"Advertising Standards Authority of South Africa - Protecting Your Standards

HEALTH PLUS DIABETES / H DAWOOD / 14705
Ruling of the : ASA Directorate
In the matter between:
MR H DAWOOD	Complainant(s)/Appellant(s)
HARMONY CHOICE TRADING CC	Respondent

05 Feb 2010

Mr Dawood lodged a consumer complaint against a Harmony Choice Trading’s print advertisement promoting several of the products in its range, one being “Health Plus DIABETES”. The advertisement was published in the 25 October 2009 edition of the Sunday Times magazine.

The advertisement contains, inter alia, the wording “Health Plus Diabetes controls blood sugar levels. Its composition of natural herbs helps lower blood sugar levels, repair damages to pancreatic cells, corrects excessive thirst, reduces drowsiness and fatigue and helps with skin infections”.

COMPLAINT
In essence, the complainant submitted that the advertiser should produce proof for its claims as they may mislead people suffering from diabetes if untrue and unsubstantiated.

RELEVANT CLAUSES OF THE CODE OF ADVERTISING PRACTICE
In light of the complaint the following clauses of the code were taken in to account:

Section II, Clause 4.1 – Substantiation
Section II, Clause 4.2.1 – Misleading claims
Appendix A – Medicinal related products and advertisements containing health claims
Appendix F – Reference to diseases in advertising

RESPONSE
The respondent submitted that the product in question is a combination of natural herbs which contains ingredient that may help patients with diabetes, e.g. Cayenne and Gymnema.

Cayenne pepper has previously demonstrated qualities that may help naturally control blood sugar.

Gymnema herb is a member of the milkweed family. It has been used in Ayurvedic medicine for over 3000 years. It added that “Gymnema has been reported to reduce excessively high blood sugar levels, possible as a result of the regenerating the cell in the pancreas responsible for the production and secretion of insulin”.

In addition to this, the respondent submitted form MBR20.8, an “Application for the submission in terms of Call Up Notice R204; Government Notice no 23128 as published on 22 February 2002 for complementary medicine {Medicines and Related Substances Act; Act 101 of 1965; Section 14(1)}”. This form relates to its Health Plus Diabetes product.

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

At the outset, it must be noted that 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 brought to the ASA, namely whether the claims concerning the efficacy of the respondent’s product can be substantiated.

The advertisement states “Health Plus Diabetes controls blood sugar levels. Its composition of natural herbs helps lower blood sugar levels, repair damages to pancreatic cells, corrects excessive thirst, reduces drowsiness and fatigue and helps with skin infections”.

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 of the opinion that the claim made in the advertisement is clearly capable of objective substantiation as envisaged by the Code. The respondent has, however, not placed before the Directorate any documentary proof emanating or evaluated by an independent and credible expert, supporting claims made, despite being afforded an opportunity to supply such substantiation.

In light of the above, the claim “Health Plus Diabetes controls blood sugar levels. Its composition of natural herbs helps lower blood sugar levels, repair damages to pancreatic cells, corrects excessive thirst, reduces drowsiness and fatigue and helps with skin infections” is currently unsubstantiated.

Accordingly the advertisement is making an unsubstantiated claim and is therefore in contravention of Clause 4.1 of Section II of the Code.

By virtue of the fact that the advertisement is making an unsubstantiated claim about the product, it is likely to mislead people in a manner that is in contravention of Clause 4.2.1 of Section II.

Turning to the form MBR20.8 submitted, the Directorate notes that it 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 the respondent merely proves that it has applied in terms of the Call-Up Notice. It is not proof of efficacy or of registration.

Following on this, the Directorate notes that Appendix F of the Code deals specifically with “References to diseases in advertising”, and prohibits advertisers from offering any products, treatments or advice on specifically listed illnesses or conditions unless such claims accord with full product registration by the Medicines Control Council. Diabetes is one of the conditions listed.

From the above discussion, it is clear that the respondent’s product is not registered at the Medicines Control Council, and that the respondent is therefore not entitled to make any reference to Diabetes in its advertising.

Accordingly, the advertisement is also in contravention of the requirements of Appendix F.

In light of the above, the respondent is required to:

withdraw the advertisement in its current format;
the process to withdraw the advertisement must be actioned with immediate effect on receipt of the ruling;
the withdrawal of the advertisement must be completed within the deadlines stipulated by Clause 15.3 of the Procedural Guide; and
The advertisement may not be used again in its current format.

The complaint is upheld.