Australia, New Zealand Examine Health Claims, Labeling (Health Claims Down Under)

P293 is a vital piece of legislation that will transform the functional food and beverage markets. A draft of the proposed framework was approved by the board at the end of March 2008; and by April of the same year, the Australia New Zealand Food Regulation Ministerial Council was informed of the standard. The framework of FSANZ, beyond providing a comprehensive standard to protect the consumer and afford opportunity to industry, is to define different types/levels of claims. These claims can be defined as nutrient function, general-level and high-level claims.

General level claims will be permitted on labels, but companies utilizing these claims will need to hold substantiation dossiers and submit them for review if requested by the relevant authority. General claims cover nutrient function or low-risk function claims such as “helps maintain a healthy digestive system” or “enhances mental function.” High-level claims carry more of a bite and will require pre-approval and cover claims such as “lowers LDL cholesterol” and “reduces the risk of diabetes.”³ The regulatory update will allow a transition period to integrate current practices while assessment of new general and high level claims are made under the proposed framework set out in P293.

Providing the level of science that would potentially allow health claim substantiation is at the heart of the framework, and is the most important section to understand for those wishing to run the regulatory gauntlet. The three prerequisites for the approval of health claims under imminent framework include:

Provision of an acceptable level of evidence: The level of evidence will be dependent on the claims being applied for but can include research data from reviews, clinical trials and authoritative texts (books).

Claims must be relevant to the populations and be defined by a high nutritional value.

The wording conditions of the claim must satisfy the examination by addressing both the target population in the context of the normal dietary experience.

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