---
title: "Energy supplement formulation: the TGA rules"
description: "Energy supplement formulation in Australia: the energy and focus claims a listed medicine can make, the TGA's caffeine and guarana conditions, and our records."
url: https://takefridayoff.com/guides/energy-and-focus-supplement-development
updated: 2026-11-10
---
# Energy and focus supplements: the rules and how to build one

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

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

- A capsule or tablet that claims to support energy, focus or mental alertness is a medicine, usually listed. Its claims come from the Permissible Indications Determination: energy claims in Part 1, mental focus and cognitive claims in Part 8.
- Energy claims must not imply or refer to chronic fatigue syndrome. Mental focus and cognitive claims must not imply or refer to mental illnesses, disorders or conditions.
- In a listed medicine taken by mouth, caffeine is limited to 100 mg from the caffeine ingredient in the maximum daily dose and 100 mg in any three hours, and the label says "Adults only". Above 10 mg a day it carries caffeine warnings, and more above 80 mg.
- As a food, caffeine is only allowed where the Food Standards Code permits it. Since 9 June 2026 a sports food can have up to 200 mg in the amount for one day.
- From our records: a practitioner tablet built on EnXtra®, a clinically studied Alpinia galanga extract, with five batches from 2021 to 2025, and a sports range rebuilt across both pathways.

## Food or medicine: where the line sits
(https://takefridayoff.com/guides/energy-and-focus-supplement-development#food-or-medicine-where-the-line-sits)

Energy drinks made only of food ingredients are foods. The TGA says sports supplements that only contain ingredients appropriate for food and come in a traditional food form, such as protein powders, nutrition bars and energy drinks, are not caught by its declaration. A product taken by mouth for sport or exercise is declared a medicine when it is presented for a therapeutic use such as increasing focus or stamina, and either comes as a tablet, capsule or pill (since 30 November 2023, unless it contains only glucose) or contains certain substances, such as anything in the Poisons Standard. More on that line in our [sports supplements guide](https://takefridayoff.com/guides/sports-supplement-development).

Outside sport, a capsule or tablet that claims to support energy or concentration is presented for a therapeutic use, so it is a medicine. Most 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 ([TGA approval](https://takefridayoff.com/guides/tga-approval)).

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

The Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025 groups its claims by body system. Each claim sets the evidence the sponsor must hold, scientific or traditional, and any requirements for using it ([permitted indications](https://takefridayoff.com/guides/permitted-indications)).

**Energy (Part 1, general health).** Among them:

- "Enhance/promote energy levels" and "Maintain/support energy levels"
- "Helps enhance/promote body energy reserves"
- "Helps enhance/promote/increase vitality" and "Maintain/support vitality"
- "Maintain/support physical endurance/capacity/stamina"
- "Relieve weariness/tiredness/fatigue/feeling of weakness", which also needs the label statement "If symptoms persist, talk to your health professional."

Each of these carries the same requirement: the product's presentation "must not imply or refer to chronic fatigue syndrome."

**Mental focus and cognition (Part 8, nervous system).** Among them:

- "Maintain/support mental concentration/focus/clarity"
- "Enhance/improve/promote/increase mental alertness/wakefulness"
- "Helps enhance/improve/promote/increase attention span"
- "Enhance/improve/promote/increase cognitive performance" and "Maintain/support cognitive function/mental function"
- "Decrease/reduce mental/cognitive fatigue" and "Maintain/support mental endurance/stamina"

Here the requirement is that the presentation "must not imply or refer to mental illnesses, disorders or conditions."

Part 7 (muscles) adds "Decrease/reduce/relieve muscle tiredness", with the "If symptoms persist" label statement.

A claim's wording on the label can be varied, but under section 6 it must not change the meaning or intent of the indication, or imply the medicine treats a serious form of a disease or prevents or cures one. Where the evidence is traditional, the claim carries a traditional context qualifier on the label.

## Caffeine and guarana in a listed medicine
(https://takefridayoff.com/guides/energy-and-focus-supplement-development#caffeine-and-guarana-in-a-listed-medicine)

The Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2026, in force since 16 October 2026, sets conditions for both ([permissible ingredients](https://takefridayoff.com/guides/permissible-ingredients)).

**Caffeine (item 1053).** For a medicine taken by mouth:

- no more than 100 mg of caffeine from this ingredient in the maximum daily dose, and no more than 100 mg of total caffeine in any three-hour period
- total caffeine no more than 33% of a divided preparation, such as a tablet or capsule, or 1% of an undivided one
- the label statement "Adults only"
- above 10 mg of total caffeine in the daily dose, a caffeine statement ("A cup of instant coffee contains approximately 80 mg of caffeine.") and the warning "Caffeine intake more than 200 mg per day is not recommended during pregnancy or breastfeeding."
- above 80 mg, statements to limit other caffeine products, such as tea and coffee, and that caffeine interacts with the liver enzyme CYP1A2

**Guarana, Paullinia cupana (item 3728).** Caffeine is a mandatory component of the entry. Total caffeine is capped at 33% of a divided preparation and 1% of an undivided one, at 400 mg in the maximum daily dose and at 100 mg in any three hours, with the same warnings as caffeine.

Both entries count total caffeine, so caffeine from every ingredient in the formula is added up before the warnings and limits are checked. We do that sum at the brief, so the dose, the pack and the label agree.

## Caffeine in a food
(https://takefridayoff.com/guides/energy-and-focus-supplement-development#caffeine-in-a-food)

Since 9 June 2026, a retail food can't contain caffeine unless the Food Standards Code permits it, as it now does for formulated supplementary sports foods under Standard 2.9.4: up to 200 mg in the amount for one day, as directed on the label, and below 5% of a powder or 1% of a liquid. Until 9 June 2028, a product may follow the Code as it was or as amended. More in our guide to [the food pathway](https://takefridayoff.com/pathways/foods).

## Evidence and branded ingredients
(https://takefridayoff.com/guides/energy-and-focus-supplement-development#evidence-and-branded-ingredients)

Every claim needs evidence the sponsor holds before the product is sold. A clinically studied branded extract can carry much of it, if the studies match the product: the same preparation, the same dose and the same population ([branded ingredients](https://takefridayoff.com/guides/branded-ingredients)). For a focus product, that means checking who was studied, then choosing claims the studies support. Format and taste matter too: a tablet, a capsule or a powder each suits a different dose and a different routine ([formats](https://takefridayoff.com/formats)).

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

- [BWellness](https://takefridayoff.com/work/bwellness-practitioner-range): a 60-tablet formula built on EnXtra®, a clinically studied Alpinia galanga extract, taken from quoting specification to manufacture, with a stability program at 3 and 12 months. Five production batches from 2021 to 2025 and a sixth order in the pipeline, among nine products for the brand.
- [ATP Science's core range](https://takefridayoff.com/work/sports-brand-core-range): four TGA-listed capsules, one built on Testofen®, and a food-pathway performance powder, each placed on its pathway at the brief. Reorders on three within a year.
- [Ora](https://takefridayoff.com/work/ora-practitioner-natural-medicine): our founder's own brand, with TGA-listed medicines and premium functional foods in one range, every formula therapeutically dosed and backed by evidence.

## Frequently asked questions

**Is an energy supplement a food or a medicine?**
It depends on its form and its claims. An energy drink made only of food ingredients is usually a food. A capsule or tablet claiming to support energy or focus is a medicine, usually listed with the TGA.

**How much caffeine can a listed medicine contain?**
Taken by mouth, no more than 100 mg of caffeine from the caffeine ingredient in the maximum daily dose, and no more than 100 mg of total caffeine in any three-hour period, under the Permissible Ingredients Determination. Guarana's entry caps total caffeine at 400 mg in the maximum daily dose. Warnings apply above 10 mg and above 80 mg a day.

**Can a focus supplement claim to improve memory or concentration?**
A listed medicine can use the permitted wording, such as "Maintain/support mental concentration/focus/clarity", with the evidence to back it. Its presentation must not imply or refer to mental illnesses, disorders or conditions.

**Can an energy supplement mention chronic fatigue?**
No. Each energy claim in Part 1 of the Permissible Indications Determination requires that the presentation not imply or refer to chronic fatigue syndrome.

**Is a "nootropic" a category the TGA recognises?**
The word isn't one of the permitted indications. A listed medicine makes the specific claims in Part 8, such as supporting cognitive function, and is presented within their requirements.

## Case studies

- [BWellness: Nine products and a long partnership](https://takefridayoff.com/work/bwellness-practitioner-range): Five production batches from 2021 to 2025
- [ATP Science: Rebuilding a sports brand's core range](https://takefridayoff.com/work/sports-brand-core-range): Five products in production from late 2023
- [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, Parts 1, 7 and 8, 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), sections 2 and 7 and Schedule 1, items 1053 (caffeine) and 3728 (Paullinia cupana), Federal Register of Legislation
- [Therapeutic Goods (Declared Goods) Order 2019](https://www.legislation.gov.au/F2019L01352/latest/text), Federal Register of Legislation, and [Changes to the regulation of sports supplements in Australia](https://www.tga.gov.au/changes-regulation-sports-supplements-australia), Therapeutic Goods Administration, as set out in our [sports supplements guide](https://takefridayoff.com/guides/sports-supplement-development)
- [Standard 2.9.4: Formulated supplementary sports foods](https://www.legislation.gov.au/F2015L00421/latest/text) and [the Code variation for Proposal P1056, the caffeine review](https://www.legislation.gov.au/F2026L00700/asmade/text), Federal Register of Legislation