Goldshield Ltd t/a Goldshield Healthcare Direct NLA Tower 12-16 Addiscombe Road Croydon Surrey CR0 0XT Number of complaints: 1

Date: 7 May 2008 Media: National press Sector: Health and beauty

Ad
A national press ad for LIPObind was headlined "The NEW Clinically Proven Fat Binding Pill ...". Text underneath stated "Forget about all the diet fads, forget about just eating salad and forget about pills that are more expensive than effective. If you want to fight the fat in food, then learn more about the incredible medically certified pill set to take the nation by storm ... Cutting a line through the swathes of products on the market that claim to aid weight management comes a pill which has been tried and tested and is proven to bind fat. There are no gimmicks, no fad diets, no additional exercise routines that have to be undertaken, in fact you can still indulge yourself with your favourite treat every now and again!" Text on the left of the ad stated "LIPObind AVAILABLE WITHOUT PRESCRIPTION  CERTIFIED MEDICAL DEVICE PRODUCT With Safety and Efficacy assessed under Medical Device Directive 93/42/EEC". Text on the right stated "What does LIPObind do? LIPObind is a weight management tool making it easy for you to take charge of your personal dietary intake. Helps to Suppress Appetite  Binds Dietary Fats  Helps to Decrease Food Cravings  Helps Lower Blood Cholesterol Weight Management". Text at the bottom of the ad stated "3 easy ways to order ... by Freephone 08700 xx xx xx ...".

Issue
1. The complainant challenged whether the 08700 telephone number was free.

The ASA challenged whether Goldshield Healthcare Direct could substantiate the claims:

2.  "The NEW Clinically Proven Fat Binding Pill ... A pill that has been tried and tested and proven to bind fat";

3. "There are no gimmicks, no fad diets, no additional exercise routines that have to be undertaken, in fact you can still indulge yourself with your favourite treat every now and again";

4. "Helps to Suppress Appetite";

5. "Helps to Decrease Food Cravings";

6. "Helps Lower Blood Cholesterol"; and

7. "Weight Management".

The CAP Code:

3.1;7.1;50.1;51.1;51.4

Response
1. Goldshield Healthcare Direct (Goldshield) said the 08700 telephone number was not free and the claim "Freephone" was a misprint that had not been picked up when the ad was checked.  They said the mistake had been amended and would not appear again.

2. Goldshield said LIPObind was a certified Class IIa Medical Device and was CE marked by a duly appointed and audited certification organisation, TUV Rhineland in Germany, under the Medical Device Directive 93/42/EEC.  They provided a copy of the relevant CE marketing approval document, which described the scope as being "production, marketing and sales of tablets for weight management".

3. Goldshield said the claim was intended as a lifestyle comment. They said, for best results, a calorie controlled diet should be undertaken but that was not a strict rule and depended on the choice of the individual consumer.

4., 5., 6. & 7. Goldshield referred to the Medical Device Directive. They argued that, because it had a CE mark and accompanying certificate, it was proven that LIPObind was safe and complied with the performance levels attributed to it by its manufacturer; they argued it was therefore fit for its intended purpose. They maintained that the Medicines and Healthcare products Regulatory Agency (MHRA) had recognized the categorization of mechanically acting fat binding tablets as medical devices. They argued that the MHRA acknowledged properly CE marked medical devices for fat binding as being fit for the purpose intended and they were therefore authorised to make medical claims for the product within the scope of its conformity assessment. They argued that the CE mark was the equivalent of a Marketing Authorisation and it was therefore their legal right to state the device's intended purpose in all advertising; namely as dietary fat binding pills for weight management.

Goldshield said they would remove the claims "There are no gimmicks, no fad diets, no additional exercise routines that have to be undertaken, in fact you can still indulge yourself with your favourite treat every now and again", "Helps to Suppress Appetite", "Helps to Decrease Food Cravings" and "Helps Lower Blood Cholesterol".  

However, in response to the "Weight Management" claim, Goldshield said the product did not make any weight loss claims and there was no direct clinical evidence that significant weight loss could be achieved with the product alone. They asserted that there was evidence to show that the ingredients contained in the product could contribute to weight management.

They sent a clinical evaluation of LIPObind by a German expert and supporting studies, which included literature reviews, in vitro studies of the product, and two proof of concept in vivo studies of the product.

Assessment
1. Upheld
The ASA noted the 08700 telephone number was not free and considered that the claim "Freephone" was therefore misleading. We welcomed Goldshield's assurance the ad had been amended.

On this point, the ad breached CAP Code clause 7.1 (Truthfulness).

2., 4., 5. & 6. Upheld
We considered that the ad implied the product could aid weight reduction. We noted the product appeared to meet the requirements of the European Medical Devices Directive but understood that the Directive did not harmonise EU law relating to the advertising of medical devices, which was subject to an EU Directive on unfair commercial practices (including in advertising) generally. We contacted the MHRA, which told us that the product was a recognised medical device and, as such, did not need to be licensed as a medicinal product, because its mode of action was purely physical rather than pharmacological; it was not absorbed by the body. They said, as a CE marked medical device, LIPObind had a legitimate right to bear claims relating to fat-binding and weight management because that was its registered primary purpose; they said the CE mark for a device provided an assurance that a product's safety had been assessed together with its performance. The MHRA said, on the basis that the performance had been assessed by a notified body, they had to assume that LIPObind was effective in its primary purpose: fat binding and weight management. They said notified bodies were subject to audit by national regulatory authorities and their assessment was expected to be recognised by all EU Member States.  

The MHRA said they understood that claims could be made for the product that were relevant to its purpose as a device; that did not, however, allow Goldshield to make any claim they wished to. They said any medicinal claims that implied changes would only be achieved through a modification of physiological functions by either metabolic or pharmacological means were not appropriate for a medical device. They considered that the claims in the ad that referred to such functions, "Helps to Suppress Appetite", "Helps to Decrease Food Cravings" and "Helps Lower Blood Cholesterol", were outside of the product's stated scope or purpose.

We noted that the MHRA accepted the fat-binding and weight management claims for LIPObind on the grounds that its performance had been assessed by a notified body but that they did not accept the other medicinal claims. We nevertheless asked to see the evidence to support the fat-binding and weight management claims as we considered that the claim "The NEW Clinically Proven Fat Binding Pill ... A pill that has been tried and tested and proven to bind fat" implied that LIPObind had been clinically tested to bind fat. We considered that, because they were for a weight reduction product, that claim, and the other claims made for the efficacy or action of LIPObind, should be backed by rigorous trials on people.

We noted much of the evidence sent by Goldshield referred to the effects of varying amounts of dietary fibre on a diet and other dietary studies. We noted there were also some studies on the dietary effect of various pectins and leaves. We noted, however, that many of those studies were in vitro and that the in vivo studies had been carried out on obese, diabetic or ileostomy subjects or hamsters and guinea pigs.

We noted other evidence sent by Goldshield related to one of the ingredients of LIPObind, Neopuntia. We noted, however, some of those studies were not in vivo and, of those that were in vivo studies, one was carried out on subjects with metabolic syndrome and the other was carried out on ten healthy subjects. We noted the results of the latter study claimed it "suggested an effectiveness for an application of Neopuntia within the framework of meals rich in fat content". We considered, however, that the two in-vivo studies did not constitute robust substantiation to support the claims made.

We considered that the claim that the product could bind to fat and the claim "Clinically Proven" were not demonstrated by the evidence sent to us.

We considered that, to substantiate the claims, we would need to see robust in vivo evidence that showed a direct link between the specific LIPObind formula and it binding fat, suppressing appetite, decreasing food cravings and lowering blood cholesterol for healthy people. We considered that we had not seen that and concluded therefore that the ad was misleading.

We welcomed Goldshields offer to remove the claims "Helps to Suppress Appetite", "Helps to Decrease Food Cravings" and "Helps Lower Blood Cholesterol".  

On points 2, 4, 5 & 6, the ad breached CAP Code clauses 3.1 (Substantiation), 7.1 (Truthfulness), 50.1 (Health & beauty products and therapies - General), 51.1 and 51.4 (Weight Control).

3. Upheld
We considered that the claim "There are no gimmicks, no fad diets, no additional exercise routines that have to be undertaken, in fact you can still indulge yourself with your favourite treat every now and again" and further text "You can still treat yourself to a piece of cake without having to think twice and without feeling the usual pangs of guilt" implied that LIPObind would enable people to lose weight without dieting or doing exercise. We considered that, because we had not seen evidence to show that LIPObind would enable people to lose weight without dieting or doing exercise, the ad was misleading.

We welcomed Goldshields offer to remove the claim.

On this point, the ad breached CAP Code clauses 7.1 (Truthfulness), 50.1 (Health & beauty products and therapies - General), 51.1 and 51.4 (Weight Control).

7. Upheld
We considered that the claim "weight management" was likely to be understood by readers to mean that LIPObind could aid weight loss. We considered that we had not seen robust evidence to show that that was the case and therefore concluded that the claim was misleading.

On this point, the ad breached CAP Code clauses 7.1 (Truthfulness), 50.1 (Health & beauty products and therapies - General), 51.1 and 51.4 (Weight Control).

Action
We told Goldshield to remove the claim "The NEW Clinically Proven Fat Binding Pill ... A pill that has been tried and tested and proven to bind fat" and not to imply that the product could bind to fat in the absence of robust evidence that proved it could. We also told them to remove the claims "There are no gimmicks, no fad diets, no additional exercise routines that have to be undertaken, in fact you can still indulge yourself with your favourite treat every now and again", "You can still treat yourself to a piece of cake without having to think twice and without feeling the usual pangs of guilt", "Helps to Suppress Appetite", "Helps to Decrease Food Cravings", "Helps Lower Blood Cholesterol" and "Weight Management" unless they held robust evidence to support them. We advised them to seek advice from the CAP Copy Advice team before advertising again.

Adjudication of the ASA Council (Non-broadcast)