More rigour required: Leatherhead on latest EFSA health claim rejections

I believe this batch of opinions highlights once again the importance of rigour and quality of the science submitted as evidence for the health claim.

Probiotics-digestive health​

Characterisation is still a key point for probiotic claims but a clear definition of the food supplement for which the health claim is submitted for is equally important.

PiLeJe (3085​ and 3086​) had to clarify to EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) that the submission was for the combination of four strains of probiotics and not for the commercial product (Lactibiane Reference).

The lack of characterisation of one of these four strains has resulted in a rejection of this claim.

Potato extract-weight loss; fizzy water-GI response; ​krill-menstrual discomfort​

Another important factor across many of the health claim submissions is the relevance and quality of statistical analysis. In some cases there was no statistical significance of activity (Slendesta 3083​; Vichy Catalan 3087​).

Also highlighted was the importance of the study design and the limitations of the statistical analysis performed on resulting data which has been at the root of a number of rejections (EFAX 3081​; Slendesta; Vichy Catalan).

Cranberries​

Cranberries are still facing the same difficulties. Monurelle claim (3082​) on E.Coli​ adhesion of uroepithelial cells is still being rejected on the basis that the in vitro​ evidence cannot be considered a prediction of the in vivo​ health benefit.

Also highlighted here is that the data submitted has to be product-specific and not simply based on general scientific evidence on cranberries.

Upsides​

Overall the same issues seem to be appearing and the focus stays on the quality and the relevance of the scientific evidence presented that has to be able to support a product-specific claim and not be simply based on scientific evidence on active ingredients.

On a positive note we are getting a good feel for the time line involved in the health claim process. For this batch, most opinions were provided six months after submission.

The Leatherhead view is that providing that the study design, science and statistical analysis is sound and product-specific, claims will be approved.