There is no surprise in the latest batch of European Food Safety Authority (EFSA) article 13.5 health claim rejections as the science presented in six dossiers was “lousy”, a consultant told us today.
Claims experts noted serious flaws in the dossiers for probiotics-digestion (2), krill-menstrual discomfort, potato extract-weight management, cranberry-UTI and carbonated water-GI response around characterisation, inadequate primary endpoints, lack of human data and limited trial design.
One wondered under what circumstances the applicants were advised to submit such flawed dossiers, or why they were not withdrawn after stop-the-clock contact with EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA).
Stoffer Loman, PhD, senior consultant at Dutch claims adviser NutriClaim, slated the dossiers.
“It is lousy science that was the basis on which many claims have been made for too long a time and that the NHCR [nutrition and health claims regulation] is meant to put a halt to,” Loman observed.
“How on earth would you expect to get away with a health claim based on such lousy science? It seems many companies still think they can get away with this.”
Burning, not learning…
Christiane Alexander, PhD, business development manager at German consultancy, analyze&realize (a&r), said weak submissions which were destined for rejection damaged the whole nutrition sector.
“Unfortunately applicants have not learned from previous opinions,” she said.
“In these 13.5 evaluations, EFSA pointed out the same issues as before. I am tired of seeing this. We at a&r are very pleased with the scientific attitude and competence of Professor Ambroise Martin and his NDA panel. Our conclusion is: Successful applications require scientific know how and common sense.”
While the likes of a&r remain optimistic about the potential of article 13.5 to deliver positive results for well-built scientific dossiers, others are losing faith in the avenue based on proprietary and emerging science under the NHCR.
After it became clear in 2009 and 2010 that most article 13.1 general function and article 14 disease risk factor reduction and children's health and development dossiers were failing to impress the NDA, many thought revised files submitted under article 13.5 would have a greater chance of success.
“…very little room for manoeuvre…”
UK-based food law expert, Brian Kelly, from Covington and Burling, noted this was proving not to be the case and was particularly bad news for smaller players.
“The article 13.5 route is proving not to be the answer to everyone’s prayers,” Kelly said.
“The large number of rejected claims under this process is worrying and leaves food operators concerned – particularly small companies – with very little room for manoeuvre in the market place.”
Freedom of health claim speech
Owen Warnock, a partner at Eversheds in London, said with even stronger dossiers not guaranteed success, further legal challenges to those already lodged could lie ahead.
“Perhaps food businesses should now consider taking the approach that was adopted in the USA – of challenging the law as an unnecessary restriction on freedom of speech,” he said.
Mechanisms of action
Anne Laure Tardy from RNI Conseil in France - which worked with Nutriinks on the rejected krill-menstrual discomfort claim - said EFSA continues to demand too much of nutrition science.
“In addition, there are also now questions regarding the mechanism of action of the product that contributes to increase the level of science asked.”
“There is clearly a distortion of evaluation since claims on vitamins and minerals were only based on their physiological role in the organism and on the effect of an insufficient intake and not to the impact of a supplementation.”
“Basically at the end, no industries with new interesting ingredients will want to apply for any health claim in Europe, even if they have scientific data to sustain a claim and will stop investing money in this field.”
“Perhaps a new way to evaluate the application should be performed maybe with a method based with different levels of evidence and disclaimers on the packaging.”