Background
Summary of Council decision:
Four issues were investigated, of which two were Not upheld and two Upheld.
Ad description
A Christmas gift catalogue for a high street chemist that stated "Lloydspharmacy Blood Pressure* Lowering System. £129.99. Available from 27th October. Highly effective breathing management system proven to help lower blood pressure. Can be used alongside medication. Use for 15 minutes a day 3/4 times a week. No side effects. Relaxing and easy to use". A footnote at the bottom of the page stated "*Not suitable for use with a pacemaker or other implanted medical devices or for people with Heart rhythm problems".
Issue
Intercure Ltd challenged whether:
1. the claim "highly effective breathing management system proven to help lower blood pressure" was misleading and could be substantiated;
2. the claim "no side effects" was misleading and could be substantiated;
3. the claim "use for 15 minutes a day 3/4 times a week. No side effects" could encourage consumers to use the product to excess; and
4. the ad could discourage essential treatment for a condition: high blood pressure, for which medical supervision should be sought.
Response
1. Lloyds Pharmacy explained that the Blood Pressure Lowering Device (the Device) was classed as a Class IIa Medical Device under the Medical Devices Directive 93/42EEC. They said that it was manufactured and supplied by two separate companies and that both companies had registered and CE marked the Device for use in the UK. They provided copies of the relevant certificates that confirmed the Device's Class IIa certification.
Lloyds Pharmacy said that before a medical device could be placed on the market, a Technical Construction File (TCF) must be submitted to a Notified Body responsible for the regulation of medical devices. They explained that the TCF contained the clinical data, which took the form of a literature review, and the artwork for the device.
Lloyds Pharmacy confirmed that the Notified Bodies for the manufacturer and the supplier had conducted reviews of the clinical data submitted as part of the TCF and those Notified Bodies had deemed it sufficient to prove that the Device did what it claimed. They explained that the selected literature that formed part of the TCF was evaluated in order to assess its suitability to address questions about the Device and its contributions to demonstrating safety and performance. They believed that the clinical trials referred to in the TCF provided evidence that device-guided breathing exercises had an antihypertensive effect, and they provided us with copies of those trials.
2. Lloyds Pharmacy said that several of the clinical trials they submitted stated that there were no reported side effects. They explained that the Device was designed as a relaxation treatment device for lowering blood pressure by leading the user through guided and monitored breathing exercises. They explained that the users listened to music that gradually slowed in tempo and told the user to breathe in and breathe out. Consequently, relaxation was achieved and in turn, that lowered their blood pressure.
Lloyds Pharmacy said it was well recognised that slow and regular breathing played a prominent role in behavioural methods like yoga and meditation. They said neither of those had side effects and that as relaxation techniques, they had had success in treating high blood pressure.
3. Lloyds Pharmacy said the amount of time for which the subjects used the Device in the studies varied from 10 or 15 minutes a day to 180 minutes over eight weeks.
Lloyds Pharmacy said that their recommended use of 15 minutes three to four times a day fell within the minimum and maximum usage shown in the clinical trials. They considered that their Device aided relaxation and that relaxation had been shown to reduce blood pressure without side effects. They did not believe their recommended use was excessive.
4. Lloyds Pharmacy said that high blood pressure was a serious yet silent condition that often caused no symptoms or immediate problems. They explained that it was, however, a major risk factor for developing a serious cardiovascular disease such as a stroke or heart disease. They explained that they worked closely with the Department of Health, its associated bodies and the British Hypertension Society to help raise the importance of being aware of blood pressure levels. They explained that they provided consumers with information in support of the wider picture for total control of blood pressure, which covered topics such as who may be at risk, healthy lifestyle advice and ways of monitoring blood pressure levels.
Lloyds Pharmacy believed that the packaging and information booklet included with the Device made clear that patients should not stop taking any prescribed medication without consulting their doctor and that the Device could be used alongside medication. They considered that statement showed that patients should continue to seek advice from their doctor. They did not believe that they were discouraging patients from seeking essential treatment for a serious medical condition.
Assessment
1. Upheld
The ASA noted the studies provided by Lloyds Pharmacy and that we had already received expert advice on those studies when they had been submitted in a separate investigation for a similar breathing management device.
We understood Intercure were concerned that those studies, which used their device, had been submitted as evidence by Lloyds Pharmacy because, amongst other things, their device, which used musical tones to guide the user's inhalation and exhalation, typically reduced the user's breathing rate to five to six breaths per minute. We understood that the advertised Device worked by using two audio tones – one for inhalation and another for exhalation – by leading the user through interactively guided and monitored breathing exercises to adjust their breathing rate to an eventual, target breathing rate of less than ten breaths per minute.
We sought expert advice on that point and we understood from the expert that a reduction in blood pressure with slow and regular breathing rates below ten breaths per minute had been established in several studies but that there were no published studies that had directly compared the effectiveness of a breathing rate of five to six breaths per minute to a breathing rate of nine to ten breaths per minute in blood pressure reduction. We sought further advice from that expert on the studies submitted and we understood that only two of the submitted studies specified a particular breathing rate (seven and eight breaths per minute), whereas three simply referred to the lowest breathing rate convenient to the user and one study referred to a breathing rate most comfortable for the user. We understood that those studies demonstrated that device-guided breathing, where the user achieved a breathing rate of less than ten breaths per minute and they continued with that breath rate for long enough, could help lower blood pressure.
Although we acknowledged that the studies provided as evidence by Lloyds Pharmacy had not used their own device, because we considered that both devices worked in a similar way to achieve the same outcome, we considered the evidence was suitable and we assessed it accordingly.
We understood from the expert, whose advice we sought on the studies in a separate investigation, that when used for 15 minutes daily for eight weeks, the device in the studies could reduce blood pressure by an average of 5 mmHg, which could be quoted more precisely as 5 mmHg for systolic blood pressure and 4 mmHg for diastolic blood pressure, and that those values were in keeping with the range of reductions from the studies provided. We also understood that, although the device used appeared to show a statistically significant reduction in blood pressure, which in itself did not equate to clinical value, that reduction represented only a modest effect. We understood, however, that any reduction in blood pressure was desirable and useful and that it was important to achieve a much greater reduction if blood pressure was higher than recommended.
We understood that the Device guided users to a breathing rate of less than ten breaths per minute and therefore, we considered Lloyds Pharmacy held evidence to support the latter part of the challenged claim "... proven to help lower blood pressure". However, we considered the evidence did not support the claim that the product was a "highly effective" breathing management system which we considered readers would understand as having a significant effect on lowering blood pressure. We concluded that the former part of the challenged claim was therefore misleading.
We noted from the expert that the studies did not support a claim that the Device could lower blood pressure, when used for 15 minutes, three to four times a week, as directed in the ad. In almost all of the studies he had examined, the subjects used the device for 15 minutes every day for eight weeks. We considered consumers would understand from the ad that the Device lowered blood pressure when used as directed. Because the evidence did not demonstrate that, we concluded that claim was also misleading.
On this point, the ad 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) and
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 and beauty products).
2. Not Upheld
We noted that the Device had been Class IIa CE marked which we understood meant that it was safe and fit for its intended purpose, taking into account any risks as specified by the manufacturer. We understood from the expert's report that there were no inherent physical, electrical or other safety problems likely to be associated with a breathing management device like the one featured in the ad. We understood that the participants in four of the submitted studies achieved a slow breathing rate of less than ten breaths per minute and reported no side effects. We understood that the Device guided users to a target end breathing rate of less than 10 breaths which we noted was the same or similar to the end breathing rate achieved in the studies, without side effects. Notwithstanding our concerns as set out below in point 4, we concluded that the claim "no side effects" was not misleading.
On this point, we investigated the ad under 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) and
12.9
12.9
Marketers must not encourage consumers to use a product to excess and must hold proof before suggesting their product or therapy is guaranteed to work, absolutely safe or without side-effects (subject to 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.
).
(Medicines, medical devices, health-related products and beauty products) but did not find it in breach.
3. Not Upheld
We noted that the ad directed consumers to use the Device for 15 minutes a day, three to four times a week. However, we understood that the device used in the studies showed the participants had used it for either 10 or 15 minutes a day for a period of eight weeks. We understood from the expert's report that in order for the device to be effective, it should be used for 15 minutes a day, for a period of eight weeks. We also understood that none of the studies had shown that the Device would have a significant effect on high blood pressure, if used as directed in the ad. Notwithstanding our concerns as set out above in point 1, we considered that the recommended usage stated in the ad was less frequent than what had been shown to be used safely in the studies. We therefore concluded that the ad did not encourage consumers to use the Device to excess.
On this point, we investigated the ad under CAP Code (Edition 12) rule
12.9
12.9
Marketers must not encourage consumers to use a product to excess and must hold proof before suggesting their product or therapy is guaranteed to work, absolutely safe or without side-effects (subject to 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.
).
(Medicines, medical devices, health-related products and beauty products) but did not find it in breach.
4. Upheld
We noted the Code (Edition 12) stated that marketers should not discourage essential treatment for conditions for which medical supervision should be sought, such as by offering specific advice on, diagnosis of or treatment for such conditions unless conducted under the supervision of a doctor or other suitably qualified health professional. We considered that the claim that the Device was a "highly effective ... system proven to help lower blood pressure" would be understood by consumers to mean that the product was a treatment for high blood pressure.
Although we noted that the ad stated that the product "could be used alongside medication", we considered that it was unlikely that all consumers who used the device would already be under the supervision of a doctor, or other suitably qualified health professional, or already be receiving treatment for high blood pressure. We also considered the claim suggested that consumers who had already seen their doctor about high blood pressure could add the Device to their existing treatment without going back to their doctor to supervise the process. Whilst we noted that the product did not have any negative effects in itself and did have some beneficial effect in reducing blood pressure, we were concerned that the ad could encourage consumers to use the Device as an alternative to having a check up or seeking advice from a suitably qualified health professional, and thereby discourage or delay essential medical treatment for a serious medical condition.
On this point, the ad 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 ad must not appear again in its current form.
