Codex drops gold standard approach

By Shane Starling

- Last updated on GMT

Related tags Human intervention studies Codex alimentarius

The World Health Organization’s food supplements regulation guideline body, Codex, has broadened its definition of what can be considered worthy scientific evidence to back health claims.

The move has been welcomed by industry, which was concerned about the ‘gold standard’ approach Codex had been pursuing that favoured human intervention studies over kinds of evidence such as epidemiological studies.

In a Codex Nutrition Committee meeting in South Africa last week Codex eased its position to acknowledge that all forms of scientific evidence should be considered when assessing the veracity of a health claim.

It removed the word ‘clinical’ from its text after it met with government and non-governmental organisations.

The International Alliance of Dietary/Food Supplement Associations (IADSA) said Codex’s revised position had brought it close to being in alignment with its own ‘Recommendations on the Scientific Basis of Health Claims’.

While IADSA acknowledged human intervention studies can provide the strongest evidence, it argued other forms of backing should not be discounted out of hand.

Codex’s statement of intent comes at a time when the European Union has begun assessing thousands of health claim submissions. Its scientific assessment arm, the European Food Safety Authority (EFSA), has drawn criticism for favouring human intervention trials.

Unlike Codex, EFSA has indicated its methodologies will not be changing as they are bound by the nutrition and health claims regulation of 2006.

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

“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 is expected to be adopted by the Codex Alimentarius Commission in July next year.

IADSA represents more than 50 trade associations and 20,000 companies.

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