Homemark Aragan Secret Nail Treatment Oil

Posted 20 December 2024

Homemark submitted several documents to the ARB, along with an explanation why it believes that these documents substantiate the claims that this product is making.

After considering the substantiation, the ARB was not willing to accept the 2014 report from “Dr M Burnstein Research & Development” as substantiation for efficacy claims previously ruled against.

And significantly, there is very little aragan oil in this product!

Decision of the ADVERTISING REGULATORY BOARD

Advertiser: Homemark (Pty) Ltd
Consumer/Competitor: Consumer
File reference: 3392 – Homemark Aragan Secret Nail Treatment Oil
Outcome: New substantiation not accepted
Date: 20 November 2024

The Directorate of the Advertising Regulatory Board has been called upon to consider new substantiation submitted by the Advertiser in this matter.

Background to the dispute

In 3392 – Homemark Aragan Secret Nail Treatment Oil (6 September 2024), the Directorate ruled that the Advertiser did not provide any evidence to support its direct and implied efficacy claims that the product was able to treat or improve ingrown nails, thick nails, broken nails, flaky nails, brittle nails or deformed nails. The Advertiser was instructed to withdraw any claims to this effect, as well as claims that the product had been “tried and tested”, until new substantiation was submitted, evaluated, and a new ruling issued in accordance with Clause 4.1.7 of Section II of the Code.

At the time, the Directorate indicated that it would not consider any claims relating to the treatment of fungus, as these were not present in the advertising at issue.

On 26 September 2024, the Advertiser submitted several documents to the ARB, along with an explanation why it believes that these documents substantiate the claims at issue.

Both complainants who were party to the original matter were afforded an opportunity to address the Directorate on the new submissions received from the Advertiser.

Description of the advertising

The Commercial “introduces” the Advertiser’s “… tried and tested Aragan Secret Nail Treatment Oil, which is harvested from the Aragan tree found only in Marrocco …” It explains that this oil contains various oils which ensure “… low pH levels to not only keep your nails smooth and attractive …” and features various visuals of people applying this to their fingernails or toenails (some of which appear chipped or discoloured), with words such as “Strong” and “Moisturised” appearing on-screen. In one scene, an animated image shows, what appears to be badly damaged or infected nail being treated with this oil, and transforming into a clear, smooth nail.

New evidence submitted by the Advertiser

The Advertiser submitted the following documentation:

1. The original Nail treatment Efficacy report (issued in 2014, a few months before it started marketing the product in South Africa).
2. The certificate of origin as evidence of the product being manufactured in Spain,
3. The Material Safety Data sheet (MSDS) as required by EU
4. A signed document by the Manufacturer confirming that the product formulation and ingredients used in South Africa is identical to those marketed in the UK and the EU by the manufacturer or its appointed licensees.

The Advertiser explained that this product is rich in bioactive compounds like essential fatty acids, vitamin E (tocopherols), sterols, and antioxidants that support nail health. It made reference to certain studies done on Argan Oil (the active ingredient of its product), which were published in various journals, and argued that these submissions constitute adequate substantiation for the claims in question, as well as any claims to help fight fungus.

Response from the Complainants

In accordance with the principle of audi alteram partem and the procedures laid out in the Code, both Complainants who were party to the previous ruling were afforded an opportunity to consider the new substantiation.

The first Complainant submitted that the evidence put forward should not be trusted, as the substantiating entity “Dr M Burnstein” manufactures and sells similar products to those advertised. In addition, Dr Burnstein’s claim to have a Ph.D. in alternative medicine from York University (as stated on his website https://www.drmbernstein.com/pages/dr-m-bernstein) appears doubtful, as one is unlikely to obtain a Ph. D without an undergraduate degree in medicine. This complainant added that York University has not existed for several years, and when it existed, was regarded as an unaccredited university where no one had medical degrees or a medical background.

Dealing with the study on which the Advertiser relies, the complainant pointed out that product contains less than 1% Argan Oil, a key active ingredient. Furthermore, none of the ingredients listed on the product composition document supplied by the Advertiser have a therapeutic purpose of use. The study did not have a control group and was not published in any peer-reviewed journals. Finally, the Complainant pointed out that all participants started seeing results after 6 months of use. This is a long time to wait, and should probably be emphasised in the advertising to avoid inaccurate expectations.

The Second Complainant also took issue with the fact that efficacy appears to only be proven after 6 months of use, which is not made clear in the advertising, and would likely not be the expectation of an average consumer. He added that there are six ingredients that have been approved by the US Food and Drug Administration (FDA) for treating Onychomycosis (toenail fungus), and that none of these ingredients are present in the advertised product. Unless it is made clear to customers that they should apply this product three times a day for at least six months before any improvement will be seen, the advertising remains misleading and unsubstantiated.

Application of the Code of Advertising Practice

As this is a request for new substantiation to be accepted, the ARB must determine whether the new substantiation before it constitutes adequate evidence in accordance with Clause 4.1 of Section II of the Code (Substantiation).

Should the substantiation be accepted, the ARB may need to determine whether the advertising complies with Clause 4.2.1 of Section II, which was identified as a relevant clause in the ruling of 6 September 2024.

Decision

Having considered all the material before it, the Directorate of the ARB issues the following finding.

The ruling of 6 September 2024 noted that claims communicating that this product is capable of treating or repairing ingrown nails, thick nails, broken nails, flaky nails, brittle nails or deformed nails required substantiation. Given the absence of any evidence, the ruling also held that the claim “tried and tested” in the context of being able to treat and repair nails was unsubstantiated.

The Advertiser made the point that this is a cosmetic product, which is not generally required to undergo peer-reviewed research as is typically the case for medicinal products (which was a concern raised by the First Complainant). The Directorate accepts this, and notes that the advertising does not present the product as a medicinal-type product. Having said this, it is noted that cosmetic products are still required to provide adequate substantiation for any direct or implied efficacy claims. This is borne out not only by the wording of Clause 4.1 of Section II, but also by Appendix B (Cosmetic Advertising Code of Practice).

Clause 4.1 of Section II requires advertisers to submit independent, objective substantiation for all direct and implied claims. It specifically points out that such substantiation should emanate from, or at the very least be evaluated and ratified by an independent and credible entity who could, objectively, be regarded as an expert in the field to which the claims relate. It further requires advertisers to ensure that the evidence relied on is up to date and current, and relevant to the product at issue.

It is noted that the Advertiser’s evidence is a decade old, which might suggest that it is out of date. However, nothing in the submissions before the Directorate suggests that this product has ever undergone a formulation change. Neither of the Complainants pointed out any formulation change between 2014 (the date of the evidence recently shared with the Complainants) and now. The Directorate therefore assumes, based on the submissions before it, that this product still contains the same ingredients as was the case in 2014.

The Directorate further accepts that, on the assumption that the product has not changed, the advertised efficacy is not one that would change over time. If the product worked in 2014 (as implied by the Advertiser’s submissions), there is no reason that it should not work in 2024. None of the likely variables would have changed in that time.

The report on which the Advertiser relies emanates from “Dr. M. Burnstein Research &

Development”. It purports to have tested 3 products, namely:

• Simon & Tom Fungusless,
• Simon & Tom Yoffee Clear,
• Aragan secret nail treatment (the product at issue).

The Advertiser also submitted a document titled “Confirmation of Product Ingredients” from “Simon & Tom Barcelona” confirming that the Advertiser’s Aragan Secret Nail Treatment sold in South Africa is “… identical in formulation to the products marketed and sold by ourselves under the brand names FungusLess, Yoffee Clear, Purity Nails, Dr Nails, and Nails Pro in Europe”.

The next question therefore has to be whether the report from “Dr M. Burnstein Research & Development” constitutes adequate substantiation for the purposes of Clause 4.1 of Section II (taking into account that this is a cosmetic product).

This is where the Directorate encountered some difficulties.

Firstly, no information was provided about “Dr M Burnstein Research & Development” laboratories where the research was reportedly conducted during 2014, making it hard for the Directorate to determine whether these laboratories or Dr Burnstein himself constituted an independent and credible expert in the field to which the claims relate. A Google search for this entity reveals that the trademark seen on the 2014 report was abandoned in 2016, and that the “pseudo mark” would have been “Doctor Moalem Burnstein Research and Development”. However, nothing on LinkedIn, Google or even Google Scholar was helpful in determining the credibility and expertise of “Dr M Burnstein Research & Development” or a “Dr Moalem Burnstein”.

The First Complainant referred to information appearing on a website for a Dr M Burnstein (see https://www.drmbernstein.com/), but it is not entirely clear whether this is the same Dr M Burnstein, especially as his first name is Michael. Aside from claiming that this Dr Burnstein has had “… an illustrious career spanning several decades in organic chemistry and alternative medicine”, nothing was placed before the Directorate to show that this is one and the same, or to demonstrate that Dr Burnstein (assuming this is the same person) would constitute an independent and credible expert in the field of nail fungus treatment, or nail repair and improvement. It is noted, however, that this Dr Burnstein sells a very similar product called “Nail Care Pro – Nail Strengthener and Repair Serum”.

In the absence of clarity from the Advertiser or Dr Burnstein himself, the Directorate cannot simply assume that this is the same entity, or that this entity can be considered an independent and credible expert in the field to which the claims relate.

However, if the Directorate assumes for a moment that this is the same person it would appear that he is not independent, as he sells the same or a very similar product. An independent expert is typically someone who would suffer no commercial repercussions from a negative finding.

Similarly, the “Study Investigator” is identified as “Dr. Nino Rebecca Eliahu Ph. D”, another person for whom no information was provided, making it hard for the Directorate to determine whether they constituted an independent and credible expert. As with Dr M Burnstein, LinkedIn, Google and Google Scholar revealed nothing helpful that would constitute evidence of their credibility and or expertise in the field to which the claims relate.

What’s more, as will become evident below, the Directorate has questions pertaining to how the substantiating documents relate to the advertising claims (if at all). These questions were not addressed by Dr Burnstein, and therefore remain unresolved, making it hard for the Directorate to simply accept that the advertising is adequately substantiated in terms of Clause 4.1 of Section II.

The study on which the Advertiser relies states that its “Zone” was “Toenails & Fingernails infected by Onychomycosis (Fungal infection)”, suggesting that it was focussed on, and limited to the product’s effect on fungal infections, which appears to be much more focussed than the general claims of broken, discoloured and deformed nails as communicated in the advertising. At the very least, nothing is said about repairing brittle or broken nails, ingrown nails or any other ailments.

The document states that the “Primary objective” of the study was “… to see no reactions non [sic] whatsoever to the product, no irritations, and participant’s convenience”. This appears to have nothing to do with product efficacy, but only with tolerance for the product in general.

The “Secondary objective” is stated as “… to see the results on the nails; status of the nails; general visual of the nails, the condition of the nails, and the efficacy of the product on each participant”. However, the study does not report any findings in this regard, and the conclusion is couched only in terms of the treatment of Onychomycosis (nail fungus). It reads:

“Preface: Onychomycosis (nail fungus) is a challenging disease that infects significant percentage of the population … The treatment is not simple and it takes long time until achieving results …

Conclusion: these three products that were tested proven to be effective; easy to apply; no side effects were observed and totally safe for use”.

Even if the Directorate were to accept Dr M Burnstein and Dr Nino Rebecca Eliahu as independent and credible experts in the field of nailcare and treatment (a finding which it is not in a position to make at this time), these conclusions pertain only to the treatment of Onychomycosis – something which is not claimed in the advertising (as was pointed out in the ruling of 6 September 2024). No mention is made of repairing broken nails (which are clearly seen in the advertising) or the ability to keep nails smooth and attractive, moisturised or strong (all claims made in the advertising).

Finally, it is also noted that the study conducted in 2014 specifically points out that the Advertiser’s Aragan Secret Nail Treatment was only tested on toenails, whereas the advertising shows it being applied to fingernails as well as toenails. While this may be irrelevant from a scientific efficacy point of view, it is a distinction drawn in the research report. Before the Directorate can simply assume that this distinction is irrelevant from an efficacy point of view, an independent, credible expert would need to address it and explain why it is irrelevant despite being pointed out in the report.

The Directorate is, therefore, not willing at this time to accept the 2014 report from “Dr M Burnstein Research & Development” as substantiation for efficacy claims previously ruled against.

In addition to the above-referenced report, the Advertiser referenced the following research articles:

• “Skin hydration in the Sahara: A prospective study on the moisturizing and anti-aging effect of argan oil” said to have been published in the Journal of Cosmetic Dermitology in 2017. As this appears to relate to skin hydration, it does not appear to be relevant to the claims at issue. In any event, this article was not placed before the Directorate, and it did not appear to be available online for consideration. It is therefore of no help at this time.

• “Antimicrobial and antifungal activity of argan oil against Candida albicans and Aspergillus fumigatus” said to have been published in the International Journal of Biological Macromolecules in 2016. Again, this article was not provided, and the Directorate was unable to find it However, as it appears to relate to Candida albicans and Aspergillus fumigatus, it does not appear to be relevant here. In any event, nothing was placed before the Directorate to demonstrate that these findings are relevant to the claims at issue.
• “Argan oil: Occurrence, composition and impact on human health” said to have been published in The European Journal of Lipid Science and Technology in While a copy was not provided, a copy thereof is available online from, inter alia, https://onlinelibrary.wiley.com/doi/epdf/10.1002/ejlt.200700220. The article makes no mention of “nails” or the Advertiser’s product, and contains nothing to suggest that using argan oil would deliver any benefit in terms of improving nail appearance, condition or any similar issues. It therefore does not appear to be relevant to the matter at hand.
• “Therapeutic potential of argan oil: A review” said to have been published in the Journal of Pharmacy and Pharmacology in 2010. While a copy was not provided, the Directorate was able to access a full text version of it online from https://www.researchgate.net/publication/47698407_Therapeutic_potential_of_a rgan_oil_-_A_review. The article does not appear to make any reference to nails, meaning it does not appear to be relevant to this decision.

Finally, it must be pointed out that even if the efficacy of aragan oil is established, the Directorate does not have the expertise to know whether it is included in the product in a sufficient amount to have efficacy. It is for this reason that the Code calls for verification from an independent expert, and does not expect the Directorate to interpret medical articles for itself.

For the benefit of the Advertiser, the following summary explains why the new information placed before the Directorate does not appear to satisfy the requirements of Clause 4.1 of Section II of the Code:

• Insufficient information was provided with regards to “Dr M Burnstein” and “Dr Nino Rebecca Eliahu”. The Directorate has no information as to who they are, what their experience and expertise are, and why they should be regarded as independent and credible experts in the treatment of nail damage, or even nail
• The report prepared by “Dr M Burnstein” and “Dr Nino Rebecca Eliahu” appears to focus only on the products purported efficacy against nail fungus (Onychomycosis), and not to any other impact or effect on nails. Given that the advertising contains direct and implied claims that go beyond this (as set out in the ruling of 6 September 2024), this is not sufficient.
• The ability to treat nail fungus was not considered in the previous ruling, as no claims to this effect appeared in the television commercial placed before the Directorate. It would, therefore, be inappropriate for the Directorate to pronounce on such a claim now. Even if the Directorate were able to consider such a claim now, it has only been presented with the report from “Dr M Burnstein” and “Dr Nino Rebecca Eliahu” which, as noted above, remains problematic.
• The additional articles referenced by the Advertiser do not appear to be relevant, as they do not appear to relate to the advertised product, and do not appear to reference any efficacy on nails.
• The additional articles also do not address whether the product itself contains sufficient Aragan Oil to show efficacy.

Considering the concerns highlighted above, the Directorate is not convinced that the information put forward by the Advertiser constitutes substantiation in accordance with Clause 4.1 of Section II of the Code.