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    What health claims can supplement brands make under FSANZ in Australia?

    CompliGUARD reviews this compliance area against TGA · AHPRA · FSANZ · ACCC frameworks for Australian health brands — here's what the regulations say.

    CompliGUARD reviews food-classified supplement health claims against the FSANZ Food Standards Code. Supplement brands whose products are classified as foods under FSANZ can only make health claims that appear on the pre-approved list in Standard 1.2.7 of the Australia New Zealand Food Standards Code, or that have been self-substantiated through the FSANZ process.

    The rule: Australia New Zealand Food Standards Code, Standard 1.2.7 (Nutrition, Health and Related Claims)

    Standard 1.2.7 of the Australia New Zealand Food Standards Code governs all nutrition content claims, general level health claims, and high level health claims made on food products in Australia. General level health claims — which link a food or nutrient to a health effect that is not a disease — must be from the FSANZ pre-approved list or self-substantiated. High level health claims — which link a food or nutrient to reduction of disease risk — may only be made from the Schedule 2 pre-approved list. You cannot make a health claim simply because you believe the science supports it — the claim must be on the approved list or formally self-substantiated.

    What this means in practice

    • Before writing any health claim for a food product, check whether the claim is on the FSANZ general level health claim pre-approved list — available on the FSANZ website.
    • If the claim is not on the approved list, you must complete the FSANZ self-substantiation process — this requires a systematic review of the scientific evidence and a documented assessment.
    • High level health claims (linking to disease risk reduction) can only be made from the Schedule 2 pre-approved list — there is no self-substantiation pathway for high level claims.
    • Nutrition content claims (e.g. 'high in protein', 'source of calcium') are permitted where the product meets the prescribed nutrient thresholds in Schedule 1 of Standard 1.2.7.
    • Confirm your product is classified as a food, not a therapeutic good — if your marketing claims push it toward therapeutic territory, TGA rules apply instead.

    Common mistakes

    Mistake

    Making claims based on ingredient research without checking the approved list

    Problem

    A claim may be scientifically defensible but still be prohibited under FSANZ if it is not on the pre-approved list and has not been self-substantiated through the required process. Scientific evidence alone does not authorise the claim.

    Fix

    Check the FSANZ pre-approved general level health claims list first. If the claim is not there, either use a claim that is on the list or complete the self-substantiation process before publishing.

    Mistake

    Using high level health claims without checking Schedule 2

    Problem

    High level health claims — which reference disease risk reduction — are only permitted from the Schedule 2 pre-approved list. There is no self-substantiation pathway. Using a high level health claim that is not in Schedule 2 is a direct breach of Standard 1.2.7.

    Fix

    Check Schedule 2 of Standard 1.2.7 before using any disease risk reduction language. If the specific claim is not listed, do not use it.

    Mistake

    Treating FSANZ and TGA claim rules as interchangeable

    Problem

    FSANZ and TGA operate separate claim frameworks. A claim permitted under TGA Permitted Indications for a Listed Medicine may not be permitted under FSANZ for a food product — and vice versa. The frameworks are not interchangeable.

    Fix

    Determine product classification first. Apply TGA Permitted Indications rules to Listed Medicines. Apply FSANZ Standard 1.2.7 rules to food products. Never apply one framework's rules to a product regulated by the other.

    Compliant vs non-compliant example

    ❌ NON-COMPLIANT

    Making claims based on ingredient research without checking the approved list

    ✅ COMPLIANT

    Check the FSANZ pre-approved general level health claims list first. If the claim is not there, either use a claim that is on the list or complete the self-substantiation process before publishing.

    The enforcement context

    FSANZ and state food authorities can take action against food businesses making health claims that exceed what Standard 1.2.7 permits. The ACCC can also act under the Australian Consumer Law where health claims on food products are misleading — regardless of which framework primarily applies. In 2023–24, the TGA separately pursued brands whose food products crossed into therapeutic good territory through unapproved claims.

    Before you publish, check it.

    CompliGUARD reviews food product health claims against FSANZ Standard 1.2.7 and flags where claims exceed the approved list.

    Start free review

    Related questions

    Regulatory references

    • Australia New Zealand Food Standards Code, Standard 1.2.7 (Nutrition, Health and Related Claims)
    • Australia New Zealand Food Standards Code, Standard 1.2.7, Schedule 1 (nutrient thresholds)
    • Australia New Zealand Food Standards Code, Standard 1.2.7, Schedule 2 (high level health claims)
    • FSANZ Self-Substantiation Framework for General Level Health Claims