Background
Summary of Council decision:
Two issues were investigated, both of which were Upheld.
Ad description
A national press ad for Actegy Ltd, seen on 17 December 2019, featured claims for the Revitive DX and the Revitive Medic medical devices. The ad featured the prominent claim “MEDICAL BREAKTHROUGH. Tired, Heavy Legs & Puffy Feet? REVIVE YOUR CIRCULATION – WITH – DRUG-FREE REVITIVE CIRCULATION BOOSTER. Scientifically proven to: Actively increase circulation. Relieve tired, heavy legs & feet. Reduce puffy feet and ankles. Strengthen leg muscles”. Further text stated “REVITIVE MEDIC. NOW SUITABLE FOR THOSE WITH: - Leg Aches & Pains – Swollen feet/ankles – Leg Cramps – Numbness Symptoms commonly experienced by people with High Blood Pressure – High Cholesterol – Diabetes – Arthritis. Also improves the symptoms associated with Varicose Veins”. The ad featured the price claim “CHRISTMAS SALE SAVE £143 ON REVITIVE MEDIC BUNDLE”. In a box further down the page, text stated “READER OFFER. OFFER VALUE. £172.97 (struck-through) INCLUDES REVITIVE DX device, PLUS…- NOW ONLY £149.99”.
Issue
1. The complainant, who understood that the Revitive Medic cost £299, challenged whether the ad was misleading by implying that the advertised device cost £149.99.2.
The ASA challenged whether the following claims were misleading and could be substantiated: “NOW SUITABLE FOR THOSE WITH: Leg Aches & Pains, Swollen feet/ankles, Leg Cramps. Numbness Symptoms commonly experienced by people with: High Blood Pressure, High Cholesterol, Diabetes, Arthritis. Also improves the symptoms associated with Varicose Veins”.
Response
1. Actegy Ltd believed that the ad made a clear distinction between the offers for the different devices. They said the text “Alternatively, Save £143 on Revitive Medic Bundle” was immediately after the £149.99 price claim for the Revitive DX. They said the claim “Alternatively Save £143” was in an even more prominent red colour. They said there was only a single occurrence of the £149.99 being shown, which was in a box with the picture of the Revitive DX.
Actegy said the DX device was named with an image provided that they believed was clearly different from the Revitive Medic device, with its price offer in a separate box. They said that enabled consumers to see the name, image and price of the product Revitive DX.Actegy said that the Revitive Medic was recommended for individuals with relevant medical conditions that enabled customers to claim VAT exemption, a 20% discount, and purchase the product for £249.99. Actegy needed to ensure that customers qualified for VAT exemption before providing the 20% discount. They pointed out that the ad included the qualification “call us for details about VAT relief”. In addition, the device contained a built-in rechargeable battery, which was a significant extra cost. If the user did not require the battery, they could step down to a model with no battery, which had a different cost at £166.63 with the VAT exemption. Further, the device was available “as new” at £199, or £166.63 if they were eligible for VAT exemption. The device was also available for less than £149.99 from the device manufacturer. Therefore, as the price of the product varied for different customers, they said they could not show the price of the product in their advertising.
Actegy argued that it was normal to have more than a single product in a category, such as “good”, “better”, “best” with different price points. It was also normal that features might vary creating price differences – for example, a corded product with a lower price point than one with a rechargeable battery. They said consumers were well educated that products were offered at different price points for different features and reasons.
Actegy said that all transactions from the press ad required a second contact with their organisation to confirm the DX product was right for them. If a consumer called the call centre, the device range was discussed, while if the consumer sent a coupon via the post, they received a call back from the call centre to confirm the product offered at the price point shown was right for them. The DX version of the product was not available via retailers or online. Therefore, they argued a transaction could not occur if the consumer was not happy with the product and matching price.
2. Actegy said the Revitive Medic was registered with the MHRA for use for people with peripheral arterial disease (PAD), and Chronic Venous Disease/ Varicose Veins based on product specific clinical trials. They said they had chosen to follow the new regulatory requirements of the Medical Devices Regulation (MDR) and provided a letter from their notified body, BSI, which stated that the product conformed to the requirements of the MDR.
Actegy said the Medic device was also registered as suitable for people with diabetes, diabetic neuropathy, and osteoarthritis. They said the ads did not make a medical claim of reducing aches and pains, leg cramps and numbness, but rather educated the public on the suitability of use of the device.
Actegy provided two papers as evidence of the claims made in the ad alongside a detailed expert report in support of the studies.
They said the first paper showed significant improvements in maximum walking distances due to reduced symptoms effects and the disease-specific quality of life of patients with PAD. They said that PAD was an artery disease with multifactorial causes and risk factors including, diabetes, smoking, obesity, high blood pressure, increasing age, high cholesterol and family history of heart disease. They said the results showed that the device could reduce symptoms of leg aches and pains and leg cramps in patients with PAD enabling them to walk further without pain and increasing their tolerance to exercise before pain occurred and disease-specific quality of life, and enabling symptom relief of pain, cramp, numbness or discomfort in the leg.
They said the second paper showed the significant improvement of patients who received Revitive treatment alongside a supervised exercise programme compared to those who only used exercise. They said the study showed that 60 minutes of using the device each day increased blood flow (circulation), prevented ankle swelling during use, and produced symptom and disease level improvements in line with surgical intervention in patients with varicose veins.
Actegy explained that one of the reports provided had been published in a peer-reviewed journal after the ad was originally seen. They had also commissioned a new independent statistical analysis of the data from the other study, which they provided.Full details of the papers (as at time of writing) are: Babber, A., Ravikumar, R., Onida, S., Lane, T. R. A., & Davies, A. H. (2020). Effect of footplate neuromuscular electrical stimulation on functional and quality-of-life parameters in patients with peripheral artery disease: pilot, and subsequent randomized clinical trial. British Journal of Surgery. https://doi.org/10.1002/bjs.11398Ravikumar, R., Lane, T. R., Babber, A., Onida, S. & Davies, A. H. (2021). A randomised controlled trial of neuromuscular stimulation in non-operative venous disease improves clinical and symptomatic status. Phlebol. J. Venous Dis. 36, 290–302.
Assessment
1. Upheld
The ASA noted the ad featured the prominent claim “Our Most Medically Powerful Circulation Booster. Revitive Medic”, which appeared in the centre of the ad. The two most prominent price claims in the ad stated “CHRISTMAS SALE SAVE £143 on REVITIVE MEDIC BUNDLE”. The other prominent price claim in the ad featured a struck-through price of “£173.97” followed by the claim “INCLUDES REVITIVE DX device … - NOW ONLY £149.99”. Although the text stated “Revitive DX”, which was the name of a different, less advanced model, we considered that consumers were unlikely to understand the price was for a different model given that the rest of the ad appeared to promote the Revitive Medic. The fact that the ad did not reference the price of Revitive Medic throughout the rest of the ad we considered contributed further to the impression that £149.99 was the price of the Revitive Medic. While we acknowledged that the two products as shown in the ad had slightly different designs, we considered that they nevertheless looked very similar to each other such that consumers were unlikely to notice the difference.
Actegy argued they had not included the cost of the Revitive Medic because it varied depending on whether the customer was entitled to VAT relief (due to a disability or long-term illness) and whether the customer purchased a rechargeable battery too. However, we considered that did not prevent them from including those different costs of the Revitive Medic in the ad, or making clearer that the £149.99 price claim referred to a separate model.
We acknowledged that prior to purchasing the product from the press ad (which could be done by phone or sending in a coupon in the post), customers would speak to a customer service representative, who could clarify the cost of the product. However, we considered that phoning the call centre after the viewing the ad and sending the coupon via the post both constituted a transactional decision.
Because the ad did not make clear that the £149.99 price related to a separate, less advanced model, and was not the cost of the Revitive Medic, we concluded that the ad was likely to mislead consumers into taking transactional decisions they otherwise would not have taken.
On that point, the ad breached CAP Code (Edition 12) rules 3.1 and 3.3 (Misleading advertising).
2. Upheld
The ASA noted that Actegy had chosen to comply with the requirements of the Regulation (EU) 2017/745 on medical devices (EU MDR); the EU MDR had not been fully implemented at the time the ad was published. We understood that at the time, the MDR had been due to come into full application across all Member States, after a transition period, in May 2020 and that was then deferred until May 2021 (after the implementation period of the UK’s withdrawal from the European Union), meaning that it did not come into force in Great Britain. We noted Actegy’s comments that the product appeared to meet the requirements of the Directive 93/42/EEC on medical devices (EU MDD) but understood that the EU MDD (and indeed the MDR) did not harmonise EU law relating the advertising of medical devices, which was subject to Directive 2005/29/EC on unfair business to consumer commercial practices (including advertising) generally (UCPD). That meant that advertisers still had to meet the requirements of the CAP Code, which reflected the provisions of UCPD. Under the CAP Code, medical claims could be made for CE-marked medical devices provided they complied with other requirements of the Codes, including those relating to substantiation. We understood that the Revitive Medic was classified as Class IIa medical device. However, CE certification in itself did not constitute evidence for medical efficacy claims, and advertisers needed to ensure that they held evidence for such claims.
We considered that, in the context of the whole ad, consumers were likely to interpret the claims “NOW SUITABLE FOR THOSE WITH: Leg Aches & Pains, Swollen feet/ankles, Leg Cramps” to mean that the circulation booster was able to effectively reduce leg aches and pains, swollen feet and leg cramps. We considered that consumers were likely to understand from the claim “NOW SUITABLE FOR THOSE WITH … Numbness symptoms commonly experienced by people with: High Blood Pressure, High Cholesterol, Diabetes, Arthritis” to mean that the Medic device was efficacious at reducing the sense of numbness in the legs that people felt with those conditions. We considered consumers would understand the claim “Also improves the symptoms associated with Varicose Veins” to mean that the device could reduce the symptoms experienced as a result of varicose veins. The ad was addressed, at least in part, to consumers experiencing symptoms as a result of the specific underlying conditions listed, as opposed to those who were otherwise healthy and experienced occasional symptoms. In the absence of qualification to the contrary, consumers were likely to understand that the device would have effects in relation to the aforementioned conditions and symptoms that lasted beyond the time when it was actually in use.
The ASA had previously investigated similar claims for the less advanced model, Revitive DX, and found that the claims “for fast relief from aching legs & swollen feet”, and “may help reduce the swelling and … pain and discomfort of aching legs, feet and ankles” had not been substantiated and were therefore misleading. The claims in this ad related to the more advanced model, Revitive Medic. We took expert advice on the new evidence submitted by Actegy.
Actegy submitted two papers in support of the claims. The first paper (Babber et al., 2020) was a pilot study which we had previously considered to be inadequate substantiation in the previous investigation, and the second paper was a new randomised controlled study. The new study compared the outcomes of a six-week trial on those with PAD using a Revitive model alongside a structured exercise program (SEP) with those using SEP alone. We noted that the study used Revitive IX, which was a different model to the one advertised. Actegy subsequently provided evidence showing that Medic and Revitive IX were substantially equivalent in terms of clinically relevant parameters, and we understood that findings obtained using the Revitive IX could be regarded as applying to the Revitive Medic device. That said, the lack of an inactive control, such as a sham device, and the fact participants were not blinded to their treatment, were significant drawbacks likely to have influenced the results.
We considered that the results of the study could not be extended to situations where the device was used alone without structured exercise, as promoted in the ad. Similarly, we considered that the study could not be extended to patients without PAD. Therefore, while Actegy had based the claims regarding high blood pressure, high cholesterol and diabetes on the higher prevalence of patients in the study with those symptoms, any benefit could not be assumed to apply to patients with those symptoms who did not have PAD. Evidence regarding arthritis had been presented in relation to a previous case, and was not found to be adequate to substantiate the claims.
The results showed no statistically significant difference in maximum walking distance between the group using structured exercise alone and the group using structured exercise alongside the circulation booster, meaning that the results could not be attributed to the use of the Revitive IX. The results for Time Averaged Mean Velocity (blood flow velocity) showed an improvement for the exercise-only group, but not for the group using exercise and the Revitive IX circulation booster. According to subsequent statistical analysis carried out after the ad appeared, for maximum walking distance before the onset of claudication (pain/cramp), a significantly greater improvement was achieved in the change between week zero and week six in favour of the Revitive IX group. However, those results were less important than the maximum walking distance, because the maximum walking distance had been chosen as the primary outcome measure, that is, the main indicator that the trial set out to measure.
Furthermore, the results were of lower quality as although objective, they were sensitive to patient effort, and hence susceptible to bias due to the non-blinded nature of the study. While there was a greater increase in disease-specific quality of life for those using the circulation booster, there were no significant differences in overall quality of life change between the two groups. More importantly, we considered that subjective measures such as quality of life were not adequate evidence on their own, for measuring improvements in the symptoms listed in the ad, especially given that the participants in the study had not been blinded, meaning that the higher quality of life scores could have been caused by a placebo effect. For those reasons, we considered that the paper was not adequate evidence.
The second paper (Ravikumar et al., 2021) was initially provided as an unpublished internal report (subsequently published as indicated above), and compared three groups of participants: one group used the Revitive IX for 30 minutes each day, a second group used it for 60 minutes each day and a third group did not use it at all. Again, no sham device was used and patients were not blinded. Neither the subjective nor objective measures were administered blind, although the assessors were blinded when analysing the data. The results showed that there was a temporary increase in blood flow when using the circulation boosters, which was not maintained after ceasing device use.
The results showed that resting limb volume marginally increased in all groups, although this was not statistically significant for any group - meaning that there was no evidence that the circulation booster led to a reduction in limb swelling over the time period. According to subsequent statistical analysis carried out after the ad appeared, the 30-minute stimulation group came very close to having a significantly smaller increase in volume after 30 minutes of sitting (p = 0.0505); the 60-minute group had a significantly smaller increase in volume (p = 0.0195), indicating that the device reduced the short-term swelling associated with sitting for 30 minutes. That indicated that the device could reduce the short-term swelling associated with sitting for 30 minutes, when used instead of quiet sitting – however, it was not the same as being able to reduce swelling. The study also reported a statistically and clinically significant improvement in disease-specific quality of life measures for the 60-minute group. However, we considered that subjective measures were not adequate evidence on their own, for the reasons mentioned above.For those reasons, we considered that the paper did not provide adequate evidence in support of the claims.
We considered that the studies provided inadequate evidence to substantiate the claims that the circulation booster was able to reduce leg aches and pains, swollen feet and leg cramps, as consumers were likely to understand them in the context of the ad. We further considered that inadequate evidence had been provided to demonstrate the efficacy of the advertised DX and Medic devices in treating the sense of numbness in the legs that people experienced directly as a result of the stated conditions of high blood pressure, high cholesterol, diabetes and arthritis, or improve the symptoms associated with varicose veins.
We therefore concluded that the ad was misleading.
On that point, the ad breached CAP Code (Edition 12) rules 3.1 (Misleading advertising), 3.7 (Substantiation) and 12.1 Medicines, medical devices, health-related products and beauty products.
Action
The ad must not appear again in the form complained about. We told Actegy Ltd to make clear to which products the price claims referred. We also told them not to claim or suggest through the overall impression of the ad that the Revitive Medic was able to reduce leg aches and pains, swollen feet and leg cramps; that it was able to reduce the sense of numbness in the legs that people feel with high blood pressure, high cholesterol, diabetes and arthritis, and that it was able to improve the symptoms associated with varicose veins. The ASA reminded Actegy Ltd of the Codes’ requirement that evidence to support advertised claims must be held before an ad was submitted for publication.
