Omega-3 and fish oil supplements: how to build one

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). 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

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

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). 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).

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).
• 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).

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).
• 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).

From our records

• A format rescue, then a range: 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: nine products for a practitioner-channel brand, including an algal omega-3 capsule built on life's®OMEGA with VitaShine™ vegan vitamin D3.
• Ora: our founder's own practitioner brand, with around 19 products built on clinically studied ingredients, life's®OMEGA among them.