Vogel’s Echinaforce

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A consumer laid a complaint with the ASA against Vogel’s Echinaforce advert. The advertorial was headed, “A. Vogel Echinaforce proven in-vitro to inhibit Swine Flu, Bird Flu and Seasonal Flu”. The advertorial contained, inter alia, the claim “in the first round Echinaforce was effective against 97.85% of the viruses”. Reference is also made to Echinaforce’s prophylactic and antibacterial qualities.

In essence, the complainant submitted that the advertorial is misleading as the product is not registered with the authorities in any way. She also contested the validity of the claim that the product is able to protect against, inter alia, Swine Flu, arguing that this study has not been subjected to any form of peer review. 

How did the ASA rule?

ECHINAFORCE / S KAYE / 15677

http://www.asasa.org.za/ResultDetail.aspx?Ruling=5253 

Ruling of the : ASA Directorate

In the matter between:

Sydney Kaye Complainant(s)/Appellant(s)

SA Natural Products (Pty) Ltd t/a SANP Respondent

13 Aug 2010

Mr Kaye lodged a consumer complaint against an SANP advertorial promoting A. Vogel’s Echinaforce. The advertorial was published in the Lifestyle Magazine in the Sunday Times during May 2010.

The advertorial is headed, “A. Vogel Echinaforce proven in-vitro to inhibit Swine Flu, Bird Flu and Seasonal Flu”. The advertorial also refers to a research study by Prof. Stephan Pleschka of Giessen University, Germany and Prof Jim Hudson of British Columbia University, Vancouver, which was presented by Dr Andy Suter of the A. Vogel Company.  

The advertorial contains, inter alia, the claim “in the first round Echinaforce was effective against 97.85% of the viruses”. Reference is also made to Echinaforce’s prophylactic and antibacterial qualities. 

COMPLAINT 

In essence, the complainant submitted that the advertorial is misleading as the product is not registered with the authorities in any way. She also contested the validity of the claim that the product is able to protect against, inter alia, Swine Flu, arguing that this study has not been subjected to any form of peer review. The research quoted was funded by the owners of the Echinaforce trade mark. 

Finally the complainant submitted that it is unbelievable that the product was effective against 97.85% of viruses. 

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 

RESPONSE 

The respondent submitted, inter alia, that the product in question is a complimentary medicine submitted according to the Complimentary Listing System (MBR 20.8) of the Medical Control Council of South Africa. 

It added that in Echinaforce / D C Schroeder / 14021 (14 October 2009) where a similar issue was considered, the Directorate accepted an independent opinion regarding the product’s efficacy and anti-viral properties. 

The respondent also submitted a copy of an article that was published in the Virology Journal, titled “Anti-viral properties and mode action of standardized Echinacea purpurea extract against highly pathogenic avian Influenza virus (H5N1, H7N7) and swine-origin H1N1 (S-OIV)”. 

ASA DIRECTORATE RULING 

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

Form MBR20.8 

The complainant’s concern is that the product is not registered in any way with the authorities. 

The respondent submitted that the product in question is a complimentary medicine submitted according to the Complimentary Listing System (MBR 20.8) of the Medical Control Council of South Africa. 

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 reference to a Complimentary Listing System of the Medicine Control Council 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. 

It should also be noted that it is not the Directorate’s duty to determine whether or not a product should be registered with the MCC. The fact that the respondent is not currently registered does not have a material effect on this ruling. 

Merits 

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. 

It is also significant to note that the complainant did not specifically indentify any claims other than the claimed efficacy against the Flu and Swine Flu and the claim that it was effective against 97.85% of all viruses tested. The Directorate will therefore limit its consideration to the following claims only: 

“A. Vogel Echinaforce proven in-vitro to inhibit Swine Flu, Bird Flu and Seasonal Flu”; and “in the first round Echinaforce was effective against 97.85% of the viruses”. 

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. It is trite that the Directorate cannot interpret scientific jargon and data to the extent that an expert could, and as such the unequivocal verification from an expert is crucial in any dispute relating to the substantiation for efficacy claims. 

The respondent opted to only send the relevant research article and a document that appears to be an interview done with the researchers, but no verification as such from an independent and credible expert. Given that the Directorate has no means of determining the authenticity of the “interview” submitted, it cannot consider this document at this time. It is noted, however, that Prof Hudson is quoted as saying “ We certainly still have a way to go before the effect against H1N1 viruses we have discussed will also be confirmed in clinical studies …”. 

The research article published in the Virology Journal is titled “Anti-viral properties and mode action of standardized Echinacea purpurea extract against highly pathogenic avian Influenza virus (H5N1, H7N7) and swine-origin H1N1 (S-OIV)”. In the abstract it states that the respondent’s Echinaforce © product was used for the testing. 

The conclusion in the abstract reads as follows: 

“As a result of these investigations, we believe that this standard Echinacea preparation, used at the recommended dose for oral consumption, could be a useful, readily available and affordable addition to existing control options for IV replication and dissemination”. 

This appears to be, at best, a potential recommendation that the product “COULD” be a useful “ADDITION” to existing methods of controlling these viruses. This does not amount to unequivocal verification of the claim that the product has been “proven … to inhibit Swine Flu, Bird Flu and Seasonal Flu”. Similarly, the “Conclusion” contained in the body of the research article suggests that the product “… HAS THE POTENTIAL to impair influenza virus propagation, including seasonal strains and strains of highly pathogenic avian influenza viruses as well as the new pandemic strain of swine origin …” (our emphasis). This is not akin to claiming that has been “proven” as claimed to inhibit these types of flu. 

It is also noted that the figure “97.85%” as contained in the claim “In the first round Echinaforce was effective against 97.85% of the viruses” does not appear in the article submitted to the Directorate. 

Based on the above, and in the absence of unequivocal verification from an independent and credible expert, the claims “A. Vogel Echinaforce proven in-vitro to inhibit Swine Flu, Bird Flu and Seasonal Flu” and “… Echinaforce was effective against 97.85% of the viruses …” are currently unsubstantiated and in breach of Clause 4.1 of Section II of the Code. 

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

withdraw the claims “A. Vogel Echinaforce proven in-vitro to inhibit Swine Flu, Bird Flu and Seasonal Flu” and “… Echinaforce was effective against 97.85% of the viruses …” in their current format;

the process to withdraw the claims must be actioned with immediate effect on receipt of the ruling;  

the withdrawal of the claims must be completed within the deadlines stipulated by Clause 15.3 of the Procedural Guide; and  

The claims may not be used again in their current format. 

In light of the above it is not necessary to consider Clause 4.2.1 of Section II (Misleading claims) at this time. It is specifically noted, however, that in the event that the Directorate accepts new substantiation, or that an appeal is filed, this clause may well be open for consideration again. 

The complaint is upheld.

Editor's comment: 

Having read the Virology journal article, after initially hearing the product being promoted in similar fashion by Ms Schreiber of SANP — what has been missed by the ASA is that these results were not in humans but only in MDCK cells — Madin-Darby canine kidney cells (MDCK).

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