Background
Summary of Council decision:
Two issues were investigated, both of which were Upheld.
Ad description
A website and tweet by CryojuvenateUK, a cold-air treatment provider, seen in April 2017:
a. The website www.cryojuvenate.com, stated “Cryotherapy is a non-invasive, fast and effective hyper-cooling treatment for anyone seeking muscle recovery, injury treatment, weight loss or skin rejuvenation”. Further text stated “HOW CAN CRYOTHERAPY HELP?” and listed a number of ailments or conditions: “Reduce inflammation, Relieve muscle pain, Speed Recovery, Collagen diseases, Acne Reduction, Anti-ageing, Cellulite, Stretch marks, Atopic Eczema, Rheumatic diseases, Chronic back & joint pain, Arthritis, Depression, Anxiety, Insomnia, Increase energy, Boost energy, Boost your metabolism and Burn calories”.
b. The tweet on the @CryojuvenateUK Twitter feed stated “Got a sports injury? CRYO LOCAL helps reduce pain, inflammation and swelling. See website for more info”. It also included the website link.
Issue
The complainant challenged whether:
1. the claims that cryotherapy was a “treatment for anyone seeking muscle recovery, injury treatment, weight loss or skin rejuvenation” and could treat the ailments and conditions listed in ad (a) were misleading and could be substantiated; and
2. the ad discouraged essential treatment for conditions for which medical supervision should be sought.
Response
1. Cryojuvenate provided a number of documents in support of the claims which included a number of clinical studies, a consensus declaration on the therapeutic benefit of whole body cryotherapy (WBC) and extracts from a book about WBC.
2. Cryojuvenate said that they did not offer medical advice or diagnosis. They said that all of their staff had been trained in the use of equipment by the manufacturer. They said that in order to obtain specialist insurance for their treatments, all staff were required to be qualified to the specifications of the insurer and manufacturer. They said that their minimum qualification requirement was NVQ level 3 in anatomy and physiology which all their staff possessed. They also provided a copy of their insurance certificate.
Assessment
1. Upheld
The ASA noted that the ads featured a range of claims regarding WBC. We considered that consumers would interpret ad (a) to mean that WBC could provide effective treatment for muscle recovery, injury treatment, weight loss and skin rejuvenation, and could also treat the various conditions listed under the sports, beauty, wellbeing and weight loss headings. We considered that consumers would interpret ad (b) to mean that WBC could help with sports injuries by reducing pain, inflammation and swelling.
Cryojuvenate provided one clinical study, a consensus declaration signed by a number of academics and professionals and extracts from a book in support of the claims about reduction of inflammation and swelling. We acknowledged that the clinical study included a sample size of 54 participants. However, the study assessed cryotherapy as an accompany therapy meaning that it was not possible to separate the effect of the therapy itself from that of other interventions participants might have undertaken. Furthermore, the study dated back to 1992 and acknowledged that the evidence was not conclusive and that further clinical studies which used control groups would be required in future. The consensus declaration provided information about the background of WBC and the procedure. However, the declaration did not provide any sources or references, which we considered was necessary to assess its credibility. The extracts from the book mainly provided general information about WBC and anecdotal evidence; it did not provide any analysis of the efficacy of WBC.
Cryojuvenate provided one clinical study, the same consensus declaration as above and a different extract from the same book in support of the claims about relieving muscle pain. The study aimed to compare the psychological responses to different cryostimulation techniques on human physiology when using whole-body cryostimulation. We considered that the study’s aim did not sufficiently relate to the claims about relieving muscle pain. Furthermore, we noted that a Cochrane Review, although not submitted by Cryojuvenate, concluded that currently available evidence was insufficient to support the use of WBC for preventing and treating muscle soreness after exercise. It is also stated the best prescription of WBC and its safety was unknown.
Cryojuvenate submitted a document which included eight studies on WBC and another extract from the same book in support of the claims about speed recovery in sports. A significant proportion of the clinical studies were not randomised or controlled and included sample sizes which were relatively small. We considered that because the studies had no control group or any form of comparison, and because of the low sample size, they could not be used as evidence. We also noted that there was low female participation in a number of the studies and therefore considered that the results may not be applicable to women. Furthermore, a number of studies only included the abstracts or summaries of the studies. We considered that without that information, we were unable to properly assess the methodology or results of the studies. The extract from the book only briefly discussed the effects of WBC on the autonomic nervous system and did not relate sufficiently to the claim in the ads.
Cryojuvenate provided one clinical study and one of the same documents mentioned above in support of the anti-aging and scar reduction claims. While the study assessed the use of Intralesional cryotherapy for treatment of keloid scars, ad (a) made a general claim about the treatment of “scar reduction”. We considered that claim was likely to be understood to mean that the treatment could reduce a wide range of scars and not just a specific type of scarring such as keloids. Furthermore, the study included a small sample size of 27 and assessed a specific type of cryotherapy, which to our knowledge, Cryojuvenate did not provide. Moreover, the study stated that the results showed a 24% reoccurrence in keloid scars and did not make any reference to anti-ageing.
Cryojuvenate provided one prospective clinical study in support of the claim about acne reduction. The study evaluated the safety and efficacy of acne scars treatment using integrated cooling-vacuum assisted equipment. However, we considered the study only involved 25 participants and did not provide any information regarding the inclusion/exclusion criteria or methods used to assess the results. In addition, Cryojuvenate did not provide any randomised controlled trials as evidence for the claim about acne reduction.
Cryojuvenate submitted one clinical study regarding the use of WBC for atopic dermatitis to support the claim about atopic eczema. However, the study was not randomised or controlled. Furthermore, two of the eighteen participants did not complete the treatment period, one owing to worsening dermatitis. The participants also did not complete the same amount of treatment sessions and therefore we were concerned about the reliability of the conclusions of the study.
Cryojuvenate provided two extracts from a book regarding stress and anxiety and one of the documents referenced above. Given the limitations listed above, we considered that to substantiate claims about such conditions, we required robust randomised controlled clinical studies as evidence which sufficiently related to those conditions.
A document was provided which included a range of clinical studies and a literature review to substantiate the claims regarding increased energy, anti-ageing, detoxification, insomnia, rheumatic diseases and arthritis. However, the majority of the studies were not randomised or controlled. Furthermore, there was no statistical analysis of the significance of the results. We also noted that one of the studies was authored by a clinic that offered WBC, which we considered potentially limited the reliability of the studies’ findings. Finally, we noted that the review concluded that WBC may be used as part of a combination therapy rather than a single therapy as implied in the ads.
Cryojuvenate used some of the same documents as noted above in relation to the, detoxification and weight loss claims. In light of the limitations noted already, we considered that the evidence was insufficient to substantiate the claims. The additional clinical study included three studies with samples sizes between five and ten. We considered that insufficient information was provided about the inclusion/exclusion criteria and that the sample size was not sufficient to support the weight loss claims.
Finally, Cryojuvenate had not provided any evidence in support of a number of the efficacy claims listed in the ad (a): collagen diseases, skin rejuvenation, cellulite, stretch marks and boosting metabolism. We therefore considered that those claims had not been substantiated.
Because of the limitations identified with the evidence supplied, we considered that we had not seen sufficient evidence to support all the efficacy claims listed. We therefore concluded that they had not been substantiated and were therefore misleading.
On that point, ads (a) and (b) 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),
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), and
13.1
13.1
A weight-reduction regime in which the intake of energy is lower than its output is the most common self-treatment for achieving weight reduction. Any claim made for the effectiveness or action of a weight-reduction method or product must be backed, if applicable, by rigorous trials on people; testimonials that are not supported by trials do not constitute substantiation.
(Weight control and slimming).
2. Upheld
The CAP Code stated that marketers must not discourage essential treatment for conditions for which medical supervision should be sought. For example, they must not offer specific advice on, diagnosis of or treatment for such conditions unless that advice, diagnosis or treatment was conducted under the supervision of a suitably qualified health professional.
We noted that some of the conditions listed in the ads were not those for which medical supervision should be sought. However, we considered that the following conditions listed in ad (a) required medical supervision: rheumatic diseases, chronic back and joint pain, arthritis, depression and insomnia.
We acknowledged Cryojuvenate’s assertion that they did not offer medical advice. However, ad (a) featured the claim “fast and effective hyper-cooling treatment for anyone seeking muscle recovery claim, injury treatment, and weight loss or skin rejuvenation”. It also stated “How can Cryotherapy help” and listed a number of specific conditions below that. We considered that the overall impression of the ads was that cryotherapy could cure or treat the listed conditions.
We understood that staff members at Cryojuvenate possessed a Level 3 qualification in Anatomy and Physiology. The content of the course varied according to the course provider, but generally the course covered an introduction to the human body, the skeletal and reproductive systems and omitted content which covered the conditions in the ads. Therefore, the qualification did not demonstrate the expertise to provide treatment for the listed conditions.
Because the treatment was not carried out under the supervision of a suitably qualified health professional, we concluded that both ads discouraged essential treatment for which medical supervision should be sought and therefore breached the Code.
On that point, ads (a) and (b) breached CAP Code (Edition 12) rule
12.2
12.2
Marketers must not discourage essential treatment for conditions for which medical supervision should be sought. For example, they must not offer specific advice on, diagnosis of or treatment for such conditions unless that advice, diagnosis or treatment is conducted under the supervision of a suitably qualified health professional. Accurate and responsible general information about such conditions may, however, be offered (see rule
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.
).
Health professionals will be deemed suitably qualified only if they can provide suitable credentials, for example, evidence of: relevant professional expertise or qualifications; systems for regular review of members' skills and competencies and suitable professional indemnity insurance covering all services provided; accreditation by a professional or regulatory body that has systems for dealing with complaints and taking disciplinary action and has registration based on minimum standards for training and qualifications.
(Medicines, medical devices, health-related products and beauty products).
Action
The ads must not appear again their current form. We told Cryojuvenate UK Ltd not to state or imply that cryotherapy was efficacious for the treatment of the health conditions or ailments listed in the ads, including weight loss and the cited skin treatments. We also told them to ensure they held adequate evidence for future claims on the efficacy of cryotherapy. We similarly told them not to offer specific advice on, diagnosis of or treatment for conditions for which supervision of a suitably qualified health professional was necessary.
