Background

Summary of Council Decision:

Six issues were investigated all of which were Upheld.

Ad description

A leaflet from Aquil Ltd, selling supplements to help with the prostate, seen in January 2012.  On the front of the leaflet, text stated "Discover the ideal food supplement to soothe the prostate and stimulate sexual vigour ... At last, here is the solution that will help you:  Works on your prostate to soothe the bladder  Regulates the urge to urinate too frequently  Stimulates the libido".  Further text on another page of the leaflet stated "PROFASTAFEN+ is not a medicine but an exclusive food supplement containing plant extracts which have been recognised for centuries for helping to fight prostate problems and the lack of libido that can result from them ... Two capsules in the morning at breakfast will give your prostate maximum support because it contains the ingredients which will regulate that urgent desire to urinate during the day and night and keep your prostate healthy. A full sex life is restored after a few weeks of using this product.  PROSTAFEN+ will ease all your unpleasant symptoms. Studies carried out on the all-natural ingredients have shown that there are no harmful side effects. As a food supplement, PROSTAFEN+ can be taken alongside prescribed medication. So, if you are taking a course of medication, do not stop it but seek advice from your doctor or pharmacist ... SATISFACTION GUARANTEED OR YOUR MONEY BACK ...".

On a further page of the leaflet which discussed the prostate, text stated "... Today, these problems can be sorted out speedily thanks to ongoing scientific progress.  So, there is every reason to try PROSTAFEN+ now ... Scientific studies vouch for it  All the ingredients of our food supplement PROSTAFEN+ have been the subject of studies and tests showing their effectiveness".  Running along the bottom of one of the pages of the leaflet, text stated "Taken daily, PROSTAFEN+ will keep your prostate youthful and healthy and you will regain your vigour and vitality".

Issue

The London Borough of Havering Council Trading Standards Department challenged whether the following claims were misleading and could be substantiated:

1.  "At last, here is the solution that will help you:  Works on your prostate to soothe the bladder";

2.  "... Regulates the urge to urinate too frequently";

3.  "... Stimulates the libido";

4.  "A full sex life is restored after a few weeks of using this product";

5.  "Scientific studies vouch for it"; and

6.   "Taken daily, PROSTAFEN+ will keep your prostate youthful and healthy and you will regain your vigour and vitality";

Response

Aquil Ltd (Aquil) provided ten studies in support of the claims.

Assessment

1. – 4. Upheld

 The ASA noted the studies provided by Aquil, however, we noted that material comprised a selection of abstracts, articles and studies about various natural ingredients and did not relate to the efficacy of Prostafen+ specifically. Notwithstanding that, we considered that the specific claims that Prostafen+ could soothe the bladder, regulate the urge to urinate, stimulate the libido and restore a full sex life implied that the product had a physiological effect on the body and were therefore medicinal claims.   We noted however that Aquil had not provided an MHRA marketing authorisation which would allow them to make those claims for the product and therefore concluded that the ad breached the Code.

On this point, the ad breached CAP Code (Edition 12) rules  3.1 3.1 Marketing communications must not materially mislead or be likely to do so.  (Misleading advertising),  3.7 3.7 Before distributing or submitting a marketing communication for publication, marketers must hold documentary evidence to prove claims that consumers are likely to regard as objective and that are capable of objective substantiation. The ASA may regard claims as misleading in the absence of adequate substantiation.  (Substantiation) and  12.1 12.1 Objective claims must be backed by evidence, if relevant consisting of trials conducted on people. Substantiation will be assessed on the basis of the available scientific knowledge.
Medicinal or medical claims and indications may be made for a medicinal product that is licensed by the MHRA, VMD or under the auspices of the EMA, or for a CE-marked medical device. A medicinal claim is a claim that a product or its constituent(s) can be used with a view to making a medical diagnosis or can treat or prevent disease, including an injury, ailment or adverse condition, whether of body or mind, in human beings.
Secondary medicinal claims made for cosmetic products as defined in the appropriate European legislation must be backed by evidence. These are limited to any preventative action of the product and may not include claims to treat disease.
 (Medicines, medical devices, health-related products and beauty products).

5.  Upheld

 We considered for the reasons given above that Aquil has not shown that the efficacy claims for the product were backed by robust scientific evidence.  We therefore considered that the claim "Scientific studies vouch for it" had not been substantiated and was therefore misleading.

On this point the ad breached CAP Code (Edition 12) rules  3.1 3.1 Marketing communications must not materially mislead or be likely to do so.  (Misleading advertising) and  3.7 3.7 Before distributing or submitting a marketing communication for publication, marketers must hold documentary evidence to prove claims that consumers are likely to regard as objective and that are capable of objective substantiation. The ASA may regard claims as misleading in the absence of adequate substantiation.  (Substantiation).

6.  Upheld

 We considered that the claim "Taken daily, PROSTAFEN+ will keep your prostate youthful and healthy and you will regain your vigour and vitality" was a health claim that would be acceptable if Aquil were in possession of a body of robust evidence such as clinical trials conducted on people, to substantiate it.  We noted however that the material supplied by Aquil did not relate to the efficacy of Prostafen+ and we concluded that the claim had not been substantiated and was misleading.

On this point, the ad breached CAP Code (Edition 12) rules  3.1 3.1 Marketing communications must not materially mislead or be likely to do so.  (Misleading advertising),  3.7 3.7 Before distributing or submitting a marketing communication for publication, marketers must hold documentary evidence to prove claims that consumers are likely to regard as objective and that are capable of objective substantiation. The ASA may regard claims as misleading in the absence of adequate substantiation.  (Substantiation) and  12.1 12.1 Objective claims must be backed by evidence, if relevant consisting of trials conducted on people. Substantiation will be assessed on the basis of the available scientific knowledge.
Medicinal or medical claims and indications may be made for a medicinal product that is licensed by the MHRA, VMD or under the auspices of the EMA, or for a CE-marked medical device. A medicinal claim is a claim that a product or its constituent(s) can be used with a view to making a medical diagnosis or can treat or prevent disease, including an injury, ailment or adverse condition, whether of body or mind, in human beings.
Secondary medicinal claims made for cosmetic products as defined in the appropriate European legislation must be backed by evidence. These are limited to any preventative action of the product and may not include claims to treat disease.
 (Medicines, medical devices, health-related products and beauty products).

Action

The claims must not appear again in their current form.  We told Aquil Ltd not to make claims about Prostafen+ which could not be substantiated.  We also told Aquil Ltd not to make unauthorised medicinal claims for the product.

CAP Code (Edition 12)

12.1     3.1     3.7    


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