ASA Ruling: Homemark Detox Footpads

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Posted 23 February 2014

Homemark claims that Detox Footpads can remove toxins from your body. They are supported by Dr Frederick Motz, who claims this is true. 

We say this is rubbish.

The USA FDA/FTC says this is rubbish.

In fact, physiology and common sense tells us this is rubbish.

See what an investigative reporter has to say: Detox Con!

See also: Kinoki Foot Pad marketers charged

Then read how the ASA ruled.

Detox Foot Pads / HA Steinman / 8938
Ruling of the : ASA Directorate In the matter between:
Dr Harris Steinman Complainant(s)/Appellant(s) 
Homemark (Pty) Ltd Respondent

20 Aug 2007

Dr Steinman lodged a consumer complaint against a Homemark television commercial for its Detox Foot Pads that was flighted on E.TV during April 2007.

The voice-over in the commercial states, inter alia, “If you feel tired, irritable, then you need to get rid of toxins, now! Introducing the fantastic new Detox Foot Pads. An amazingly simple system that helps you detox your body while you sleep…”.

 

The words “get rid of TOXINS”, “eliminate IMPURITIES NOW!”, “FDA Approved” and “DETOX while you sleep” appear on screen during the commercial. COMPLAINT In essence, the complainant requested that the respondent substantiate the health effects claimed, e.g. stress relief, etc., as well as the claimed detoxifying effect.

The claim “FDA approved” infers that the FDA approved the efficacy of the product whereas sometimes it only means the product is either free of toxins or contains certain ingredients.

The complainant requested proof that the average human body requires aid to “detoxify” and that this particular product is able to do this, as skin is not an excretory organ and does not excrete toxins.

Finally, the implication that the body builds up unhealthy toxins is misleading and untrue.

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 4.1 – Substantiation Section II, Clause 4.2.1 – Misleading claims Appendix A – Medicinal and related products and advertisements containing health claims.

RESPONSE

In essence, the respondent submitted that: The “FDA approved” issue has already been dealt with in Fountainhead Chi Detox Patches / Health Products South Africa / 3339 (20 December 2005).

The product currently sold by the respondent is exactly the same and the respondent submitted a letter from Fountainhead (Pty) Ltd to confirms this.

The skin does assist in detoxification, as stated by Dr Alta Smit, Chairperson of The Homotoxicology Association, MB ChB (Wits), BSc Physio (UOFS), MF Hom (UK). The respondent referred to examples of literature to support this fact.

In a further response the respondent submitted documentation from Dr Frédéric Motz, a registered practitioner in Osteopathy, Acupuncture, Homeopathy, Ayurvedic Medicine and Health Profiling in support of the claims made, as well as his CV.

The submissions from Dr Motz will be dealt with more fully below.

ASA DIRECTORATE RULING

The ASA Directorate considered the relevant documentation submitted by the respective parties. The Directorate specifically notes that the ASA considers medical matters only in so far as they relate to advertising and the rules in the Code. The ASA is not tasked with evaluating the general efficacy, quality or safety of a product, and the outcome of this ruling should be read in this context.

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. 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. Claimed efficacy

The complainant submitted that the commercial implies “…beneficial health effects for a number of related conditions, e.g., stress etc., as well as a detox effect…there is no proof…”. He also disputed the levels of ingredients contained in this product. It is firstly noted that the commercial does not make any claim of reducing stress and therefore the Directorate cannot consider it. In addition, the commercial does not mention any ingredients or their level.

Accordingly, the respondent’s concerns about the ingredient levels cannot be addressed in this forum. The complainant is reminded that there are other regulatory bodies that deal with such issues, and the ASA only considers the content of advertising.

The only remaining and relevant questions raised by the complainant are: Does the human body require aid in detoxifying?; Does human skin excrete toxins? and Does this product assist in this detoxification process?

Clause 4.1 of Section II of the Code requires substantiating documents to emanate from, or be evaluated by an entity which is independent, credible and an expert in the field to which the claims relate. Because the ASA is not a medical or technical expert body, it has to rely on the opinion received from the “independent, credible expert”.

Should the Directorate be satisfied that the relevant person is indeed independent and credible and an expert in the field to which the claims relate, the only thing left to consider is whether or not this expert confirms the claims in question as valid for the product as a whole.

From the documentation submitted to the Directorate, it appears that Dr Motz is a registered practitioner in Osteopathy, Acupuncture, Homeopathy, Ayurvedic Medicine and Health Profiling.

In its research, the Directorate found Dr Motz has been in the practice for some time and is recognised in one of South Africa’s well known medical advise websites, www.women24.com. The Directorate further established that Dr Motz is registered with the Allied Health Professions Council, a professional accreditation body for this particular industry.

 The Directorate is therefore satisfied that Dr Motz is independent, credible and an expert in this particular filed. Dr Motz states that the because of the environment we all live in, the human body does require “aid” to detoxify because it can find itself in an environment of “toxin overload”. As a result, there are categories of humans that require “aid” to detoxify at a greater or lesser degree than others, despite the fact that the organs of the humans body do carry out the function of detoxification. Based on the above it appears that the body does sometimes require aid to detoxify.

This addresses the first question. Dr Motz concludes, “Our body is designed to utilise natural substances which include foods, herbs, and photochemical. Any foreign substance will serve as a stimulus to our immune system, which has the function of removing these substances. Although, the toxicity of a chemical may vary, it is the job of the liver to reduce toxins into compounds that the body can safely handle and eliminate through the kidneys (as urine), skin (as sweat), lungs (as expelled air), and bowels (as faeces)”. From this, it appears that the skin does indeed excrete toxins via sweat. This addresses the second question.

Dr Motz submitted that the product pulls and absorbs toxins out through the skin. Ingredients in the product (tourmaline in particular), when in contact with skin, release Far Infrared Rays (FIR) and negative Ions (Free Radical Scavenger), which causes resonance with water molecules in human bodies.

The FIR and Negative Ions stimulate both blood circulation and reflexes on the sole of the feet, which in turn stimulate the body’s natural organs.

He concludes, inter alia, that the product “improves…cleansing”. From this it appears ex facie that the product would prove effective in assisting in detoxifying the body. The third question is therefore answered.

Accordingly the detoxifying claims in this commercial appear to be adequately substantiated as envisaged by Clause 4.1 of Section II.

Given that the claims appear to be factual, they cannot be in contravention of the Clause 4.2.1 of Section II (Misleading claims). In addition, the advertisement is therefore not in breach of Appendix A based on the current complaint.

FDA approval
The complainant submitted that the claim “FDA approved” implies that the product has been tested and approved by this body for efficacy. The respondent submitted that the FDA issue has already been dealt with by the ASA in a similar ruling. In Fountainhead Chi Detox Patches / Health Products South Africa / 3339 (20 December 2005) the Directorate accepted documentation to show that the FDA and ISO registration is valid, and applicable the products that was advertised.

The respondent in this matter gave satisfactory verification from its manufacturers that its product and the one considered in the Fountainhead ruling are the same. The only change made was the packaging and name. It is important to note that in the Fountainhead matter, the advertisement merely had a logo that read “FDA”.

In this matter, the advertisement states “FDA approved”. The word ”approved” implies to the reasonable consumer that this product is safe and checked by the FDA.

However, upon investigation, the Directorate found that the FDA registration number used by the respondent for the device is actually for Forest Bandage manufactured by KJI Industrial, which is in a class that does not need FDA approval or clearance. The product “Detox Foot Pads” was not on the FDA database.

This therefore means that the product is not FDA approved as claimed in the advertisement. The Directorate notes that it is possible that the respondent could have been misled into thinking that it is buying rights to a product that is approved by the FDA and that the claim was therefore not mala fides.

The claim “FDA approved” is therefore misleading and in contravention of Clause 4.2.1 of Section II. Given the above finding, the respondent is required to: withdraw the claim in its current format; the process to withdraw the claim must be actioned with immediate effect on receipt of the ruling; the withdrawal of the claim must be completed within the deadlines stipulated by Clause 15.3 of the Procedural Guide; and the claim may not be used again in its current format until new substantiation has been submitted, evaluated, and a new ruling is made. The complaint is partially upheld.

 

At the time of this posting, 23 February 2009, Homemark continues to claim the product has been tested/registered with the FDA! 

Below is the FDA comment:

Date: 21/01/2009 08:14 PM From: “CDRH Small Manu. Assistance” <[email protected]> Subject: 01-213 gsc Detox foot pads FDA registration

After reading this response to your inquiry, please feel free to contact me for clarification or elucidation.

According to the limitations of exemption, you are correct that a detoxifying claim would alter the conditions for this device to be legally marketed moving it from step 1a to 1b of the 3 basic steps. Because this change would represent new indications for use this change would trigger the “Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act)” as listed in the classification regulations 8##.9 of Title 21 CFR. The modified device would not be exempt from the 510(k) requirements. The Quality System Regulation [Part 820] would apply to the modified device unless specifically exempted in the classification regulation. Company A’s current establishment registration & medical device listing would cover the modified device as soon that the 510(k) is cleared.


See also: Detox Con!

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