Background
Summary of Council decision:
Four issues were investigated, all of which were Upheld.
Ad description
Two ads for an oral gel, seen in February, March and June 2017:
a. A web page, seen on www.enteromed.co.uk, describing the uses of Enterosgel, and related linked pages, stated, “ENTEROSGEL as an oral intestinal adsorbent has a capacity to adsorb harmful medium-weight substances such as pathogens, bacterial toxins or some allergens in the gut. Gut nasties are naturally expelled with the stool, helping towards treatment of diarrhoea, some allergies with gastrointestinal symptoms and IBS-D … ENTEROSGEL is an effective adjuvant in treatment of allergies with gastrointestinal symptoms in children and adults … Drug-free ENTEROSGEL is shown to help as a supportive treatment of diarrhoea dominant IBS. Enterosgel has a positive effect, reducing abdominal pain severity and normalizing stool frequency in IBS-D patients, thus contributing to the harmonization of quality of life … Enterosgel is developed to adsorb bacterial toxins and other harmful medium-weight molecular substances, including allergens … The unique ENTEROSGEL porous molecules are scientifically developed to adsorb harmful medium-weight substances in the stomach and gut, such as bacterial toxins, pathogens and allergens, not attaching to the good bacteria and vitamins”.
An FAQ page stated, “ENTEROSGEL can be used as a supportive treatment of gastroenteritis … IBS”.
A web page entitled “Enterosgel technology” stated, “Enterosgel works like a CLEVER SPONGE adsorbing only harmful medium-weight substances in the gut (bacterial endo and exo-toxins, pathogens, allergens)”.
A web page entitled “Detoxification” stated “Exposure of the gastrointestinal tract to pathogens, toxins, allergens can result in development of gastrointestinal infections, intoxication and allergic reactions. Vital bodily functions are associated with the production of harmful and toxic metabolites. Part of them having reached the gut are usually eliminated from the body with faeces, but some of harmful substances may be reabsorbed into the bloodstream again and transported back to the liver, remaining in the enterohepatic circulation … Supportive detoxification is an important step towards achieving recovery, optimal health and longevity”.
b. An advertorial seen in the national press stated, “The drug-free remedy for IBS” and made a number of efficacy claims for treatment of IBS and its symptoms. It also stated, “Enterosgel … acts like a clever sponge to selectively soak up harmful substances in your gut, such as bacterial toxins, pathogens and allergens, and expels them from your body naturally”.
Issue
Johnson and Johnson Ltd and two members of the public challenged whether the following claims were misleading and could be substantiated, that Enterosgel could:
1. adsorb “toxins”, including pathogens and bacterial toxins, and remove them from the body, thus resulting in health benefits such as the prevention and treatment of gastrointestinal infections; and
2. treat irritable bowel syndrome (IBS).
Johnson and Johnson Ltd challenged whether the following claims were misleading and could be substantiated, that Enterosgel could treat:
3. allergies; and
4. gastroenteritis.
Response
1. EnteroMed Ltd provided a certificate from the relevant Notified Body showing that Enterosgel met the requirements of Annex V of Council Directive 93/42/EEC concerning medical devices and was a Class IIa medical device. They stated that Enterosgel had been used in the Commonwealth of Independent States (former Soviet Republics) for 30 years and was the number one antidiarrhoeal product on the market in those countries
EnteroMed said that Enterosgel (polymethylsiloxane (PMS)) was an enterosorbent with a high surface area that could irreversibly bind various substances and gases. It had a globular porous structure that gave it a low capacity for adsorbing low molecular substances and a high capacity for adsorbing high molecular weight substances. They said that the claim that Enterosgel could adsorb toxins was supported by a number of in vitro studies, which they provided. They said the website did not claim that Enterosgel could prevent gastrointestinal infections.
2. EnteroMed said that the website stated that Enterosgel could be used as an adjuvant treatment for allergies with gastrointestinal symptoms, and did not claim that it could treat allergies. They provided evidence that they believed supported the claim that Enterosgel could be used as a supportive treatment for allergies.
3. EnteroMed said that they did not claim that the product alone could treat IBS. They provided a study that they believed demonstrated that Enterosgel could be used as a supportive treatment for IBS.
4. EnteroMed said that they did not claim that the product alone could treat gastroenteritis. They provided several studies that they said supported the claim that the Enterosgel could be used as a supportive treatment for gastroenteritis.
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.
EnteroMed submitted a large volume of evidence. This included a market report, a paper discussing the chemistry of the product, information on the safety of competitor products, and a number of clinical studies that were provided solely in abstract or conference summary form. These documents were not assessed due to lack of relevance to the issues under investigation, or incompleteness.
1. Upheld
The ASA noted that ads (a) and (b) made a number of claims regarding the ability of Enterosgel selectively to adsorb harmful substances in the gut, including “pathogens” and “bacterial toxins” and expel them from the body, while not attaching to other substances such as “good bacteria and vitamins”. Ad (a) also stated “Exposure of the gastrointestinal tract to pathogens, toxins, allergens can result in development of gastrointestinal infections, intoxication and allergic reactions” and “Supportive detoxification is an important step towards achieving recovery, optimal health and longevity”.
We considered that consumers would understand these claims to mean that Enterosgel could bind with a variety of different harmful substances in the body and remove them, resulting in improved health, including through the prevention and/or treatment of gastrointestinal infections and their symptoms. We considered that the substances referred to were likely to be understood as ones that could cause intermittent infection in otherwise healthy adults and children. Therefore we expected to see evidence, in the form of randomised clinical trials, to demonstrate that taking Enterosgel would result in improved health through the prevention and/or treatment of gastrointestinal infections and their symptoms in that population.
A number of studies submitted by the advertiser measured the ability of Enterosgel to adsorb bacterial toxins and viruses, or to inhibit bacterial growth, in a laboratory environment. However, we did not consider that in vitro studies on the function of the product were sufficient to support the claims as consumers were likely to understand them.
EnteroMed also provided a number of studies conducted on humans. However, we noted that many of these were conducted on participants with additional conditions, for example, atopic dermatitis, kidney infections and periodontal disease. Several were only conducted on children. We noted that the papers did not primarily study the efficacy of Enterosgel 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; population baseline information was lacking; outcomes were poorly defined; and statistical analysis was missing. One was an interim report on an ongoing study. We therefore considered that the papers submitted were not adequate to support the claims made for Enterosgel.
Because we had not seen adequate evidence that Enterosgel could bind with and remove different harmful substances from the body, resulting in improved health through the prevention and/or treatment of gastrointestinal infections and their symptoms, we concluded that the claims in ads (a) and (b) had not been substantiated and were therefore misleading.
On that point, ads (a) and (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).
2. Upheld
Ad (a) stated, “Drug-free ENTEROSGEL is shown to help as a supportive treatment of diarrhoea dominant IBS. Enterosgel has a positive effect, reducing abdominal pain severity and normalizing stool frequency in IBS-D patients, thus contributing to the harmonization of quality of life” and “ENTEROSGEL can be used as a supportive treatment of …IBS”. Ad (b) stated, “The drug-free remedy for IBS”. We considered that consumers would understand this to mean that Enterosgel could prevent, treat, help to treat or alleviate IBS and its symptoms. EnteroMed submitted one study that assessed the efficacy of Enterosgel in treating participants with diarrhoea-predominant IBS (IBS-D). While the study reported significant reduction in the frequency and intensity of some symptoms, it featured a number of methodological flaws. For example, it was unclear if (or how) the subjects had been randomised, population demographic baseline data was missing, and there was a poor control. We considered that the evidence was inadequate to support the claims as consumers were likely to understand them, that is, that the Enterosgel could prevent, treat, help to treat or alleviate IBS and its symptoms. We concluded that the claims in ads (a) and (b) had not been substantiated and were therefore misleading.
On that point, ads (a) and (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).
3. Upheld
Ads (a) and (b) made a number of claims that Enterosgel could bind with allergens in the gut. We considered that consumers would understand this to mean that the product could remove allergens from the body, thus alleviating, treating or helping to treat allergic symptoms. Ad (a) also stated, “helping towards treatment of … some allergies with gastrointestinal symptoms”. We considered that consumers would understand this to mean that Enterosgel could treat or help to treat some allergies with gastrointestinal symptoms. We considered that consumers would understand from the context of the ads that the “allergens” referred to were those that could cause intermittent symptoms in otherwise healthy adults and children. We therefore expected to see evidence, in the form of randomised clinical trials, to demonstrate that taking Enterosgel would result in improved health through the prevention and/or treatment of allergic symptoms in otherwise healthy adults and children.
EnteroMed provided a number of studies assessing the efficacy of Enterosgel in treating patients with various types of allergies and symptoms. However, we noted that most of these were only conducted on children. 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; population baseline information was lacking; outcomes were poorly defined; and statistical analysis was missing. We considered that the papers submitted were not adequate to support the claims made for Enterosgel.
Because we had not seen adequate evidence that Enterosgel could bind with and remove different allergens from the body, thus alleviating, treating or helping to treat allergic symptoms, we concluded that the claims in ads (a) and (b) had not been substantiated and were therefore misleading.
On that point, ads (a) and (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).
4. Upheld
Ad (a) stated, “ENTEROSGEL can be used as a supportive treatment of gastroenteritis”. We considered that consumers were likely to understand this to mean that Enterosgel could prevent, treat, help to treat or alleviate gastroenteritis and its symptoms. We understood that “gastroenteritis” referred to diarrhoea and vomiting that could be caused by a number of different bacteria or viruses. We noted that EnteroMed had submitted a number of studies assessing the efficacy of Enterosgel in treating different types of gastrointestinal infections. As discussed above (point 1) , we did not consider that the evidence provided was sufficient to demonstrate that Enterosgel could prevent and/or treat gastrointestinal infections and their symptoms in general, as implied by the ads. We therefore considered that we had not seen evidence that it could treat or help to treat gastroenteritis. We concluded that the claim had not been substantiated and was therefore 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).
Action
The ads must not appear again in the forms complained of. We told EnteroMed Ltd not to claim that Enterosgel could remove harmful substances from the body unless they held robust evidence to substantiate their claims. We also told them not to make direct or indirect claims that Enterosgel could prevent, alleviate or treat gastrointestinal conditions and symptoms (including IBS, allergies and gastroenteritis) in the absence of robust evidence to substantiate them.
