Background
Summary of Council decision:
Four issues were investigated, of which one was Not upheld and three were Upheld.
Ad description
Claims on www.lloydspharmacy.com promoted the TENS Digital Pain Reliever and the TENS Period Pain Reliever.
a. Text on one web page stated "Over half of us suffer from chronic pain such as back or joint pain. Whether you have one of these conditions or just suffer from intermittent pain, you know it can stop you doing even the simplest of things. What if there was a safe, affordable and effective form of pain relief for a range of different complaints which you could use alongside over the counter or prescription pain relief medication? The Lloydspharmacy TENS machine delivers small, painless electrical pulses to the body via electrodes placed on the skin. This blocks the way pain signals are sent to the brain and stimulates the body to produce its own pain relieving chemicals called endorphins. TENS is a highly effective treatment for pain. It is used worldwide and recommended by sports coaches, physiotherapy departments, pain clinic, doctors and other medical practitioners. A TENS unit will ease pain, and should result in a decrease of drug intake. For many the relief is dramatic ... Pain Facts 1 in 7 people suffers from chronic pain ... Fast, effective pain relief".
b. Text on another web page stated "70% of women in the UK suffer with period pain between the ages of 17 to [sic] 50 years. The Lloydspharmacy Period Pain Reliever is a highly effective way to control period pain and menstrual cramps. It can be used for 20 minutes twice a day providing lasting relief and can be used alongside pain medication. TENS stands for Transcutaneous (through the skin) Electrical Nerve Stimulation and is now regularly recommended by doctors, physiotherapists and pharmacists throughout the UK. The Lloydspharmacy Period Pain Reliever works by passing harmless electrical signals into the body from its pad (controlled by the user at all times). This relieves pain in two ways: It blocks the body's pain signals. These are normally transmitted from the area of pain through the nerve fibres to the brain. TENS interrupts these pain signals. TENS stimulates the body's production of endorphins - its own natural painkillers. Features: Safe and effective TENS pain reliever for period pain and menstrual cramps. Can be used alongside pain medication”.
c. A tweet stated "Hey, sorry to hear that you're in pain. Have you considered our Period Pain Reliever? It's really effective!"
Issue
The complainant challenged whether the claims in ad (a):
1. "A TENS unit will ease pain";
2. "TENS is a highly effective treatment for pain"; and
3. the implied claim that the TENS Digital Pain Reliever could treat chronic pain,
were misleading and could substantiated.
The complainant also challenged whether:
4. the claims in ads (b) and (c) that the Period Pain Reliever was "highly effective" and "really effective" in relieving period pain and menstrual cramps, and provided lasting relief were misleading and could be substantiated.
Response
1. – 4. Lloyds Pharmacy Ltd (Lloyds) stated that the TENS Digital Pain reliever was a Class IIa Medical Device under the Medical Devices Directive 93/42 EEC and was CE marked for use in the UK. They said the device was manufactured by Andon in China, supplied by Harvard Medical Devices and the Notified Body was TUV Rheinland. They stated that the Technical File, which they said included clinical data in the form of a literature review, and product artwork was submitted to the Notified Body, and the packaging was approved. They said that, because the packaging contained similar claims, including "Highly Effective Pain Relief", "1 in 7 people suffers from chronic pain ...", "Period Pain Reliever", "highly effective way to control period pain and menstrual cramps" and "providing lasting relief", and understood that the data provided was therefore deemed sufficient to prove to that Notified Body that the product was a highly effective treatment for pain. They provided a copy of the Technical File submitted for approval, which consisted of a literature review which contained six abstracts of specific trials on TENS machines, and a Clinical Data Compilation that summarised trials on specific types of pain or areas of pain.
Assessment
1. Not upheld
The ASA noted that advertisers were required to provide documentary evidence to the ASA to support advertising claims and that the substantiation and the relevant claims would be considered under the advertising Code.
We noted that ad (a) stated "What if there was a safe, affordable and effective form of pain relief for a range of different complaints which you could use alongside over the counter or prescription pain relief medication" and "A TENS unit will ease pain, and should result in a decrease of drug intake" and considered that consumers would understand that the device was intended for use as an adjunctive treatment for pain, alongside core treatment, such as pain medication. In light of that, we considered that consumers were likely to understand the claim "A TENS unit will ease pain" to mean that the device could lead to the temporary relief of minor aches and pains in conjunction with other core treatment.
We sought expert advice. We understood that the evidence available supported the likelihood that TENS was effective for temporarily relieving pain in general.
Because we considered that ad (a) made clear that the device was intended for use as an adjunctive treatment for pain alongside core treatment and that consumers would understand the claim "A TENS unit will ease pain" mean that the device could lead to the temporary relief of minor aches and pains, and because we had seen sufficient supporting evidence, we concluded that the claim, in the context in which it appeared, was unlikely to mislead.
On that point, we investigated ad (a) 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
12.1
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.
2. Upheld
We noted that ad (a) stated "Over half of us suffer from chronic pain such as back or joint pain. Whether you have one of these conditions or just suffer from intermittent pain, you know it can stop you doing even the simplest of things" and considered that consumers would therefore infer from the claim "TENS is a highly effective treatment for pain" that the device was able to treat general pain in all areas. We considered that the claim "a highly effective treatment for pain" was a strong efficacy claim, which would be understood, for example, to mean that the device could lead to the complete removal of pain for all patients, as opposed to the temporary or partial reduction of pain for some patients.
Although we understood that the evidence available supported the effectiveness of TENS as an adjunctive treatment for pain in general, we understood that there was insufficient evidence in the technical file to support claims that TENS was effective for low back pain specifically. We also considered that the evidence was not sufficient to support the stronger efficacy claim "TENS is a highly effective treatment for pain" and therefore concluded that the claim that "TENS is a highly effective treatment for pain" was misleading.
On that point, ad (a) 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 products and beauty products)
3. Upheld
We noted that ad (a) stated "Over half of us suffer from chronic pain such as back or joint pain" and "1 in 7 people suffers from chronic pain" and therefore considered that, in light of those references, readers would understand the ad's efficacy claims to relate to chronic pain. We noted that the ad made a number of general claims about the effectiveness of TENS and considered that the strongest claim stated "TENS is a highly effective treatment for pain". We therefore considered that some readers would understand from ad (a) that the product could provide a highly effective treatment for chronic pain.
Although we understood that the evidence available supported the effectiveness of TENS as an adjunctive treatment for pain in general, we considered that the evidence was not sufficient to support a claim that TENS was a "highly effective treatment" for chronic pain and therefore concluded that the implied claim was misleading.
On that point, ad (a) 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 products and beauty products)
4. Upheld
We noted that ad (b) stated "The Lloydspharmacy Period Pain Reliever is a highly effective way to control period pain and menstrual cramps" and "It can be used for 20 minutes twice a day providing lasting relief" and that ad (c) stated "Hey, sorry to hear that you're in pain. Have you considered our Period Pain Reliever? It's really effective!". We considered that readers would understand from the ads that the Period Pain Reliever was "highly effective" and "really effective" in relieving period pain and menstrual cramps, and provided lasting relief. We understood that the evidence presented in the technical file did not support the efficacy of the TENS Period Pain Reliever for menstrual cramps specifically and considered that the evidence was not sufficient to support the claim that the Period Pain Reliever was a "highly effective treatment" for relieving period pain and menstrual cramps or to show that the device provided lasting relief. We therefore concluded that the claims were likely to mislead.
On that point, ads (b) and (c) 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 products and beauty products).
Action
The ads must not appear again in their current form.
