP Ltd (Institute of Cellular Pharmacology), the Maltese firm behind the application, is appealing the European Food Safety Authority (EFSA) rejection of the joint health benefits of its herbal Dictyolone prototype food supplement, with its managing director Charles Saliba expressing bafflement at the opinion.
However consultants spoken to by NutraIngredients said they were not surprised by the stance of EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) on the dossier based on a marine-sourced herbal extract called Padina pavonica that featured four human intervention trials.
Dose dilemmas
Pauline Louette, a specialist in health claims and food safety at French consultancy, NutraVeris, said the dossier was never likely to succeed when it had flaws like unspecified dosages.
“If the petitioner had detailed the active dose in the extract and the lyophilised powder and that the doses were similar, [or just used] studies performed on the powder…EFSA could evaluate the effectiveness of the active compound, as EFSA did for Transitech,” she said.
Transitech is a herbal bowel function supplement made by elusive French firm Vivatech that won a positive NDA opinion at the end of last year based on medical data for an extract called hydroxyanthracene.
“In my opinion, the big difference between the opinions… is that there is not detailed dosage of active compound,” Louette continued.
“The positive opinion about hydroxyanthracene derivatives is based on studies which were all conducted on Transitech, a complex food supplement supplying 10 mg of active compound.”
No correlation
Stoffer Loman from Dutch consultancy, NutriClaim, said there were significant differences between the two article 13.5 proprietary and emerging science opinions under the EU nutrition and health claims regulation (NHCR).
“The word ‘extract’ does not appear one single time in the Transitech opinion,” he said.
“The supposedly active components were all – except for the bacteria – dried parts like root, petal, leaves and seeds of plant material, standardised for the already known active ingredients.”
“The product was consistently used throughout the studies and, more importantly, an effect was shown. Even if it were the same principle here, then still the extract wasn’t effective.”
“frustration is understandable”
Luca Bucchini, PhD, managing director of Rome-based Hylobates Consulting, sympathised with ICP but agreed the dossier was lacking scientific strength.
“When you have invested significant resources in a project, the frustration is understandable, and sometimes regulators do come across as indifferent,” he said.
“It is to be appreciated that a food company has invested resources into human studies, and it has trusted the EFSA process as a route to law-based communication of products it believes in. Perhaps EFSA could do more to understand this, and improve its communication channels and style.”
“This specific situation is proof of how hard it is for SMEs to work with the scientific requirements of the regulation, that sometimes are light years ahead of what they were used to.”
Bucchini noted the Vivatech opinion had been arrived at using European Medicines Agency (EMA) data.
“EMA assesses herbal medicines and, when looking at plant extracts with hydroxyanthracene derivatives, the NDA found valid human studies.”
“In this case, even if the Panel brushed away the studies submitted for Padina pavonica by the applicant, which did not support the claim, it would not have found any authoritative statements, based on human studies, that could somehow save the application. Such studies or assessments do not exist.”
“Therefore, the assessment, however frustrating, seems consistent with the science and past opinion.”
More broadly he advised potential NHCR applicants: “Unless you have unlimited resources my view is to start with where mainstream nutrition science is.”
Limitations
In its opinion the NDA noted: “The Panel notes the limitations of the statistical analyses performed by the applicant (i.e. transformation of data, lack of baseline adjustments in the analysis of absolute values, lack of consideration of the repeated measures design of the study) and that the requested re-analysis of data addressing these limitations was not presented by the applicant.”
“The Panel also notes that the results of the different statistical analyses, i.e. percent change in BMD (bone mineral density) analysed with the Mann Whitney test and ANOVA (analysis of variance), and absolute values of BMD analysed with ANOVA, were inconsistent both between the different statistical tests and between bone sites investigated.”