Phyto-Force Milk Thistle Tincture – ASA ruling

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Posted 20 February 2013

A consumer laid a complaint against an advertisement headed: “LOOK AFTER YOUR LIVER MILK THISTLE TINCTURE”, which made a number of health claims including “Helps to protect the liver from damaging free radicals” and “helps to protect the liver from toxins of alcohol and drugs including damaging prescription drugs.” 

The complainant submitted that, among other, that milk thistle is a schedule 3 substance, meaning that it can only be obtained on prescription and that it is illegal to advertise it to persons other than medical practitioners.

NB: In the complaint of February 2013 below, Prof Jobson pointed out that Milk thistle was a schedule 3 drug. However in October/November 2015 this ingredient was rescheduled. Its active ingredient is Silymarin, which except when present in a complementary medicine with an accepted low risk indication or health claim, providing not more than 600 mg of silymarin per day (calculated as silibinin/ silybin). (Scedule 0) The initial application for registration of a product containing silymarin was for the management of liver disease, which required a medical diagnosis, hence the initial S3 inscription.
Phyto-Force Milk Thistle Tincture / R Jobson / 21505
Ruling of the : ASA Directorate
In the matter between:
Professor M R Jobson Complainant(s)/Appellant(s)
Phyto-Force Herbal Laboratories cc Respondent

15 Feb 2013

http://www.asasa.org.za/ResultDetail.aspx?Ruling=6401
Professor Jobson lodged a consumer complaint against advertising featured in the December edition of South African Journal of Natural Medicine.

The advertisement is headed: “LOOK AFTER YOUR LIVER MILKTHISTLE TINCTURE”, and explains that “The liver is a VITAL organ in the human body. It is the largest gland, which performs many critical life support functions. Milkthistle has been used for centuries to assist in healing, repair, regeneration and efficient functioning of the human living.” It also lists the following benefits:

“Helps to protect the liver from damaging free radicals
Helps to protect the liver from toxins of alchohol and drugs including damaging prescription drugs
Helps to assists the liver to return to normal functionality after Alcoholic liver disease
Helps to improve liver functionality after Chronic and Viral Hepatitis
Helps to improve liver functionality after Cirrhosis of the Liver
Helps to stop gallstones forming
Helps your liver cope with excess alcohol intake, rich and fatty foods
A simple natural Medicine that can help prevent a hangover
An essential natural Medicine to help you cope with the stresses of life”.

COMPLAINT
The complainant submitted that milk thistle is a schedule 3 substance, meaning that it can only be obtained on prescription and that it is illegal to advertise it to persons other than medical practitioners. He also added that the advertising is misleading because it omits to mention the above, and encourages people to buy this product online.

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

• Section II, Clause 3.3 – Legality

• Section II, Clause 4 – Substantiation

• Section II, Clause 4.2.1 – Misleading claims

RESPONSE
The respondent submitted that it has withdrawn the advertisement and claims in question. It added that it would not advertise the product until the Medicine Control Council changes its classification from a schedule 3 and makes it permissible to sell directly to consumers.

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

The ASA has a long standing principle which holds that where an advertiser provides an unequivocal undertaking to withdraw or amend its advertising in a manner that addresses the concerns raised, the undertaking may, at the discretion of the ASA, be accepted without considering the merits of the matter.

As the respondent’s undertaking to remove the advertising addresses the complainant’s concerns, there is no need for the Directorate to consider the merits of the matter at this time.

The undertaking is therefore, at the discretion of the ASA, accepted on condition that the advertising is withdrawn in its current format within the deadlines stipulated in Clause 15.3 of the Procedural Guide, and is not used again in future.

The respondent is also reminded of the provisions of Clause 15.5 of the Procedural Guide, which effectively require it to remove the advertising from any and all media in which they appear.

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