Background
Summary of Council decision:
Two issues were investigated, both of which were Upheld.
Ad description
The website www.betteryou.com, for health supplements, included a link to "Transdermal Magnesium". Under the heading "Why transdermal delivery?" the website stated "Transdermal delivery has been proven as the most effective method of supplementation outside of a hospital environment, increasing the body's magnesium levels up to five times faster than oral supplementation. This means the positive effects of magnesium are felt faster".
A subheading "Our trials" stated "Cardiff University (2011) …To observe the actual absorption of magnesium chloride through the skin we asked Dr [Name] and his team at Cardiff University to measure elemental magnesium delivery through the skin using our Magnesium Oil. They showed that the solution is absorbed and magnesium is indeed transported through the skin. The act of massaging the solution into the skin is an important part of the effectiveness of the process … A pilot study by [Name] and [Name] (2010) illustrated a dramatic increase of cellular magnesium within subjects after a 12 week course of Magnesium Oil application and foot soaking. They found an increase in cellular magnesium of 60 per cent, five times faster than traditional oral supplementation”.
The website also included a video in which the presenter stated, "The magnesium quickly enters the skin before slowly entering the blood stream and then feeding every cell within the body … Clinical trials have shown that BetterYou's magnesium oil can elevate magnesium levels up to five times faster than traditional tablets or capsules."
An additional link "Sport Supplementation" stated "Why do we need to supplement magnesium? Muscle function: Research has shown that optimising magnesium levels during periods of training makes you stronger. Muscle endurance and total work capacity declines rapidly with nutritional deficiency in the area of key minerals like magnesium … Stronger bones: Without sufficient amounts of vitamin D and magnesium, calcium struggles to enter the skeleton. Magnesium activates the biochemical pathway which enables calcium absorption and enables bone building … Energy production: Without magnesium, it is impossible for the body to produce adenosine tri-phosphate (ATP), the primary currency of energy in the body".
Issue
The complainant, a physician, challenged whether:
1. the claims related to the transdermal absorption of magnesium were misleading and could be substantiated; and
2. in the context of a topically applied product, the efficacy claims were misleading and could be substantiated.
Response
1. BetterYou Ltd said that they recognised that the process of transdermal magnesium supplementation was currently poorly researched despite the method being practised for many years. They said their product contained a solution of water and magnesium chloride hexahydrate, at a concentration of 31%, which maintained a stable brine solution.
BetterYou said that scientific, but not clinical studies existed and the results were compelling. They said a clinical trial has been proposed to investigate magnesium absorption through the skin in patients with small bowel stomas. An additional trial would investigate changes in oxygen intake and energy output comparisons when magnesium oil was used by athletes.
BetterYou supplied documentation, which they believed supported the claims made in their advertising.
2. They said they supplied a number of professional sports teams with their magnesium oil and was used to enhance their anti-cramping and stiffness protocols. They said that those facts were suitable to satisfy the claim that magnesium ions pass through the skin into the body.
Assessment
1. Upheld
The ASA considered that consumers would understand from BetterYou's ad that the application of magnesium oil and foot soak would mean that it was a more efficient method of supplementation in humans.
We did not consider studies undertaken on competitor products, pre-trial protocols, in vitro testing and laboratory analysis of BetterYou's products were suitable to substantiate their claims because they were not related to the analysis of their product on human volunteers. We were concerned that the studies conducted with BetterYou's magnesium products on human volunteers contained a number of omissions and methodological flaws. For example, they were not placebo controlled, inclusion and exclusion criteria were not stated and statistical analysis was missing. One study consisted of nine subjects which we considered was too small a sample to have any statistical significance in this case. Another study used hair samples as an indicator of transdermal magnesium uptake. We understood, however, that there was no simple or accurate laboratory test that could determine the amount of magnesium in the body and therefore considered hair samples to be an inadequate method for analysis. Because of these factors, we could not have confidence in the study outcomes and considered the evidence was not sufficient to support the claims. We therefore concluded the claims were misleading.
On this point the claims 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),
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).
2. Upheld
We noted that the ad made claims that the use of magnesium, through topical application or bathing, had a beneficial effect on muscles, bone and energy production. Because BetterYou had provided anecdotal evidence rather than adequate clinical trials, we concluded the claims had not been substantiated and were misleading.
On this point the claims 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),
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 ad must not appear again in its current form. We told BetterYou Ltd to avoid making future claims for their magnesium products in the absence of adequate substantiation.
