---
title: "Immune supplement manufacturer: the TGA rules"
description: "Immune supplement manufacturer guide for Australia: the immune claims a listed medicine can make, what they can't imply, the advertising rules, and our records."
url: https://takefridayoff.com/guides/immune-supplement-development
updated: 2026-11-10
---
# Immune supplements: the rules and how to build one

https://takefridayoff.com/guides/immune-supplement-development · Guide · last reviewed 2026-11-08

## In short
(https://takefridayoff.com/guides/immune-supplement-development#in-short)

- A capsule, tablet or powder that claims to support the immune system is a medicine, usually listed. Its immune claims sit in Part 6 of the Permissible Indications Determination.
- The immune function claims, such as "Maintain/support healthy immune system function", require that the presentation not imply or refer to serious immunological diseases.
- Allergy and hayfever claims in Part 6 also need the label statement "If symptoms persist, talk to your health professional", and several must not imply or refer to serious allergic conditions such as anaphylaxis.
- The ad rules apply to the label, the website and social posts alike: accurate, balanced, substantiated, and consistent with the indications on the ARTG.
- From our records: an immune powder built on Wellmune® for the practitioner brand BWellness, and an immune formula among nine products we developed and quoted for an established natural health company.

## Why an immune supplement is a medicine
(https://takefridayoff.com/guides/immune-supplement-development#why-an-immune-supplement-is-a-medicine)

A product presented for a therapeutic use, such as supporting immune function, is a medicine. Most immune supplements are listed medicines (AUST L): every ingredient from the Permissible Ingredients Determination, every claim from the Permissible Indications Determination, and the evidence held for each claim before the product is sold. The TGA can ask for that evidence at any time ([TGA approval](https://takefridayoff.com/guides/tga-approval)).

## The immune claims a listed medicine can make
(https://takefridayoff.com/guides/immune-supplement-development#the-immune-claims-a-listed-medicine-can-make)

Part 6 of the Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025 holds the claims relating to the immune system. All 18 can rest on scientific or traditional evidence ([permitted indications](https://takefridayoff.com/guides/permitted-indications)). Among them:

| Claim (as worded in the Determination) | Requirements |
| --- | --- |
| Enhance/improve/promote immune defence/immunity | None set |
| Helps enhance/improve/promote immune system function | Presentation must not imply or refer to serious immunological diseases |
| Helps stimulate a healthy immune system response | As above |
| Maintain/support healthy immune system function | As above |
| Maintain/support immune system to fight illness | As above |
| Decrease/reduce/relieve post nasal drip | Label statement "If symptoms persist, talk to your health professional." |
| Helps decrease/reduce/relieve facial tenderness associated with allergic rhinitis | The label statement, and presentation must not imply or refer to serious allergic conditions such as anaphylaxis |
| Soothes/relieves swelling/welts associated with hives | As above |

Other Part 6 claims cover allergies, hayfever and mild allergies. Where the evidence is traditional, the claim carries a traditional context qualifier on the label. Under section 6, a claim's wording can be varied, but not so it changes the meaning or intent of the indication, or implies the medicine treats a serious form of a disease or prevents or cures one. That rules out wording that promises to stop a person catching an illness.

## Advertising an immune supplement
(https://takefridayoff.com/guides/immune-supplement-development#advertising-an-immune-supplement)

Advertising is any statement, picture or design meant to promote the product, and that includes the label and the pack. Under the Advertising Code an ad must be accurate, balanced and not misleading, substantiated before it is published, and not inconsistent with the indications on the ARTG. It can't call the product safe, a guaranteed cure or miraculous, or say "TGA approved". Most ads must carry the medicine's name, at least one accepted indication and "ALWAYS READ THE LABEL AND FOLLOW THE DIRECTIONS FOR USE". The TGA enforces after the fact: it gave over 75 infringement notices in the second half of 2025, mostly for alleged unlawful advertising. More in our [TGA advertising guide](https://takefridayoff.com/guides/tga-advertising).

For an immune product, the risk is in the extra words around the claim: a seasonal campaign, a product name or a post that drifts from "supports healthy immune system function" towards preventing or fighting off a named illness. We check the claims at the brief, against the permitted indications, so the formula, the evidence, the label and the launch copy are built around claims the product can make.

## Evidence, branded ingredients and format
(https://takefridayoff.com/guides/immune-supplement-development#evidence-branded-ingredients-and-format)

Each claim needs evidence that matches the product. A clinically studied branded ingredient can carry much of it, if the studies used the same preparation, at the same dose, in the same population the product is for ([branded ingredients](https://takefridayoff.com/guides/branded-ingredients)). Every ingredient, branded or not, must also be in the Permissible Ingredients Determination for the use it's put to, with the conditions its entry sets ([permissible ingredients](https://takefridayoff.com/guides/permissible-ingredients)).

Choose a powder when the serve is too big for a capsule, as with BWellness's immune powder, or a capsule or tablet for a smaller daily dose ([powders and sachets](https://takefridayoff.com/formats/powders-sachets), [capsules, tablets and softgels](https://takefridayoff.com/formats/capsules-tablets-softgels)).

## From our records
(https://takefridayoff.com/guides/immune-supplement-development#from-our-records)

- [BWellness](https://takefridayoff.com/work/bwellness-practitioner-range): a practitioner-channel brand and distributor serving naturopaths and nutritionists across Australia and New Zealand. Among nine products we developed for it is an immune powder built on Wellmune®, beside a practitioner tablet built on EnXtra® with five production batches from 2021 to 2025. The brand was acquired in 2024 by an ASX-listed company for A$7 million.
- [An established natural health company](https://takefridayoff.com/work/eye-health-tablet-format-rescue): across the relationship we developed and quoted nine products for the brand, spanning eye health, omega-3s, probiotics, liver, immune, prostate and more, and took three into production.
- [Ora](https://takefridayoff.com/work/ora-practitioner-natural-medicine): our founder's own brand, around 19 products recommended by naturopaths, herbalists and functional medicine practitioners, with every formula therapeutically dosed and backed by evidence.

## Frequently asked questions

**Can an immune supplement claim to prevent colds or flu?**
The permitted immune claims are about supporting the immune system, such as "Maintain/support healthy immune system function". A claim's wording can't be varied to imply the medicine prevents or cures a disease, and immune function claims must not imply or refer to serious immunological diseases.

**Which part of the permitted indications covers immune claims?**
Part 6, indications relating to the immune system, of the Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025. It has 18 claims, covering immune function and support, allergies and hayfever.

**Can I say "boosts immunity"?**
The permitted wording includes "Enhance/improve/promote immune defence/immunity" and "Helps enhance/improve/promote immune system function". A claim's wording can be varied on the label only if it keeps the indication's meaning and intent, so the safest course is the permitted words, with the evidence to back them.

**Is an immune powder a food or a medicine?**
If it is presented for a therapeutic use, such as supporting immune function, it is a medicine. BWellness's immune powder, built on Wellmune®, is one of nine products we developed for that brand.

## Case studies

- [BWellness: Nine products and a long partnership](https://takefridayoff.com/work/bwellness-practitioner-range): Five production batches from 2021 to 2025
- [Rescuing a product that wouldn't encapsulate](https://takefridayoff.com/work/eye-health-tablet-format-rescue): The eye-health tablet shipped in 2024
- [Ora: Practitioner-recommended natural medicine, formulated from clinical evidence](https://takefridayoff.com/work/ora-practitioner-natural-medicine): A brand in practitioner clinics and premium retailers across Australia and New Zealand, a member of 1% for the Planet, and expanding into new markets.

## Sources

General information, checked against these sources on 8 November 2026. It isn't advice on a particular product. Our work is from Take Friday Off's records.

- [Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025](https://www.legislation.gov.au/F2025L00450/asmade/2025-04-02/text/original/pdf), section 6 and Schedule 1, Part 6, and its [explanatory statement](https://www.legislation.gov.au/F2025L00450/asmade/2025-04-02/es/original/pdf), Federal Register of Legislation
- [Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2026](https://www.legislation.gov.au/F2026L01382), Federal Register of Legislation
- [Therapeutic Goods Advertising Code](https://www.legislation.gov.au/F2021L01661/latest/text), Federal Register of Legislation, as set out in our [TGA advertising guide](https://takefridayoff.com/guides/tga-advertising)