Irish group questions EFSA's reliance on 'gold standard'

IHTA chief executive officer, Alan Ruth, has begun an email campaign directed at the executive director of EFSA, members of the Panel on Dietetic Products, Nutrition and Allergies (NDA), as well leading Commission officials and Irish MEPs to highlight what he calls EFSA’s ‘disproportionate focus’ on the 'gold standard' - pharmaceutical based randomised controlled trials - in terms of article 13.1 dossiers.

He maintains that the Parma based agency is almost completely ignoring evidence based on epidemiological/observational evidence and Ruth is urging the Commission to exercise more flexibility in its interpretation of the regulation.

Ruth said that the view of the IHTA is backed by prominent nutrient researchers such as Dr Andrew Shao, vice president for scientific and regulatory affairs at the Council for Responsible Nutrition in the US and Professor Jeffrey Blumberg of Tufts University, who “have also raised concerns over what they perceive to be the misapplication of the drug based approach to assess nutrition questions.”​

He also cites a paper published in the New England Journal of Medicine​ which promotes the view that observational studies should be accorded much more prominence in weighing the evidence even in the case of pharmaceuticals:

"The popular belief that only randomised, controlled trials produce trustworthy results and that all observational studies are misleading does a disservice to patient care, clinical investigation, and the education of health care professionals,”​ said the authors of the paper.

Synadiet, the French dietary and food supplements manufacturers association, told NutraIngedients.com that it fully supports IHTA's position regarding EFSA's regulatory approach.

And three of Europe’s largest food supplement and healthy product trade groups recently issued a 17-page paper also laying out their many concerns with EFSA’s scientific evaluation of claims.

Responding to the publication of 523 article 13.1 health claim opinions by EFSA on October 1, EHPM (European Federation of Associations of Health Product Manufacturers), ERNA (European Responsible Nutrition Alliance) and EBF (European Botanical Forum) highlighted what they believe are several serious defects in the regulation and the manner of its implementation.

The groups criticised the agency over what they maintain is its failure to communicate with applicants, inconsistent application of scientific criteria, failure to publish substance characterisation guidelines and unclear distinction between sufficient and insufficient evidence.

While the groups are holding out hope that dialogue can be opened about these issues with regulators, at a recent meeting they acknowledged this was increasingly unlikely and a legal challenge might be the only way forward.

This position followed a meeting with DG Sanco where industry concerns won little favour with EC representatives, who stated they were powerless to mediate the impact of the scientific opinions so far issued by EFSA.

EFSA scientific methods will be discussed at the NutraIngredients Health Claims​ 2010​ conference to be held in Brussels on Thursday, 10th December. Other speakers include Unilever, analyse&realise, Cantox, academics, industry groups, lawyers and market experts. For more information and to register, please click here ​ .