Australia's Therapeutic Goods Administration (TGA) operates one of the most rigorous regulatory frameworks for supplements and complementary medicines in the world. You might not think that this was the case, however, given the flood of advertisements for various supplements that hits your social media as soon as the algorithm picks up that you might be carrying an injury.
Every product advertised to Australian consumers as a therapeutic good must be included on the Australian Register of Therapeutic Goods (ARTG) before it can be lawfully supplied in Australia. This is intended to ensure that consumers receive products that have been assessed for safety, quality and appropriate labelling. Yet a growing number of overseas sellers, including some based in New Zealand, have found a way to reach Australian consumers without obtaining ARTG listing. Many sellers rely on the Personal Importation Scheme (the Scheme) as the preferred pathway for supply.
What the Scheme was designed to do
The Scheme is a legislative mechanism that permits individual Australians to import therapeutic goods not entered on the ARTG, provided that several strict conditions are met. The imported products must be for the individual's own personal use or for the use of an immediate family member. The quantity is capped at a three-month supply per order at the maximum recommended dose, with no more than a fifteen-month supply within any twelve-month period. The Scheme was intended to operate as a consumer-initiated safety valve. It allows individuals to access products that may not be available domestically and not as a commercial distribution channel.
Critically, products imported under the Scheme are not evaluated by the TGA. Their safety, quality and efficacy cannot be guaranteed and they may not adhere to Australian manufacturing and labelling standards.
How the Scheme is being misused
The problem lies in the gap between the Scheme's intended purpose and its practical exploitation. Several overseas supplement companies, including a growing number based in New Zealand, have built e-commerce businesses that are effectively directed at Australian consumers. These businesses typically ship products from outside Australia by mail or courier and rely on the argument that each transaction constitutes a lawful personal importation by the individual customer, rather than a commercial supply into the Australian market.
The result is a regulatory asymmetry that disadvantages compliant Australian businesses. Local manufacturers and sponsors must invest in ARTG listing, Good Manufacturing Practice (GMP) compliant manufacturing, proper labelling and ongoing post-market obligations. Overseas sellers operating under the personal importation model avoid many of these costs, yet compete for the same customer base. Industry stakeholders have flagged this as a pre-existing competitive concern across a range of products, not limited to any single category.
For consumers, the risks are real. Products that bypass TGA oversight may contain undeclared ingredients, incorrect dosages, contaminants such as heavy metals or bacteria, or even substances that are prohibited imports under Australian customs law. The TGA has specifically warned consumers to avoid ordering dietary supplements and herbal preparations online unless they are fully aware of the product's ingredients, have verified the legal requirements for importing and have only ordered what a health practitioner has recommended.
Why not simply sell across the Tasman?
A common misconception is that New Zealand supplements can be freely sold in Australia under the Trans-Tasman Mutual Recognition Arrangement (TTMRA). The TTMRA was a landmark agreement between Australia and New Zealand in the late 1990s designed to remove regulatory barriers to the movement of goods between the two countries. Under the TTMRA’s basic principle, a good that may legally be sold in one jurisdiction may be sold in the other. However, the TTMRA contains a list of permanent exemptions for categories of goods deemed too significant from a public health perspective to be subject to automatic mutual recognition. Therapeutic goods are expressly and permanently exempt from the TTMRA. This means that a supplement lawfully sold in New Zealand cannot automatically be supplied in Australia. Suppliers must independently comply with the requirements of the Australian Therapeutic Goods Act 1989 (TG Act), including ARTG listing.
The reason this exemption matters so acutely in the supplement’s context is the stark difference between the two countries' regulatory regimes. In New Zealand, dietary supplements are regulated under the Dietary Supplements Regulations 1985, which fall under the Food Act 2014 and are administered by Medsafe. Critically, there is no pre-approval process for dietary supplements in New Zealand. It is the responsibility of the sponsor to ensure the product complies with the law, is safe to use and is made to an acceptable quality. The regulations specify certain requirements including labelling and maximum permitted daily doses for several vitamins and minerals, but do not require government evaluation before a product reaches the market. New Zealand's export certificates for dietary supplements include a disclaimer stating that the products "are not assessed by a Government agency" and that no assurance can be provided regarding quality or safety standards. By contrast, in Australia, supplements that make therapeutic claims or contain regulated ingredients are generally regulated by the TGA as complementary medicines under the TG Act. This requires compliance with applicable standards relating to safety, quality, manufacturing and advertising.
New Zealand has itself acknowledged that its regulation of supplements is not fit for purpose. A New Zealand Cabinet paper observed that the current arrangements for regulating natural health products do not ensure consumer safety or support industry development and that a new regulatory scheme is needed. In September 2024, the Government agreed that natural health products would be regulated under separate standalone legislation, following the development of a new Medical Products Bill to replace the Medicines Act 1981. However, as at the date of publication, that standalone natural health products legislation has not yet been enacted.
Together, the TTMRA exemption for therapeutic goods and New Zealand's comparatively light-touch supplements regime create the regulatory gap that the Scheme is being used to bridge. Products that face minimal regulatory scrutiny in New Zealand cannot enter the Australian market through normal trade channels because of the TTMRA exemption, so sellers instead rely on individual consumers to import the products under the personal importation pathway. This typically happens without Australian consumers even being aware that this is happening.
Advertising prohibition
The most significant legal vulnerability for overseas sellers is advertising law. Under the TG Act, it is an offence to advertise a therapeutic good to Australian consumers if the product is not entered on the ARTG. ‘Advertising’ is defined broadly: it includes any statement or representation that is intended, or even likely, to promote the use or supply of therapeutic goods. This captures websites, social media posts, sponsored content, influencer endorsements, email marketing and product listings on e‑commerce platforms.
An overseas company that operates an Australian-facing website, targets Australian consumers through digital advertising or promotes specific supplement products to an Australian audience is almost certainly engaging in the advertising of unapproved therapeutic goods. This is so regardless of whether the actual importation is technically affected by the individual consumer. Representations made directly to the public about accessing unapproved therapeutic goods are likely to contravene one or more advertising laws. The TGA has very strong powers to initiate compliance or enforcement action for such breaches.
What the TGA is doing
The TGA has significantly sharpened its enforcement posture in recent years (see our earlier article). In January 2026, the TGA released its Compliance Principles for 2026 and 2027, setting out a proactive and risk-based approach to enforcement across all regulated sectors. The framework is guided by five core principles: safeguarding therapeutic goods, educating to empower, protecting those most at risk, leveraging digital capability and strengthening enforcement. Priority focus areas are reviewed quarterly to ensure the TGA can respond swiftly to emerging risks.
Among the TGA's current priority focus areas are the detection and disruption of unlawful supply and advertising of unapproved and high-risk medicines used in the wellness industry, including supplements and weight loss products. The TGA routinely monitors advertisements on digital platforms and social media sites and continues to target advertising of unapproved products online. Recently, the TGA has been sending advertisers guidance letters encouraging supplement distributors to review their advertising for compliance.
The enforcement toolkit is substantial. The TGA can and does issue infringement notices carrying significant financial penalties, with civil penalties of up to $1.65 million per breach for individuals and $16.5 million per breach for corporations. It can issue enforceable directions requiring businesses to cease supply, relabel or destroy non-compliant products. It can seek website blocking orders under the Telecommunications Act 1997 to prevent Australian consumers from accessing non-compliant websites. In the most serious cases, criminal prosecution can result in imprisonment of up to five years.
Recent enforcement outcomes demonstrate this is not theoretical. In April 2026, the TGA issued four infringement notices totalling $79,200 to Switch Nutrition Pty Ltd for the alleged unlawful advertising of therapeutic goods. In January 2026, eleven infringement notices totalling $43,560 were issued to six individuals for the alleged importation and unlawful advertising of therapeutic goods. The landmark Vapor Kings civil penalty of $4.9 million further underscores that the TGA is prepared to pursue large-scale financial consequences. In the past five years, tens of thousands of ads have been forcibly removed from social media platforms and hundreds of warning letters and infringement notices have been issued.
The message for overseas sellers and for Aussie consumers
For New Zealand and other overseas supplement companies relying on the Scheme as a de facto market entry strategy, the regulatory risk is clear and growing. The TGA is actively monitoring digital platforms, issuing infringement notices for advertising breaches and pursuing both civil and criminal enforcement where warranted. The line between facilitating genuine personal importation and engaging in unlawful supply and advertising is one that the TGA is increasingly willing to enforce.
For Australian consumers, the takeaway is equally straightforward: products imported under the Scheme have not been assessed by the TGA and there is no guarantee of their safety, quality or efficacy. The ARTG listing (evidenced by an AUST L or AUST R number on the label) remains the gold standard of assurance for any supplements purchased in Australia.
The personal importation pathway serves a legitimate purpose for individuals who need access to specific products not available domestically. It was never intended to be and should not be treated as, a loophole for the commercial distribution of unregulated supplements into the Australian market.
For overseas supplement manufacturers and suppliers concerned about compliance, we are well placed to advise on the regulatory pathways available for lawful supply into Australia, including registration on the ARTG, sponsor structuring requirements, GMP compliance, advertising restrictions and the significant criminal and civil penalties that attach otherwise to non-compliant supply.