Health claims should be scientifically evaluated using all available scientific evidence, rather than focusing only on clinical human intervention studies, the Codex Nutrition Committee has agreed.
The decision was reached at a meeting last month in Cape Town, South Africa, where Codex finalised the text of its Recommendations on the Scientific Basis of Health Claims document.
The document had proved contentious, with the International Alliance of Dietary/Food Supplement Associations (IADSA) raising concerns over an earlier version. This stated that short-term clinical human intervention studies in healthy subjects should be the prime source of evidence in claims substantiation.
IADSA told Codex it acknowledged that human intervention studies could provide the most persuasive evidence of efficacy in human subjects. But it also argued that the lack of well-designed randomised controlled trials should not disqualify a body of substantiating evidence from other sources.
Following discussions among government and non-governmental organisations, the text has now been revised to remove the word 'clinical.' It also 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 Byron Johnson, chairman of the Brussels-based IADSA, which represents 50 trade associations and 20,000 companies.
"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.
Codex, which was established in 1963 jointly by the Food and Agriculture Organisation and the World Health Organisation, is not a regulatory body, so its views are not legally binding. However, its views are influential and may be taken into account by governments when drawing up legislation.