Codex Agrees to Consider All Evidence for Scientific Basis of Health Claims

Health claims will be scientifically evaluated through systematic and objective compilation of all the available scientific evidence rather than focusing on only human intervention studies, the Codex Nutrition Committee has agreed.

Decided at last week’s Codex meeting in Cape Town, South Africa, the agreed document endorses a number of comments made by the International Alliance of Dietary/Food Supplement Associations (IADSA) on the ‘Recommendations on the Scientific Basis of Health Claims’.

IADSA highlighted its concerns over both the structure of the previous document and the weight given to the different types of evidence required for scientific substantiation, and after discussions at last year’s Codex meeting the text was sent back to the drawing board.

The text previously stated that short-term clinical human intervention studies in healthy subjects should be the prime source of evidence in claims substantiation.

While IADSA has acknowledged that human intervention studies could provide the most persuasive evidence of efficacy in human subjects, it argued that the lack of well-designed randomised controlled trials should not disqualify a body of substantiating evidence from other sources.

The text has now been revised to remove the word ‘clinical’, following discussions among government and non-governmental organisations, and gives more weight to observational and epidemiological studies, to indicate clearly that these contribute to the totality of the evidence.

“We are very pleased with the Codex Nutrition Committee’s decision,” said IADSA Chairman Byron Johnson. “A number of different types of studies can show the relationship between a food constituent and a health outcome. A simple hierarchical approach to evidence on causal links cannot rely only on randomised controlled human intervention trials, and each type of study can provide a different type of evidence.”

The text will now be forwarded to the Codex Alimentarius Commission (the decision-making body in Codex) for its endorsement and final adoption, scheduled for July next year.