Guides to the rules a supplement, food or cosmetic meets in Australia

Every guide sits under the pathway or service it belongs to, so its breadcrumbs lead back there: the TGA listing, ARTG, claims, advertising, new ingredients, stability, sponsor, assessed listing and export guides under listed medicines, the novel foods guide under foods, the AICIS and beauty supplements guides under skincare, the labelling guide under packaging, the timeline and the costs under formulation, the GMP clearance guide under manufacturing, and pet supplements under the pathways. This page lists them all in one place.

How the guides are written

Each guide opens with its answer in a few lines, then the detail, step by step, then the questions people ask us and the sources it was checked against, with the date. The facts come from the regulator's own pages and the legislation: the TGA, FSANZ, AICIS, the ACCC and the Federal Register of Legislation. Where a guide quotes a figure, such as a TGA fee or a caffeine limit, it was checked on the date the guide shows.

The guides are general information, not advice on a particular product. Timelines from our own records are marked as such.

The guides

• Starting a supplement brand: every step from the idea to the first batch on a shelf, in order, with the guide for each.
• TGA listing for a supplement: the AUST L pathway step by step, with the TGA's fees.
• The ARTG and AUST L numbers: what the register is and what the number on the label means.
• Claims and permitted indications: what a listed medicine can claim, and the evidence behind each claim.
• Stability testing: what the TGA expects, and how the shelf life on the label is supported.
• AICIS registration: who registers to import or make cosmetics and their ingredients, and what it costs.
• How long it takes to develop a supplement: the stages, from our records, and what holds a launch up.
• What it costs to develop a supplement: the development work, the TGA's fees, the minimum order and the cost of goods.
• Advertising a supplement: the TGA's Advertising Code, influencers, social media and penalties.
• New ingredients: how an ingredient that isn't permitted gets into the Permissible Ingredients Determination.
• Pet supplements: when a product for animals needs APVMA registration, and when it is a pet food.
• GMP clearance: what a listed medicine made overseas needs from the TGA, and why supplement factories often need an inspection.
• Choosing a manufacturer: what a TGA licence covers and how to check it, the GMP agreement, release for supply and the standards each batch is tested to.
• The TGA sponsor: who is legally responsible for a listed medicine, what an overseas brand does, and the sponsor's duties.
• Assessed listed medicines: the AUST L(A) pathway for claims stronger than the permitted list, with the TGA's fees and timeframes.
• Novel foods: when a new food ingredient needs FSANZ approval, what it costs and how long it takes.
• Exporting a supplement: export-only listings, the TGA's export certificates and what the importing country decides.
• Beauty supplements: why a skin, hair or nail supplement is a medicine, the claims it can make, collagen and the advertising rules.
• Labelling a supplement: what a listed medicine's label must show under TGO 116, from the main label to the warnings.

Where to start

• A brand of your own, from the start. The guide to starting a supplement brand takes the steps in order, from the pathway and the permitted ingredients to the sponsor, the manufacturer, the label, the listing and the launch, and points to the guide for each.
• A supplement you want to sell as a medicine. Start with the TGA listing guide, which covers the AUST L listing step by step with the TGA's fees, then the claims and indications guide and the stability testing guide.
• A powder, drink or bar that could be a food. The pathways page settles whether a product is a medicine, a food or a cosmetic, and the food pathway covers the sports food, claims and label rules.
• A cream, serum or sunscreen. The skincare page settles the claim, and the AICIS guide covers who registers and what it costs.
• A supplement for skin, hair or nails. The beauty supplements guide covers why it is a medicine, the claims it can make and the ingredients it can use.
• A launch date and a budget. The development timeline guide sets out the stages, from our records, and what holds a launch up; the cost guide sets out what each part of the budget covers.
• An ingredient that isn't permitted yet. The new ingredients guide covers the TGA's application levels, fees and timeframes, and the options meanwhile.
• The label. The labelling guide covers what TGO 116 requires, from the main label to the warnings and the transition from TGO 92.
• The marketing. The advertising guide covers what every ad must say, what influencers can and can't do, and what the TGA can do about an ad that breaks the rules.
• A product for animals. The pet supplements guide covers where the APVMA draws the line, the products the law excludes or lists, and what registration costs.
• A manufacturer to choose. The guide to choosing a supplement manufacturer covers what a TGA licence covers and how to check one, the five steps a listing names, the GMP agreement and the standards each batch is tested to, with the questions to ask before you sign.
• A factory overseas. The GMP clearance guide covers the three routes to the TGA's clearance, the evidence and the fees.
• A brand based overseas. The sponsor guide covers who can be the Australian sponsor, how to become one and what the role involves.
• A claim the permitted list doesn't cover. The assessed listed medicines guide covers the AUST L(A) pathway, its evidence, fees and timeframes.
• A new ingredient in a food. The novel foods guide covers when it needs FSANZ's approval, and what the application involves.
• Selling overseas. The export guide covers exporting a listed medicine, export-only listings and the TGA's certificates.

Where we come in

We take a product through what the guides describe: the pathway at the brief, the formula inside the permitted ingredients and indications, the evidence, the stability program, the label and the listing, then we manage the manufacture. See Friday Launch Engine™, or book a call.