The radio commercial states, inter alia, “Bioter Health’s Arthro Joint Forté is a clinically proven, natural solution for the treatment of Osteoarthritis, Rheumatoid Arthritis and lower back pain. Its triple-action effect assists with bone and cartilage regeneration, provides pain and inflammation relief and increased flexibility.”
The ASA ruled: "In light of the above, the respondent’s claims are currently unsubstantiated and in breach of Clause 4.1 of Section II."
Arthro Joint Forte / Sanofi-Aventis / 12553
Ruling of the : ASA Directorate In the matter between:
Sanofi-Aventis South Africa (Pty) Ltd Complainant(s)/Appellant(s)
Bioter Health CC Respondent
05 Mar 2009
Sanofi-Aventis lodged a competitor complaint against a radio commercial, pamphlet and Internet advertisement for Arthro Joint Forté.
The radio commercial states, inter alia, “Bioter Health’s Arthro Joint Forté is a clinically proven, natural solution for the treatment of Osteoarthritis, Rheumatoid Arthritis and lower back pain. Its triple-action effect assists with bone and cartilage regeneration, provides pain and inflammation relief and increased flexibility.” The pamphlet states, inter alia, “Take Charge of Your Arthritis Now… introducing a Clinically Proven Natural Solution for Bone & Cartilage Regeneration in Joint Disease and for Pain and Inflammation Associated with Arthritis…”
The pamphlet and Internet advertisement (www.bioterhealth.net/joint_health.html) both state, inter alia, “Action 1 – PAIN & INFLAMMATION RELIEF IN OSTEAORTHRITIS, RHEUMATOID ARTHRITIS AND LOWER BACK PAIN”; “Action 2 – REGENERATION OF BONE & CARTILAGE IN OSTEAORTHRITIS, AND RHEUMATOID ARTHRITIS”; “Action 3 – CUSHION EFFECT BETWEEN JOINTS (HYALURONIC ACID) FOR INCREASED FLEXIBILITY AND MOBILITY OF JOINTS”.
The complainant submitted, inter alia, that the respondent’s references to treatment for Arthritis, backache, Osteoarthritis and Rheumatoid Arthritis are in breach of Appendix F. It also requested documentary evidence to support the claims that the product was clinically tested, that it has a positive effect in Osteoarthritis, Rheumatoid Arthritis and Seronegative Arthritis (as implied by reference to back symptoms), that there is a link between the product and Hyaluronic acid, and that the product regenerates cartilage in Rheumatoid Arthritis.
RELEVANT CLAUSES OF THE CODE OF ADVERTISING PRACTICE
The complainant identified the following clauses of the Code as relevant: • Section II, Clause 4.1 – Substantiation • Appendix F – References to diseases in advertising
The respondent submitted, inter alia, that the only active ingredient in Arthro Joint Forté is IridoForce™, a patented ingredient containing purified Harpagosides, which are found in the Devil’s Claw Root (Harpagophytum procumbens). It submitted documentary evidence to show that this active ingredient in the product has the claimed benefits.
At the Directorate’s request, the respondent clarified, inter alia, that “Arthro Joint Forté is registered as a complimentary [sic] medicine with the Medicines Control Council (MCC) submitted as an MBR1 dossier.” It submitted a document from the MCC titled “MBR20.8”.
ASA DIRECTORATE RULING
The ASA Directorate considered the relevant documentation submitted by the respective parties. MCC registration and references to the treatment of Arthritis, Osteorthritis and Rheumatoid Arthritis Clause 1 of Appendix F states, inter alia, that advertisements should not offer products, treatments or advice for certain illnesses unless the product is fully registered with the MCC and the claim is formally approved by the MCC. The respondent submitted that its product is registered with the MCC as a complementary medicine, and submitted a document from the MCC titled “MBR 20.8” in support of this contention. The Directorate notes that the document was ex facie issued by the MCC and contains the heading, “APPLICATION FOR THE SUBMISSION IN TERMS OF CALL UP NOTICE R204… FOR COMPLEMENTARY MEDICINE”. The following also appears on the document: “This document indicates that the Medicine Control Council Registry has taken receipt of the above-mentioned documents.”
The Directorate dealt with a similar situation in Comfrey Capsules / The Pharmaceutical Society of SA / 9092 (21 June 2007). In that matter, the respondent submitted a similar document as proof of registration of the product with the MCC. The Directorate approached the MCC for clarification.
The MCC indicated as follows: “[The] call-up Notice for Complementary Medicines dated February 2002 makes provision for an applicant wishing to sell a so-called complementary medicine to submit certain information to the [MCC] for evaluation… On application to the [MCC], an acknowledgement letter with an acknowledgement number is issued to the applicant. This number will enable the Council to trace the documentation in future.”
The Directorate held that, in light of this, it was clear that the document submitted by the respondent was proof of its application in terms of the Call-up Notice for Complementary Medicines, and that it was not a certificate of registration. The above ruling similarly applies to the present matter and the document submitted by Bioter Health.
Since there is no other proof of registration before the Directorate, the respondent’s product, Arthro Joint Forté, appears not to be registered with the MCC for the purposes of Clause 1 of Appendix F.
The Directorate notes that Arthritis, Osteorthritis and Rheumatoid Arthritis are all listed conditions in Clause 1 of Appendix F.
Because the respondent’s product is not registered with the MCC, the respondent may not offer it as a treatment for these three conditions. Accordingly, the respondent’s claims in respect of Arthritis, Osteorthritis and Rheumatoid Arthritis are in breach of Clause 1 of Appendix F.
Given the above: The claims must be withdrawn; The process to withdraw the claims must be actioned with immediate effect on receipt of this ruling; The withdrawal of the claims must be completed within the deadlines stipulated by Clause 15.3 of the Procedural Guide;
The claims may not be used again in their current format in future. The respondent’s attention is also drawn to Clause 15.5 of the Procedural Guide.
In light of this ruling, there is no need for the Directorate to consider Clause 4.1 of Section II in respect of these claims. This aspect of the complaint is upheld. Seronegative Arthritis The complainant requested substantiation for the positive effect of Arthro Joint Forté in, inter alia, Seronegative Arthritis. The Directorate notes, however, that there are no references to Seronegative Arthritis anywhere in the respondent’s advertisements.
The complainant did reference this condition and stated, in brackets, “as implied by reference to back symptoms”. This seems to suggest that, according to the complainant, references to back symptoms are references to Seronegative Arthritis. There is, however, no explanation as to why this is so.
The Directorate cannot merely accept, without clarification, that references to back symptoms are references to Seronegative Arthritis. The complaint is therefore too vague in this regard, and the Directorate is not satisfied that the hypothetical reasonable person will understand references to “back symptoms” as references to Seronegative Arthritis. This aspect of the complaint is accordingly dismissed.
Lower back pain, Hyaluronic acid and regeneration of cartilage The Directorate firstly notes that Clause 1 of Appendix F lists certain diseases to which only limited reference may be made. One of these is “Backache”, unless the reference is to chronic or persistent backache, in which case no reference may be made. None of the parties submitted any arguments as to whether or not the references to “lower back pain” in the respondent’s advertising should be regarded as references to chronic or persistent backache.
The Directorate is accordingly not equipped to deal with this issue at this time. The complainant requested substantiation for the following claims: That Arthro Joint Forté was clinically tested to have a positive effect on lower back pain; That there is a link between Arthro Joint Forté and Hyaluronic acid; and That Arthro Joint Forté regenerates cartilage in Rheumatoid Arthritis. Clause 4.1 of Section II states, inter alia, that an advertiser must hold documentary evidence to support all claims that are capable of objective substantiation.
In addition, it clarifies that such documentary evidence shall emanate from or be evaluated by an independent and credible expert in the particular field to which the claims relate.
The Directorate is not a scientific expert, and is therefore unable to interpret scientific data and to draw scientific conclusions from it. What the Directorate requires is confirmation from an independent and credible expert in the relevant field that the data supports the claims made in the advertising.
It is also trite that where claims are made for a product, the supporting evidence must confirm the validity of the claims for that product, and it is not enough to show that an ingredient in the product has the claimed benefits (refer, for example, Grace Pharmaceuticals / Ingelheim Pharmaceuticals / 11893 (29 October 2008)).
The respondent is therefore required to submit independent documentary evidence which shows that the product Arthro Joint Forté has the claimed benefits. All of the evidence submitted by the respondent deals either with IridoForce™, Devil’s Claw Root or Harpagophytum procumbens. None of it actually refers to Arthro Joint Forté, nor does any of it unequivocally confirm the validity of the specific claims for Arthro Joint Forté. It also appears that some of the evidence emanates from the manufacturer of IridoForce™.
Accordingly, the evidence submitted by the respondent does not comply with the requirements of Clause 4.1 of Section II, and can therefore not be accepted as substantiation for the claims in respect of Arthro Joint Forté.
In light of the above, the respondent’s claims are currently unsubstantiated and in breach of Clause 4.1 of Section II.
Given the above: The claims contested must be withdrawn; The process to withdraw the claims must be actioned with immediate effect on receipt of this ruling; The withdrawal of the claims must be completed within the deadlines stipulated by Clause 15.3 of the Procedural Guide;
The claims may not be used again in their current format until new substantiation has been submitted, evaluated and a new ruling is made in terms of Clause 4.1.7 of Section II of the Code.
The respondent’s attention is also drawn to Clause 15.5 of the Procedural Guide. This aspect of the complaint is upheld.