Compounding Pharmacy of SA – ASA ruling

Posted 24 April 2013

A consumer lodged a consumer complaint against the respondent’s print advertisement regarding bioidentical hormones appearing in Solal’s Health Intelligence Magazine during 2012. Ms Allana Moskovitz of Health Intelligence Magazine claimed that this particular advertisement was published in error. Huh? Really?

Compounding Pharmacy of SA / R Jobson / 20413
Ruling of the : ASA Directorate
In the matter between:
Professor M Roy Jobson Complainant(s)/Appellant(s)
Antiaging Technologies (Pty) Ltd t/a The Compounding Pharmacy of South Africa Respondent

10 Apr 2013

Professor Jobson lodged a consumer complaint against the respondent’s print advertisement appearing in the Health Intelligence Magazine during 2012.

The advertisement is headed “UNCLEAR about Hormone Replacement Therapy?” and details, inter alia, how the respondent’s “… uniquely formulated …” bioidentical hormones are “… adjusted according to a patient’s specific needs, symptoms or blood results”.

It elaborates on the fact that its bioidentical hormones are “… identical to the hormones produced naturally in the body …” and that these include progesterone, estradiol, estriol, DHEA and testosterone. It emphasises that bioidentical hormones are “… significantly safer than non-bioidentical hormones in terms of cancer and blood clotting risk …”

The complainant effectively raised seven issues or concerns:

Many of the hormones referred to in the advertisement require a prescription, as they are all schedule 3 or higher, and may not be advertised to the general public in terms of the Medicines and Related Substances Act. This renders the advertisement misleading.

In order to manufacture bioidentical hormones they would either have to be synthesised (unnaturally) or derived from human substances (such as for example female urine). The sources of the respondent’s hormones are not stated, and unless they can be verified as substantiation, the claim would be misleading.

In order to prove that the respondent supplies bioidentical hormones, a laboratory analysis would be required, preferably one showing that the molecular structure of the active ingredients is identical to the hormones as found in humans. The complainant recommended that the Directorate obtain assistance from a biochemist to ascertain whether any evidence submitted in this regard is sufficient.

The respondent should substantiate its statement that “bioidentical hormones are “… significantly safer than non-bioidentical hormones in terms of cancer and blood clotting risk …” Such substantiation should also show to what extent the respondent’s products are safer.

The claim that “… Bioidentical hormone replacement therapy (HRT) offers a safer and more individual alternative to conventional HRT …” needs to be substantiated based on direct comparison studies.

The complainant submitted that the advertising implies that bioidentical HRT is at least as effective as conventional HRT. This requires adequate clinical substantiation.

The efficacy claims for the respondent’s Estriol Vaginal Gel in treating “… vaginal dryness and associated problems”, which are listed as “… painful intercourse, a burning sensation when urinating, incontinence and slight bleeding after intercourse” needs to be substantiated.

In light of the complaint, the Directorate identified Clause 4.1 of Section II (Substantiation) as relevant.

Stefan Vos Marketing Regulation Advisers, on behalf of the respondent, initially argued that the complainant is a professor of pharmacy and would therefore be well aware that compounded bioidentical hormones require professional intervention. It would be unlawful for any such professional to prescribe such products unless he /she were satisfied of the efficacy of such products.

Arguments were made as to why the complainant is not a bona fide complainant but is rather abusing ASA processes get the ASA to act as a quasi-medicine regulator, which is not proper.

In the event that the Directorate does not agree, it attached an email from the Advertising and Marketing Manager of the Health Intelligence Magazine (Ms Allana Moskovitz), which confirms that this particular advertisement was published in error. It argued that this means that the advertising was not published “at the instance” of the respondent.

When the Directorate approached the respondent for clarity on whether or not its submission about the advertisement being published in error could to be interpreted as an indication that it would not use this advertisement again in future, it did not address this question, but merely reiterated its initial arguments.

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

Despite the Directorate affording the respondent the opportunity to clarify whether it has any intention of using the disputed (and allegedly erroneously placed) advertisement again, the respondent did not engage on this issue. The Directorate therefore had no option but to consider the complaint.

The respondent correctly noted that the ASA is not mandated to fulfil the role of the Medicines Control Council (MCC), which means that even if one assumes for the sake of argument that the respondent was acting in contravention of the Medicines and Related Substances Act, the Directorate would not be in a position to pronounce on this or take any remedial action.

The complainant argued that the products referred to in the advertisement are (in many instances) schedule 3 or higher, which means that they may not be advertised to the general public, which in turn renders the advertisement misleading.

Firstly, the complainant did not explain why the medicines’ scheduling status would render the advertisement misleading. In addition, it is noted that there is nothing in the ASA Code of Advertising Practice which prohibits the advertising of medicines with a certain scheduling status. Such provisions are contained within the Medicines and Related Substances Act, which is not enforced by the ASA.

The Directorate is therefore unable to deal with or rule on the first objection raised by the complainant. This aspect of the complaint is accordingly dismissed.

This does not mean, however, that the rest of the complaint automatically falls away.

The complainant took issue with several of the respondent’s claims on the basis that they were not substantiated. The issue of substantiation falls squarely within the ambit of the Code and of the ASA, and therefore requires the Directorate to make a decision in this regard.

Having said this, however, the Directorate notes that the complaint is effectively little more than unmotivated allegation.

The complainant’s second objection raised above implies that, unless the respondent indicates the source of its bioidentical hormones (presumably in the advertisement), the complainant has no way of verifying that they are indeed bioidentical.

While the Directorate accepts that the respondent did not state its source(s) in the advertisement, there is no requirement in the Code to do so. Similarly, while the Directorate accepts that the source of a bioidentical hormone will impact on whether it could truly be regarded as “bioidentical”, the complainant has not produced anything that would support an allegation that the respondent does not source its bioidentical hormones from an appropriate source. In fact, the complainant has not even alleged that this is the case.

In keeping with the principle established in Nature’s Choice Products / Mc Cain Foods / 16283 (12 November 2010) (which emphasised the need for proper grounds and motivation for an objection, rather than mere allegation), the Directorate sees no reason to concern itself with the origin or source of the respondent’s bioidentical hormones at this time.

Applying the above approach to the remaining five objections, the Directorate again notes that all these objections effectively call for substantiation, and emphasise the need for substantiation, but do not provide any reason or any reasonable explanation as to what basis the complainant has (if any) to allege that the respondent does not hold such substantiation.

The Directorate agrees with the complainant that the claims objected to require substantiation in terms of the Code. However, in the absence of any motivation as to WHY the complainant believes that the respondent does not hold such substantiation, the complaint is effectively no more than an unmotivated allegation, which does not meet the criteria for a valid complaint in terms of Clause 3 of the Procedural Guide.

The Directorate is therefore not in a position to consider and rule on the issue of substantiation at this time and based on the complaint at hand.

1 comment to Compounding Pharmacy of SA – ASA ruling

  • Fernanda

    For the last 20 years i have been using the biodentical hormone creams from solal (south africa) and always up to know felt great, normal and had not any menopause symptoms.

    Before, tried conventional tablets and other, immediately got bloated, put on 5 kgs of weight and feel terrible.

    Please do not remove from South Africa market the biodentical hormones creams.

    Other complications , can be caused by eating the wrong food and i think not from the biodentical hormone creams.

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