Background
Summary of Council decision:
Three issues were investigated, two of which were Not upheld and one was Upheld.
Ad description
A poster and website for an oral gel:
a. The poster, seen on 12 November 2015, stated “STOMACH BUGS? Viral or bacterial Diarrhoea? ENTEROSGEL … Helps to cleanse the gut from viruses and bacterial toxins. For children and adults … diarrhoea … Indigestion … Travellers [sic] tummy”. The ad included an image of the product packaging which included the wording “For effective relief from … Diarrhoea … Indigestion … Food poisoning … Travellers [sic] tummy … Food Allergy”.
b. The website www.enteromed.co.uk, seen on 20 November 2015, stated “Enterosgel removes allergens from the gut which helps fast normalisation of allergy status and skin condition … Food allergy is an adverse reaction to food mediated by an immunologic mechanism. The most common symptoms of food allergic and toxic reactions are rash, itching, urticaria, eczema, atopic dermatitis, accompanied with intestinal dysbiosis and diarrhoea. The treatment can be most effective if the allergen is physically removed from the body. Enterosgel absorbs histamines (Allergens) in the gut and removes them with normal stool within 12-24 hours … Enterosgel can be used by babies 0+, children and adults … It can be used as a first aid to lessen or prevent allergic reactions … Enterosgel is highly effective in treatments [sic] of food allergy …”.
Issue
The ASA received two complaints from GPs, one of whom was also a freelance journalist.
1. One of the complainants challenged whether the efficacy claims in ad (a) were misleading and could be substantiated.
2. The same complainant challenged whether ad (a) discouraged essential treatment for conditions for which medical supervision should be sought.
3. One of the complainants, who believed the ad encouraged consumers to consume foods they were allergic to, challenged whether ad (b) was irresponsible.
Response
1. EnteroMed said that gastroenteritis, or stomach bugs, were often caused by a virus and they provided background information from several sources on that topic. They also provided information on the physical properties and description of the mechanism of Enterosgel which they said was evidence that it absorbed molecules such as bacterial toxins. EnteroMed said that all adsorbents absorbed bacterial toxins and viruses and Enterosgel had a higher affinity towards toxins than, for example, charcoal. They also provided studies which they said substantiated the claims that Enterosgel was effective in treating the conditions listed. They said, because the guidelines for medical devices made it possible to use clinical studies on similar products, papers on those products could also be used to support the claims made for Enterosgel.
2. EnteroMed said the product packaging stated “In case of food poisoning take double dose of Enterosgel and seek medical help”.
3. EnteroMed did not comment in detail on this point.
Assessment
The ASA understood that Enterosgel held a Class IIa medical device certification, and while medical devices were regulated by designated ‘Notified Bodies’, marketing communications in the UK were assessed by the ASA against the Advertising Codes.
1. Upheld
We noted that ad (a) made claims that Enterosgel could be effective for the relief of diarrhoea, indigestion, traveller's tummy, food poisoning and food allergies for adults and children. It also made specific references to the product’s efficacy to cleanse viruses and bacterial toxins from the gut. We therefore considered that consumers would interpret the claims to mean that Enterosgel would be effective in not only resolving or relieving those conditions referred to, but also, in relation to diarrhoea, food poisoning and traveller's tummy, it would treat their causes, by removing any underlying viral or bacterial toxins, and therefore resolve them more quickly than usual. Furthermore, we considered that consumers were likely to understand that diarrhoea, indigestion, food poisoning and traveller's tummy, were symptoms likely to be experienced intermittently by otherwise healthy adults and children.
We took expert advice. We noted the range of papers submitted which were in the form of abstracts, theoretical discussions on absorbent products, a thesis synopsis, clinical guidelines, a conference abstract and several studies conducted on participants with additional symptoms, for example, asthma, atopic dermatitis and irritable bowel syndrome. We noted that the papers did not primarily study the efficacy of Enterosgel on the conditions listed in the ad on participants reflective of the target audience, that is, children and adults, that were likely to be otherwise generally healthy.
Furthermore, we noted that many of the papers contained methodological flaws, for example, randomisation had either not been carried out or was not adequately described; some were not doubled blinded and comparisons were based on a poor control; outcomes were poorly defined; and statistical analysis was missing. We therefore considered that the papers submitted were not adequate to support the claims made for Enterosgel.
Because we had not seen adequate evidence to support the claims that Enterosgel could cleanse the gut from viruses and bacterial toxins or relieve diarrhoea, indigestion, traveller's tummy, food poisoning and food allergies in children and adults, we concluded ad (a) 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),
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.
and
12.6
12.6
Marketers should not falsely claim that a product is able to cure illness, dysfunction or malformations.
(Medicines, medical devices, health-related products and beauty products).
2. Not upheld
We considered that because ad (a) made specific references to cleansing the gut from viruses and bacterial toxins and that Enterosgel could relieve diarrhoea, indigestion, food poisoning, traveller's tummy and food allergies, consumers would understand that the product could relieve those symptoms. We understood that in certain circumstances, consumers might need to seek medical attention if an episode of those conditions and associated symptoms were particularly prolonged. However, because the ad contained no references to serious or prolonged episodes of the conditions listed, we did not consider that the ad implied that Enterosgel should be used in those circumstances. Notwithstanding the point above regarding the lack of adequate evidence to support Enteromed’s efficacy claims, because ad (a) made only general claims regarding the use of Enterosgel, we concluded that it was unlikely to discourage essential treatment for conditions for which medical supervision should be sought.
On that point, we investigated ad (a) under CAP Code 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), but did not find it in breach.
3. Not upheld
We noted that ad (b) made several references to removal of food allergens as an effective treatment for allergic reactions. For example, “Food allergy is an adverse reaction to food mediated by an immunologic mechanism … The treatment can be most effective if the allergen is physically removed from the body”. We considered that by describing how a food allergy occurred and a reaction could be avoided, those statements were likely to be interpreted by consumers as background information only. However, notwithstanding the point above about the lack of evidence to support the product’s efficacy claims, we considered that the ad implied that Enterosgel should be taken to alleviate an allergic reaction after a food had been consumed rather than as a preventative measure. Nevertheless, we considered that consumers with food allergies were likely to take a very cautious approach to ensure they avoided foods they knew or were likely to cause an allergic reaction, and the ad contained no explicit encouragement to use Enterosgel as a means to forego their usual food management regime.
Because the ad had not encouraged the use of Enterosgel as an alternative to avoiding foods a consumer was allergic to, we concluded it was not irresponsible.
On this point we investigated ad (b) under CAP Code (Edition 12) rule 1.3 1.3 Marketing communications must be prepared with a sense of responsibility to consumers and to society. (Responsible advertising), but did not find it in breach.
Action
The ad must not appear again in its current form. We told EnteroMed Ltd not to claim that Enterosgel could cleanse the gut from viruses, bacterial toxins, relieve diarrhoea, indigestion, travellers tummy, food poisoning and food allergies in the absence of adequate evidence.
