Summary of Council decision:

Two issues were investigated, both of which were Upheld.

Ad description

A Snapchat story ad and a Facebook post for Hi Smile Pty Ltd:

a. The Snapchat story ad, for teeth whitening, seen on 11 September 2020 included a shot of a model placing the whitening product into her mouth and the text “tap to shop now”, a shot with a selection of reviews and the superimposed text “THE CLINICALLY TESTED TEETH WHITENING KIT” and a third shot that included the superimposed text “Advanced LED technology Paired with our unique PAP formula Whiter Teeth Without Sensitivity”. The cover image for the ad included an image of a mouth and the text “Clinically proven at home teach whitening”.

b. The Facebook post, appearing on HiSmile’s Facebook page, dated 24 November 2020, included the text “2.2X FASTER THAN TRADITIONAL WHITENING … Clinically proven teeth whitening”. The post included a video of a model using the product. Prior to using the product he had very yellow teeth and after using the product his teeth were shown as very white.


The ASA received two complaints:

1. Both complainants challenged whether the claims “clinically proven” and “CLINICALLY TESTED” in ads (a) and (b) and “2.2X FASTER THAN TRADITIONAL WHITENING” in ad (b) were misleading and could be substantiated.

2. One complainant challenged whether the video in ad (b) exaggerated the performance of the product because they believed that the model’s teeth had been edited to appear more yellow for the ‘before’ image and white for the ‘after’ image.


1. & 2. HiSmile Pty Ltd provided an independent cosmetic product safety report to demonstrate the product’s legality and safety as a cosmetic teeth whitening product; an independent clinical test which evaluated the tolerability and whitening cosmetic effect of the teeth whitening ingredient in their product; and an in vitro study the purpose of which was to test the whitening effect of the ingredient in comparison to peroxide-based whitening agents on human teeth.

HiSmile also provided an in vitro laboratory report to verify the claim that the product caused “whiter teeth in 10 minutes” using bovine enamel. They provided further in vitro studies which they believed substantiated the use of bovine enamel in efficacy tests. They highlighted the comments made by the independent testing house which stated that the testing method and the use of bovine enamel as the underlying test substance had been published in peer reviewed journals. The data from the test was shown to broadly correlate with the data from clinical studies using the same whitening agents. HiSmile provided a clinical test report which they said directly related to the performance of their product. They highlighted the conclusion of the report which stated that their product caused “a visible and noticeable whitening effect … after one treatment”. This treatment took 10 minutes.

HiSmile provided a protocol for future clinical trials that they would undertake to ensure that future ads were compliant with the Code.


1. & 2. Upheld

The ASA considered consumers would understand from the claims in both ads that the product had been clinically tested or proven, and that the clinical trials had produced a robust body of data and with an adequate methodology to prove that the product would work as shown in the ads. In the case of ad (b), we considered that consumers would understand that the claims that the product had been clinically proven, alongside the claim “2.2X FASTER THAN TRADITIONAL WHITENING” and the before and after images, to mean that the product would be able to whiten teeth much faster than traditional whitening treatments. We further considered that consumers would understand from the ad that clinical trials supported that claim. We therefore expected HiSmile to hold sufficient evidence to demonstrate that was the case.

We assessed the evidence provided by HiSmile. One clinical trial was conducted on the active whitening ingredient in the product, but had not used the HiSmile product itself. It did not include a control group and the participants were evaluated after 15 and 30 days. Another clinical study was also conducted on a different product, and each participant was treated for a period of 20 minutes before results were captured. The evidence also included in vitro studies on bovine teeth. While we acknowledged that in vitro studies could form an important part of research in the area, the purpose of only one of those studies was to quantify the product’s whitening effect on teeth. We did not consider it sufficient to demonstrate visible effects on human teeth. One study which measured the effects of the product on human teeth was not blinded and did not use a control group. We therefore considered that the methodology was not robust enough to prove the claims in the ads. We believed therefore that it would not meet what consumers would understand by the claims “clinically proven” or “tested”.

Given the above, we considered that the evidence provided by HiSmile was not adequate to demonstrate that the product was capable of whitening teeth “2.2x faster” than other whitening products, or that it could produce the effects demonstrated by the model in ad (b). We further concluded that the evidence was not adequate to substantiate the claims that the product was “clinically tested” or “clinically proven”. We therefore concluded that the claims in ads (a) and (b) had not been substantiated and were misleading.

The ads breached CAP Code (Edition 12) rules  3.1 3.1 Marketing communications must not materially mislead or be likely to do so.  (Misleading advertising),  3.7 3.7 Before distributing or submitting a marketing communication for publication, marketers must hold documentary evidence to prove claims that consumers are likely to regard as objective and that are capable of objective substantiation. The ASA may regard claims as misleading in the absence of adequate substantiation.  (Substantiation),  3.11 3.11 Marketing communications must not mislead consumers by exaggerating the capability or performance of a product.  (Exaggeration) and  12.1 12.1 Objective claims must be backed by evidence, if relevant consisting of trials conducted on people. Substantiation will be assessed on the basis of the available scientific knowledge.
Medicinal or medical claims and indications may be made for a medicinal product that is licensed by the MHRA, VMD or under the auspices of the EMA, or for a CE-marked medical device. A medicinal claim is a claim that a product or its constituent(s) can be used with a view to making a medical diagnosis or can treat or prevent disease, including an injury, ailment or adverse condition, whether of body or mind, in human beings.
Secondary medicinal claims made for cosmetic products as defined in the appropriate European legislation must be backed by evidence. These are limited to any preventative action of the product and may not include claims to treat disease.
 (Medicines, medical devices, health-related products and beauty products).


The ads must not appear again in their current form. We told HiSmile Pty Ltd not to claim that their product had been clinically tested or proven unless they held a robust body of evidence to show that it had. We further told them not to exaggerate the potential effects of the product or to claim that it could whiten 2.2x faster than traditional whitening treatments unless it held a robust body of evidence to support that claim.

CAP Code (Edition 12)

3.1     3.7     12.1     3.11    

More on