---
title: "Fish oil supplement manufacturer: omega-3 in Australia"
description: "Fish oil supplement manufacturer guide for Australia: the TGA rules for omega-3 fish oil, the heart and brain claims, softgels, stability and our records."
url: https://takefridayoff.com/guides/omega-3-supplement-development
updated: 2026-11-06
---
# Omega-3 and fish oil supplements: how to build one

https://takefridayoff.com/guides/omega-3-supplement-development · Guide · last reviewed 2026-11-01

## In short
(https://takefridayoff.com/guides/omega-3-supplement-development#in-short)

- Most omega-3 supplements in Australia are TGA-listed medicines. Every ingredient must be in the Permissible Ingredients Determination, and the claims must come from the Permissible Indications Determination.
- The Determination lists "Fish oil - rich in omega-3 acids" as an active ingredient, "Only for use in oral medicines."
- An ingredient also has to meet its quality standard. Where a default standard applies, such as a European or British Pharmacopoeia monograph, it comes first. A TGA compositional guideline isn't a legal requirement, but the TGA says an ingredient that doesn't meet it may raise safety concerns.
- Heart and brain claims are available, such as "Maintain/support heart health" and "Maintain/support brain health", but the product can't imply or refer to serious cardiovascular conditions or mental illnesses.
- From our records: a fish oil and a krill oil capsule in production for an established natural health company, with the fish oil reordered, and an algal omega-3 capsule built on life's®OMEGA for BWellness.

## The ingredient rules
(https://takefridayoff.com/guides/omega-3-supplement-development#the-ingredient-rules)

A listed medicine can only contain ingredients in the Therapeutic Goods (Permissible Ingredients) Determination, in the roles it allows and within any limits it sets ([permissible ingredients](https://takefridayoff.com/guides/permissible-ingredients)). The current Determination, (No. 3) 2026, has an entry for "FISH OIL - RICH IN OMEGA-3 ACIDS". It can be used as an active ingredient, with one requirement: "Only for use in oral medicines."

Each oil in the formula needs its own check. Krill oil, an algal oil and a fish liver oil are different ingredients, and some entries carry conditions of their own. The entry for halibut-liver oil, for example, makes vitamin D and vitamin A mandatory components, caps vitamin D at 25 micrograms a day and requires vitamin A warnings above a set level. We check the entry for every oil and every other ingredient before the formula is fixed.

## Quality standards for the oil
(https://takefridayoff.com/guides/omega-3-supplement-development#quality-standards-for-the-oil)

The Determination says what can go in. The quality of the oil itself is set by standards:

- **Default standards come first.** The British Pharmacopoeia, the United States Pharmacopeia-National Formulary and the European Pharmacopoeia are default standards under the Therapeutic Goods Act 1989. If one applies to the ingredient, the ingredient must comply with it.
- **Compositional guidelines fill gaps.** Where no default standard applies, the TGA may publish a compositional guideline: in its words, "a summary of descriptions, tests and acceptance criteria" for the ingredient. The TGA says "compliance with the compositional guideline is not a legal requirement", but using an ingredient that doesn't meet it may raise safety concerns.

In practice, the supplier's specification and certificate of analysis for each batch of oil are checked against the standard that applies before the oil is used.

## The claims an omega-3 product can make
(https://takefridayoff.com/guides/omega-3-supplement-development#the-claims-an-omega-3-product-can-make)

A listed medicine can only carry indications from the Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025, and the sponsor holds the evidence for each one ([permitted indications](https://takefridayoff.com/guides/permitted-indications)). There are no omega-3 claims as such. The claims are about the body, and the ones most used for omega-3 products sit in Part 3 (cardiovascular system) and Part 8 (nervous system):

| Indication | Evidence | Requirement |
| --- | --- | --- |
| Maintain/support heart health | Scientific or traditional | Must not imply or refer to serious cardiovascular conditions |
| Maintain/support cardiovascular system health | Scientific or traditional | Must not imply or refer to serious cardiovascular conditions |
| Helps in the maintenance of healthy blood lipids/blood fats | Scientific only | Must not imply or refer to lowering blood lipids, blood fats and triglycerides |
| Helps maintain/support healthy cholesterol | Scientific only | Must not imply or refer to lowering or raising blood cholesterol levels from outside the normal healthy range |
| Maintain/support brain health | Scientific or traditional | Must not imply or refer to mental illnesses, disorders or conditions |
| Maintain/support brain function | Scientific or traditional | Must not imply or refer to mental illnesses, disorders or conditions |

The wording of an indication can be varied on the label, but the varied wording must not change its meaning or intent, imply a serious form of a disease, or imply that the medicine prevents or cures a disease. So "lowers your triglycerides" or "protects against heart disease" is outside what a listed omega-3 product can say. Advertising has to stay within the claims on the ARTG too ([TGA advertising](https://takefridayoff.com/guides/tga-advertising)).

## Softgels, capsules and vegan options
(https://takefridayoff.com/guides/omega-3-supplement-development#softgels-capsules-and-vegan-options)

- **Oils go in softgels.** Fish oil and krill oil are built as softgel capsules. We make bovine and fish gelatin, vegan, chewable and enteric-coated softgels ([capsules, tablets and softgels](https://takefridayoff.com/formats/capsules-tablets-softgels)).
- **Vegan omega-3.** An algal oil gives a plant-based omega-3. In our records, BWellness's omega-3 capsule is built on life's®OMEGA, with VitaShine™ vegan vitamin D3.
- **Branded oils.** A branded ingredient brings its supplier's research and specification, and the claims still have to fit the permitted list ([branded ingredients](https://takefridayoff.com/guides/branded-ingredients)).

## Stability and the label
(https://takefridayoff.com/guides/omega-3-supplement-development#stability-and-the-label)

- **Oxidation.** Oils oxidise, and the stability program has to cover it. The shelf life rests on stability data for the product in its final pack ([stability testing](https://takefridayoff.com/guides/stability-testing)).
- **Declared substances.** Under TGO 116, the label declares the Schedule 1 substances the medicine contains, for the routes and thresholds Schedule 1 sets. Fish, crustacea and molluscs are among them, so a marine oil product's label is checked against the schedule ([supplement labelling](https://takefridayoff.com/guides/supplement-labelling)).

## From our records
(https://takefridayoff.com/guides/omega-3-supplement-development#from-our-records)

- [A format rescue, then a range](https://takefridayoff.com/work/eye-health-tablet-format-rescue): for an established Australian natural health company, we developed and quoted nine products, spanning eye health, omega-3s, probiotics and more, and took three into production. A fish oil and a krill oil capsule are in production, with the fish oil reordered.
- [BWellness](https://takefridayoff.com/work/bwellness-practitioner-range): nine products for a practitioner-channel brand, including an algal omega-3 capsule built on life's®OMEGA with VitaShine™ vegan vitamin D3.
- [Ora](https://takefridayoff.com/work/ora-practitioner-natural-medicine): our founder's own practitioner brand, with around 19 products built on clinically studied ingredients, life's®OMEGA among them.

## Frequently asked questions

**Is a fish oil supplement a medicine in Australia?**
In most cases. A fish oil capsule sold with a health claim is usually a TGA-listed medicine (AUST L), so its ingredients come from the Permissible Ingredients Determination and its claims from the permitted list.

**Can a fish oil supplement claim to lower cholesterol or triglycerides?**
No. The blood lipid and cholesterol indications require that the product doesn't imply or refer to lowering blood lipids, triglycerides or cholesterol. Claims such as "Maintain/support heart health" are available, with scientific or traditional evidence.

**Can you make a vegan omega-3?**
Yes. An algal oil in a vegan softgel or capsule gives a plant-based omega-3. BWellness's omega-3 capsule is built on life's®OMEGA, an algal omega-3.

**What format suits fish oil?**
A softgel. Fish oil and krill oil are built as softgels, sealed in a shell, with a stability program that covers oxidation.

## Case studies

- [Rescuing a product that wouldn't encapsulate](https://takefridayoff.com/work/eye-health-tablet-format-rescue): The eye-health tablet shipped in 2024
- [BWellness: Nine products and a long partnership](https://takefridayoff.com/work/bwellness-practitioner-range): Five production batches from 2021 to 2025
- [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 1 November 2026. It isn't advice on a particular product. Our work is from Take Friday Off's records.

- [Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2026](https://www.legislation.gov.au/F2026L01382), Schedule 1, items 2228 (fish oil - rich in omega-3 acids) and 2483 (halibut-liver oil), Federal Register of Legislation
- [Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025](https://www.legislation.gov.au/F2025L00450/asmade/2025-04-02/text/original/epub/OEBPS/document_1/document_1.html), section 6 and Schedule 1, Parts 3 and 8, Federal Register of Legislation
- [Overview of compositional guidelines and templates](https://www.tga.gov.au/resources/resource/guidance/overview-compositional-guidelines-and-templates), Therapeutic Goods Administration
- [Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026](https://www.legislation.gov.au/F2026L01312/asmade), Schedule 1, Federal Register of Legislation, as summarised in our [labelling guide](https://takefridayoff.com/guides/supplement-labelling)