Advertisment
An advertisement feature for Fitzwilliam FoodTEST appeared in two different publications, one print and one online. The features were similar, however, the print feature focused on diet and lifestyle while the online feature focussed on allergies. The print advertisement stated:
“ADVERTISEMENT
Rheumatoid Arthritis
Why Treat Symptoms? Treat the root cause, writes Martin Healy.
Rheumatoid arthritis is a chronic inflammation which spreads like a virus throughout the body attacking and destroying joints. By the time one hip replacement operation has been completed, the disease process has already begun attacking other joints and so on relentlessly. This gives us a clear picture of the destructive power of inflammation.
This is the very same destructive force behind the inflammatory conditions listed below. The Inflammation process is destroying the tissues and causing:
• Thyroid Disease
• Eczema
• Irritable Bowel
• Asthma
• Autoimmune disease
• Crohn’s Disease
• Ulcerative Colitis
• Psoriasis
• Fibromyalgia.
The medical treatments for the above conditions range from surgery to steroids to immune suppressant drugs. Such treatments can be lifesaving but you should also bear in mind that the root cause of this inflammation is mostly rooted in diet and lifestyle.
The treatment of inflammation responds well to dietary changes. A study published in PubMed indicated a link with food Intolerance. This concurs with findings at Fitzwilliam FoodTEST Clinic. People who followed the dietary recommendation of the food intolerance test demonstrated a clear reduction in symptoms and CRP inflammation levels.
The treatment of rheumatoid arthritis, asthma, eczema, Irritable bowel etc. is exactly the same. All of these conditions are but different manifestations of inflammation. Once the inflammatory food trigger is detected and removed the inflammation stops.
Thyroid Disease is another autoimmune condition which follows a similar path and according to Dr. Elena Koles, MD, PhD (immunology, allergy and a physician with over 25 years’ experience) food Intolerance (sensitivity) plays a central role in terms of causation. For details about Dr. Koles and her ground-breaking work in this area see www. fitzwilliamfoodtest.com.
Food Intolerance Test
A range of food Intolerance tests are available and all are CE [1] marked (comply with EU regulation of medical tests). They are analysed at a registered laboratory. All of these tests can be processed from a finger prick blood sample and are available from the clinic or as a mail order test through www.fitzwllllamfoodtest.com.
A testimonial from a patient was also included in the advertisement.
“US Healthcare is the most expensive in the world ($3.5 trillion a year), but has the poorest outcomes in terms of patient recovery. Over 40% of population suffer from chronic diseases and it is estimated that chronic Illness will affect 50% of the population by 2025 (Sunday Business Post 07/05/17).
For those who are interested, a new approach to chronic inflammatory illness – treating the root cause – is available. As [testimonial name] describes above, change your diet and you too might be greatly surprised by the outcome.
[Contact details for advertiser given]”
The online feature stated:
“Rheumatoid arthritis – why treat symptoms? Treat the root cause
Martin Healy
April 21 2017 11:35 AM
Chronic inflammation is the driving force behind many health conditions
Rheumatoid arthritis is a chronic inflammation which spreads like a virus throughout the body attacking and destroying joints. By the time one hip replacement operation has been completed, the disease process has already begun attacking other joints and so on relentlessly. This gives us a clear picture of the destructive power of inflammation. This is the very same inflammatory force behind conditions such as, Thyroid Disease, Asthma, Eczema, Psoriasis, Irritable Bowel, some cancers, heart disease and autoimmune disease.
The medical treatments for the above conditions range from surgery to steroids to immune suppressant drugs. Such treatments can be lifesaving, but you should also bear in mind that the root of the problem is inflammation and inflammation is rooted in “allergy”.
Hayfever – is a classic example. The condition manifests in the eyes as stinging and irritation. The sinuses and nose becomes blocked and people suffer with chronic sneezing and all because of an “allergy” to pollen. The arrival of summer and pollen marks the beginning of months of suffering for a lot of people. However, once September arrives and the pollen disappears, all of these terrible symptoms of inflammation disappear.
Avoiding the allergy trigger stops the inflammatory condition
The treatment of rheumatoid arthritis, asthma, eczema, irritable bowel etc, is exactly the same. All of these conditions are but different manifestations of inflammation as a result of some allergy. Once the allergy trigger is detected and removed, the inflammation stops.
Food Intolerance is responsible for the vast majority of these reactions. These trigger foods are difficult to find without specialist testing. A new “Indicator” test for €15 has been launched to identify if you have “food intolerance” antibody markers in your blood. A NEGATIVE result means you don’t have food intolerance issues. A POSITIVE result means you do.
All of these tests are CE marked (comply with EU regulation of medical tests). They are analysed at a registered medical laboratory. All of these tests can be processed from a finger-prick blood sample and are available from the clinic or as a mail order test here.
Don’t just treat the symptoms, treat the cause
More details on food intolerance testing at Fitzwilliam FoodTEST can be found here. Fitzwilliam FoodTEST is on Lower Fitzwilliam Street, Dublin 2, Tel: 01-4733790.”
The same testimonial that appeared in the Irish Times also appeared in the Irish Independent version.
Footnotes:
[1] CE marks signify that products sold in the EEA have been assessed to meet high safety, health, and environmental protection requirements. By affixing the CE marking to a product, a manufacturer declares that the product meets all the legal requirements for CE marking and can be sold throughout the EEA. This also applies to products made in other countries that are sold in the EEA. Source https://ec.europa.eu/growth/single-market/ce-marking_en
Complaint
Print Advertisement:
Two Consultant Immunologists and a Professor of Paediatrics and Child Health objected to the print advertisement. The Professor made his complaint on behalf of the Irish Food Allergy Network and the Irish Association of Allergy and Immunology.
One of the complainants commented that food intolerance testing had been extensively reviewed by numerous organisations, including the Irish Association of Allergy and Immunology, the Irish Food Allergy Network, the European Association of Allergy and Clinical Immunology, the British Society for Allergy and Clinical Immunology, the UK House of Lords and the UK Advertising Standards Authority and was not recommended.
The complaints were based on the following grounds:
Issue 1:
There was no robust nor scientific evidence to support food intolerance testing in the setting of rheumatoid arthritis or other inflammatory disease. The claims were considered to be seriously misleading and to contribute to diets of no proven value.
Issue 2:
While the role of dietary modification in the setting of chronic inflammation was an area of active research, the advertisement was misleading as it quoted the on-going scientific research. The complainant considered that there was no evidence that the tests being promoted had any impact on any chronic condition.
Issue 3:
There was no evidence for the claims in the advertisement that food intolerances were the basis for multiple autoimmune diseases and inflammatory conditions.
Issue 4:
In regards to the tests being CE marked, one complainant considered that this did not indicate that the tests delivered had a clinical utility. They considered that the use of the terminology was misleading as there was no evidence that the testing process delivered was accredited.
Online Advertisement:
Two consumer complaints were received regarding the online advertisement on the following grounds:
Issue 5:
The claim that autoimmune diseases such as rheumatoid arthritis were caused by food intolerances, was untrue.
Issue 6:
No scientific evidence to substantiate the claims.
Issue 7:
The implication that if the food intolerance tests were carried out and the consumer avoided the foods listed, then their symptoms would ‘go away’ which they felt was not true. The complainant said that there was no cure for autoimmune diseases and while avoiding certain foods may help, the results would vary from person to person. They said that the only way to treat an auto-immune disease was to dampen the immune system with the use of immune-suppressants. They considered that the information in the advertisement could be harmful to people with such conditions.
Response
The advertisers stated that they did not consider that the articles were advertisements as they regarded them as vanity publishing.
The advertisers also stated that they considered that the complaints had to be examined and balanced against the principles of freedom of speech and the principles of the public good.
They noted that three of the complaints had been submitted by doctors and while two further complaints were from consumers, they considered that the terminology used in one of the consumer complaints suggested they also had a medical background. In regards to the medical complainants, the advertiser noted that one of the complainant’s made their complaint on behalf of the Irish Food Allergy Network (IFAN) while another used quotes from the IFAN as a reference to support their complaint.
The advertisers said that the IFAN Group have been one of the most vocal critics of their work and they noted that IFAN are funded by the pharmaceutical industry. They also said that as they used diet and nutrition to treat conditions that specialists treated with pharmaceuticals, therefore from a business perspective, these specialists and pharmaceutical companies were mutually opposed to the advertisers’ work and that there has been a well organised and ongoing campaign against the advertisers’ work. The advertisers also stated that there was no point in the Executive forwarding the scientific publications provided by the advertisers to a medical doctor as, regrettably, when it came to food intolerance testing, they said that it was hard to find a medical doctor who would give an impartial opinion.
Issues 1, 2, 3, and 6:
The advertisers provided a list of publications that they considered supported their food intolerance test:
1. “Food Elimination Based on IgG [1] Antibodies in Irritable Bowel Syndrome: a Randomised Controlled Trial” [3]
By W Atkinson, T A Sheldon, N Shaath, PJ Whorwell Gut 2004:53 1459-1464
doi: 10.1136.
CONCLUSION: Food elimination based on IgG antibodies may be effective in reducing IBS symptoms and is worthy of further biomedical research.
2. “The clinical relevance of IgG food allergy testing through ELISA (Enzyme-Linked Immunosorbent Assay)”
Townsend Letter for Doctors and Patients – Date: 1/1/2004 – Author: Suen, Raymond M.; Gordon, Shalima.
Appropriate tests must be utilized to identify possible causes, including food-antigen specific IgG antibodies.
3. “Serum IgG responses to food antigens in the Italian population evaluated by highly sensitive and specific ELISA test”
By Volpi N, Maccari F. J Immunoassay Immunichem 2009;30(1):51-69.Department of Biologia Animale, Biological Chemistry Section, University of Modena and Reggio Emilia, Modena, Italy
We conclude that the validated ELISA test may be applied for the serum/plasma IgG antibody level determination as a useful indicator of adverse reactions to food and food hypersensitivity.
4. “Testing for food reactions: the good, the bad, and the ugly”
By Mullin GE, Swift KM, Lipski L, Turnbull LK, Rampertab SD. Nutr Clin Pract 2010 Apr;25(2):192-8. Johns Hopkins University School of Medicine, Baltimore, MD 21205, USA
Among modalities used by many conventional and alternative practitioners, immunoglobulin G (IgG)-based testing showed promise, with clinically meaningful results. It has been proven useful as a guide for elimination diets, with clinical impact for a variety of diseases.
5. “Dietary advice based on food-specific IgG results.”
By Geoffrey Hardman Centre for Health Economics, University of York, Heslington, York, UK, and Gillian Hart YorkTest Laboratories Ltd, York Science Park, York, UK.
Originality/value – These data provide evidence for the use of elimination diet based on food specific IgG blood test results as an aid to management of the symptoms of a range of chronic medical conditions.
The advertisers considered that the papers below supported Food Intolerance Testing in Rheumatoid Arthritis / Inflammatory disease:
6. “The gut–joint axis: cross reactive food antibodies in rheumatoid arthritis “
By M Hvatum, L Kanerud, R Ha¨llgren, P Brandtzaeg [4]
The advertisers also said that given that Rheumatoid Arthritis was a chronic inflammatory autoimmune disease, the publication below highlighted the link between inflammation and food intolerance.
7. “IgG Antibodies Against Food Antigens are Correlated with Inflammation and Intima Media Thickness in Obese Juveniles”
By M. Wilders-Truschnig, H.Mangge, C.Lieners, H.J.Gruber, C Mayer, W Marz Exp Clin Endocrinol Diabetes 2008; 116:241-245. Dec 10 PubMed
OBJECTIVE: Systemic low grade inflammation may contribute to the development of obesity, insulin resistance, diabetes mellitus and atherosclerotic vascular disease. Food intolerance reflected by immunoglobulin G (IgG) antibodies may predispose to low grade inflammation.
DISCUSSION: We show here, that obese children have significantly higher IgG antibody values directed against food antigens than normal weight children. Anti- food IgG antibodies are tightly associated with low grade systemic inflammation.
When asked to provide a full copy of each study (having submitted the front page initially), the advertisers provided a copy of some of the above studies together with a copy of other studies not previously referred to, including:
8. “IgG-Based elimination Diet in Migraine Plus Irritable Bowel Syndrome”. [5]
By elif Hgaz Aydinlar, MD; Pinar Yalinay Dikmen, MD; Arzu Tiftikci, MD; Murat Sarue, MD; Muge Aksu; Hulya G. Gunsoy; Nurdan Tozun, MD.
Conclusion: Findings indicate that food elimination based on IgG antibodies in migraine patients who suffer from concomitant IBS may effectively reduce symptoms from both disorders with possible positive impact on the quality of life of the patients as well as potential savings to the health-care system.
9. “IgG-Mediated allergy: A new mechanism for migraine attacks? [6]
By Julio Pascual and Agustin Oterino
The advertisers said that the study told that food specific IgG antibodies (detected by the food intolerance test) were statistically more frequent in the migraine patients, who then improved on an elimination diet without the need of medication. They said that the study also said that concurring with migraine results, the levels of IgG antibodies had been shown to be increased in IBS patients with significant improvement in IBS symptoms in patients on the food elimination diet.
10. “Serological Investigation of Food Specific Immunoglobulin G Antibodies in Patients with Inflammatory Bowel Diseases.” [7]
By Chenwen Cai, Jun Shen, Di Zhao, Yuqi Qiao, Antao Xu, Shuang Jin, Zhihua Ran, Qing Zheng.
Conclusion: The study demonstrated a high prevalence of serum IgG antibodies to specific food allergens in patients with IBD. IgG antibodies may potentially indicate disease status in clinical and be utilised to guide diets for patients.
The advertisers stated that the publications supported the proposal that many of the conditions listed do respond well to dietary changes when based upon the IgG food intolerance test. They said that once you removed the food trigger, in many cases the conditions do respond well.
In regards to the article itself, the advertisers said that the statement that rheumatoid arthritis was an inflammation condition was a statement of fact. They said that the conditions listed were purely a list of a group of conditions where inflammation was central to the condition and that this was also fact. In regards to the treatment of inflammation, again they said that this information was also fact, surgery and medication were the standard treatment and these treatments dealt with the symptoms of the inflammation but did not deal with the root cause of the inflammation. They said that the core theme of the article was to highlight the link between food intolerance and inflammation. They referred specifically to one of the articles quoted by them (article 7 above) as substantiation for their claims.
In regards to the statement that “inflammation responds to dietary changes”, they said that the article provided also supported the link between food intolerance (specific IgG antibodies) and inflammation, therefore, there was sufficient evidence to suggest that food IgG antibody testing may prove useful in guiding an exclusion diet by identifying reactive foods that may be contributing to symptoms. They also provided a further list of supporting publications.
In regards to the statement about the treatment of rheumatoid arthritis, they said that inflammation was central to all of the conditions listed in the paragraph and they considered that removing the food antigen trigger would stop the inflammation process. They referred to the fact that Coeliac disease was a chronic inflammatory autoimmune disease where the food trigger was gluten. Once the gluten was diagnosed and removed from the diet, the inflammation and associated symptoms stopped.
In regards to the reference to Thyroid disease, they said that they were reiterating the link between food intolerance and autoimmune thyroid disease and that genetically susceptible individuals, when their gut barrier was breached, there was translocation of the antigen from the gut into the bloodstream which triggered the autoimmune response. They provided details of an article on “gut permeability” for the Executive’s reference.
Issue 4:
The advertisers said that their tests were available from their clinic and were CE marked, meaning that they complied with EU regulation.
Issue 5 & 7:
The advertisers again stated that the statement that rheumatoid arthritis was an inflammation condition was a statement of fact. They said that the conditions listed were purely a list of a group of conditions where inflammation was central to the condition and that this was also fact. In regards to the treatment of inflammation, again they said that this information was also fact, surgery and medication were the standard treatment and these treatments dealt with the symptoms of the inflammation but did not deal with the root cause of the inflammation. They said that the core theme of the article was to highlight the link between food intolerance and inflammation. They referred specifically to one of the articles quoted by them (article 7 above) as substantiation for their claims.
The advertisers also referred to an open letter that was published in “Today’s Dietitian” that was written by a registered dietician who had referred to a paper written by Dr. Alessio Fasano which showed that autoimmune conditions may share a common root, that is a leaky gut.
Finally, the advertisers said that the complainants were incorrect to say that changing the diet in accordance with a food intolerance test would produce no beneficial outcome for patients suffering with inflammatory conditions such as rheumatoid arthritis, irritable bowel syndrome, crohn’s disease etc , as there was scientific evidence to show the link between food intolerance and various inflammatory conditions.
Additional Information:
The Executive requested an opinion from the Health Products Regulatory Authority (HPRA) on food intolerance testing. In reply the HPRA stated that products that are marketed for the purposes of food intolerance testing are generally considered as medical devices and classified as in-vitro diagnostics (IVD). They said that regulations of these are covered by the IVD Directive 98/79/EC which is transposed into Irish law in SI. 304 of 2001. They said that food intolerance tests fall under one of two categories either ‘self-test’ IVDs or ‘self-declared’ general category IVDs. While the HPRA are the competent authority in Ireland for the regulation of medical devices which include IVD products, they do not approve or certify medical devices for sale in Ireland, rather the certification or approval is based on either a self-declaration by the manufacturer or for ‘self-tests’, by assessment and certification by an independent third party known as a notified body.
They said that they began market surveillance of food intolerance tests in January 2015 due to an increase in prevalence of these tests and based on their initial findings they published a notice in March 2015 to warn the public against utilising tests without seeking medical advice in order to highlight that ‘intolerance’ and food allergy were distinctly different conditions and to alert the public that they may suffer adverse health outcomes as a result of restricting their diet based solely on such test results. They said that they engaged with scientific and clinical experts and found that the pathophysiology underlying food intolerance was not yet know and it may include toxic, immunologic or metabolic causes. Without a clear pathophysiology, any test purporting to be able to ‘diagnose’ food intolerance was not supported by clinical data.
The HPRA said that with respect to IgG based tests, they found that this was a blood marker which increased in every person following exposure to proteins found in food and that this was to be expected as part of the normal function of the immune system in every person. In regards to food intolerance, however, they said that it had not yet been shown that an increase in IgG was anything other than a marker that someone had recently been exposed to a certain protein.
They also said that other tests, such as bioresonance or genetic based tests, did not have a clear scientific basis. They said that the only clinically valid method for diagnosis and treatment of food intolerance was an elimination diet; that is, eliminating a particular food from your diet to detect whether your symptoms resolve or disappear altogether as a result. They said that food intolerance could be diagnosed only after a reintroduction of the eliminated food. If symptoms returned this made it very likely that the eliminated food was responsible for the symptoms. They said that an elimination diet should only be undertaken in close consultation with a registered dietician.
Additional response from advertisers:
The Executive requested further comments from the advertisers in regards to the opinion from the HPRA.
The advertisers said that their services were totally compliant with HPRA guidelines. They considered that the HPRA, in stating “Other tests such as bioresonance or genetic based tests, did not have a clear scientific basis”, accepted that their IgG test did have a scientific basis and said that the HPRA has always accepted that their test had the European CE mark of conformity.
They agreed with the HPRA’s statement that the elimination diet was the only valid way to diagnose food intolerance and explained that all they were saying was that the elimination diet was very difficult to manage when people were in acute symptom distress. They said that all they have ever claimed is that the IgG test could be used to guide the elimination diet process.
The advertisers considered that the issue relates to confusion about how best to describe the test. They said that the term “food intolerance test” evolved over many years and while technically it was correct, a more precise definition would have been “that it measures food specific IgG antibodies and this may be used to guide the food elimination diet process” as this is how they describe it. They also said that they always advise all patients to work with their GP and agreed that the scientific publications strongly supported this food intolerance approach for some conditions, but not all.
Further additional comments:
The advertisers said that they have always accepted that exposure to food will possibly produce an increase in IgG levels, however, it was only when the IgG levels were significantly increased above normal levels that they note the reading. This is the information used to guide the Elimination Diet. They said that it was standard practice to report blood test results according to a specific range whereby only elevated readings outside the reference range are noted. They said that they did not state that only ‘elevated’ or ‘significantly elevated’ readings were noted for attention because they took it for granted that people would understand this but not stating this was not an attempt to mislead. They said that the adverts were designed to inform people about food intolerance and that they only had about 600 words to explain a very complex subject so they provided a general overview. They said that the matter of highlighting “elevated” readings had never been an issue for any client.
They provided a copy of test results for a patient which showed results in the normal, borderline and elevated ranges for various foods. They did not agree with the HPRA’s statement that the IgG test only indicated foods that had been eaten as, in the example provided by them, the patient regularly ate the 60 foods included in the test yet they only showed elevated reactions to 8 of the foods. They said that this result was to be used by the patient to guide their Elimination Diet and that eliminating these foods from their diet would rest their digestive system and immune system. They said that it was important to note that 70% of the immune system was located within the intestinal tract, and that when this tract was overloaded with undigested, sour, fermenting foods, the immune system was overloaded and inflammation was triggered. They queried where a patient would start without the IgG test.
Throughout the time the advertising was published the advertisers stated that they employed a Nutritional Therapist as Clinic Manager and they had stated on their website that consumers should seek the advice of their doctor or GP before taking a test.
The Executive requested further information from the HPRA in response to the advertisers’ comments. In reply the HPRA stated that their food intolerance market surveillance case was closed. They referred again to their safety notice which had summarised their findings in the case. They said that they were not in a position to comment on an individual’s treatment or on the provision of healthcare services as neither of these were within their remit. They also said that they were satisfied that the information they had highlighted helped raise awareness to the limitations of these products and that they had based their information campaign on a scientific evaluation of the facts.
In response to the advertisers’ reference to “elevated scores” for which “removal from the diet” is recommended or “borderline” or “normal” scores, the HPRA referred to the advice provided in their Information Notice which stated:
“As the cause of food intolerance is as yet unknown, any test which claims to indicate an intolerance to food is of little clinical validity. In other words, a positive or negative test result is unlikely to be specifically related to any particular symptom or clinical condition. Many of the tests available on the Irish market examine a blood marker known as ‘immunoglobulin G’ (IgG). This is a blood marker which increases in every person following exposure to proteins found in food and this is to be expected as part of the normal function of the immune system in every person. It has not yet been shown that an increase in IgG is anything other than a marker that someone has recently eaten a certain food.”
They said that the HPRA had informed the public in their Information Notice that raised IgG related to food was a marker of exposure i.e. having eaten the food, but that it had not been demonstrated to be diagnostic for food intolerance.
In response to the advertisers’ reference to an “overloaded immune system”, they said that they were not aware that this was a recognised disease state or pathological phenomenon.
Footnotes:
[2] Immunoglobulin G (IgG) is a type of antibody. Representing approximately 75% of serum antibodies in humans, IgG is the most common type of antibody found in blood circulation. Source: https://en.wikipedia.org/wiki/Immunoglobulin_G
[3] Complete paper submitted
[4] Complete paper submitted
[5] Complete paper submitted
[6] Editorial on a study submitted
[7] Complete paper submitted
Conclusion
Complaints Upheld In Part
The Complaints Committee considered the detail of the complaints and the advertisers’ response.
The Committee confirmed that the two articles were advertisements for the purposes of the Code which stated at 1.1(c) “Advertising or advertisement includes, but is not limited to, a form of marketing communication carried by the media, usually in return for payment or other valuable consideration or in a space that would generally be provided for in return for payment.”
The Committee noted the advertisers’ comments in relation to freedom of speech, opposing views from pharmaceutical companies and challenges seeking impartial opinions from medical doctors. The Committee however, considered the complaints in the context of the standards and requirements set out in the Code.
They also noted that food intolerance testing had been reviewed by a number of organisations, those listed by the complainants and also by the HPRA, and had not been recommended by these organisations.
Issues 1, 2, 3, 5 6 and 7:
The Committee considered these issues particularly in the context of Code Sections 4.9, 4.10 and 11.1 which all related to substantiation. They pointed out that the requirements under these Code Sections were that any claim made by an advertiser must be backed by substantiation. The claim can be direct, indirect, expressed or implied and an advertiser should have documentary evidence to support the claims. In regards to claims about health products, the substantiation should include the results of robust and reputable trials on human subjects of sufficient rigour, design and execution as to warrant general acceptance of the results.
The Committee noted that the advertising referenced particular types of autoimmune diseases and inflammatory conditions, with suggestions that food intolerance or allergy could be a causative factor and offered a test to identify ‘trigger’ foods. They reviewed the various research papers and articles which had been submitted and noted that they were carried out on patients with various ailments including rheumatoid arthritis, irritable bowel disease and migraine. The Committee noted that the studies’ conclusions were not definitive, but rather suggestive; in two of the studies, further research was suggested, in two studies, the sample size was considered to be small.
The Committee noted that the test worked by identifying if IgG antibodies were triggered on exposure to foods and while the extract of one study forwarded [8] concluded that the occurrence of IgG was higher in obese children than in normal weight children, the information provided by HPRA on the basis of their review was that it had not been shown that an increase in IgG was anything other than a marker that someone had recently been exposed to a certain protein.
In light of the above the Committee considered that the advertising was likely to mislead and was in breach of Sections 4.1, 4.4, 4.9, 4.10 and 11.1
Issue 4:
In regards to the claim that the tests were all CE marked, the Committee noted that the advertisement had included a clarification that the tests were compliant with EU regulations of medical tests. The Committee did not consider that the reference to be compliant with EU regulation of medical tests inferred that the tests delivered a clinical utility, nor did they consider that the terminology used was misleading. In the circumstances the Committee did not consider that Issue 4 was in breach of the Code.
ACTION REQUIRED:
The claims in the advertisements highlighted in issues 1, 2, 3, 5, 6 and 7 should not be re-published.
Footnotes:
[8] No 7 in the advertisers’ response
