A number of allergies and intolerances are very difficult to diagnose, even by experts, which has resulted in a great number of scam or unsubstantiated tests being advertised that claim to be able to be able to determine the allergens or substances that are affecting you. The evidence for these tests are either scant or totally absent. This includes the ALCAT, IgG testing, hair analysis, etc. The Allergy Society of South Africa have published a Position Statement on the first two. Other international organisation, including EAACI (European Academy of Allergy and Clinical Immunology) have also made Position Statements on IgG Testing. In South Africa, two companies are marketing this test: Food Detective by Davies Diagnostics and ImuPro by Molecular Diagnostic Services.
|These tests have no proof that they have any benefit in predicting the correct foods or substances causing your symptoms: not a single robust study to show that they can accurately predict the foods effecting you. If you have had these tests done and feel no better, demand your money back.|
A complaint was laid with the ASA for the claims being made for the Food Detective. The ASA agreed, there was lots of marketing claims but little evidence in support for the claims.
Food Detective / HA Steinman / 15038
Ruling of the : ASA Directorate
|In the matter between:|
|Dr Harris Steinman||Complainant(s)/Appellant(s)|
|Davies Diagnostics (Pty) Ltd||Respondent|
26 Mar 2010
Doctor Steinman lodged a consumer complaint against a pamphlet distributed to healthcare professionals for the respondent’s “Food Detective” kit.
The pamphlet is headed “FOOD DETECTIVE” and features visuals of various fruits, milk and nuts.
The copy states, inter alia, “Sufferers of food intolerance frequently complain of lethargy and generally not feeling well….” It further states, “Food Detective is an easy to use test for food intolerance that can be performed in your practice with results in just 40 minutes. It identifies food causing IgG antibody production which may be involved in food intolerance…”
Under a heading “More Information” it states that this product “has been developed and manufactured by Cambridge Nutritional Sciences Ltd … part of Omega Diagnostics Group PLC”.
At the bottom of the second page it gives the respondent’s company information, and displays an SABS and SANAS logo’s.
In essence, the complainant submitted that the efficacy claims made by the respondent require substantiation. Furthermore, the use of the SABS and SANAS logo’s creates the impression that the test is certified by these bodies when it is not. Accompanying the complaint was a letter from the Allergy Society of South Africa stating that the measurement of IgG is not predictive for either allergy or intolerance.
RELEVANT CLAUSES OF THE CODE OF ADVERTISING PRACTICE
In light of the complaint the following clauses of the Code were taken into account:
• Section II, Clause 4.1 – Substantiation
• Section II, Clause 4.2.1 – Misleading claims
The respondent submitted that it is a small company that supplies medical laboratory diagnostic products to laboratories throughout the country. Food allergy and intolerance testing is a subject that scientists throughout the world are still debating. Lots of patients throughout the world are feeling better having been tested and adjusting their diets accordingly.
The advertising complained of was produced by the manufacturer and has been used in Europe with no problems from their authorities. The communication was sent out to dieticians and nutritionists only. The brochure mentions that the test is available to professionals who can advise the patient after the test results and that changes to one’s diet should only be made after consultation with a qualified person.
The SABS and SANAS logo’s refer to the company and show that the company has an accredited quality programme. The Food Detective Kit is CE marked which is an internationally accepted symbol of product compliance with various factors.
It also submitted a wealth of documentation as well as reports relating to Food Allergy and Intolerance from Allergy UK, highlighting the effects of Food Intolerance and referring to the CNS Food Detective kit. In addition to this, it submitted a response from the product manufacturer, Cambridge Nutritional Sciences Ltd.
At the request of the Directorate, the SABS (South African Bureau of Standards) and SANAS (South African National Accreditation System) provided opinions on the usage of their respective logo’s.
SANAS, submitted that it was not in a position to confirm whether the tests are accredited but informed that the organisation was not.
The SABS submitted that the company Davies Diagnostics is listed on its SABS Commercial register of ISO 9001 certified companies. The company had been certified by SABS Commercial since 14 August 2001. It added that “the logo is utilised in such a manner that it does not imply that the product complies with a standard. On the pamphlet received, the SABS ISO 9001 logo is positioned in relation to the company’s name and does appear to imply that the product is ‘SABS Approved’.”
The SABS also advised that the respondent was not permitted to utilise the SANAS logo as it may only be utilised by SANAS Accredited Certification Bodies.
RESPONSE TO THE OPINION
The respondent submitted that it has been using both the SANAS and SABS logo’s since being accredited in 2001. Despite being audited every six months nobody had informed them that the use of the SANAS logo was incorrect.
ASA DIRECTORATE RULING
The ASA Directorate considered all the relevant documentation submitted by the respective parties.
In terms of Clause 4.2.1 of Section II, “Advertisements should not contain any statement or visual presentation which, directly or by implication, omission, ambiguity, or exaggerated claim is likely to mislead consumers”.
The second page of the advertisement lists the foods that the Food Detective may be tested on and at the bottom of the page, below a thick, blue line, features the respondent’s logo with its contact details. A visual of the SABS and SANAS logo’s appear next to the contact details.
The complainant submitted that the logo’s create the impression that the test was certified by both authorities and thereby gives credibility to the test. The Directorate does not share this view. There is no mention in the copy of the advertisement that the respondent’s test has been certified. There is also no reference to the test as such where the logo’s appear. Given that the logo’s only appear at the footer of the pamphlet adjacent to the respondent’s corporate details, the Directorate is satisfied that a hypothetical reasonable person would associate the logo’s with the respondent as an entity, and not with its test or product.
The SABS submitted that the respondent’s company is listed and certified by SABS Commercial. It added that “On the pamphlet received the SABS ISO 9001 logo is positioned in relation to the company’s name and does not appear to imply that a product is ‘SABS Approved’.”
Based on the above, the use of the SABS logo is not misleading in terms of Clause 4.2.1 of Section II.
However, the SANAS representative confirmed that the respondent may not utilise the SANAS logo as it is not accredited.
As such, the use of the SANAS logo appears unjustified and therefore unsubstantiated.
The use of the SANAS logo is in breach of Clause 4.1 of Section II of the Code.
In light of the above finding, the respondent is required to:
- Withdraw the SANAS logo;
- The process to withdraw the SANAS logo must be actioned with immediate effect on receipt of this ruling;
- The withdrawal of the SANAS logo must be completed within the deadlines stipulated by Clause 15.3 of the Procedural Guide;
- The SANAS logo may not be used again in its current format in future.
Clause 4.1 of Section II states, inter alia, that advertisers should hold documentation on hand to substantiate all claims that are capable of objective verification. It further requires that such substantiation emanate from, or be evaluated by an independent, credible expert in the field to which the claims relate.
The claims objected to are:
“Sufferers of food intolerance frequently complain of lethargy and generally not feeling well….”, and “Food Detective is an easy to use test for food intolerance that can be performed in your practice with results in just 40 minutes. It identifies food causing IgG antibody production which may be involved in food intolerance…”
The complainant objected to these claims on the basis that food intolerance symptoms are specific, and do not amount to “Lethargy and generally not feeling well”. In addition, there is no accepted evidence that food intolerances can be tested with IgG testing.
Because the ASA is not a technical expert body, Clause 4.1 of Section II requires it to rely on the opinion from an “independent, credible expert”. Should the Directorate be satisfied that the relevant person or entity is indeed independent, credible and an expert in the field to which the claims relate, the Directorate will consider whether or not the expert confirms the claims in question as valid for the product as a whole.
The respondent submitted documentation from Cambridge Nutritional Services Ltd, the manufacturer of the Food Detective kit. This clearly does not meet the criteria of been an “independent” verification, as the manufacturer obviously has a commercial interest in the claims made.
The Directorate therefore cannot accept this document as substantiation for the advertised claims.
It also submitted press clippings relating to food intolerances.
As indicated above, the Directorate is not a scientific expert. As such, these press clippings are inadequate as they do not appear to have been evaluated by an independent and credible expert. In fact, they are largely editorial in nature and emanate from, at best, people with an interest, but no illustrated and acknowledged expertise or credibility in the field of allergies.
Accordingly, the press clippings do not comply with the requirements of Clause 4.1 of Section II, and can therefore not be accepted as substantiation for the claims made.
Finally, the respondent submitted a report titled “STOLEN LIVES 7 Food Allergy & Intolerance Report” by Allergy UK, a medical charity established to “represent the views and needs of people with allergy, food intolerance and chemical sensitivity” (see www.allergyuk.org).
On the website, the following information appears:
“GPs & Primary Health Care Services
We work closely with GPs and Primary Health Care Services by providing up to date information and training in all aspects of allergy. Our Health Advisory Panel are a group of leading health care professionals with specialist knowledge in allergy. We are able to call on their services to assist Primary Care staff seeking professional advice and to assist our Helpline with any query on involved or less common allergies”.
The report claims to “highlights the need for not only better services to diagnose food allergy and food intolerances but also the need to find specialist foods easily at local supermarkets and at comparable prices to normal foods”. It concludes that the “Food Detective” kit “detects food specific lgG antibodies …”
While the Directorate accepts that Allergy UK has a specific interest in this topic, the question remains whether Allergy UK meets the criteria of being an independent and credible expert entity.
Any expert put forward should be an expert in issues relating to the field. It must be emphasised that the term “expert” is interpreted in the ordinary sense, meaning someone with specialist knowledge and skill in a particular area, who has obtained substantial experience in that particular speciality or field. One would expect an expert to speak as an acknowledged authority on an issue.
The information provided by the respondent, and indeed that on the www.allergyuk.org website is lacking in relation to the expertise of this entity. Having extensively perused the website www.allergyuk.org, the Directorate could find no information on any of the purported “leading health care professionals with specialist knowledge in allergy” referred to on the website. The only detail about any people associated with the organisation relates to the trustees, of which only one is a medical doctor.
In addition, it is noted that the website, under the heading “Food Intolerance Testing” states, inter alia, as follows:
“There is controversy about the role of IgG; it may be present in the blood as a marker for the foods we eat most often, rather than actually being involved in the food intolerance reaction. Nevertheless, some people find the test helps them decide which foods to avoid.
Note that IgG tests are not tests for true food allergy”.
Finally, the Directorate notes that, while the report titled “STOLEN LIVES 7 Food Allergy & Intolerance Report” does suggest that the respondent’s Food Detective product uses IgG testing for food intolerances, the lacking information on the expertise of Allergy UK in conjunction with the claim “Note that IgG tests are not tests for food allergy” on the website casts doubt over the acceptability of this as adequate substantiation in terms of the requirements of Clause 4.1 of Section II of the Code.
In light of the above, the claims “Sufferers of food intolerance frequently complain of lethargy and generally not feeling well….”, and “Food Detective … identifies food causing IgG antibody production which may be involved in food intolerance…”are currently unsubstantiated and in breach of Clause 4.1 of Section II of the Code.
The respondent is therefore required to:
- Withdraw the claims complained of in its current format;
- The process of withdrawing the claims must be actioned with immediate effect;
- The process of withdrawing the claims must be completed within the deadlines stipulated in Clause 15.3 of the Procedural Guide; and
- The claims may not be used again in its current format in the future.
The complaint is partially upheld.