A gut-health powder that “reduces inflammation”. A serum that “treats eczema”. A supplement that “supports healthy blood sugar”. A device that “relieves back pain”.

These are not just marketing choices. Depending on the product and its presentation, they may bring a business within Australia's therapeutic goods regime, with obligations that reach from importation and supply to the wording of an Instagram post.

For a wellness, supplement, skincare or online health business, the most expensive mistake can happen before the first sale: assuming the product sits outside medicines regulation because it is natural, available overseas or described as a cosmetic.

In our earlier articles, we examined the TGA's unapproved-peptide enforcement focus and practical compliance questions for clinics. This article steps back to the question every health product business should answer first: is the product a therapeutic good, and what follows if it is?

01 What makes a product a therapeutic good?

Section 3 of the Therapeutic Goods Act 1989 (Cth) defines therapeutic goods broadly. It includes goods represented in any way to be, or likely to be taken to be, for therapeutic use or as ingredients in therapeutic goods. It also covers classes of goods whose sole or principal ordinary use is therapeutic, and goods declared to be therapeutic goods. Statutory inclusions, exclusions and declarations must be considered.

“Therapeutic use” extends beyond treating a diagnosed illness. It includes preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury; influencing, inhibiting or modifying a physiological process; testing susceptibility to a disease or ailment; influencing or controlling conception or testing for pregnancy; replacing or modifying parts of the anatomy; and testing for a physiological condition. It also includes specified uses connected with in-vitro testing of human specimens.

The TGA regulates categories including medicines, medical devices, biologicals and other therapeutic goods. Classification is not determined by the business's preferred label alone.

It is not just what is in the bottle

The words “represented in any way” matter. Labels, packaging, websites, social media, imagery and statements made to customers may all contribute to how a product is presented. Composition, dosage form, intended purpose and specific legislative rules also matter.

A moisturiser promoted only to hydrate skin may be a cosmetic. A product promoted to treat eczema may be a therapeutic good. Those examples illustrate the importance of claims, not a rule that wording overrides every other classification requirement.

For products taken by mouth, the food–medicine boundary requires particular care. A vitamin capsule is not simply a food because the seller calls it a snack. Ingredients, form, presentation, applicable food standards and any declarations or exclusions must be considered together.

The compliance question is not simply “What are we selling?” It is also “What are we telling people this product will do?”

The TGA's product-classification tools provide a useful starting point. They do not replace a product-specific assessment where the answer is uncertain.

02 The ARTG: inclusion is the starting point, not the whole answer

Unless an exemption, exclusion or other lawful pathway applies, therapeutic goods generally need to be entered in the Australian Register of Therapeutic Goods (ARTG) before importation, supply or export. Manufacturing and state or territory requirements may apply separately.

The Australian sponsor is the person or business responsible for the relevant ARTG entry and associated obligations. A distributor should check that the entry covers the actual product being handled, rather than rely on a supplier's assertion that something similar is “TGA approved”.

Three main pathways for medicines

  • Listed medicines: AUST L. These generally use permitted low-risk ingredients and permitted indications. The sponsor certifies compliance and must hold evidence supporting the indications. The TGA does not individually evaluate each listed medicine's efficacy before listing, although it can review compliance after entry.
  • Assessed listed medicines: AUST L(A). These use eligible low-risk ingredients but can make certain higher-level indications. The TGA assesses the evidence supporting those indications before listing. Safety and quality requirements remain subject to sponsor certification. This is not the same as the full evaluation of a registered medicine.
  • Registered medicines: AUST R. These include prescription medicines and many over-the-counter medicines. They undergo pre-market evaluation for quality, safety and efficacy.

An AUST L number is not a licence to say that the TGA has clinically proven the product's effectiveness. Advertising still needs to reflect the relevant indications and supporting evidence.

Exempt and excluded are different

Exempt goods remain therapeutic goods, but do not require ARTG inclusion where the particular exemption and its conditions apply. Other obligations may remain. Certain patient-specific compounded medicines provide an example, but the exemption has express limits and product exclusions.

Excluded goods are outside the therapeutic goods regime where the legal exclusion applies. Some foods and cosmetics fall outside that regime, but the precise statutory criteria matter. Exclusion does not mean that consumer, food, chemical or other product-safety laws disappear.

Specific access arrangements, including the Special Access Scheme, Authorised Prescriber arrangements and clinical-trial mechanisms, can permit access to goods not entered in the ARTG under their conditions. They are not general permissions for unrestricted retail sale.

A permission to supply a product does not necessarily permit public advertising. Check the legal basis for each activity separately.

03 The boundaries that catch health product businesses

Supplements: food or medicine?

“Dietary supplement” is not a standalone Australian regulatory category that avoids food or medicines law. An orally consumed supplement may be regulated as a food or a therapeutic good depending on its composition, presentation and the applicable legal rules.

Foods are regulated under food legislation and the Australia New Zealand Food Standards Code, with enforcement by the relevant authorities. Medicines fall within the TGA framework. Food health claims are themselves regulated; being a food does not allow a business to make any claim it chooses.

A familiar food ingredient in a different concentration or dosage form may require a different assessment. Certain sports supplements are declared therapeutic goods under specific criteria. Do not assume every sports supplement is a medicine, or that every product sold as a sports food is outside TGA regulation.

Skincare and cosmetics

Products used to cleanse, perfume, moisturise or alter appearance may be cosmetics. Claims about treating eczema, acne, hair loss or other conditions can raise therapeutic goods questions. Some cosmetic claims and products are subject to specific exclusions, so an isolated phrase should not be treated as a definitive classification test.

Primary sunscreens are generally therapeutic goods. Some secondary sunscreen products can be excluded where the conditions are met. Check the particular formulation, purpose, claims and exclusion rather than treat all products with an SPF identically.

Devices and wellness technology

Light-therapy equipment, pain-relief devices, home testing kits and software can be medical devices depending on their intended purpose and the applicable definitions. A product is not exempt merely because it is called a wellness gadget or runs on a phone.

Some software is excluded or exempt under specific rules. Medical devices also have their own risk classifications and ARTG inclusion requirements. Non-IVD devices are classified as Class I, IIa, IIb or III, with additional requirements for Class I devices supplied sterile or with a measuring function. Implantability is a classification factor, not a separate highest class. In-vitro diagnostic devices use a separate Class 1–4 framework.

04 Importing, drop-shipping and selling from overseas

The Personal Importation Scheme is for an individual's personal use or use by their immediate family, subject to its conditions. It generally permits no more than a three-month supply per importation at the recommended maximum dose. For medicines, the total ordinary limit is 15 months’ supply over a 12-month period. Prescription requirements, customs restrictions, product exclusions and other conditions must also be checked.

It is not an authority to import stock for resale or onward supply. For prescription-only medicines, the scheme generally requires a valid Australian prescription or written authority at the time of importation. An overseas prescription alone is not enough.

Routing orders through customers does not automatically make a commercial arrangement lawful. Equally, assistance with a genuine personal import is not automatically unlawful in every case. The actual arrangement matters: who imports, who supplies, who receives payment and whether the scheme's conditions are genuinely met.

An overseas website or warehouse does not remove Australian regulatory questions. Australian importers, resellers, drop-shippers and marketplace participants should assess their own role, the product's status and the conduct directed at Australian customers. Foreign approval is not a substitute for an Australian lawful pathway.

If you import therapeutic goods, check whether you are taking on sponsor obligations and whether a relevant ARTG entry or other authority actually covers the importation and supply. Retain records of the product, supplier, batch and legal pathway.

05 Advertising: a compliant product can still have unlawful marketing

The Act's advertising definition reaches statements, images and designs intended, directly or indirectly, to promote the use or supply of therapeutic goods. Websites, social-media posts, promotional emails, labels and influencer content may fall within it. Not every educational reference is an advertisement; purpose and context matter.

Public advertising must comply with the applicable provisions of the Act and, where applicable, the Therapeutic Goods Advertising Code 2021. A useful review should cover:

  • Product status. Do not promote unapproved therapeutic goods to the public unless a specific legal exception permits the advertising. ARTG exemptions do not automatically confer advertising permission.
  • Indications and evidence. Claims must be consistent with the product's ARTG entry where required, accurate and supported. A listed medicine cannot be promoted for a new or stronger indication simply because a marketing team considers it persuasive.
  • Prescription and pharmacist-only medicines. Public advertising of prescription medicines is prohibited. Many Schedule 3 pharmacist-only medicines are also restricted, subject to specific exceptions such as eligible substances in Appendix H of the Poisons Standard. Advertising exclusively to eligible health professionals is treated differently.
  • Testimonials and endorsements. The Code distinguishes personal-use testimonials from endorsements. Testimonials induced by payment, free products or other valuable consideration are prohibited, and people involved in producing, marketing or supplying the goods cannot provide testimonials. Current or former health practitioners, health professionals and medical researchers cannot provide testimonials or endorsements. Otherwise-permitted endorsements may be paid if required disclosure is made. Separate conditional rules apply to eligible healthcare facilities and organisations; they are not a general exception for individual practitioners.
  • Overall impression. Advertising must not be misleading or create prohibited impressions about safety or results. Avoid claims suggesting guaranteed success, a miraculous cure, no side effects or universal safety. Qualifications in small print do not necessarily correct an overstated headline.
  • Serious-condition claims. Representations about serious diseases or conditions can be restricted or prohibited and may require permission. ARTG inclusion alone does not authorise every disease claim.

Review the whole customer journey

The TGA announced prescription-medicine advertising guidance and updated health-service guidance on 18 June 2026. These explain existing restrictions, rather than create a new ban. The guidance looks beyond whether a medicine is expressly named. Business names, logos, imagery, linked pages, price lists, booking systems and communications to past patients can contribute to the overall impression. A consumer login or membership wall does not necessarily remove promotional material from the public advertising rules.

Businesses should review influencer and affiliate material as carefully as their own accounts. Free products, commissions and other benefits can affect whether a testimonial is prohibited. Written agreements, approval processes and monitoring are useful safeguards, but a contract does not cure non-compliant content.

A separate TGA consultation ran from 9 July to 3 September 2026 on targeted Advertising Code improvements. It included possible AI disclosure and warning requirements for software as a medical device, not every health product using AI. Consultation proposals are not legal requirements unless enacted and commenced; businesses should check the current Code rather than assume a proposal is already law.

The Australian Consumer Law applies too

TGA compliance does not displace the Australian Consumer Law. Misleading health claims, false representations and unsupported promotional statements can create separate exposure, including action by consumer regulators. If the business also advertises a regulated health service, the applicable health-practitioner advertising rules need a separate review.

06 What happens if you get it wrong?

The TGA can use infringement notices, civil penalty proceedings and, for relevant offences, criminal prosecution. It also has powers concerning advertising directions, injunctions, enforceable undertakings, recalls, seizure and ARTG suspension or cancellation, subject to the applicable statutory requirements.

The TGA’s Compliance Principles 2026 and 2027 emphasise proactive, risk-based enforcement, including attention to digital platforms, online sales and social media. These priorities guide enforcement; they do not create new offences or change the statutory liability tests.

These measures are not interchangeable. An infringement notice alleges a contravention and provides an alternative to proceedings; it is not itself a court finding. A warning letter, compulsory information notice and court document also require different responses.

For a single alleged contravention occurring on or after 1 July 2026, an infringement notice amount is the lesser of one-fifth of the applicable maximum court penalty and $4,368 for an individual or $21,840 for a company. Notices can also cover specified continuing contraventions with aggregated amounts. Payment is not an admission of guilt or liability. For specified advertising civil contraventions, the maximum court penalties are 5,000 penalty units for an individual and 50,000 for a company: currently $1.82 million and $18.2 million respectively, using the $364 Commonwealth penalty unit. Those are not universal maxima across the Act, and continuing contraventions have their own rules.

In July 2019, the Federal Court ordered the Peptide Clinics business to pay $10 million in aggregate penalties for unlawful advertising, including advertising prescription-only medicines to the public. That was a court outcome in that case, not a fixed penalty for one advertisement. Some advertising breaches are criminal offences; imprisonment can be available under the relevant offence provision, and harm is not an element of every advertising offence.

Multiple products, publications or periods of conduct can increase exposure. The number of contraventions and the penalty imposed depend on the relevant provisions and facts. It is not safe to assume one campaign is one breach, or that every post automatically attracts the maximum penalty.

Removing advertising can stop an ongoing problem, but does not erase historical conduct. Preserve relevant versions and records, address current risks promptly and obtain advice about the appropriate response.

07 Directors and managers can face personal exposure

A company structure does not eliminate personal liability. The Act's definition of an executive officer extends to people concerned in, or taking part in, a company's management, whether or not formally appointed as directors.

Under section 54B, an executive officer can be personally liable for a company’s civil contravention if they knew the contravention would occur, were in a position to influence the relevant conduct and failed to take all reasonable steps to prevent it. Similar liability applies to specified criminal offences. The precise statutory elements must be established. Compliance education for employees, agents and contractors, and the officer’s response on becoming aware of contraventions, are among the matters a court must consider under section 54C.

Accessorial liability may also arise where a person participates in a contravention in the way required by the relevant provision. The evidence of involvement, knowledge and the applicable statutory elements matters; not every director or manager is automatically liable for every company breach.

The practical lesson is to allocate responsibility for compliance, document reviews and escalation, and ensure concerns reach people who can act. Delegating marketing to an agency or product sourcing to a supplier is not a substitute for checking the business's own obligations.

08 Before you launch: eight checks worth making

  1. Classify the actual product. Assess ingredients, form, purpose, claims and the relevant declarations or exclusions. Use the TGA tools as a starting point, and obtain advice on borderline products before launch.
  2. Verify the lawful pathway. Search the ARTG where applicable and confirm that the entry covers the product. If relying on an exemption, exclusion or approval, document its conditions and what activities it permits.
  3. Identify the sponsor and your role. Check responsibilities as importer, manufacturer, sponsor, distributor, retailer or advertising participant. Do not assume a foreign supplier holds the necessary Australian authority.
  4. Audit every claim. Review packaging, websites, social media, sales scripts, booking flows and linked material. Check consistency with permitted or approved indications, evidence and any restricted-representation requirements.
  5. Check influencers and affiliates. Review payments, free products, commissions, testimonials and endorsements. Use agreements and active monitoring, not a one-time disclaimer.
  6. Check the import model. Do not use personal importation as a stock or resale pathway. Examine drop-shipping and customer-assisted imports on their actual facts.
  7. Keep evidence and traceability records. Retain substantiation for claims and records of suppliers, products, batches and legal pathways. Establish systems for complaints, safety concerns and relevant reporting or recall obligations.
  8. Have a response plan. If the TGA contacts you, identify the recipient, power, deadline and documents sought. Preserve records and obtain advice before making admissions or overlooking a compulsory requirement.

09 How GopherWood Lawyers can help

The boundary between a wellness product and a therapeutic good can be narrower than a business expects. Understanding the product's status and reviewing its claims before launch can help prevent avoidable enforcement exposure later.

We can help you:

  • Assess whether your product falls within therapeutic goods, food or cosmetics regulation.
  • Understand obligations as an importer, sponsor, retailer or online seller.
  • Review labels, websites, social media and marketing claims.
  • Prepare or review influencer, affiliate and supplier agreements addressing regulatory responsibilities.
  • Develop compliance policies and staff-training material.
  • Respond to TGA correspondence, information notices, infringement notices and investigations.

If you sell, import or promote health products, contact GopherWood Lawyers for a confidential discussion, call 02 9160 2157 or email info@gopherwoodlawyers.com.au.

This article reflects material reviewed on 28 October 2026. It is general information, not legal or medical advice. Product classification and obligations depend on the particular product, claims, activities and jurisdiction. Check current legislation and guidance before acting.

10 Sources and further reading

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