The practical guide to the Therapeutic Goods Advertising Code 2021 (2026)
The Therapeutic Goods Advertising Code 2021 sets the rules for every advertisement about a therapeutic good in Australia, including listed complementary medicines such as vitamins and supplements, and medical devices. It requires advertising to be accurate and substantiated before publication (s.8). It bans claims that a product is safe, guaranteed or miraculous (s.9), and requires specific mandatory statements (Part 4). It also tightly controls testimonials and endorsements (s.24). The Code applies to anyone who advertises the goods, including brands, retailers, practitioners and paid influencers.
For a supplement brand, the Advertising Code isn't background reading. It decides whether a product page, an Instagram reel or a creator brief can go live. The TGA reported removing more than 13,700 unlawful advertisements in 2024–25. For corporations, the maximum civil penalty for advertising contraventions under the Therapeutic Goods Act is $15.65 million.
Most breaches aren't deliberate. A claim drifts from the product's accepted indication, a mandatory statement drops off a mobile layout, or a creator says "this cured my bloating". The Code is precise, though, and that makes these breaches predictable and avoidable before publication rather than after a takedown request.
Note: the Code is under formal review by the TGA (2025–26). This guide reflects the Code as currently in force.
Who and what the Code covers
The Code applies to advertisements about therapeutic goods: medicines (including listed complementary medicines), medical devices and other therapeutic goods. Its objects (s.2) are to make sure advertising:
- promotes safe and proper use, minimising misuse, overuse or underuse
- is ethical, and doesn't mislead or create unrealistic expectations
- supports informed health care choices
- is consistent with current public health campaigns
Liability isn't limited to the product sponsor. Anyone who advertises the goods is responsible, including e-commerce brands, retailers, pharmacies, practitioners who sell products, affiliates and influencers. Advertising about a health service (rather than a product) is governed primarily by AHPRA or state Codes of Conduct. When a service ad names a product, both sets of rules apply.
General requirements: ss.8–12
Accuracy and substantiation (s.8). An advertisement must be accurate, balanced and not misleading. It may only contain information the advertiser has substantiated before publication (s.8(1)). For goods on the ARTG, it must not be inconsistent with the indications accepted for that product (s.8(2)). For listed medicines, that ties every claim back to the permitted indications chosen at listing.
Safe and proper use (s.9). An advertisement must not represent goods, expressly or by implication, as:
- safe, or without harm or side effects (s.9(1)(a))
- effective in all cases, or a guaranteed cure (s.9(1)(b))
- infallible, unfailing, magical or miraculous (s.9(1)(c))
It also must not cause undue alarm, fear or distress (s.9(2)(a)). Nor may it discourage people from seeking medical attention, exaggerate efficacy, encourage excessive use, or suggest other treatments are harmful or ineffectual (s.9(3)(b)–(f)).
Scientific representations (s.11). If an ad refers to research, it must identify the researcher, the financial sponsor (where known) and give a proper citation consumers can access (s.11(3)). "Clinically proven" with no citation is a common breach.
Children (s.12). Advertising must not be directed at children under 12.
Practical example: "100% natural, so it's completely safe for the whole family" breaches s.9(1)(a). "Our clinically proven formula" without a citation breaches s.11(3).
→ Related: Can supplement brands use "immune support" claims?
Mandatory statements: Part 4
Part 4 sets the statements and information an advertisement must include. For most supplement advertising, s.19 applies:
- s.19(1): the name of the medicine, one or more accepted indications, and the statement "ALWAYS READ THE LABEL AND FOLLOW THE DIRECTIONS FOR USE", prominently displayed or communicated.
- s.19(2): where the ad lets consumers buy without inspecting the product first, as on a website, social shop or app, it must also show the dosage form, the quantity, each active ingredient, and any health warnings (listed, or linked directly).
Other formats have their own statements:
- Short-form ads (s.17): "ALWAYS FOLLOW THE DIRECTIONS FOR USE"
- Products available only through a health professional (s.16): "THIS PRODUCT IS NOT AVAILABLE FOR PURCHASE BY THE GENERAL PUBLIC"
- Pharmacist-only medicines (s.15): "ASK YOUR PHARMACIST ABOUT THIS PRODUCT"
Medical devices follow s.20, and other therapeutic goods follow s.21.
Practical example: a Shopify product page with an "Add to cart" button is an advertisement that directly facilitates supply. It needs the s.19(1) statement and the s.19(2) information: dosage form, quantity, active ingredients and warnings. These are often missing from mobile templates.
→ Related: Mandatory statements in supplement advertising
Testimonials and endorsements: s.24
Section 24 is where influencer and customer-review marketing most often goes wrong.
Testimonials must:
- be consistent with the label, directions for use and accepted indications (s.24(2))
- describe a typical benefit, not an exceptional one (s.24(3))
- be verified by the advertiser, both the content and the identity of the person (s.24(5))
They must not come from anyone engaged in producing, marketing or supplying the goods (s.24(4)(a)). The Code's note to s.24(4)(a) states this includes influencers and others who receive valuable consideration for the testimonial. Undisclosed immediate family members and corporations are also excluded.
Endorsements must not be given by governments, hospitals, current or former health practitioners or professionals, medical researchers, or anyone presenting themselves as qualified to diagnose or treat (s.24(6)). Consumer and professional bodies may endorse only with disclosure of their name and any payment.
Practical example: a paid creator posts "I've taken this every day for a month and my energy is through the roof." The payment makes this a prohibited testimonial under s.24(4)(a), whatever the wording. A naturopath recommending the brand on the brand's own channels is a prohibited endorsement under s.24(6)(d)–(e).
→ Related: Can I use customer testimonials in supplement advertising? · Influencer obligations for supplement brands
Restricted representations, samples and incentives: Parts 7–8
Restricted representations (s.28). References to a serious form of a disease, condition, ailment or defect need prior TGA approval or permission. A serious form is one that is medically accepted as needing diagnosis, treatment or supervision by a qualified health practitioner, or one for which a test exists that needs medical interpretation. Supplement copy referencing depression, diabetes, cancer or cardiovascular disease almost always enters this territory.
Samples (s.25). Free samples are allowed only for goods listed in Annexure 2 and meeting its conditions. "Buy one, get one free" of the same product isn't a sample.
Incentives (s.26). Ads must not offer personal incentives or commissions to pharmacy assistants or non-professional retail staff for recommending the goods.
How CompliGUARD automates this check
CompliGUARD reviews supplement and therapeutic goods advertising against the Therapeutic Goods Advertising Code 2021. That covers accuracy and ARTG indication consistency, s.9 prohibited claims, Part 4 mandatory statements, s.24 testimonials and endorsements, and restricted representations. It also checks FSANZ Standard 1.2.7 for food-medicine boundary products and the Australian Consumer Law. Each review returns a low, medium or high risk assessment for every claim, the clause it relates to, a compliant rewrite that keeps your creative intent, and a timestamped audit record. Teams can publish at campaign speed with evidence of due diligence behind every asset. It doesn't replace legal advice.
Before you publish, check it.
CompliGUARD reviews therapeutic goods advertising against TGA · AHPRA · FSANZ · ACCC requirements automatically.
Start a free review →Key takeaways
- Every claim must be substantiated before publication and consistent with the product's accepted ARTG indications (s.8).
- Never describe a therapeutic good as safe, side-effect free, guaranteed or miraculous (s.9(1)).
- Online product pages that allow purchase need the s.19(1) statement plus dosage form, quantity, active ingredients and warnings (s.19(2)).
- Paid influencers can't give testimonials, and health practitioners can't endorse therapeutic goods (s.24(4), s.24(6)).
- References to serious diseases or conditions need TGA approval before use (s.28).
Regulatory references
- Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 (Compilation No. 1, 20 December 2022), ss.2, 8, 9, 11, 12, 15, 16, 17, 19, 20, 21, 24, 25, 26, 28
- Therapeutic Goods Act 1989 (Cth), ss.42DD, 42DF, 42DL, 42DLB
- Therapeutic Goods (Permissible Indications) Determination
- FSANZ Food Standards Code, Standard 1.2.7 (for food-medicine boundary products)
- Competition and Consumer Act 2010 (Cth), Schedule 2 (Australian Consumer Law), s.18
CompliGUARD provides compliance and creative marketing insights based on TGA, FSANZ, ACCC and AHPRA guidance as current at the time of review. The Therapeutic Goods Advertising Code is currently under formal review by the TGA (2025–26). CompliGUARD assessments reflect the current Code; guidance may be subject to change. This output does not constitute legal advice.
