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Are Your Health and Wellness Claims Legal? Where Australian Law Draws the Line

Health and wellness is one of the fastest-growing advertising categories in Australia, and one of the most heavily regulated. If your business sells a supplement, skincare product, fitness program, or wellness service, you’re likely operating under at least two overlapping legal frameworks at once, and it’s worth knowing roughly where the line sits before your next campaign goes out. If you’d like your specific claims reviewed, you can book a Strategy & Advice Consult any time.



The general rule still applies first

Sections 18 and 29 of the Australian Consumer Law apply to health and wellness claims in the same way they apply to any other advertising. A claim generally needs to be accurate, substantiated, and unlikely to create a false overall impression. “Clinically proven” should generally mean there is an actual clinical study behind it that supports the specific claim being made, not a general association with the idea of clinical testing. “Doctor recommended” should generally mean an actual doctor actually recommends it, and ideally that you could produce evidence of that if asked.


Where the Therapeutic Goods Act adds a second layer

If a claim goes further than general wellness (feeling better, more energy, general support) and starts to suggest the product treats, prevents, cures, or alleviates a specific disease, condition, or symptom, it is likely to become a therapeutic claim. Therapeutic claims trigger a separate set of obligations under the Therapeutic Goods Act 1989, including, in many cases, a requirement that the product be included on the Australian Register of Therapeutic Goods before that claim can be made at all. The TGA’s advertising legal framework page sets out how this applies in more detail.

This is the line that trips up the most businesses. “Supports healthy digestion” is likely to be treated as a general wellness claim. “Treats irritable bowel syndrome” is likely to be treated as a therapeutic claim. The difference between those two sentences can be the difference between a compliant ad and a TGA infringement notice.


A side-by-side comparison

General wellness claims tend to sound like: supports immune function, helps maintain healthy energy levels, contributes to general wellbeing, may help support a healthy lifestyle. Therapeutic claims tend to sound like: treats arthritis, cures insomnia, prevents colds and flu, alleviates anxiety, reduces symptoms of menopause. The first group describes a general contribution to how someone feels. The second group makes a specific promise about a named condition. If your marketing copy is closer to the second list than the first, it’s worth checking your product’s regulatory status before that copy goes live.


Unsubstantiated claims about serious conditions

The ACCC and the TGA both tend to treat claims about curing or preventing serious illness as some of the most serious conduct they regulate, because the potential consumer harm isn’t just financial.

Someone who believes a product will manage a serious health condition may delay or forgo proper medical treatment. Both regulators have taken enforcement action against wellness and supplement businesses making unsubstantiated claims of this kind, and penalties in this category tend to be applied more aggressively than in other advertising categories.


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Testimonials and influencer content generally don’t count as evidence

This is worth stating plainly because it surprises a lot of health and wellness businesses. A customer testimonial saying a product worked for them, or an influencer’s personal experience, is generally not accepted by the TGA or the ACCC as substantiation for a therapeutic claim. If you’re making a claim that a product does something therapeutic, you generally need actual clinical or scientific evidence behind it, not anecdotal reports, however genuine those reports are. Relying on “but real customers say it works” as your only evidence is unlikely to be treated as a defence. We cover how testimonials are treated more broadly in Are Your Testimonials and Reviews Legal?


The “clinically proven to eliminate anxiety” scenario

A supplement business sells a magnesium powder with the tagline “clinically proven to eliminate anxiety.” In reality, the business has a small internal customer satisfaction survey showing most customers reported feeling calmer, and a general scientific literature review showing magnesium plays a role in nervous system function. Neither of these is likely to constitute the kind of clinical evidence “clinically proven” implies, and “eliminate anxiety” is likely to be treated as a specific therapeutic claim about a recognised condition, rather than a general wellness statement. A safer, still persuasive alternative might be “formulated to support relaxation, as part of a healthy lifestyle,” paired with genuine substantiation for the ingredient’s general role, without claiming to treat a diagnosed condition.


A practical way to check your own claims

Before a health or wellness claim goes into an ad, run it through three questions.

Is this a general wellness claim (how someone might feel, general support, lifestyle benefit) or is it actually a claim about treating, preventing, or curing a specific disease or condition? If it’s the latter, you’re likely in Therapeutic Goods Act territory and should check your product’s regulatory status before making the claim.


Do you have actual evidence, not customer anecdotes or influencer experience, that supports the specific wording you’re using? “Clinically proven to reduce fine lines” is likely to need a study behind those exact words, not just a general reputation for skincare efficacy.


Would a reasonable consumer, reading the ad as a whole rather than parsing each word, come away with an accurate impression of what the product can and can’t do? If the overall impression overstates what the evidence supports, the specific wording being technically defensible is unlikely to be enough on its own.


The cost of getting it wrong

Beyond the ACL penalties outlined in this month’s first blog, Is Your Advertising Legal? (up to 100 million dollars for a corporation, or 2.5 million dollars for an individual, for conduct from 28 March 2026), the TGA has its own enforcement powers, including infringement notices, mandatory corrective advertising, and public naming of businesses found to be non-compliant. For a small wellness business, a public TGA infringement notice can potentially do more lasting damage to trust than the fine itself.


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This blog is intended for general information purposes only and does not constitute legal advice. The content is based on Australian law and may not be current at the time you read it. Legal requirements may vary depending on your circumstances. Always seek independent legal advice tailored to your specific situation before acting on any information provided.

 
 
 

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