Nycomed-Dona – ASA ruling

Posted 18 January 2013

On 16 August 2012, the ASA held that the claims made by the respondent in its advertising was unsubstantiated and in breach and in breach of Clause 4.1 of Section II: “… DONA ® has been clinically proven to not only aid in the reduction of pain, inflammation and swelling of affected joints in OA, but also to improve mobility and prevent further progression of OA”.  Nycomed-Dona submitted new substantiation in terms of Clause 4.1.7 of Section II. The ASA accepted the new evidence and the previous ruling was therefore overturned and Nycomed-Dona may continue using the claim.

Nycomed-Dona / K Charleston / 20066
Ruling of the : ASA Directorate
In the matter between:
Kevin Charleston Complainant(s)/Appellant(s)
Nycomed (Pty) Ltd Respondent

16 Jan 2013

http://www.asasa.org.za/ResultDetail.aspx?Ruling=6370

BACKGROUND
On 16 August 2012, the Directorate held, inter alia, that the following claim made by the respondent in its advertising was unsubstantiated and in breach and in breach of Clause 4.1 of Section II:

“… DONA ® has been clinically proven to not only aid in the reduction of pain, inflammation and swelling of affected joints in OA, but also to improve mobility and prevent further progression of OA”.

SUBSEQUENT TO THIS RULING
The respondent submitted new substantiation in terms of Clause 4.1.7 of Section II.

The evidence consisted, inter alia, of a letter from Dr Ian Mackenzie Rogan and a number of scientific studies considered by him.

The respondent submitted that Dr Rogan is currently a practicing Orthopaedic Surgeon in Morningside Clinic. His qualifications include an MBCHB, FCS (SA) and FRCS (UK).

RELEVANT CLAUSE OF THE CODE OF ADVERTISING PRACTICE
In light of the previous rulings and the respondent’s new substantiation, Clause 4.1 of Section II (Substantiation) was considered relevant.

COMPLAINANT’S COMMENTS ON NEW SUBSTANTIATION
In accordance with procedure, the complainant was afforded an opportunity to submit comments in relation to evidence and independence, credibility and expertise of the expert, as per Clause 4.1.4 of Section II.

The complainant corresponded to enquire as to whether all the relevant documentation had been successfully sent to him, but submitted no comments on the actual substantiation other than to refer to it as a “document dump”.

ASA DIRECTORATE RULING
The ASA Directorate considered the relevant documentation submitted by the respective parties.

Clause 4.1.1 of Section II states, inter alia, that an advertiser must hold documentary evidence to support all claims that are capable of objective substantiation. Clause 4.1.4 of Section II states that documentary evidence other than survey data shall emanate from, or be evaluated by, an independent and credible expert in the particular field to which the claims relate and be acceptable to the ASA.

Dr Rogan submitted his CV with his report, which shows that he obtained his B.Sc at the University of the Witwatersrand in 1964 with majors in Micro Anatomy and Biochemistry. Following this, he obtained his MB BSc as well as his Fellowship of the Royal College of Surgeons in 1968 and 1974 respectively. He obtained his Fellowship of the College of Surgeons of South Africa in 1977, and has, inter alia, been involved with and worked at various hospitals in the field of orthopaedics. He currently practices as an orthopaedic surgeon in private practice. He has also served as the President of the SA Knee & Arthroscopy Society and the Honorary Secretary of the SA Orthopaedic Association. The Directorate is satisfied that he qualifies as an independent and credible expert for the purposes of this matter in terms of Clause 4.1 of Section II.

Dr Rogan submitted, inter alia, that the studies submitted were valid and reliable, and that the claim “Dona is clinically proven to not only aid in the reduction of pain, inflammation and swelling of the affected joints in OA, but also improve mobility and prevent further progression of OA.” is substantiated without a doubt.

Dr Rogan further submitted that the trials relied on “… were performed on the registered Glucosamine Sulfate formulation – Dona® and the claims made are thus specifically ONLY applicable to Dona”.

The Directorate notes that D Rogan unequivocally validates the new substantiation and points out specifically that the tests were done on the product. In light of the above, the respondent’s claim now appears to be substantiated in accordance with the provisions of Clause 4.1 of Section II.

The previous ruling is therefore overturned in this regard, and the respondent may continue using the claim.

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