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Posted 11 October 2013
We have to commend Glomail for at least putting some money into testing whether Celltone “Regenerative gel”, that it would “… assist with the management of various skin afflictions” and that it “Helps diminish the appearance of stretch marks, scarring, spots and wrinkles” as claimed by Glomail.
However, here it gets interesting. The study done locally by Future Cosmetics appeared to Glomail to support the claims that the product works. And Mr John Knowlton of Cosmetic Solutions who has substantiated a number of other products complained to the ASA about, and previously regarded as an expert by the ASA, substantiated the product’s claims (mostly) based on this study.
However we carefully examined the findings and found that the evidence was actually against the claims! Yep, did not support the claims at all. In fact, it confirmed what we had been saying, it just does not work and explains why consumers were complaining!
Credit to the ASA who read the two arguments carefully, examined the evidence, and using common sense came to the same conclusion as we had done!
1. The ASA ruling
2. Our arguments against the claims of the product.
[note note_color=”#f8f8aa”]Glomail Celltone / HA Steinman /18897
Ruling of the : ASA Directorate
In the matter between:
Dr Harris A Steinman Complainant(s)/Appellant(s)
Africom International (Pty) Ltd t/a Glomail Respondent[/note]
10 Oct 2013
In a ruling dated 25 October 2012, the Directorate considered advertising promoting the respondent’s Cell Tone product. The Directorate held that claims that the product was a “Regenerative gel”, that it would “… assist with the management of various skin afflictions” and that it “Helps diminish the appearance of stretch marks, scarring, spots and wrinkles” were not substantiated and had to be removed.
In a subsequent ruling issued on 11 July 2013, the Directorate dismissed a breach allegation lodged by the complainant.
SUBSEQUENT TO THESE RULINGS
In its submissions to the ASA in September 2013, the respondent argued that the claims are now adequately substantiated. It relied on verification from Mr John Knowlton of Cosmetic Solutions and studies done by Future Cosmetics CC.
In light of the verification, the following claims are now permissible:
• “Lightens and brightens complexion”
• “Rejuvenates the skin for a more youthful appearance”
• “Reduces the appearance of dark spots”
• “Reduces the appearance of fine lines and wrinkles”
• “Reduces the appearance of stretch marks”.
The verification letter from Mr Knowlton concludes that “… it is my considered expert opinion that the following claims are adequately supported in terms of Clause 4.1 (Substantiation) and are not in breach of Clause 4.2.1 (Misleading advertising) …
• ‘Regenerative Gel’
• ‘Celltone assists in the management of various skin afflictions’
• ‘Helps diminish the appearance of stretch marks, sports and wrinkles’
The evidence provided to me however does not provide adequate substantiation … for the following claim:
• ‘Helps diminish the appearance of … scarring …’ …”
RELEVANT CLAUSES OF THE CODE OF ADVERTISING PRACTICE
In light of the new substantiation, the following clauses of the Code were considered relevant:
• Section II, Clause 4.1 – Substantiation
• Section II, Clause 4.2.1 – Misleading claims
In accordance with established procedure, the complainant was asked to comment on the new substantiation.
In essence, the complainant argued that the substantiation is inadequate, follows flawed statistical interpretation of the testing, and used very small, non-representative sample sizes which means that the findings cannot be extrapolated to the general public. Reference was also made to comments obtained from a Professor Martin Kidd of the University of Stellenbosch’s “Centre for Statistical Consultation” at its Department of Statistics and Actuarial Sciences. These comments suggest that the studies would not pass academic scrutiny and could not be relied on as proof of efficacy.
ASA DIRECTORATE RULING
The ASA Directorate considered all the relevant documentation submitted by the respective parties.
Over the years, the issue of substantiation as called for in Clause 4.1 of Section II has been the subject of many ASA rulings, resulting in some definitive criteria being established. In simple terms, the Directorate requires the following in order to be satisfied that the substantiation submitted adequately verifies the claims:
1) The substantiation must emanate from, or be evaluated by an independent and credible expert in the field to which the claims relate.
2) The substantiation and testing done must relate to the product as sold to consumers, and not to bits and pieces of ingredients.
3) The expert relied on to verify the claims, must unequivocally verify that the claims as made in the advertising are true.
4) The supporting documentation relied on by the expert have to appear to support his findings (in other words, if the supporting documentation finds that a claimed effect is not likely, and the expert claims that it is, such discrepancy would likely result in the Directorate rejecting the claim).
The respondent appears to have had its actual product tested, and appears to have obtained expert opinion from independent expert entities practicing in the cosmetic field. While the ASA has accepted both Mr Knowlton and Future Cosmetics CC as experts for such purposes, it is not necessary to express a view on their expertise in this ruling for the reasons articulated below:
The Directorate cannot overlook the concerns highlighted by the complainant in terms of the apparent contradictions and disparity between Mr Knowlton’s verification and the findings articulated in the supporting studies. It is trite that the Directorate is not a technical expert entity, and cannot interpret scientific data with the same level of understanding. This is predominantly why the Code allows for the Directorate to rely on the unequivocal verification of an appropriate expert. Having said this, the Directorate cannot relinquish its duty to interrogate the substance of the substantiation and satisfy itself that the verification is sound and supported by the supporting evidence.
In Lifebouy / Dettol / 14813 (27 August 2010), the Directorate’s acceptance of substantiation from an expert opinion came under scrutiny, and the Advertising Industry Tribunal (the AIT) had to determine to what extent the Directorate should accept or rely on expert verification. Effectively, in accepting the substantiation, the Directorate relied merely on a letter from the relevant expert. The AIT ruled, inter alia, as follows:
“Once such substantiation has been submitted it is obviously the duty of the Directorate or any other body of the ASA charged with disposing of the complaint, to satisfy itself that the substantiation submitted complies with the requirements of the Clause 4.1 and that the claims are indeed substantiated. In so doing, like with any other decision it takes, it is required to apply its mind to the matter, in this instance, to the substantiation submitted and to satisfy itself that there was sufficient evidence before it showing that there is credible documentary evidence supporting the claims. As the decision maker and primary enforcer of the Code it was ultimately its duty to establish this. Ordinarily in our view this would presuppose that it had considered the documentary evidence / substantiation in issue.
While we accept and indeed agree that because the Directorate (or any other ASA body for that matter) invariably may not or will not have the technical expertise to evaluate technical or scientific documentary evidence, it will often be required to rely, if not heavily, upon any expert views or opinions furnished, this does not mean that the Directorate may relinquish its responsibility to ensure that sufficient documentary substantiation in fact exists to any such expert. It is accordingly required, as would any other administrative body, or a court of law, in a similar position, to assess any expert view proffered and satisfy itself as to the adequacy, at the very least, of the expert view.
In the instant case we do not believe that the Directorate did properly satisfy itself of the adequacy of the expert view and in our view did not properly apply its mind to the question of whether sufficient and adequate substantiation had been put before it to support the claims in issue”.
If one has regard merely for the letter of Mr Knowlton, one might be forgiven for interpreting it to show that the product will deliver on the claims at issue. However, on closer reading of the supporting documentation (as mandated by the principle established in the Lifebuoy ruling referred to above), the Directorate notes as follows:
Scars or scarring
Both Mr Knowlton and Future Cosmetics CC state unequivocally that references to improving the appearance of scars or scarring has not been established. This means that no such claims can be made.
Report on In Vivo Combination Study: FCAH096, dated 30 July 2013
• The results for reducing the appearance of dark spots on the hands only demonstrated efficacy at day 28 of a 70 day trial. The Future Cosmetics report concludes “It can therefore be concluded that the test product … was effective on reduction of darks [sic] spots on hands after twenty-eight (D28) days of consecutive use (application twice a day) when compared to the placebo control …” It also points out that no statistically significant difference was measured between the effect of the advertised product and that of the placebo at days 14, 56 and 70.
• The results for reducing the appearance of wrinkles only demonstrated efficacy on (and presumably between) days 28 and 56 of a 70 day trial. The report concludes “It can therefore be concluded that the test product … was effective in wrinkle reduction on after twenty-eight (D28) and fifty-six (D56) days of consecutive use (application twice a day) when compared to the placebo control …” The report also points out that no statistically significant difference was measured between the product and the placebo on days 14 and 70.
• These tests were all conducted on “… Caucasian human subjects …”, all of whom were female.
At the very least, the above suggests that the references to improving the appearance of wrinkles and dark spots ONLY appear at very specific times, and do not last even with continued use. While the Directorate accepts that the effect on spots on the female “décolletage” (upper part of a womans torso, between her waist and neck, comprising her neck, shoulders, back and chest) appear to continue lasting, it has reservations about the general applicability of this study, seeing that it was ONLY done on white females. The respondent’s expert has not submitted anything to suggest that the findings are applicable to other skin types typically found in South Africa.
Report on In Vivo Combination Study: FCAH096 dated 29 July 2013
The summary at the beginning of the report suggests that the product was unable to demonstrate efficacy in “Uneven Skin Tone Reduction Efficacy (Uneven Skin Tone)”, “Skin Smoothing Efficacy (Dark Spots)” and “Uneven Skin Tone Reduction Efficacy (Uneven Skin Tone).
It does, however, appear to suggest that “Skin Lightening Efficacy (Dark Spots) was proven at days 14, 28, 56 and 70. It concludes that “It can therefore be concluded that the test product … was effective on reduction of darks [sic] spots after fourteen (D14), twenty-eight (D28), fifty-six (D56) and seventy (D70) days of consecutive use (application twice a day) when compared to the placebo control …”
• The results for testing whether the product outperformed the placebo with regards to improving “Uneven Skin Tone” concludes that “It can therefore be concluded that the test product … was not effective on reduction of uneven skin tone after fourteen (D14), twenty-eight (D28), fifty-six (D56) and seventy (D70) days of consecutive use (application twice a day) when compared to the placebo control …”.
• The results for testing whether the product outperformed the placebo with regard to “Skin Rejuvenation” suggests that statistically significant differences were seen from day 14 right up to day 70. It concludes that “It can therefore be concluded that the test product was effective on increasing the ‘Rejuvenated Look’ after fourteen (D14), twenty-eight (D28), fifty-six (D56) and seventy (D70) days of consecutive use (application twice a day) when compared to the placebo control …”
• The results for testing whether the product outperformed the placebo with regards to “Smoothness (Dark Spots)” concludes that “It can therefore be concluded that the test product … was not effective in increasing the smoothness of dark spots after fourteen (D14), twenty-eight (D28), fifty-six (D56) and seventy (D70) days of consecutive use (application twice a day) when compared to the placebo control …”
• The results for testing whether the product outperformed the placebo on increasing the smoothness of uneven skin tone also concludes “It can therefore be concluded that the test product … was not effective in increasing the smoothness of uneven skin tone after fourteen (D14), twenty-eight (D28), fifty-six (D56) and seventy (D70) days of consecutive use (application twice a day) when compared to the placebo control …”
In this instance, the testing involved 30 females, of which 22 were Caucasian, and 8 were listed as “Negroid”.
It is a commonly understood principle that cosmetic products offer a temporary improvement and that the continued appearance of improvement is subject to the continued use of the product. The results summarised above, appear to suggest that in most instances (even the ones where an initial improvement was seen) this improvement was not sustained despite the continued use of the product for 70 days, with it being applied twice a day. This appears to contradict Mr Knowlton’s assertion that the claims at issue are adequately supported.
A hypothetical reasonable person would expect the claims to apply as long as the product is being used, but the evidence appears to suggest only temporary effect for the majority of skin conditions tested (the exceptions appear to be the impact on dark spots on the décolletage of Caucasian females, Skin Rejuvenation perceptions). In some instances, no effect appears to have been demonstrated.
In addition to this, the Directorate has to be satisfied that the findings of the tests are applicable to the South African consumer likely to be influenced by the advertising. For the purpose of this ruling, the Directorate assumes that this typical consumer would be a female South African, but there is no reason to presuppose that it would predominantly be limited to only Caucasian women, within the age groups of those tested. The respondent has not suggested that this is the case, and Mr Knowlton has not submitted anything to suggest that the findings are applicable to any South African female. The advertising at issue does not appear to narrow the scope of the claims to any specific population group, and the Directorate therefore expects the hypothetical reasonable person (female) exposed to this marketing to interpret the claimed benefits as applicable to them irrespective of race or age or where on their bodies they plan on using the product.
Given the apparent discrepancies between Mr Knowlton’s verification and the findings of Future Cosmetics CC, the Directorate is not, at present, convinced that the claims as previously considered are adequately supported by the documentation Mr Knowlton relies on.
Accordingly, the ruling of 25 October 2012 remains binding, and the respondent is not permitted to make the claims ruled against.
Our response to the substantiation
1 October 2013
Advertising Standards Authority of South Africa
Re: Glomail Celltone / HA Steinman / 18897
Thank you for your letter of the 6th September 2013 requesting me to comment on the substantiation that Glomail has supplied in support of their Celltone product. Subsequently a further document was received in which Mr John L Knowlton accepts aspects of the study claiming that the study substantiates many of the claims.
I must commend Glomail for having for the first time, made an attempt to substantiate one of their products.
However, the substantiation falls far short of an adequate substantiation. In fact, the documents supplied in fact confirm that this product has little to no benefit at all. I also contest the conclusions that Mr Knowlton has reached and these will be addressed below.
Firstly, my general comments.
I have asked Professor Martin Kidd of the University of Stellenbosch, Centre for Statistical Consultation, Dept of Statistics and Actuarial Sciences University of Stellenbosch* for an opinion of the study supplied in support of Celltone.
The salient points Prof Kidd made were the following
What is also a concern for me is the double blindness of the study. Were the participants blind to the treatment they received, and were the people doing the measurements blind to the treatment? How were areas on the body selected for treatment and who decided that? Were these people also blinded?
Ethical clearance is also a serious issue. If no formal ethical clearance from a recognized body was received for this study, then it indicated irresponsible behaviour on the part of the company.
I also cannot confirm whether the statistical analyses were done correctly. They mention t-tests, and ANOVA but do not seem to understand the similarity between the two methods. They also do not indicate whether paired t-tests/repeated measures ANOVA’s were done. The way I understand the experimental layout, this should have been the case. However for the major significant findings (p<0.001) its probably not going to make much difference.
In other words, Prof Kidd has confirmed my concerns that there is no mention of allocation concealment. The (obvious?) selection bias possibly nullifies any objective outcomes.
In photographic tests – how were photos randomised for blinded experts?
Finally – there is no evidence of ethics clearance of the studies.
Specific comments include:
I argue that the study group is NOT representative of the population in general and therefore the results cannot be extrapolated to the general population. For example, there is a significant difference in the skin between a young individual an older people. This study was conducted on only 24 individuals, all women, and aged 41-68 years. There is no proof that this product will benefit younger skin. No men were included in the study. Only Caucasian women were studied and therefore the conclusions cannot automatically be extrapolated to dark skinned individuals. For example, does the product affect skin with high levels of melanin (dark skinned individuals) differently? The advertising of this product is aimed at all ages and all race groups, yet one part of the study was conducted on only Caucasians.
Nonetheless, even if all the above arguments were correct and acceptable, the data contradicts the claims being made by Celltone.
“….the appearance of …….spots……”
Mr Knowlton concludes that “the study conducted on the hands using 22 subjects demonstrates an improvement in the visible appearance of dark spots, versus the placebo, after period of 28 days with the result being achieved with a statistical significance of p < 0.05 (95% confidence level).“
However, the data in Appendix G of the document Future Cosmetics 1.pdf, show that Mr Knowlton is not giving the full explanation which is highly disingenuous. The data clearly shows that there was no statistical significance for the product for Dark Spots on the hands after 14 days nor at day 56 but ONLY at day 28. In other words, the study claims that using Celltone makes no difference after 14 days, that there appears to be improvement at 28 days, but then this effect is lost and there is no difference at 56 days! Scary stuff. What is also very clear from the results is that the changes were very small, up to around 14%. What this means is that there may be “statistical significance” according to mathematical principles, that there is little to no clinical significance!
Then more facts against the claims for Celltone, although there was a “statistical significant” of Dark Spots on the hands only on day 28, looking at Dark Spots on the décolletage (upper part of a woman’s torso, between her waist and neck), Appendix G also shows that the product is “statistical significant” for 28 days and upwards – an effect different from the hands. Therefore if Celltone wanted to make accurate claims that do not mislead consumers, Celltone should advertise that the product has a positive effect ONLY on the décolletage and not elsewhere! However, as mentioned, the changes to the skin were only around up to 14% (i.e., little clinical significance). Other evidence against the claims as supported by the study is that the sample size is very small, and only demonstrated in middle aged and older women. Therefore, to be accurate in Celltone’s claims, and not misleading, Celltone will have to advertise that Celltone is partially of benefit to middle aged white women in a study with a confidence of 5%!
The same study on the face, shows the same effect of having “statistical significant” changes at 28 days and 56 days, but not at 14 or 70 days! Therefore to be accurate, Celltone should advertise that the product is ineffective up to 28 days and only has an effect up to 56 days, and no longer!
“….the appearance of stretch marks……”
For stretch marks, the same type of pattern is shown, the product only has some efficacy after 56 days – not before, but then the effect is lost by 70 days.
Mr Knowlton states: “In summary, the results of this study demonstrate an improvement in the visible appearance of stretch marks, versus the placebo, after a period of 56 days, with the result being achieved with a statistical significance of p < 0.001 (99.9% confidence level).”
Mr Knowlton therefore states or implies that the claim that Celltone is beneficial for stretch marks. It is unfathomable how Mr Knowlton can consider the claim substantiated when in fact the product has NO benefit on the “visible appearance of stretch marks” at 14 days, or at 28 days, or at 70 days, but is ONLY at 56 days! How long does the effect last before disappearing at 70 days! Surely this is highly misleading?
Most damning, is the objective sensory report which demonstrates NO significant differences between Celltone and a placebo. Although the report claims no significant differences for H0 and a significant difference for H1, in fact the p value is 0.64 which is NOT significant.
“….the appearance of ……scarring……”
I concur with Mr Knowlton that the study does not support the claims that Celltone is beneficial for scarring, i.e., “In summary, the results of both of these studies demonstrate no significant improvement in the visible appearance of the homogeneity of the scars, even after the test period of 70 days.”
In the document Future Cosmetics 2.pdf, the conclusions are summarised: that Celltone passed the test for Skin Lightening Efficacy (Dark Spots) and Skin Rejuvenation but FAILED Uneven Skin Tone Reduction, Skin Smoothing Efficacy and Uneven Skin Tone Reduction. Surely therefore for Celltone to not be misleading, it should advertise exactly these findings?
However, I argue that one CANNOT accept the conclusions that “that Celltone passed the test for Skin Lightening Efficacy (Dark Spots) and Skin Rejuvenation “ for the same problem exists with the study group: they are not fully representative of the population and the same size is very small. In this case, the study group are all women, but in this case include 22 Caucasian women aged 41 years of age to 68 years of age, and 8 Negroid women aged 21 to 49 years of age. Surely the results of 8 Negroid women cannot be extrapolated to all Negroid women? And significantly, although this document claims that Celltone passed for i.e. Skin Rejuvenation, examining the actual data in Appendix G of the same document, it shows that Celltone was statistically significant at day 14 and 56 and 70 but NOT at day 28! Imagine selling a product that works on some days and not on others! Furthermore, these values DIFFER from Table 3 where the results are summarised which suggests that the whole study should fail.
“….the appearance of……wrinkles”
The study concludes that for Wrinkle Reduction Efficacy that “there was a statistical significance difference on a 5% level of confidence on D56 and D70”. Mr Knowles concludes that “the results of this study demonstrate an improvement in the visible appearance of wrinkle, versus the placebo, after period of 28 days, with the result being achieved with a statistical significance of p < 0.05 (95% confidence level).”
Prof Kidd commented: “I am not sure whether they actually mentioned 5% confidence intervals. If so then its just incorrect terminology. As far as I can gather they use a 5% significance level which is acceptable.” (Yes, they did state 5% confidence which if this is what they claim, this means that there is NO confidence in the result. One needs a confidence level of >90%)
However, Mr Knowles again ignores the blatantly obvious results in Table 3 which demonstrates that the wrinkles were improved by Celltone at Day 28 and Day 56 and NOT Day 70. A p-Value of less than 0.05 is statistically relevant. The p-values for Day 28 and Day 56 are 0.019 and 0.034 respectively and 0.073 for Day 70. In other words, Celltone will start working on a consumer’s wrinkles at Day 28 till Day 56 and soon thereafter stop working so that there is no beneficial effect at Day 70! This clearly makes no sense in the context of the claims which claim that Celltone will reduce the appearance of wrinkles. In fact, an accurate claim will be that “Celltone reduces wrinkles at Day 28 until Day 56 and then stops working resulting in the wrinkles reappearing soon after” (if one accepts that the number of the study group is sufficiently representative which it is not).
In conclusion, I therefore argue that based simply on the study sample size, the study should fail. However I have demonstrated a great many other reasons why the substantiation should fail.
In the AFRICOM.pdf document, the company concludes:
“Based on the clinical results we believe the following claims can now be substantiated:
Lightens and brightens complexion
Rejuvenates skin for a more youthful appearance
Reduces the appearance of dark spots
Reduces the appearance of fine lines and wrinkles
Reduces the appearance of stretch marks
However it is absolutely clear from the actual study supplied, and as I have deconstructed above, that this is absolute nonsense.
Therefore the attached study does NOT substantiate the claims for Celltone.
I also argue that the advertising for Celltone gives the clear impression that Celltone is equivalent or better than other remedies on the market. At best this study would simply suggest that Celltone is somewhat better at certain periods, than a placebo mix in certain instances, and that the effects wear off and obviously further use will not improve the situation for the effects wear off on Day 70 in spite of Celltone still being applied.
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