The World Health Organization?s food regulation body, Codex, is rethinking of its health claims policies after concerns were raised about scientific substantiation criteria, and in particular the importance of clinical trials.
The Codex Nutrition Committee met in Germany recently and determined a reappraisal was necessary after opposition to Codex?s initial health claims draft from the International Alliance of Dietary/Food Supplement Associations (IADSA), a number of countries and other non-governmental organisations. The draft will go back to stage two of Codex?s eight-stage approval process for rewriting.
IADSA, in particular, strongly criticised the emphasis on clinical trials as being a prerequisite for the granting of a health claim. It said observational, epidemiological and other studies were also important
?We welcome the decision of the Nutrition Committee that the text should be amended,? said IADSA director of regulatory affairs, David Pineda. ?Scientific substantiation should involve a weighing of evidence taking into account the totality of the available data. This includes human studies, as well as observational and epidemiological studies.?
IADSA noted scientific data could come in the form of human intervention studies; human observational or epidemiological studies; animal and in vitro studies (experiments performed in a controlled environment outside a living organism), and traditional knowledge and experience of use.
A Codex working group will set about redrafting the text and present its findings to Codex in the second half of 2008.