British Advertising Standards Authority Upholds
Complaint against YORKTEST Laboratories
24 October 2007
Yorktest Laboratories Ltd
York Science Park
York Y010 5DQ
Number of complaints: 1
Sponsored links on the Google search engine, for a food allergy and intolerance testing service. The ads stated:
a. "Allergy Testing www.yorktest.com Clinically validated testing kit. Reliable food intolerance answers."
b. "YorkTest Laboratories www.yorktest.com "Test yourself for food intolerance. foodSCAN clinically validated test."
c. "YorkTest Laboratories www.yorktest.com "Europe's clinically validated home test. Scientific expertise and reliability."
The complainant challenged whether:
1. the claim "clinically validated" could be substantiated; and
2. the advertisers could substantiate the efficacy of the test
The ASA challenged whether:
3. the ads made claims that could lead to a mistaken diagnosis
The CAP Code: 3.1;7.1;50.1;50.2
1. YorkTest Laboratories Ltd (YorkTest) said that the Google ads in question were no longer live and that their Google advertising had now been brought "in-house". They said no sponsored links ads currently made claims about "clinical validity".
2. YorkTest said that they provided both immediate onset allergy (IgE antibody positive) blood testing with respect to food and other substances, commonly known as "classical allergy" and delayed onset allergy blood testing with respect to food, commonly known as "food intolerance" which they believed to be indicated by IgG antibodies. They said their MAST (Multi Allergy Screening Test) kit tested for classical allergy and their FoodSCAN tests tested for food intolerance. They said both their MAST and FoodSCAN tests complied with European Medical Device Directives and with the IVD (In Vitro Diagnostic) Directive 98/79/EC Annex III Section 6 (self test) under the auspices of the MHRA (Medicines and Healthcare Products Reglutatory Agency). They also said their FoodSCAN intolerance tests were endorsed by the independent charity Allergy UK.
YorkTest believed there was evidence that the consumer may benefit from eliminating food from their diet based on the results of the food-specific IgG antibodies found in the blood, and that this was the basis of the FoodSCAN tests. They said there was independent clinical data to support the positive results of food elimination based on IgG antibody tests and submitted three studies to support that.
3. YorkTest said their FoodSCAN food intolerance testing kits were not diagnostic of any condition but could be used to diagnose whether food intolerance could be a cause of "ill-health" symptoms.
The ASA noted the UL EC design certificates for the MAST and FoodSCAN tests provided by YorkTest showed acceptable design standards for medical equipment. We also noted that the tests were approved under IVD Directive Annex III Section 6, which covered the self test (consumer) aspect of the tests as medical devices, in the case of the FoodSCAN tests collecting a blood sample with a lancet and in the case of the MAST test dispatching a blood sample taken by a healthcare professional to YorkTest. However, we considered that these certificates did not constitute clinical validation of the test results. We concluded that the claim "clinically validated" could not be substantiated and was likely to mislead. We welcomed YorkTest's assurance that they had already taken steps to remove this phrase from their sponsored links.
On this point, the ads breached CAP Code clauses 3.1 (Substantiation) 7.1 (Truthfulness) and 50.1 (Health and Beauty and Therapies).
We noted evidence for the efficacy of the MAST test was not provided by YorkTest, but we understood that specific IgE antibody tests for some food allergies are clinically accepted as beneficial as part of an investigative regime carried out under the supervision of a suitably qualified medical practitioner. Nevertheless we were concerned that those tests were not used by medical practitioners as sole diagnostic tools and concluded that YorkTest had not justified the implication that allergy could be diagnosed using the YorkTest allergy testing service alone.
YorkTest provided three papers to support their claims for the FoodSCAN intolerance tests and believed those showed that the presence of IgG antibodies in the blood was indicative of food intolerances. however, we were concerned that the studies were conducted on people suffering from chronic medical conditions such as IBS and migraine and considered that those findings did not support a general claim for diagnosis of food intolerance. We noted one of the studies was published in an academic peer-reviewed journal, but also noted that although the study concluded that IgG tests may have a role in the treatment of irritable bowel syndrome symptoms, it did not refer to food intolerance among the general population and also stated that futher clinical research was required. We acknowledged that the independent charity Allergy UK endorsed YorkTest's FoodSCAN range with one of their Consumer Awards but also noted this was based on anecdotal evidence (self-reporting) that individuals felt they were benefiting from using the tests. We concluded that the evidence submitted was not sufficiently robust to prove the efficacy of the tests for diagnosing food allergy or intolerance.
On this point, the ads breached CAP Code clauses 3.1 (Substantiation) 7.1 (Truthfulness) 50.1 (Health Beauty and Therapies)
We noted the sponsored links did not refer to any specific medical condition, but were concerned that references to "clinically validated" and "scientific expertise and reliability" in the context of a home testing kit could encourage consumers to self-diagnose symptoms without consulting a suitably qualified medical practitioner.
On this point, the ads breached 50.2 (Health and Beauty and Therapies)
The ads should not be repeated in their current form. We advised YorkTest to consult the CAP Copy Advice team before producing future ads in the form of sponsored links.
This article was posted on October 24, 2007.