Solal Breast Protection Formula – ASA ruling

Posted: 17 February 2012

Prof Jobson, claiming to be acting on behalf of the Association for Responsible Health Information and Advertising (ARHIA), laid a complaint with the ASA against Solal’s Breast Protection FormulaTM. Among other, the complaint states claims that the advertising at issue promotes, inter alia, the respondent’s “Breast Protection FormulaTM” product on the basis that “there are nutrients and plant extracts that can reduce your risk of developing breast cancer, and are healthy for you at the same time”.  In essence, the complainants disputed the factual accuracy of the respondent’s claims that this product prevents breast cancer in women with a high risk of developing breast cancer and / or women with purported contributing factors to a high risk of developing breast cancer. 

The ASA’s ruling was in part in favour of Solal and in favour of Prof Jobson, with the major finding in favour of the latter: ” As a result, the respondent’s claims that its “Breast Protection FormulaTM” is able to help prevent breast cancer, and all claims to that effect, are at present unsubstantiated, and in breach of Clause 4.1 of Section II of the Code.”

Solal Breast Protection Formula / R Jobson / 18707
Ruling of the : ASA Directorate
In the matter between:
Proffessor M Roy Jobson Complainant(s)/Appellant(s)
Solal Technologies (Pty) Ltd Respondent


15 Feb 2012
http://www.asasa.org.za/ResultDetail.aspx?Ruling=5959


Prof Jobson, claiming to be acting on behalf of the Association for Responsible Health Information and Advertising (ARHIA), as well as the South African Oncology Consortium and Campaigning for Cancer, lodged a complaint against advertising for Solal’s “Breast Protection FormulaTM”. The complaint was signed by Prof Jobson, Dr Martyn Schickerling, the Chief Executive Officer of the South African Oncology Consortium, and Ms Lauren Pretorius, the Chief Operating Officer for Campaigning for Cancer.

The advertising at issue promotes, inter alia, the respondent’s “Breast Protection FormulaTM” product on the basis that “there are nutrients and plant extracts that can reduce your risk of developing breast cancer, and are healthy for you at the same time”. It explains, inter alia, that this product “… contains these nutrients and plant extracts that help prevent breast cancer”.

The advertising complained of was accessed by the first complainant directly from the respondent’s website.

COMPLAINT
In essence, the complainants disputed the factual accuracy of the respondent’s claims that this product prevents breast cancer in women with a high risk of developing breast cancer and / or women with purported contributing factors to a high risk of developing breast cancer.

In addition to this, attention was drawn to a disclaimer or statement appearing on some advertising which reads “The information presented above is the opinion of SOLAL Technologies”. The complainants argued that this possibly implies that the information conveyed about the efficacy of the product is not based on fact, but merely an opinion. Such statements are unacceptable for medicines to make.

Other than the above, the complainants noted that the advertising is in breach of Appendix F by virtue of the references to “Breast diseases” and “cancer”, misleading and irresponsible (by virtue of the fact that unsubstantiated claims are made) and exploits the fear that many women have of developing breast cancer. Lastly, the complainants added that the advertising is disparaging of “prescription medicines” and / or those who prescribe or dispense them, because it draws a comparison between this product and such medicines and highlights how the advertised product is superior. An allegation was also made that the product in question is a Schedule 3 medicine, and may therefore not be advertised or dispensed without a prescription, yet the respondent is actively marketing and distributing it online.

RELEVANT CLAUSES OF THE CODE OF ADVERTISING PRACTICE
The complainant identified the following provisions of the Code as relevant:

• Section I, Clause 1.2 – Responsibility to the consumer

• Section II, Clause 3.1 – Fear

• Section II, Clause 4.1 – Substantiation

• Section II, Clause 4.2.1 – Misleading claims

• Section II, Clause 6 – Disparagement

• Appendix F – References to diseases in advertising

RESPONSE
Fluxmans attorneys, on behalf of the respondent, replied to the complaint, effectively raising five issues:

It disputed whether the second and third complainants were actually party to the complaint or permitted to be party to a consumer complaint as lodged by the first complainant.

It argued that the advertising can appropriately be termed “controversial”, and can therefore not be ruled on in accordance with the provisions of Clause 2.4 of Section I of the Code.

Insofar as the efficacy claims are concerned, it relied on information obtained from PubMed, arguing that this information sufficiently supports the claims. The point was also made that the advertising does not claim to prevent cancer, but rather lists the relevant predisposing factors and contributors, and explains that the relevant individual nutrients and plant extracts help to prevent breast cancer. Both the references to contributing factors and efficacy are adequately substantiated. Given that the claims are made in relation to nutrients and plant extracts, the substantiation need only apply to such nutrients and extracts, and not the respondent’s product as a whole.

Any potential play on fear (which the respondent denies is present) is justifiable, given the implications of this disease and of informing the public of appropriate treatment. In the same breath, the allegation of disparaging pharmaceutical products or dispensers of such products is denied outright.

In relation to Appendix F, the respondent requested the Directorate to suspend this particular complaint until its pending appeal before the Final Appeal Committee in another matter, and possibly the Court, can be finalised. Alternatively, it argued why this appendix is unconstitutional, irrelevant, and not being contravened. For reasons set out hereunder, however, it is not necessary to repeat the respondent’s arguments here.

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

There are a number of issues to clarify before the merits of the matter can be considered:

Appendix F
A recent ruling handed down by the Final Appeal Committee and issued on 3 February 2012 (Solal Tech Omega 3 & 6 / K Charleston / 16711), the Final Appeal Committee (the FAC) had to, inter alia, determine the proper interpretation and application of the provisions contained in Appendix F. it ruled, inter alia, as follows:

“The second argument concerned and interpretation on the limitation on advertising in regard to the illnesses and conditions listed in Appendix F. It was argued … that on a proper construction of Appendix F it only dealt with curative claims and not preventative claims. As the advertisement claimed that taking omega 3 would result in a reduction of the risk of contracting the listed illnesses and conditions it was preventative and not hit by the provisions of Appendix F.

As pointed out above, the Appendix refers to illnesses and conditions. The language of the Clause is that one cannot offer a product, treatment or advice for any of the illnesses or conditions unless the product concerned has been registered by the MCC …

It is to be seen that the wording refers to existing illnesses and conditions. Thus in the Christ Embassy Church matter, the FAC held that faith healing, which was claimed to be a treatment for an existing heart condition, was a breach of Appendix F. The finding was on the basis that the condition existed.

We have concluded that Appendix F is intended to protect consumers WHO HAVE ANY OF THE ILLNESSES OR CONDITIONS and take a product which has not been registered with the MCC …

… The advertisement is intended to offer consumers a product to reduce omega 3 deficiency which it claims can increase the risk of contracting some of the illnesses and conditions listed in Appendix F. it consequently does not deal with consumers who have an existing illness and condition as listed in Appendix F …”

The implication of this is that the intention of, and proper interpretation of Appendix F should be that it is intended to prevent unregistered products from advertising specifically to people who already have any of the illnesses or conditions listed in Appendix F. put simply, Appendix F does not apply to advertising that promotes a product on the basis that its use or consumption would prevent the user from contracting a specific illness or condition.

The advertising at issue consistently refers to the product’s ability to “help prevent breast cancer”. No offers or advice appear to be made to people who already have breast cancer, and as such, for the reasoning followed in the Solal Tech Omega 3 & 6 matter, this Appendix does not apply to the advertising at issue.

This aspect of the complaint is dismissed.

Status / standing of the complainants
The respondent’s argument here is effectively that:

The South African Oncology Consortium (the SAOC) promotes cost effective products relating to cancer, the reduction of risk of contracting cancer and / or its treatment. This effectively means that the SA Oncology Consortium is a competitor of the respondent, and any complaints by it should be treated as a competitor complaint in accordance with the relevant procedures of the Code (including, but not limited to payment of the relevant filing fee).

The Chairman of Campaigning for Cancer, Mr Neil Kirby, advised the respondent’s Mr Colin Levine that he was unaware of Prof Jobson being authorised to lodge a complaint on behalf of Campaigning for Cancer.

From http://www.saoc.org.za/about.php the Directorate was able to ascertain the following:

“The South African Oncology Consortium (SAOC) was established to facilitate cost-effective oncology treatment to the broader South African population.

In support of its objective, the SAOC has developed a ‘tiered’ oncology treatment guideline in which chemotherapy and radiation therapy options are tailored to meet the financial constraints of the individual patients healthcare insurance benefits.

This is supported by a comprehensive peer-to-peer and utilisation review program.

Represented in SAOC are members of the professional associations including the South African Society of Radiation and Clinical Oncologists (SASCRO), the South African Society of Medical Oncologists (SASMO) and the South African Society of Haematologists (SASH).

The SAOC is an unlisted public company and an accredited managed healthcare organisation.

SAOC also administers the accreditation of Anti-Neoplastic Therapy Facilities on behalf of the professional associations”.

From this it would appear that the SAOC indeed represent individuals and / or associations that have either a direct or an indirect commercial interest in the treatment of and presumably to some extent the prevention of cancer.

This appears to satisfy the requirements of Clause 4.12 of Section I for being termed a “competitor complaint”. By virtue of this, the Directorate will not accept a consumer complaint from the SAOC on this particular issue. It is for this reason that the SAOC was not officially cited as a party to this dispute at the top of this ruling.

Insofar as the endorsement of the complaint from Campaigning for Cancer, the Directorate notes that subsequent to the response being received, an official letter from the CEO of Campaigning for Cancer was received. This letter states as follows:

“Dear ASA Directorate,

Correspondence Regarding Solal Technologies: Breast Formula

We refer to the above matter and a complaint submitted to your organisation by Mr Roy Jobson of the Association for Responsible Health Information and Advertising (ARHIA), of which Campaigning for Cancer endorsed …
We respectfully request that our participation and endorsement in and of this complaint be withdrawn …”

Accordingly, the Directorate also did not include Campaigning for Cancer in its citation of the parties at the top of this ruling.

The complaint from Prof Jobson, however, still has to be determined.

Controversial advertising
The respondent requested the Directorate to dismiss the complaint in relation to Clause 4.2.1 of Section II (Misleading claims) on the basis of the provisions of Clause 2.4 of Section I, which reads as follows:

“To the extent that any advertisement:
Expresses an opinion on a matter which is the subject of controversy; and
That controversy involves issues within the areas, broadly defined, of public policy and practice, then that opinion shall not be subject to the provisions of the Code relating to misleading claims except that-

All advertisements which contain such controversial statements should:
be readily recognisable as advertisements;
cause no confusion as to the identity or status of advertiser;
Whenever such information is not readily available state the advertisers address and telephone number”.

While it is debatable whether the advertisement at issue qualifies as “controversial” as alleged by the respondent, this is of no material import at this time, as this exclusion only relates to the provisions of the Misleading claims clause (Clause 4.2.1 of Section II of the Code).

The only portion of the complaint that appears to relate to this clause reads as follows:

“The advertising could also be considered ‘misleading’ as described in Section 2, Clause 4.2.1 of the Code because there is unlikely to be any validation of the product”.

As such, this does not materially influence the decision insofar as determining whether or not the respondent’s substantiation’s accuracy is concerned. It stands to reason that, if the claims at issue are factually accurate, they cannot be regarded as misleading.

It is therefore not necessary for the Directorate to expressly rule on whether or not the advertisement at issue is “controversial” for the purposes of Clause 2.4 of Section I at this time.

Disparagement
The complainant essentially argued that the advertisements are disparaging of not only pharmaceutical products aimed at treating or curing cancer, but also at those practitioners who prescribe and dispense them. The respondent simply denied this allegation.

It is important to point out that the ASA draws a distinction between consumer complaints and competitor complaints. While both will be investigated (provided the appropriate procedures are followed), the ASA cannot allow competitors to masquerade as consumers or allow consumers to complaint in a manner that benefits commercial competitors.

The allegation that the advertising at issue is disparaging to pharmaceutical products and / or practitioners is a complaint that ought to be lodged by the affected parties (i.e. manufacturers or owners of pharmaceutical products and prescribing or dispensing practitioners). It is not for a member of the public to attempt to protect the integrity or interests of any commercial entity. To use an example, if BMW placed an advertisement disparaging Audi, it would be in the interest of Audi to complain about it. An ordinary member of the public has no standing to do so on behalf of Audi. The same approach applies here, and Prof Jobson does not ex facie have any standing to complain in a manner that seeks to protect the interests of other entities with a commercial interest.

For the above reasons, the complaint in relation to Disparagement will not be considered at this time.

Fear
Clause 3.1 of Section II of the Code reads as follows:

“Advertisement should not without justifiable reason play on fear”.

Other than quoting this clause, and alleging that the “… advertising being complained of certainly seems to play on this fear” (of developing breast cancer), the complainant has not advanced any reason for this allegation. His conclusion again simply states that the claims “… could also possibly be considered fear-inducing”.

This is not sufficient, and the Directorate cannot, in the absence of clear and concise grounds for this allegation determine whether or not the relevant clause has been contravened.

As such, in the absence of proper motivation, the Directorate cannot rule on this aspect of the complaint at this time.

This aspect of the complaint is therefore dismissed.

Substantiation
The complainant effectively asked for substantiation of the claim that the respondent’s product “Breast Protection FormulaTM” prevents breast cancer in women with a high risk of developing breast cancer and/or women who have contributing factors to a high risk of developing cancer.

In addition to this, he required substantiation for the claim that this product is “Generally well tolerated with rare reports of nausea, vomiting, heartburn, abdominal pain, skin rashes and hot flashes”.

Preventing breast cancer

Clause 4.1 of Section II of the Code requires advertisers to hold satisfactory documentary evidence of any direct or implied claims made. It stipulates that such evidence must emanate from, or be evaluated by an independent and credible expert in the field to which the claims relate.

It is also trite that the Directorate requires product-specific substantiation which unequivocally states that taking the advertised product, as is bought in-store and at the recommended dose, will deliver on the advertised claims.

The respondent argued that product-specific substantiation is not necessary, stating that:

“… An ordinary reading of the advertisement demonstrates that Solal does not claim that the product as a whole ‘in fact prevents breast cancer’. It lists people at risk of contracting cancer in the advertisement and then explicitly states that the individual ‘nutrients’ and ‘plant extracts’ help prevent breast cancer”.

“… Given the fact that the advertisement, as a whole does not claim that the product as a whole prevents breast cancer in the said group of women, but rather that the nutrients and ingredients do so, Jobson’s request for substantiation in regard to ‘the product as a whole’ is misplaced, distortive and in fact not countenanced by paragraph 3.2 Section I of the Code” [this section requires that advertising is considered to determine “… that of the probable impact of the advertisement as a whole upon those who are likely to see or hear it”, paying due regard to each part of the contents].

It explained that it was not submitting additional “irrelevant extracts” with its response as this would “simply burden the submissions unnecessarily”. It noted that the relevant PubMed information attached to its response constitute reliable documentary evidence in their own right. It also requested the Directorate to “let us know whether you require the complete articles”.

When one considers the advertising from a reasonable perspective, the only conclusion that can be drawn is that the PRODUCT being advertised (i.e. “Breast Protection FormulaTM”) contains the relevant nutrients and extracts that help prevent breast cancer. In each of the advertisement objected to by the complainant, the product is being promoted by name, and consumers are encouraged to take a specific dose of the product. While true that some comments are made about the individual ingredients, there is no doubt in the Directorate’s mind that the average, reasonable person would interpret the overall message to be along the lines of “take our ‘Breast Protection FormulaTM’ product to prevent developing breast cancer”.

It should also be noted that Clause 4.1.2 of Section II states, inter alia, that documentary evidence “shall have market relevance”. Clearly the respondent is not promoting or selling individual nutrients and extracts in isolation, but rather its own combination of such ingredients and extracts as contained in its product. For its evidence to have “market relevance” it would have to apply to the actual product available on the market under current conditions.

In light of the above, and in keeping with the long-standing approach, the Directorate is satisfied that the respondent ought to hold adequate, independent substantiation that unequivocally verifies that its product as is available on the market, when used at the recommended dose, will deliver on its efficacy claims. No such independent product-specific verification was placed before the Directorate.

The respondent has previously been advised that the Directorate requires product-specific substantiation (refer Solal Technologies / SASA / 17484 (20 September 2011) for example). This approach is also well documented in ASA rulings. So as to illustrate the extent of this, and the fact that this has been the case for some time, the Directorate refers to the following rulings, all of which held this approach to be applicable (it should be noted that this is not an exhaustive list, but one that is comprehensive enough to illustrate the point):

Ancient Wheys / Mr D Siebrits (17 March 2003),
Ultimate Sports Nutrition / University of Stellenbosch (18 August 2003),
Soya Life / Mr D Forbes / 706 (3 March 2004),
Dirol / Department of Health / 1011 (21 July 2004),
Artemisia / Ron Kemper / 1088 (22 July 2004),
Sanex Product / Unilever and Another / 1365, 1471 (25 August 2004),
Bioslim / Dr S Goldstein / 1122 (ruling of the Advertising Standards Committee dated 12 November 2004),
Carb Attack / Dr H A Steinman / 1547 (12 November 2004),
Zymalean Starch Neutraliser / Dr H A Steinman / 1682 (2 December 2004),
Avent Baby Bottle / Nuk Baby Bottle / 3509 (29 November 2005),
BMW / Audi / 5363 (15 September 2006),
Red Bull / B Burger / 13501 (17 August 2009),
Be-Trim / L De Weerdt / 8660 (2 December 2009),
Fountainhead Detox Patches / HA Steinman / 14684 (14 December 2009),
Slender Gel / H A Steinman / 14795 (18 February 2010),
Slender Max Tincture / HA Steinman / 14796 (2 March 2010),
Slender Caps / HA Steinman / 14726 (2 March 2010),
Keynote Trading & Investment / Crosscare / 15333 (31 May 2010),
Cell C / Vodacom & Others / 16341 (6 October 2010),
Organo Slim / A Blom / 16330 (16 November 2010),
Jeeves Heated Towel Rails / Bathroom Butler / 16413 (14 January 2011),
Montic Dairy / Clover SA / 16521 (1 February 2011),
Hivex / TAC / 17071 (14 June 2011),
DNA Diet / HA Steinman / 17153 (27 June 2011),
Future Life Immune Boosting Energy Meal / Pioner Foods / 17984 (16 August 2011),
Slimbetti Thermo Advance / HA Steinman / 18209 (6 September 2011),
Slimbetti Fibre Slim / HA Steinman / 18208 (6 September 2011),
Germanadjustablebeds4u / P Nunns / 18232 (31 October 2011),
Siberian Pine Nut Oil / K Charleston / 17527 (4 November 2011),

The reason for adopting a product-specific approach rather than an ingredient-based one is self-evident: Medicinal products (including such products collectively known as complementary and alternative medicines) 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. In general, the ASA does not concern itself with regulatory requirements to the level that the Department of Health or MCC would. The ASA can only consider whether or not the claim made for such products are substantiated, or potentially breach any of the other relevant provisions of the Code.

The advertising at issue promotes the product “Breast Protection Formula” under the auspices that this product will help prevent the development of breast cancer. Given that the overall impression created relates to the product, the Directorate is justified in expecting evidence that the product will, without any doubt, deliver on the claims made. No such evidence was submitted by the respondent.

It is noted that the respondent opted not to submit additional “irrelevant extracts” for fear of “burdening” its submissions, and that it asked the Directorate to advise it whether such additional articles are necessary. Given that there was no indication or suggestion that the so-called “irrelevant” extracts were product-specific (in fact the terminology used by the respondent suggests that this is not the case, as these extracts are “irrelevant”), the Directorate saw no need to invite further “irrelevant” submissions.

Lastly, the Directorate notes the respondent’s request for the Directorate to advise whether it should “… 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”. This request was made in terms of Clause 4.1.5.1 of Section II.

It should be pointed out that in terms of Clause 4.1.5 (which includes Clauses 4.1.5.1 and 4.1.5.2), the Directorate is under no obligation to require an advertiser to obtain such verification. Entitlement and obligation are clearly not one and the same concept, and on a reasonable interpretation, this clause merely means that the Directorate has the option to request such verification if it so desires.

Given the shortcomings highlighted above, the Directorate saw no need to cause an additional delay by asking for additional documentation. The respondent has had ample dealings with the ASA, and is well versed in its Code and procedures. Similarly, the complaint at hand sufficiently detailed the grounds on which it is based and identified the applicable sections of the Code. As pointed out in the Solal Technologies / SASA ruling, the Directorate requires independent and product-specific substantiation, which was not submitted by the respondent when it had the opportunity to do so.

As a result, the respondent’s claims that its “Breast Protection FormulaTM” is able to help prevent breast cancer, and all claims to that effect, are at present unsubstantiated, and in breach of Clause 4.1 of Section II of the Code.

This aspect of the complaint is upheld, and the respondent is instructed to withdraw such claims with immediate effect and within the deadlines stipulated in Clause 15.3 of the Procedural Guide. The respondent’s attention is drawn to the provisions of Clause 15.5 of the Procedural Guide.

“Generally well tolerated with rare reports of nausea, vomiting, heartburn, abdominal pain, skin rashes and hot flashes”.

This statement appears on the respondent’s product information on its website under the heading “Side Effects”. It also appears on the product labelling.

There appears to be no dispute that this claim is capable of substantiation as required by Clause 4.1 of Section II of the Code.

While the respondent submitted confidential in-house data it admitted that the spreadsheets relied on are “handled and prepared by one of Solal’s regulatory pharmacists, Mr Martin Wessels …”

Without debating whether or not this evidence falls within the realm of survey data, or whether it constitutes evidence “other than survey data”, it is noted that the information submitted emanates from the respondent, and is therefore not independently verified (either by an appropriate expert in the field or by a SAMRA accredited entity) as required by Clause 4.1 of Section II of the Code.

As such, the claim that the product is “Generally well tolerated with rare reports of nausea, vomiting, heartburn, abdominal pain, skin rashes and hot flashes” is currently unsubstantiated and in breach of Clause 4.1 of Section II of the Code.

This aspect of the complaint is upheld and the respondent is instructed to withdraw the claim with immediate effect within the deadlines stipulated in Clause 15.3 of the Procedural Guide. The respondent’s attention is also drawn to the provisions of Clause 15.5 of the Procedural Guide.

In light of the above findings, it is not necessary at this time to determine whether or not Clause 1.2 of Section I (Responsibility to the consumer) has been contravened.

2 Responses to Solal Breast Protection Formula – ASA ruling

  1. Ana Rocha 17 April, 2013 at 9:38 am #

    I want to state that I have been taking the Solal Breast Protection Formula, for at least 6 years, and I know that it saved my life. I had breast cancer, but the unusual fact about it was that the tumor stayed in my body for four years without spreading. The surgeon that operated on me told me straight forward that he could not see the reason why this tumor did not develop or spread. I told him that according to my belief, it was because of Solal breast protection. He laughed at me when I showed him the supplement, but did not laugh when I told him that the same supplement was responsible for saving my life. I did radiation, but did not have to do chemo therapy, because according to the MAMAPRINT test that was preformed in Holland, my tumor was not agressive and there was no need for chemo. I will continue to take Solal Breast Protection for the rest of my life as I do believe in it. On the other hand I have to take Tamoxifen, which is a horrible drug and gives me horrible side effects, and I hate it, but I only take half a tablet of Tamoxifen with a capsule of Breast Protection. I refuse to completely loose my quality of life for five years because of Tamoxifen. Thank you Solal for a fantastic product. Ana Rocha

  2. Harris 17 April, 2013 at 9:55 am #

    @Ana
    How do you know for a fact that your condition is thanks to Solal Breast Protection Formula and not because of Tamoxifen? Tamoxifen has proof of being effective (http://www.ncbi.nlm.nih.gov/pubmed/22786516), Solal’s product does not.

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