Immune supplements: the rules and how to build one

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).

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). 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

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.

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

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). 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).

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, capsules, tablets and softgels).

From our records

• BWellness: 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: 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: 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.