Background
One sponsored Instagram ad was also investigated and resolved informally with the advertiser’s agreement to remove it.
Ad description
A website for Supply Life, https://supplylife.com, a retailer of food intolerance tests, originally seen in December 2022 stated, “Make the change your body needs. If you’re suffering from food related Energy dips, Unwanted-weight, Bloating, Diarrhoea, Constipation, IBS, our process has helped improve so many lives. Our simple process will help you to notice a difference within just days of making dietary changes. Our qualified nutritionists will work closely with you to ensure the changes we suggest fit within your lifestyle and we will continue to offer you up to 30 days of nutrition support”.
Issue
The complainant, who understood that a blood test could not identify food intolerances or their symptoms, challenged whether the efficacy claims for the test to help with energy dips, unwanted weight and IBS symptoms could be substantiated.Response
Supplylife Group Ltd t/a Supply Life provided five studies and an expert opinion to support the claims. They also provided comments from three NHS doctors about the studies and the evidence submitted.
They further submitted results from an online customer survey. The 1585 eligible respondents were made up of those who were tested for food intolerances, were sent a nutritional advice form and who rang Supply Life’s helpline to ask questions about the results and received advice.
The results from the survey showed that 1488 answered “completely”, “not completely but significantly” or “moderately” to best describe the effect of Supply Life’s service on alleviating their symptoms versus 97 who said “not at all”. In response to the question “Did you notice a benefit to your symptoms from following the report and/or nutritional support?”, 1009 said “definitely”, 284 “probably”, 197 “possibly” and 95 said “no”. When asked “What symptoms were you trying to alleviate…”, 603 stated food related energy dips, 605 weight, 1145 bloating, 388 diarrhoea, 290 constipation and 588 irritable bowel syndrome (IBS). Those surveyed were also asked about adherence to the plan and whether lifestyle changes had been made as a result of the report, amongst other questions.
Supply Life had employed a chartered statistician to consider the survey’s design and whether it was strong enough to make accurate conclusions. In addition, the statistician had been asked to carry out a statistical evaluation of the survey responses and see whether or not those responses supported the ad. The statistician concluded the survey’s content had some limited issues but was overall adequate for the purpose intended. They said based on the survey answers it was accurate to state that for those who received a report and nutritional advice and followed completely the recommendations for at least six weeks, that 86% stated they had definitely seen a benefit to their symptoms. If respondents said they had made lifestyle changes, as well as following the recommendations completely for at least six weeks then those who reported benefits rose to 94%.Supply Life had further employed an expert, a Practitioner Health Psychologist and a Chartered Scientist, to review the statistician’s report, as well as the five studies to support the claims and the expert opinion.Supply Life said they believed the ad was compliant with the Code. Going forward, however, they would remove the claims "within days" and "energy related food dips". They would also make the ad clearer that it was based on the results of their consumer survey and not primary clinical research trials.
Assessment
Upheld
The ASA understood the NHS defined a food intolerance to be “difficulty digesting certain foods or ingredients in food”, and that the recommended way to identify the source of a food intolerance was to eliminate specific foods from a diet and monitor symptoms. The full programme offered by the advertiser at the time the ad appeared involved the testing of a diluted blood sample against extracts in laboratory conditions. Immunoglobulin G (IgG) antibody results for each extract were measured and an elimination diet was informed by the results.
The ad stated, “Make the change your body needs. If you’re suffering from food related Energy dips, Unwanted-weight, Bloating, Diarrhoea, Constipation, IBS, our process has helped improve so many lives”. We considered that consumers were likely to understand the references to the specific symptoms, alongside the claims “improving so many lives” and “Make the change your body needs”, to mean that taking an IgG test and implementing the subsequent elimination diet informed by that test, would, supported by the optional nutritional and lifestyle advice referred to in the ad, identify the food responsible for the symptoms and reduce or resolve those symptoms. That was supported by further text that stated, “Our simple process will help you to notice a difference within just days of making dietary changes”.
We understood the NHS did not currently recommend home tests for food intolerances. In addition, the British Dietetic Association (BDA) stated that there was no convincing evidence to support IgG blood tests and did not recommend them as a diagnostic tool. However, we reviewed the specific evidence submitted by Supply Life in support of their service and took expert advice. Supply Life provided a literature review and five studies, four focused on IBS and its symptoms, one of which also reported on weight loss and a second also on fatigue after meals. The fifth study was solely concerned with weight loss for those who had IBS.
The literature review was a non-systematic review of published works and studies relating to IgG testing and an elimination diet. The report outlined the background to adverse food reactions, immunological mechanisms in the body, the role of IgG antibodies and the links of elevated IgG antibodies to specific conditions, including IBS, and studies that have evaluated IgG testing and an elimination diet. Because the report was not a systematic review or a primary research study, while it was indicative, it did not represent evidence to substantiate the claims.
A preliminary observational study involved 80 patients with symptoms of delayed food allergies. They were subjected to an IgG test and had foods for which they tested positive eliminated from their diet. A range of symptoms, including those consistent with IBS and fatigue after meals, were then measured. While all symptoms showed improvement, there was no control group or randomisation, the number of participants was relatively small and it was unclear how the results had been measured. Further to that, the study had one person acting as both assessor and observer, at all stages of the study.
A second observational study looked at 22 professional athletes who took part in a three-month elimination diet based on the results of an IgG food intolerance test. The results looked at gastrointestinal symptoms, fat percentage, heart rate and flexibility. Gastrointestinal symptoms, measured by general and athlete-specific questionnaires, showed significant positive changes. Fat percentages of the athletes also decreased significantly. There was however no control group in the study, and no randomisation. The sample size was small and by only looking at professional athletes, was not representative of the wider population. The athletes were also shown before the study not to be consuming enough calories, vitamins and minerals. That was then corrected with the nutritional help given with the elimination diet, but it was unclear if the results were because of this correction or the IgG testing and elimination diet alone.
A randomised controlled trial of 150 patients with IBS divided participants into one group who were given an elimination diet based on their IgG testing, and a control group whose food exclusions were not based on those for which they had raised IgG antibodies according to the test. IBS symptoms were scored on a scale of 0 to 500. At 12 weeks, participants’ scores in the intervention group had reduced by 100 points and in the control group by 61.5 points. Although there were some concerns regarding the adequacy of the blinding and the control, overall it was a well-conducted study that suggested testing IgG antibodies could have a role in helping IBS patients identify candidate foods for elimination.
A double-blind randomised control trial of 60 participants, looked to manage IBS and headaches, where the participants were split into three groups. Over a period of 14 weeks, one group had an elimination diet informed by IgG testing, the second had probiotics and the third had probiotics and an elimination diet informed by IgG testing. The outcomes relating to IBS, abdominal distention and bowel habit, measured by an IBS questionnaire, showed improvements described by the authors as “remarkable” for bowel habit but only the group with probiotics and the elimination diet showed improvement in abdominal distention. While the study stated participants were randomised and double blinding occurred, no details were provided as to how that had been done. In addition, the overall sample size and therefore the group sizes were small. Finally, while the authors of the study claimed the results relating to IBS were “remarkable”, no statistically significant differences in outcomes between the groups was shown in the study paper.
A final randomised control trial had 82 participants who were split into two groups and looked at weight loss. One half were given an elimination diet based on the result of the IgG intolerance test. The other half (the control group) underwent a weight loss program overseen by a dietician. While the study showed statistically significant differences, favouring the elimination diet group, for weight, BMI and waist to hip ratios, it was unclear how randomisation had been achieved, whether blinding had occurred or whether the two groups were treated equally. Further to that, baseline characteristics between the two groups appeared to show that the control group was heavier. The study therefore was at a high risk of bias.
Having reviewed the studies to support the claims that IgG testing, in conjunction with an elimination diet, could assist with reducing and eliminating food related energy dips and unwanted weight, we considered that the evidence was not sufficient.Concerning IBS, and associated symptoms, two of the relevant studies were overall of an inappropriate design to support the claims. However, two of the other studies provided partial support for claims that an IgG-guided elimination diet might be able to identify specific food intolerances in people with that particular health condition and reduce symptoms. That evidence though came from studies that still contained concerns about the trial’s designs. Therefore, further research was needed to build on those studies, and they were not, of themselves, sufficient evidence to support advertising claims about the treatment of the named symptoms they referred to.
We next assessed the survey that Supply Life had carried out. We understood that Supply Life’s statistician’s opinion was that while the survey design did suffer from some issues, which increased the chances of the results not being strong enough for reliable conclusions, overall the issues were not enough to undermine the strength of the survey and it was adequate for its purpose. We further noted the statistician believed the data from the survey indicated, that the ad had been supported by the responses to the survey. The sole exception to this was, that the survey showed the benefits of Supply Life’s service were seen after at least six weeks of adherence and therefore they believed the claim “within just days of making dietary changes” in the ad was therefore not justified.
We acknowledged Supply Life’s expert opinion that the survey data also supported the suggestion that the majority of respondents following the Supply Life process perceived a benefit in terms of symptom management, but that the survey data alone could not fully substantiate the claims. They said it should be considered alongside and in the context of the scientific research submitted by Supply Life.
Specifically, regarding the claim “within just days”, the expert concluded that none of the scientific research nor the survey supported this claim. Concerning “food related energy dips” they concluded the survey was consistent with one of the studies, but as that particular study did not have a strong scientific basis, the claim could not be supported. For the remainder of the claim “Make the change your body needs. If you’re suffering from…Unwanted-weight, Bloating, Diarrhoea, Constipation, IBS, our process has helped improve so many lives. Our simple process will help you to notice a difference ...” they stated that the studies and the survey meant there was enough evidence to support the claims for weight, IBS and associated symptoms.
Therefore, we understood that Supply Life’s expert’s opinion was that in isolation neither the studies nor survey could fully substantiate the claims in the ad, but that when considered together, except for the claims “within just days” and “food related energy dips”, the combined evidence did support the remaining claims in the ad. We considered, however, that even a well-constructed survey of users of the service, was not a substitute for randomised controlled trials on humans. Therefore, whilst we recognised the indicative results of the survey, because it was not a primary research study, it did not provide sufficient evidence to substantiate the claim, even when taken together with the other studies.
Considering the evidence in its entirety, we were unable to accept that the claims had been adequately supported and concluded that the ad was likely to mislead.
The ad breached CAP Code (Edition 12) rules 3.1 (Misleadingness), 3.7 (Substantiation) and 12.1 (Medicines, medical devices, health related products and beauty products).
Action
The ad must not appear again in the form complained about. We told Supplylife Group Ltd t/a Supply Life not to state or imply that an elimination diet informed by their testing could help or alleviate food related energy dips, unwanted weight, IBS or its symptoms.
