ASA Ruling: A Vogel Prostasan

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Consumer complaints were lodged against SA Natural Products’ print advertisement appearing in, inter alia, the Weekend Argus and Sunday Times, as well as an internet advertisement that was published on the website www.sanatural.co.za during 2010.

The advertisement promotes the respondent’s Prostasan capsules contains the following claims: “A. Vogel Prostasan may relieve your: Frequent urinating during the day and night Incomplete emptying of the bladder Urinary urgency Pushing and straining while urinating”. It also contains a lengthy discussion on the product and its claimed benefits as well as references to trials done and recommended usage.

In essence, the complainants submitted that the advertisement is misleading as it there is no proof that the respondent’s product can alleviate the symptoms stated in the advertisement. 

 

A Vogel Prostasan / S Kaye & Another / 16752

Ruling of the : ASA Directorate
In the matter between:
Sydney Kaye Kevin CharlestonComplainant(s)/Appellant(s)
SA Natural Products (Pty) Ltd (SANP)Respondent

15 Mar 2011

http://www.asasa.org.za/ResultDetail.aspx?Ruling=5491

Consumer complaints were lodged against SA Natural Products’ print advertisement appearing in, inter alia, the Weekend Argus and Sunday Times, as well as an internet advertisement that was published on the website www.sanatural.co.za during 2010. The advertisement promotes the respondent’s Prostasan capsules contains the following claims:

“A. Vogel Prostasan may relieve your:
• Frequent urinating during the day and night
• Incomplete emptying of the bladder
• Urinary urgency
• Pushing and straining while urinating”.

It also contains a lengthy discussion on the product and its claimed benefits as well as references to trials done and recommended usage.

COMPLAINTS
In essence, the complainants submitted that the advertisement is misleading as it there is no proof that the respondent’s product can alleviate the symptoms stated in the advertisement. The first complainant submitted that although the respondent uses the word “may”, the advertisement read with 5 columns of waffle there is a clear attempt to misrepresent. The complainant submitted that the respondent has a proven tendency of advertising in a similar manner and simply moves on to the next product one the ASA makes a ruling.

The second complainant submitted that the symptoms described in the advertisement are those commonly described for a condition medically known as BPH (Benign Prostate Hypertrophy) or more commonly known as an enlarged prostate. The advertisement is dishonest with consumers as its uses the name Sabal Serrulata (commonly known as Saw Palmetto), an ingredient known to be infective for BPH. The complainant added that the advertisement makes medical claims such “modern medical research shows this quantity to bring about positive results on the symptoms of an enlarged prostate”; “It is just a tonic for the prostate”; and “Take one capsule daily to keep the prostate healthy”. However, there is no indication that this product has been registered with the Medicines Control Council or has been called up for registration. In addition, there is inadequate documentation to support the medical claims made.

The second complainant also requested details from the respondent about the medical study mentioned in the advertisement, but nothing was sent. The complainant submitted that there are numerous studies that have found that little or no benefit to the use of Saw Palmetto in treating BPH. The complainant made reference to a few websites which published studies of Saw Palmetto.

Lastly, the second complainant submitted that the advertisement states “If one experiences these symptoms, the best course of action would be to visit a urologist for a thorough examination.” However, this is lost in the body of the advertisement and is barely noticeable. Any advertising of this nature should clearly and boldly warn people to consult with a urologist before taking this supplement. One reason for this is that any delay in seeing a urologist could interfere with standard tests used to check for prostate cancer. According to www.priory.com/med/saw.htm, products such as these tend to mask “PSA” which is of significant importance in early detection of prostate cancer.

RELEVANT CLAUSES OF THE CODE OF ADVERTISING PRACTICE
In light of the complaint the following clauses of the Code were taken into consideration:

• Section II, Clause 2 – Honesty

• Section II, Clause 4.1 – Substantiation

• Section II, 4.2.1 – Misleading claims

• Appendix A – Medicinal and related products

• Appendix F – References to diseases

• Procedural Guide, Clause 14 – Sanctions

RESPONSE
Attorneys Adams & Adams, on behalf of the respondent, submitted the following documents in support of its argument:
 

  • a copy of a book by Dr Jen Tan entitled “A guide to the use of Saw Palmetto in BPH for healthcare professionals;
  • an extract on the properties of Saw Palmetto taken from “Martindale- The complete Drug reference”, 35th edition, page 1978;
  • an extract on the properties of Saw Palmetto, taken from “E/S/C/O/P Monographs –The scientific Foundation for Herbal Medicinal Products (2003);
  • clinical trial results in respect of Saw Palmetto preparation;
  • publication of clinical trial results in respect of PROSATAMED, its product that is identical in all aspects to PROSTASAN but sold under a different brand name overseas, as published in the medical journal “ARS 2 2005 1-3”;
  • a news report relating to a press release of the American Botanical Council in the clinical trial of Brent et al in respect of saw palmetto;
  • an extract from a 1998 article from the journal “Economic Botany 52(4): 381 – 383; and
  • verification for the claim from its expert Dr Tjaart Fourie’s, as well as his curriculum vitae.

In essence, the respondent submitted that contrary to the complainants’ allegations, its claims are adequately verified by its expert opinion, which relies substantially on the documentary evidence and his knowledge. In addition, the expert states, in response to its claim that “Prostasan brings positive results on the symptoms of an enlarged prostate” that several studies had documented an improvement in the patient’s IPSS score, reduced frequency, improved urinary flow rate and reduced residual urine, so the claims are substantiated.

The respondent further submitted that it is not within the ambit of the ASA’s duties to determine whether or not a product is, or should be registered with the MCC. However, to ease the complainant’s concerns, it submitted that Saw Palmetto is a schedule 1 substance and it is not unlawful in terms of the current applicable legislation to sell schedule 1 substances without registration with the MCC. In due course, it is possible that Prostasan would qualify as a “complimentary medicine” according to a proposed complimentary medicines listing system (MBR 20.8 of the MCC). Should this occur it is committed to complying in any specified manner.

The respondent added that its reference to the medical studies is not misleading or unreasonable, bearing in mind that the medical studies were in fact conducted and have been confirmed to be relevant by Dr Fourie. It denied that it does not clearly and prominently indicate that members of the public who experience symptoms of an enlarged prostate should consult a medical doctor. It also submitted that Saw Palmetto does not reduce PSA levels as suggested by the second complainant, and this is confirmed by its expert.

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

Medicinal products cannot be treated as an ordinary general commodity. They have the potential for having harmful effects 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 advertisements are in breach of the cited clause of the Code. The ASA is not able or authorised to rule on the quality or safety of the product in question, and this ruling must be interpreted and applied accordingly.

Defunct provisions of the Code
At the time of requesting a response from the advertiser (10 November 2010), the Code contained an Appendix A, which dealt with medicinal and related products and products making health claims. Given the nature of the complaints, the Directorate was of opinion that this appendix could be relevant.

However, this appendix has since been removed and replaced in its entirety, and therefore does not appear to have any relevance to this specific dispute.

Accordingly, the Directorate will not consider Appendix A of the Code at this time.

Product registration
The second complainant took issue with the fact that there is no evidence to show that the product, which makes medicinal claims, has been registered, or even applied to be registered with the MCC. He noted, inter alia, that “The advertisement is making medicinal claims … There is no indication that this product has been registered with the Medicines Control Council, or has been called up for registration”.

While Appendix F effectively prohibits certain claims from being made unless an advertiser’s product has been registered and such claims approved by the MCC, the allegation at this time does not appear to be that this appendix is being contravened. In essence, the respondent is not alleging that the “medical claims” referred to are in contravention of Appendix F by virtue of the fact that the product is not registered. He is rather suggesting that the product is making “medical claims”, and therefore needs to be registered with the MCC.

It is trite that the Directorate cannot determine whether or not a product needs to be registered with the MCC. In Promato / HPA / 9668 (2 June 2008) the Directorate ruled, inter alia, that:

“… the registration of medicines per se does not fall within the jurisdiction of the ASA. It is true that Clause 4 of Appendix A requires registered medicines to advertise in line with the registration. Appendices A and F set out certain limits on the claims that an unregistered medicine can make. This does not, however, bring the enquiry as to whether a particular product must be registered within the jurisdiction of the ASA”.

While the complainant appears to be correct that the product is not currently registered with the MCC, it is not for the Directorate to decide whether or not the product should be registered. Should the complainant be of the opinion that the product is subject to MCC registration, he should raise this issue with the MCC directly.

The Directorate will therefore not consider this aspect of the complaint. Accordingly, the Directorate will not consider the provisions of Appendix F at this time, based on the complaint at hand.

Efficacy claims
In essence, the complaints boil down to one key question: can the respondent substantiate its claims in the manner required by Clause 4.1 of Section II of the Code?

This clause requires an advertiser to hold independent verification for any efficacy claims. It further requires such verification to come from an entity that is regarded as a credible expert in the field to which the claims relate.

While the respondent submitted many documents, the majority of these relate only to the active ingredient, being Saw Palmetto. It is trite that the Directorate cannot accept ingredient-based substantiation as adequate for an entire product. The Directorate will therefore not consider these documents.

In addition to the above information, the respondent also submitted a copy of an article titled “Natural Treatment of BPH”, referring to information contained in a clinical trial done on its product “Prostamed”, which is the different brand name used abroad for its Prostasan product sold locally. It also submitted a letter of verification from a Dr Tjaart Fourie, a practicing urologist with more than 30 years’ experience. Dr Fourie is also the Chief Specialist and Head of Urology at the University of Kwazulu-Natal. His CV was also submitted to the Directorate.

With reference to the “Natural Treatment of BPH” article, the Directorate notes that the article was, inter alia, co-written by Mr Andy Suter, and employee of the A Vogel company that manufactures the products sold by the respondent. This article in itself therefore does not qualify as “independent”. Interestingly enough, the Directorate also notes that it appears that this exact same article is used by the A Vogel company to promote its “Sabalasan®” product. The only difference noticed was that every reference to “ProstaMed ®” contained in the article submitted by the respondent was replaced with a reference to “Sabalasan ®” (See http://www.avogel.ca/avogelinstitute/en/advice/newsletter/news_sabalasan.php). This casts doubts over the applicability of this article in relation to the respondent’s product.

The only remaining piece of evidence is the letter of verification from Dr Fourie. From his CV, the Directorate notes that Dr Fourie is registered as a urologist with the HPCSA. In 1997 he joined the Department of Urology at the University of KZN as Principle Specialist and Deputy Head. Subsequently, he was appointed as Chief Specialist and Head of Urology at the University. He is an active member of the South African Urological Association, as well as the International Continence Society, whilst still practicing as a urologist.

Given the above, the Directorate is satisfied that Dr Fourie qualifies as a credible expert in the field to which the claims relate. As the Directorate was unable to find any information that would suggest that Dr Fourie is somehow linked to the respondent or to the product, the Directorate has no reason to doubt his independence at this time.

In his letter, Dr Fourie confirms that in his opinion the relevant claims as disputed are accurate, and backed up by research. He concludes as follows:

“In my opinion then based on the documentary evidence submitted and in current Urological and medical science, the following holds true:
a. The symptoms of BPH are accurately described.
b. The product A Vogel Prostasan in its recommended dosage is beneficial for the treatment of the symptoms of mild to moderate BPH.
c. The documentary evidence submitted to substantiate the article and the product are relevant, performed by credible researchers in accordance with accepted standards and publications were accepted by peer review journals and are credible.
d. The article in general is not misleading”.

He also comments that current information shows that Saw Palmetto does not lower a patient’s PSA as suggested by the second complainant, and added that Urologists and most General Practitioners are aware that some drugs used in BPH can affect the PSA reading and will be alert thereto.

In light of this, it appears that the respondent has adequately substantiated its claims within the ambit of Clause 4.1 of Section II of the Code.

In light of the above, the claims disputed cannot be said to be misleading or dishonest in the manner alleged by the complainants. Accordingly, the advertising is therefore also not in contravention of Clauses 2 or 4.2.1 of Section II of the Code. by implication, there is no need to consider sanctions against the respondent in terms of Clause 14 of the Procedural Guide.

The complaints are therefore dismissed.

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2 Responses to ASA Ruling: A Vogel Prostasan

  1. Nathan Geffen 19 March, 2011 at 9:32 am #

    Harris, what do you make of the expert testimony and ASA's approach to it in this complaint?

  2. Harris 21 March, 2011 at 7:56 pm #

    Hi Nathan, this ruling is curious in a number of respects, but confirms the way the ASA appears to operate: once an individual is recognised as a "credible independent expert", then his substantiation is taken at face value. I remind readers of Homemark products that were declared scams in the USA, but as Dr Beverley Summers claimed the product to work, the ASA ignored the fact that the USA company had been fined and shut down. Similar with Nivea Goodbye Cellulite – despite Nivea's internal document which showed the product did not work, the fact the Prof Todd substantiated the product meant that the ASA would rule in their favour.

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