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, IADSA has revealed.
At its recent meeting in Germany the Codex Nutrition Committee agreed that the text was in need of redrafting, taking into account the comments given relating to the provisions for scientific evidence and the structure of the document.
The text, which will go through 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. But opposition from the International Alliance of Dietary/Food Supplement Associations (IADSA), a number of countries and other non-governmental organisations has resulted in the topic being referred back to step 2 in the process for redrafting.
At the meeting IADSA reiterated its position that basing all health claims only on human intervention (clinical) studies is not feasible or practical. It insisted that 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, IADSA Director of Regulatory Affairs. “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.”
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 text will now be reviewed and redrafted by a France-led electronic working group, which will present its conclusions at the next Codex Nutrition Committee meeting in Autumn 2008.
IADSA is the voice of the worldwide dietary supplement manufacturing industry and an accredited international non-governmental organization (INGO) with a seat at the table of the main international regulatory bodies. IADSA has more than doubled in size since its creation in 1998, representing 59 regional and national trade associations and over 20,000 companies.