Health claims based only on human intervention studies unrealistic says IADSA

Basing health claims only on evidence from human intervention studies is not feasible, IADSA has warned as Codex prepares to discuss its draft recommendations on the scientific basis of health claims.

Commenting on the draft set for discussion at next month’s Codex Nutrition Committee, the International Alliance of Dietary/Food Supplement Associations (IADSA) said that expectations for all health claims to be based on evidence from human intervention studies may not be practical, as many of the original health claims were based on observational studies and the study of factors that affect health and illness in populations (epidemiological studies).

The draft recommendations were improved last year taking into account the majority of comments previously pointed out by IADSA.

“While we agree it is moving in the right direction, the text still needs to be amended to allow evidence from human experimental and observational studies to form the basis of health claims, including reduction of disease risk claims,” said David Pineda, IADSA’s Director of Regulatory Affairs.

Echoing this point Professor David Richardson, Scientific Adviser to the UK Council for Responsible Nutrition and IADSA, elaborated: “Scientific substantiation should take into account the totality of the available data and involve a weighing of evidence. Human studies are given more weight than animal, in vitro and observational studies, but it is important for the Codex text to show that a health claim can be substantiated on a case-by-case basis by a number of different evidence sources.”

Sources of scientific evidence include generally accepted authoritative information that has been verified and validated over time, human intervention studies, human observational or epidemiological studies, animal and in vitro studies (experiments performed in a controlled environment outside a living organism), as well as traditional knowledge and experience of use.

Professor Richardson added that Codex should also consider evidence from history of use or traditional use, and that health claims should be re-evaluated if and when new evidence calls the scientific validity of the claim into question.

He said: “It is imperative that the use of health claims on foods and food components does not stifle academic research and product innovation. To evaluate any diet and health relationship, it is essential for the claim to reflect emerging as well as consensus science.”

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