In Imupro / H A Steinman / 14955 (11 February 2010), the Directorate accepted the respondent’s voluntary undertaking that an advertisement that contained the claim that the “the internationally respected ImuPro Food IgG Intolerance Test can pinpoint food intolerances” was a once off advertisement and will not be used again. The undertaking was accepted on condition that the claim was not used again in future.
IMUPRO / H A STEINMAN / 14955 (15 Jul 2010)
Ruling of the : ASA Directorate
In the matter between:
Dr Harris Steinman – Complainant(s)/Appellant(s)
Molecular Diagnostics Services (Pty) Ltd – Respondent
15 Jul 2010
SUBSEQUENT TO THE RULING
The respondent submitted documentation to substantiate the claim in question. This documentation emanated from, inter alia, Dr C Linard’s and Dr Daniel Cristafi. Some research articles were also submitted to the Directorate.
RELEVANT CLAUSES OF THE CODE OF ADVERTISING PRACTICE
In light of the new submissions the following clauses of the Code were taken into account:
- Section II, Clause 4.1 – Substantiation
- Section II, Clause 4.2.1 – Misleading claims
In accordance with procedure, the Directorate requested the complainant to comment on the independence, credibility and expertise of the experts.
Dr Christian Linard
The complainant submitted that Dr Christian Linard cannot be regarded as an independent credible expert as his CV states that his current position is that of Director of the Laboratory of Food Incompatibility (Danièle Henkel Inc.). According to the website www.danielehenkel.com, Imupro is one of their brands.
Dr Daniel Cristafi
The complainant submitted that Dr Crisafi does not meet the requirements of Clause 4.1 of Section II as there is no absolute proof that he is an independent expert. There is also no documentary proof that he holds any accreditation from a recognised university. In addition, the complainant added that Dr Crisafi merely expresses his personal opinion, and does not base his conclusions on scientifically and statistically valid data.
ASA DIRECTORATE RULING
The ASA Directorate considered all the relevant documentation submitted by the respective parties.
Medicinal products cannot be treated as an ordinary general commodity. They have the potential for harmful as well as beneficial effects and can cause serious problems if not used safely. For this reason, there are specific regulations that strictly control the advertising and promotion of medicinal products.
The scope of this ruling is limited to the subject matter of the complaint before the ASA, namely whether the claims concerning the efficacy of the respondent’s product can be substantiated.
Clause 4.1 of Section II requires the advertiser to “engage the services of a person/entity which is independent, credible and an expert in the particular field to which the claims relate, to confirm the accuracy of the claims…”.
Because the ASA is not a medical expert, once it is satisfied that the person appointed by the advertiser is credible, independent and an expert in the field relating to the claims, it relies on the opinion of that expert. It is therefore the expert’s duty to interpret research data and articles and extrapolate findings and then determine whether the claims in question are true. For this reason the Directorate cannot consider the research articles submitted by the respondent. The only remaining submissions are those from Dr Christian Linard and Dr Daniel Cristafi.
The Directorate has visited the website http://www.danielehenkel.com and notes that it contains a link titled “Food Intolerance”. This link redirects to a website http://www.food-intolerance.ca which carries the Danièle Henkel logo, and prominently promotes the ImuPro300 Food Intolerance Report. It also offers for sale the ImuPro 100, 200 and 300 tests. Based on this, the Directorate concurs with the complainant that Dr Linard is not independent, as he is linked to the respondent’s product through his association with Danièle Henkel Inc.
In light of this, Dr Linard cannot be accepted as an independent expert as required by Clause 4.1 of Section II of the Code.
It is firstly noted that the respondent did not submit any supporting documents to explain why Dr Crisafi should be regarded as an independent and credible expert in this particular field.
It did, however, submit that Dr Crisafi “holds a master’s degree in science and a PhD in biochemistry, with a nutritional biochemistry specialization. He has also specialized in nutratherapy and phytotherapy. He is the author of several books, including Candida albicans and Les Superaliments, and has been editor-in-chief of Health ’N Vitality and vice-president of the École d’Enseignement Supérieur de Naturopathie du Québec. Daniel Crisafi has also taught at the Association des Médecins Endocrinologues du Québec and was on the committee of the Canadian Council on Continuing Education in Pharmacy. Mr. Crisafi has over twenty years of clinical experience and recently received the Canadian Health Food Association’s Lifetime Achievement award”.
While this arguably bestows some expertise on Dr Crisafi, the Directorate does not need to determine his status as an independent and credible expert at this time for the following reason:
In his letter, Dr Crisafi states as follows:
“I have been recommending the ImuPro test for approximately three years with very different results from the previous laboratories [referring to ELISA/EIA (Enzyme Immunoassays) panels to test the presence of IgG antibodies]. The analysis has been precise and consistent, confirmed by testing more than once on the same patient.
The elimination of the offending foods has produced excellent clinical results in all patients with either a significant attenuation of the symptoms or a complete elimination thereof.
Reintroduction of the offending foods, voluntary or not, sometimes unbeknownst to the patient, has solicited a reappearance of the symptoms that had either been attenuated or disappeared.
Though it does not replace conventional test methods in assessing a patient’s status, based on my clinical experience the ImuPro test is a clinically valuable and viable test in helping patients determine the presence and degree of food intolerances as factors in their disease processes”.
From this it is clear that Dr Crisafi is, at best, expressing his opinion based on personal experience, rather than a clinical evaluation of the product and any product-related testing and literature. It therefore amounts to anecdotal evidence, which the Directorate cannot accept.
Finally, it is also noted that Dr Crisafi does not verify the claim that this test can “pinpoint food intolerances”. He simply states that it is a valuable test in determining “the presence and degree of food intolerances”. He also states that the test “does not replace conventional test methods”.
For all the above reasons, the Directorate cannot at this time accept the letter from Dr Crisafi as unequivocal verification as required in terms of the Code.
In light of the above, the claim in dispute has not yet been adequately substantiated in terms of Clause 4.1 of Section II. The Directorate therefore does not need to consider Clause 4.2.1 of Section II at this time.
The Directorate ruling dated 11 February 2010 is therefore still binding.
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