Background
Summary of Council decision:
Seven issues were investigated, all of which were Upheld.
Ad description
Claims on four pages of www.proactolxs.com, relating to a medical fat-binding product:
a. Text on a page entitled "Why Choose Proactol XS" stated, "Clinically Proven Weight Loss Solution ... Lose weight and lower your cholesterol at the same time ... UNBEATABLE FAT-BINDING CAPACITY: UP TO 800 TIMES ITS OWN WEIGHT IN FAT IN VITRO ... 33% MORE EFFICIENT THAN THE OTHER FAT BINDERS".
b. Text on a page entitled "Before / After - Client Weight Loss Stories" stated, "Alfred lost 163 lbs, freed himself from diabetes & reversed heart disease! ... CHALLENGE 4 COMPLETED ... Helen Ballard ... lost 41 lbs ... CHALLENGE 1 COMPLETED".
c. Text on the home page under the title "MEDICAL TEAM" stated, "All nutrition services are provided by Registered Dieticians (RDs), who are accredited experts in nutrition. The ad linked through to ad (d) by clicking a link entitled "Our Team". Further text on the page, under the title "About Diet & Nutrition", stated, "Obesity and all the common ailments that come with being over weight [sic] is a major problem society faces in the 21st century. Proactol XS is a new medically certified device that has been proven to help reduce obesity and diseases related to being overweight".
d. A page entitled "Medical Team" listed a number of people and their "Specialization" [sic], which included "nutrition" in all cases. A specialisation for one of the listed people was "Weight Loss".
Issue
Omega Pharma UK Ltd challenged whether the following claims were misleading and could be substantiated:
1. "UNBEATABLE FAT-BINDING CAPACITY" in ad (a);
2. "33% MORE EFFICIENT THAN THE OTHER FAT BINDERS" in ad (a);
3. "Lose weight and lower your cholesterol at the same time" in ad (a); and
4. the weight loss claims in ad (b), because they understood that the examples given were actually the result of the advertiser's previous product.
5. They also challenged whether the weight loss claims in ad (b) were irresponsible and harmful because they encouraged unhealthy weight loss within a short time frame.
6. They challenged whether the claims relating to obesity in ad (c) were misleading, irresponsible and harmful because they implied that the product was a treatment for obesity.
7. They also challenged whether the claim "All nutrition services are provided by Registered Dieticians (RDs), who are accredited experts in nutrition" in ad (c), and the claims in ad (d) were misleading because they understood that the 'dietitians' were not registered on the Health Care Professions Council (HCPC) website.
Response
Advanced Health Ltd acknowledged the complaint, but did not provide a substantive response to the ASA's enquiries.
Assessment
The ASA was concerned by Advanced Health Ltd's lack of substantive response and apparent disregard for the Code, which was a breach of CAP Code (Edition 12) rule 1.7 1.7 Any unreasonable delay in responding to the ASA's enquiries will normally be considered a breach of the Code. (Unreasonable delay). We reminded them of their responsibility to provide a substantive response to our enquiries and told them to do so in future.
1. Upheld
Because we had not seen evidence to show that the advertiser's product's fat binding capacity was unbeatable, we concluded that the claim had not been substantiated and 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),
3.38
3.38
Marketing communications that include a comparison with an unidentifiable competitor must not mislead, or be likely to mislead, the consumer. The elements of the comparison must not be selected to give the marketer an unrepresentative advantage.
(Other comparisons), 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).
2. Upheld
Because we had not seen evidence to show that the advertiser's product was 33% more efficient than all other fat binders, we concluded that the claim had not been substantiated and 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),
3.38
3.38
Marketing communications that include a comparison with an unidentifiable competitor must not mislead, or be likely to mislead, the consumer. The elements of the comparison must not be selected to give the marketer an unrepresentative advantage.
(Other comparisons), 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
Because we had not seen evidence to show that the advertiser's product could lead to weight loss and lower cholesterol at the same time, we concluded that the claim had not been substantiated and 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
Because we had not seen evidence to show that the claims in ad (b) related to the product being advertised, or any evidence that the product could lead to weight loss, we concluded that the claims had not been substantiated and were misleading.
On that point, ad (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), 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).
5. Upheld
We noted that the example of Alfred James Clark stated that he had lost 163 lbs and had completed "Challenge 4", which, according to the advertiser's website, lasted 90 days.
The example of Helen Ballard stated that she had lost 41 lbs and had completed "Challenge 1", which, according to the advertiser's website, lasted 10 days.
The Code specified that for those who were normally overweight, a rate of weight loss greater than 2 lbs a week was unlikely to be compatible with good medical and nutritional practice. For those who were obese, a rate of weight loss greater than 2 lbs a week in the earlier stages of dieting could be compatible with good medical and nutritional practice. However, only treatments for obesity that were used under suitably qualified supervision could be advertised to the public.
Because of the amount of weight lost by Mr Clark, we were concerned that the product was being marketed as a treatment for obesity. Because we had not seen evidence that the rates of loss experienced by Mr Clark and Ms Ballard were compatible with good medical and nutritional practice, nor that the product was used under suitably qualified supervision, we concluded that ad (b) had not complied with the rules on weight-loss advertising.
On that point, ad (b) breached CAP Code (Edition 12) rules 13.2 13.2 Obesity in adults is defined by a Body Mass Index (BMI) of more than 30 kg/m2. Obesity is frequently associated with a medical condition and, except where stated in 13.2.1, a treatment for it must not be advertised to the public unless it is to be used under suitably qualified supervision. Non-prescription medicines that are indicated for the treatment of obesity and that require the involvement of a pharmacist in the sale or supply of the medicine may nevertheless be advertised to the public. and 13.10 13.10 Claims that an individual has lost an exact amount of weight must be compatible with good medical and nutritional practice. Those claims must state the period involved and must not be based on unrepresentative experiences. For those who are normally overweight, a rate of weight loss greater than 2 lbs (just under 1 kg) a week is unlikely to be compatible with good medical and nutritional practice. For those who are obese, a rate of weight loss greater than 2 lbs a week in the early stages of dieting could be compatible with good medical and nutritional practice. (Weight control and slimming).
6. Upheld
The Code specified that only treatments for obesity that were used under suitably qualified supervision could be advertised to the public. Because we had not seen evidence to demonstrate that the product could be used as a treatment for obesity, nor that it was used under suitably qualified supervision, we concluded that the claims in ad (c) relating to obesity were misleading, irresponsible and harmful.
On that point, ad (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 13.2 13.2 Obesity in adults is defined by a Body Mass Index (BMI) of more than 30 kg/m2. Obesity is frequently associated with a medical condition and, except where stated in 13.2.1, a treatment for it must not be advertised to the public unless it is to be used under suitably qualified supervision. Non-prescription medicines that are indicated for the treatment of obesity and that require the involvement of a pharmacist in the sale or supply of the medicine may nevertheless be advertised to the public. (Weight control and slimming).
7. Upheld
Because we had not seen evidence to show that the listed experts were registered dietitians, we concluded that the claim had not been substantiated and was misleading.
On that point, ad (c) 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. We told Advanced Health Ltd to ensure they held sufficient evidence to support their claims. We told them not to claim that a product's fat binding capacity was unbeatable, that it was more efficient than other products, or that it could lead to weight loss and lower cholesterol, if they did not hold supporting evidence. We also told them to ensure that claims for their products related to the products being advertised.
We told them to ensure that rates of weight loss were compatible with good medical and nutritional practice and that treatments for obesity were not advertised to the public without suitably qualified supervision. We also told them not to claim that their services were provided by registered dietitians if that was not the case. We referred the matter to CAP's Compliance team.
CAP Code (Edition 12)
1.7 12.1 12.2 13.10 13.2 3.1 3.38 3.7
