Posted 12 January 2016
We have previously posted an article on Mervyn Daitz notorious for his RAYMA Balance Bracelet and BodyTrim products, and the No!No! hair removal device that Consumer Reports found not to be effective.
As IOL pointed out way back in 2012, “Professor David Whitehead, called for the harshest possible sanctions, saying that the company had shown “complete disregard” for the ASA’s initial ruling as well as a lack of remorse”. “The Rayma bracelets cost between R719 and R1 139, including packaging and posting.” “. . .of course, that decorative bracelets can be bought for far less”.
Well that did not dent Mervyn from continuing to make unsubstantiated claims for No!No! on their website, including the claims “. . . is a doctor recommended device that is based on years of research and development” and “Guaranteed Results”.
Complaints were recently laid with the UK ASA for similar claims being made, and not surprisingly, the UK company could not provide any reasonable evidence to support the claims being made.
ASA Ruling on Photo Therapeutics Ltd
Photo Therapeutics Ltd t/a no!no!
Date: 23 December 2015
Complaint Ref: A15-306676
A national press ad for the no!no! PRO hair removal device seen on 15 June 2015 was headed “SAY ‘GOODBYE!’ TO PROBLEM HAIR FOREVER and never shave, wax or bleach again!” and “Discover the instant pain-free solution to embarrassing facial hair!”. Further text included “That’s right. Say ‘goodbye’ – and good riddance – to abrasive shaving; banish your bleach to the nearest bin; and wave that wax a welcome goodbye! With your no!no! PRO, you will never suffer the embarrassment of unwanted hair again. Whether it be on your face, arms, legs or back – even your bikini line – no!no! PRO promises instant, pain-free hair removal with silky-smooth, salon-quality results that last and last! With over 5 million sold worldwide, you can rest assured – no!no! delivers that promise! .. to give you the smooth, sexy skin you’ve always wanted. No more waxing, shaving or bleaching – just lasting salon-quality results faster than ever before!”.
Two complainants challenged whether the claim “SAY “GOODBYE!” TO PROBLEM HAIR FOREVER” and references to lasting results were misleading and could be substantiated.
CAP Code (Edition 12)
Photo Therapeutics Ltd said that the no!no! device could achieve lasting results and that they considered such claims to be a more consumer friendly way of communicating that use of the product resulted in permanent hair reduction. They said that in the United States, the Food and Drug Administration (FDA) guidelines defined permanent hair reduction as long term, stable reduction in the number of hairs re-growing after a treatment regime, which might include several sessions. The number of hairs re-growing must be stable over time must be greater than the duration of the complete growth cycle of hair follicles, which varied from four to 12 months according to body location, and permanent hair removal did not necessarily imply the elimination of all hairs in the treatment area. They said that in applying that position, the FDA required a 30% hair follicle count reduction as a goal beyond which claims were approved. They believed it was uncontroversial that devices such as theirs could lead to permanent hair reduction and that the evidence they held went beyond that required for claims of this nature.
They provided a trial which had been carried out on their product in 2014 which they said demonstrated that it achieved ‘lasting results’. They also provided seven independent clinical trials previously carried out on the product, along with a review of those seven trials carried out by a leading expert in the field of trichology.
They said that they usually included a comparative table in their ads which referred to the different methods of hair removal available and included the recommended frequency of use of their product, which was two to three times per week. They said they were willing to remove the claim “SAY ‘GOODBYE!’ TO PROBLEM HAIR FOREVER” from future ads and, whilst they were able to substantiate claims that the product had lasting results, they would continue to make clear that the products had to be used continuously to achieve the best results.
We considered that in the context of the ad consumers would interpret the claims “SAY ‘GOODBYE!’ TO PROBLEM HAIR FOREVER” and references to “lasting” results to mean that use of the product would lead to a permanent reduction in the number of hairs in the areas treated. Claims such as “never shave, wax or bleach again”, “Say ‘goodbye’ – and good riddance – to abrasive shaving; banish your bleach to the nearest bin; and wave that wax a welcome goodbye” and “you will never suffer the embarrassment of unwanted hair again” added to the impression that the device would have long-term effects, given that they were short-term hair removal methods which would have to be repeated. We also considered that consumers were unlikely to be aware of how the device worked, and that in that context they would be unclear about whether the claims were referring to hair removal at the time of treatment or longer term removal. We therefore assessed whether the evidence supported those implied claims. We did not consider that it was generally established that the device could permanently reduce the number of hairs in the areas treated and therefore considered that we needed to see a robust body of evidence to support those claims. We also noted that we had not seen any evidence that the FDA had cleared the no!no! device, or similar devices, to make permanent hair reduction claims.
Photo Therapeutics had provided one trial from 2014, along with seven earlier studies and a review of those studies by an expert in the field of trichology. Those seven studies had previously been submitted to the CAP Compliance team and they had sought expert advice on them, which we took into account when considering that evidence.
We understood that human hair growth consisted of a growing phase (anagen) and a resting phase (telogen) and the duration of each phase depended on the site of the hair on the body. Temporary removal of hair from the skin surface was facilitated by various well established techniques such as epilation, shaving or waxing, which required repeated use to maintain a hairless appearance. Permanent hair removal was facilitated by action which affected the hair root and/or hair follicle stem cells in the bulge region. Those reactions would only affect hair in the anagen growth phase and such treatments would require multiple procedures to achieve complete hair removal.
In relation to the seven earlier studies, we considered they demonstrated that the no!no! device removed hair from the skin by thermal singeing, i.e. burning off hair at the point of contact. The extent of removal appeared to be related to the thickness of the hair being treated, with a lesser percentage removal of thicker hair. Hair diameters and linear hair growth rates were not measured in any of the studies and therefore claims that the product could reduce visible hair regrowth and had a greater effect on regrowth over time, which suggested a permanent effect on the hair follicle, were not supported by the evidence. We considered that to support claims of that nature we would need to see evidence of quantitative reductions in hair diameters, linear growth rates and hair density with repeated use of the device. Such measurements would ideally be undertaken for at least three complete hair cycles of the hair type under investigation. Long-term hair density data showing that the reduction in hair density had been maintained once the subjects discontinued use of the device would also be required.
The 2014 trial had not been published or peer reviewed, and the report we were provided with was described as the interim report, with an additional document detailing the final results. The trial was carried out on 51 subjects (36 females and 15 males); 45 subjects completed the treatment phase. The trial was baseline controlled (although it would have been preferable for it to have used a control sham device on, for example, the opposite arm or leg) and hair counts had been carried out by an independent evaluator who was blinded to the subject number, site of the test and time point involved using photographs. The subjects were treated with the device twice a week for 12 weeks on four sites – one on each arm and leg – and no other hair removal devices or products were used during the treatment phase. Hair count for each 2 x 3 cm site was measured at weeks 0 (baseline), 4, 8 and 13 prior to treatment that day. From weeks 12 to 24 subjects were not treated with the device and a final hair count was taken at week 24 to assess any long-term suppression or delay of hair growth. The report itself did not assess the results in detail, but the results were provided. During the 12-week treatment period, statistically significant decreases in hair count compared to baseline were observed. The mean percentage decrease in hair count varied from 57% to 43% for arms and 47% to 35% compared to baseline for legs at the treatment phase measurement points, and the majority of subjects saw a greater than 30% decrease in hair count for both arms and legs during that period. We considered that those results were consistent with the twice-weekly use of a device which removed hair at the time of use. The measurements taken following the 12-week post-treatment period showed that differences between the measured and baseline hair count had decreased. The mean percentage difference between baseline and week 24 hair count was -22% for arms and -19% for legs, although we also noted that there was some difference in the figures given in the main interim report and the additional document, which included the week 24 results. We understood this was because the hair counts had been re-evaluated for the final report and that the differences expressed the bias between the different evaluators. We had not seen any evidence that hair reduction at that level was likely to be cosmetically relevant to consumers. Although the week 24 results were statistically significant compared to baseline we noted that the hair counts appeared to be returning towards baseline, and that only 33% of subjects had a greater than 30% reduction in hair count compared to baseline at that point. We considered that the trial had not been carried out for a sufficiently long period of time to determine whether the device reduced hair permanently, as opposed to merely removing hair at the time of treatment.
Overall, we did not consider that the evidence provided by Photo Therapeutics was sufficient to substantiate the implied claims that use of the no!no! device would lead to a permanent reduction in the number of hairs in the areas treated. We therefore concluded that the claims “SAY ‘GOODBYE!’ TO PROBLEM HAIR FOREVER” and references to lasting results were misleading.
The ad breached CAP Code (Edition 12) rules 3.1 (Misleading advertising), 3.7 (Substantiation), 3.11 (Exaggeration) and 12.1 (Medicines, medical devices, health-related products and beauty products).
The ad must not appear again in its current form. We told Photo Therapeutics Ltd not to repeat the claim “SAY ‘GOODBYE!’ TO PROBLEM HAIR FOREVER”, to refer to “lasting” results or to imply that use of the product would lead to a permanent reduction in the number of hairs in the areas treated, unless they held new and robust substantiation. Depending on the context, claims such as “never shave, wax or bleach again”, “Say ‘goodbye’ – and good riddance – to abrasive shaving; banish your bleach to the nearest bin; and wave that wax a welcome goodbye” and “you will never suffer the embarrassment of unwanted hair again” were likely to imply a longer term effect than hair removal at the point of treatment and were therefore unlikely to be acceptable.