Codex Redrafting Health Claims Recommendations

BRUSSELSThe International Alliance of Dietary Supplement Associations (IADSA) reported Codex has sent its draft health claims recommendations back to the drawing board, following concerns over the weight given to the different types of evidence required for scientific substantiation. At its meeting in November in Bad Neuenahr, Germany, the Codex Nutrition Committee agreed the draft was in need of redrafting, considering the comments given relative to the provisions for scientific evidence and the structure of the document. The draft, which will ultimately undergo an eight-step process to completion, contained many references to the significance of clinical trials and their desirability as a pre-requisite for a claim. However, opposition from IADSA, various countries and other non-governmental organizations resulted in the topic being referred back to step two in the process for redrafting.

At the Nutrition Committee meeting, IADSA reiterated its position that basing all health claims only on human intervention (clinical) studies is not feasible or practical. The text should allow more weight than it presently gives to observational and epidemiological studies among others.

We welcome the decision of the Nutrition Committee that the text should be amended, said David Pineda, director of regulatory affairs at IADSA (IADSA.org). 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 sources of scientific evidence can 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); and traditional knowledge and experience of use.

The draft will be reviewed and redrafted by a France-led electronic working group, which will present its conclusions at the next Codex Nutrition Committee meeting, held in fall of 2008.