Codex Broadens Scope of Claims Substantiation

CAPE TOWN, South Africa—The International Alliance of Dietary/Food Supplement Associations (IADSA) reported at the Codex meeting here in early November, the Codex Nutrition Committee agreed that health claims will be scientifically evaluated through a compilation of all scientific evidence, not only human intervention studies. IADSA filed comments on the topic of scientific substantiation after it appeared undue weight was being given to randomized controlled clinical trials (RCTs) over all other types of scientific evidence. The revision removed the word “clinical,” broadening the scope to include observational and epidemiological studies as a key part of the body of evidence.

“We are very pleased with the Codex Nutrition Committee’s decision,” said Byron Johnson, IADSA chairman. “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 randomized 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 2009.