Many cosmetic brands unknowingly make therapeutic claims that trigger TGA regulation. Here's where the line sits — and why crossing it carries serious penalties.

The single most common — and most expensive — mistake in cosmetic marketing

A moisturiser that "hydrates and softens skin" is a cosmetic. The same moisturiser advertised as one that "treats eczema" or "repairs the skin barrier to heal damage" may no longer be a cosmetic at all — in the eyes of the regulator, it has become a therapeutic good.

That distinction is not academic. It determines which regulator you answer to, what evidence you must hold, how you may advertise, and whether your product can legally be on shelves in its current form. And it is the line that brands cross most often without realising they have done so — usually in a single line of marketing copy written long after the formulation was signed off.

In Australia, a product for external use or use in the mouth can be regulated as either a cosmetic or a therapeutic good, depending on its ingredients, its presentation, and — critically — the claims made about it. The Therapeutic Goods Administration (TGA) is explicit that claims are a decisive factor. Position your product as changing appearance, cleansing, or keeping skin in good condition, and it stays a cosmetic. Position it as treating, preventing, or curing a condition, and you may have just reclassified it into a completely different regulatory regime.

Why the claim matters more than the formula

Two identical bottles can sit on different sides of the line purely because of what the label and advertising say.

Claims that reference acne treatment, the healing of medical skin conditions, SPF and sun protection beyond certain thresholds, anti-ageing framed as a physiological change, or anything suggesting the product acts on the structure or function of the body, can all shift a product from cosmetic into therapeutic-good territory. Once there, the product is captured by the Therapeutic Goods Act 1989 and the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021.

The evidence bar also rises sharply with the strength of the claim. "May assist" sits at one end and demands relatively modest support; "treats" or "cures" sits at the other and requires robust substantiation. Brands frequently reach for the stronger, more persuasive language without appreciating that the wording itself is what determines the compliance burden.

Social media is advertising — all of it

A common and costly assumption is that regulatory scrutiny stops at the formal advertisement. It does not. The TGA treats any statement, image, or design intended to promote a therapeutic good as advertising — and that expressly includes social media posts, comments, stories, reels, livestreams, podcasts, hashtags, links, and sponsored content.

The regulator has also flagged that it actively watches for attempts to skirt the rules through acronyms, nicknames, abbreviations, and hashtags that promote a product without naming it directly. In other words, the coded language brands sometimes use to imply a therapeutic benefit is precisely what the TGA is looking for.

The enforcement is real, and it is escalating

This is not a theoretical risk. In a single recent financial year, the TGA requested the removal of around 13,500 advertisements from online platforms — spanning cosmetic injectables, weight-loss treatments, and other categories. In that same period, the compliance rate among targeted advertisers fell to 77%, down from 96% the year before, as monitoring intensified.

For companies, the consequences of getting it wrong are not trivial. Civil penalties under the Therapeutic Goods Act 1989 can run into the millions of dollars, and the TGA has secured penalties exceeding $20 million against a single company. Beyond the financial exposure, a forced advertising takedown or public enforcement action carries a reputational cost that is far harder to quantify — and far harder to undo.

Where this leaves your brand

If any of the following sound familiar, your product may be closer to the line than you think:

  • Your marketing team writes claims independently of whoever manages regulatory compliance.
  • Your social media and influencer content uses stronger language than your on-pack claims.
  • You have introduced a "hero ingredient" and want to talk about what it does to the skin.
  • You are importing an overseas product whose original market allowed claims that Australia may not.

None of these means your product is non-compliant. But each is a point at which a cosmetic can quietly become a therapeutic good — and where a short review before launch is far cheaper than a response to the regulator afterwards.

Where the line sits, and why it pays to check early

Determining which side of the cosmetic–therapeutic line a product sits on is exactly the kind of judgement we have made for brands for over 40 years. It usually comes down to the claims, not the chemistry — which means the fix, when one is needed, is often a matter of wording rather than reformulation. The catch is that the wording has to be right before the product and its marketing go live.

If you are launching a new product, refreshing your claims, or bringing an overseas range into Australia, a short review of your formulation, packaging, and advertising — social and influencer content included — will tell you where you stand and what, if anything, needs to change. It tends to be far cheaper than unwinding a claim after the regulator has noticed it.

If that would be useful, we're happy to take a look.

This article is general information only and does not constitute regulatory or legal advice for any specific product. Regulatory requirements change; confirm the current position before acting.

Further reading

Primary guidance from the Therapeutic Goods Administration:

‍

Written by 
John Attard
A chartered chemist and toxicologist John's regulatory expertise extends to pharmaceuticals, cosmetics / personal care, food, and consumer/industrial chemicals.