Bio-Life Inositol Lecithin

Posted 08 August 2013

A consumer lodged a complaint with the ASA against Biolife for a print advertisement promoting one of their products, “Inositol”, which appeared in the in the Cape Times newspaper. The advertising is headed “Can one reduce Cholesterol via the natural route?” and features an image of the Inositol product, with the claims, among other, “Helps with Cholesterol, Memory and Hair Growth”. The complainant submitted that the advertising requires substantiation for his own research on Web MD shows “insufficient evidence” (or no evidence) for the claims being made. 

The ASA asked Bio-Life to submit sufficient evidence to support their claims, and when could not, ruled against the claims. In other words, if you are going to make a claim, you require proof that the claims are true. 

 [gn_note color=”#fef1be”]Bio-Life Inositol Lecithin / K Charleston / 22112
Ruling of the : ASA Directorate
In the matter between:
Kevin Charleston Complainant(s)/Appellant(s)
Biolife cc Respondent[/gn_note]

25 Jul 2013

http://www.asasa.org.za/ResultDetail.aspx?Ruling=6643

Mr Charleston lodged a consumer complaint against Biolife for a print advertisement promoting one of their products, “Inositol”, which appeared in the in the Cape Times newspaper.

The advertising is headed “Can one reduce Cholesterol via the natural route?” and features an image of the Inositol product, with the claim “Helps with Cholesterol, Memory and Hair Growth. The body copy states, inter alia, the following:

“Those of you who do not have a cholesterol problem should proact [sic] to the possibility of fat build-up over time, in your arteries, which can lead to serious problems. Taking Lecithin and Inositol daily would be beneficial”,
“It plays a major role in preventing the collection of fats in the liver as well as promoting healthy hair growth. It also helps in the process of energy production. It has been shown to aid in the transmission of messages within the central nervous system and it is thought that it could slow the advances of Alzheimer’s disease. It has also been used in large doses to treat anxiety, depression and insomnia and is also believed to help memory”,
“Lecithin is useful in removing cholesterol out of the body and maintaining a healthy liver. The choline found in the liver attracts the LDL or ‘bad cholesterol’ in the blood and removes it. Lecithin tends to increase HDL or the ‘good cholesterol’.”, “I might conclude by telling you that at a recent ultra-sound performed on me after a general check-up, the specialist while performing the ultra-sound asked if I ate no fats at all as I had no fatty deposits in the liver. I have been taking the two products prophylactically for some years”.

COMPLAINT
In essence, the complainant submitted that the advertising requires substantiation. He explained that his own research on Web MD shows “insufficient evidence” for problems metabolising fat, high cholesterol, insomnia, and hair growth in relation to Inositol. It is “possibly ineffective for Alzheimer’s disease and depression. A small study of 11 Alzheimer’s disease patients carried out in 1996 showed insignificant improvement in cognitive scores and suggested a need for longer trials.

Lecithin is “possibly ineffective” for liver disease – although the study only refers to patients on long term intravenous feeding. The claim that Lecithin increases HDL appears to be only supported by rat-studies. The advertiser would need to substantiate the claims with respect to normally fed humans.

The complainant added that the respondent’s testimonial in conjunction with the other claims implies that the lack of fatty deposits can be attributed to the products themselves. This is an efficacy claim as alluded to in Clause 10.2 of Section II (Testimonials – Efficacy claims). The reality is that the advertisement is merely hearsay, and the advertiser should (in accordance with the Code) provide his specialist’s verification and evidence that the ultrasound indeed revealed no fatty deposits.

RELEVANT CLAUSES OF THE CODE OF ADVERTISING PRACTICE
The complaint identified the following clause to be taken into consideration:

Section II, Clause 4.1 – Substantiation

Section II, Clause 10.3 – Testimonials (Efficacy claims) – the complainant incorrectly numbered this Clause “10.2”

Section II, Clause 10.7 – Testimonials (Copies for inspection)

The complainant also cited Clause 4.25 of Section I (Definitions – Scientific substantiation). It should be noted however, that the purpose of this section of the code is for clarity on definitions. It is therefore understood that Clause 4.1 of Section II will be considered with respect this definition.

RESPONSE
The respondent, acting through its attorneys Neville R Cohen & Associates, submitted that Web MD show an overview of Inositol as “…used for diabetic nerve pain, panic disorder, high cholesterol, insomnia, cancer, depression, schizophrenia, Alzheimer’s disease, attention deficit disorder, autism, promoting hair growth”. It submitted the relevant page to this overview.

It also submitted information form Wikipedia indicating the use of Inositol for reducing cholesterol and depression and a reference to a Double-blind, controlled trial of Inositol treatment of depression.

An article from the Health Supplements Guide was submitted to show that there is some evidence for cholesterol reduction, depression and hair growth by Inositol.

The references relied on by the complainant also indicated Lecithin as “possibly ineffective” for High Cholesterol, which in itself suggests that it could be effective. The respondent submitted a “Clinical Study” published in the Hindawi Publishing Corporation’s “Cholesterol” journal which it argues supports the claims that Lecithin is effective in lowering Total Cholesterol and LDL cholesterol.

The respondent concluded that it believes that the results for his ultra-sound, which was done at Morton and Partners in Cape Town, were as a result of the fact that the respondent has been taking Inositol and Licithin. It understands that this is effectively hearsay on his part and is willing to withdraw that part of the advertising should the ASA not be convinced.

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

At the outset, it should be noted that the complainant specifically identified Clause 10.2 of Section II, but then titles this section “Efficacy claims”, which is actually the title for Clause 10.3 of Section II. Given this discrepancy, the Directorate will not consider this aspect at this time.

The complainant’s main concern appears to be that the claims made are not true. Clause 4.1 of Section II states that before advertising is published, advertisers shall hold in their possession documentary evidence as set out in Clause 4.1, to support all claims, whether direct or implied, that are capable of objective substantiation. The clause further states that documentary evidence, other than survey data, shall emanate from or be evaluated by a person/entity, which is independent, credible, and an expert in the particular field to which the claims relate and be acceptable to the ASA.

It is trite that the ASA is not a medical or technical expert body, and cannot draw conclusions from scientific publications in the same manner that such an expert would be able to. What’s more relevant, however, is the requirement for substantiation to relate to the product as a whole as sold in the market. In short, the ASA requires the respondent to submit verification from an independent and credible expert that the product being advertised will, as a matter of fact, deliver on the claims made.

Nothing in the submissions made by the respondent appear to relate to, or even mention its product. There is nothing before the Directorate to show that the respondent’s product contains all the necessary components, or that these ingredients / components are present at the correct dose to ensure efficacy.

The efficacy claims made for the product are therefore currently unsubstantiated in terms of Clause 4.1 of Section II of the Code.

The respondent further acknowledged that the claim “I might conclude by telling you that at a recent ultra-sound performed on me after a general check-up, the specialist while performing the ultra-sound asked if I ate no fats at all as I had no fatty deposits in the liver. I have been taking the two products prophylactically for some years” could be regarded as hearsay, and that it would be willing to remove this if the Directorate so desired.

Clause 10.7 of Section II stipulates that advertisers should be in possession of signed and dated copies of testimonials used. no such copy was presented to the Directorate. Similarly, given that the claims to be able to alleviate or prevent cholesterol-related problems have not been substantiated, there is nothing before the Directorate to show that this claim is true or accurately supported by evidence relating specifically to the use of this product and nothing else.

Accordingly, the respondent is instructed to:

Withdraw the advertising material and relevant claims in its current format.

Action the process of withdrawing this material with immediate effect,

Complete the process of withdrawing the material within the deadlines stipulated in Clause 15.3 of the Procedural Guide, and

Ensure that the material is not used again in its current format.

The complaint is upheld.

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