Background

Summary of Council decision:

Three issues were investigated, all of which were Upheld.

Ad description

The website www.betteryou.com, seen on 7 April 2016, included various claims about the benefits of a magnesium oil recovery spray product. Text stated “Magnesium Oil Recovery Spray efficiently replaces magnesium lost through sweat and the increased metabolism of exercise regimes. Magnesium is the single most important mineral to sports nutrition that no serious athlete can afford to overlook. An athlete with sufficient cellular magnesium will sleep better, recover quicker and resist fatigue for longer. Magnesium encourages the body to absorb calcium which could otherwise, over time result in a build-up on soft tissue and muscles, causing them to harden. During Paleolithic times, when our bodies formed into how they are today, the ratio of calcium to magnesium was 1:1. In today’s Western diets it is in excess of 20:1. Our Magnesium Oil Recovery Spray can plug the gaps left by diet. A clinical trial by Cardiff University showed how well magnesium is absorbed through the skin, feeding every cell. A further study by Watkins & Josling showed that BetterYou Magnesium Oil will elevate cellular magnesium levels up to 5 times faster than traditional tablets or capsules. The award winning spray contains pharmaceutical grade Zechstein Inside magnesium chloride. Mined in Northern Holland from a seam one mile below ground, our magnesium chloride has been naturally condensed and purified for over 250 million years. As open water sources contain elevated man-made pollutants and heavy metals, Zechstein Inside magnesium chloride guarantees the most naturally pure source known. It is totally ionized for effective absorption and retention by the body. This means the essential mineral is delivered directly into the skin tissue, entering cells immediately, efficiently replacing magnesium lost through sweat”.

Issue

The complainant challenged whether the following claims were misleading and could be substantiated:

1. the efficacy claims about the product’s ability to replace magnesium, and its benefits;

2. the claims about the body’s ability to absorb magnesium via the skin; and

3. “mined in Northern Holland from a seam one mile below ground, our magnesium chloride has been naturally condensed and purified for over 250 million years. As open water sources contain elevated man-made pollutants and heavy metals, Zechstein Inside magnesium chloride guarantees the most naturally pure source known”.

Response

1. BetterYou Ltd believed the benefits of magnesium were very well documented. They said there were a number of studies related to elemental magnesium, and provided several pieces of evidence in support of their claims. They included an opinion by EFSA (the European Food Safety Authority) as well as studies that involved BetterYou’s product and other forms of magnesium.

2. They said the claims about absorption were also supported by the studies they had submitted, the more recent of which used BetterYou’s form of magnesium chloride, a more soluble form than used in previous testing.

3. BetterYou said the source of their magnesium oil was in northern Holland, and it was mined from a rich seam of magnesium chloride one mile below ground and 250 million years old. Unlike open-source magnesium compounds, the seam was protected from exposure to man-made pollutants. They said every batch was chemically finger printed and there was no evidence that there was any natural source that was more pure. They provided a certificate in relation to the chemical make up of the brine they used.

Assessment

1. Upheld

The ASA considered the claims, which also appeared under the heading “Training and recovery aid” and, for example, the text “… one of its greatest uses is for sport …”, were likely to be understood to mean that the product was immediately beneficial for those who took part in sport, or exercise regimes. We considered they would be understood to mean that the product had particular efficacy in replacing magnesium lost in sweat, and/or boosting poor dietary magnesium supplies, which would provide for better sleep, lessened fatigue and quicker recovery, as well as encouraging calcium absorption to prevent soft tissue and muscle hardening.

We assessed the evidence submitted by BetterYou. We firstly noted that the EFSA Opinion related to dietary magnesium intake in infants and young children’s bone development, and therefore considered it was not relevant to claims for a topical product intended for sportspeople, which did not in any case refer to bones. We noted that the efficacy study that used the advertiser’s product (the Watkins & Josling study referred to in the ad) was a pilot only, and involved a small number of human subjects spraying the product 20 times per day, in conjunction with using a magnesium foot soak twice per week, whereas the ad referred to the magnesium delivery achieved by ten sprays of the product used alone. While it stated that the majority of the subjects experienced an increase in magnesium levels, there was no evidence of what, if any, benefits that could provide, in particular for the sportspeople the ad was targeted at.

Several of the studies submitted related to use of topical magnesium in animals, rather than human subjects, and none of them related to use following exercise. Studies involved skin damage or vascular applications and one of those involved magnesium being administered intravenously, rather than only topically. The evidence often did not involve measuring for immediate effect, but related to magnesium levels measured at later stages. In addition, some of the documents submitted did not take the form of published clinical trials and the majority of the studies, including the one on the advertiser’s product, nevertheless appeared to have no blinding and/or control and lacked statistical analysis. They were also carried out on a small scale, generally using products other than the advertiser’s, and some used methods of testing, such as hair testing, which the evidence did not demonstrate were adequate methods for assessing magnesium in the body. We further noted that the evidence indicated that the mechanisms that led to the absorption of magnesium ions through skin were not well understood. For the reasons given, we considered the evidence BetterYou submitted was not adequate to support the efficacy claims related to the topical use of their product in sport.

We concluded that the claims had not been substantiated and that the ad therefore breached the Code.

On that 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).

2. Upheld

We considered the claims about the Watkins & Josling and Cardiff University studies, as well as the wider efficacy claims about topical use of the product, were likely to be understood to mean that it would be effectively absorbed through the skin and into other cells.

Both of the studies referred to in the ad were carried out using the advertiser’s products. However, as discussed above in relation to the Watkins & Josling study, they involved no blinding (or control, in the case of Watkins & Josling) and used other products in addition to the magnesium oil spray advertised. The Cardiff University study was carried out in vitro, on pig ears, rather than involving humans and stated that massaging the skin was key to achieving delivery of a high dose of magnesium, whereas the ad referred only to spraying the product onto skin. That study also involved the product being administered differently to the ten sprays shown in the ad. In addition, the Watkins & Josling study did not include any formal comparison with the speed of delivery of traditional tablets or capsules, as was stated in the ad. We considered the two studies were therefore not adequate to demonstrate that magnesium could be effectively absorbed into cells through the skin as claimed. We noted that some of the other evidence submitted in support of the efficacy claims also involved discussion of absorption. However, as referred to above, we similarly considered that, for various reasons, it was inadequate to support the advertising claims.

For the reasons given, we concluded that the claims about absorption of magnesium into the skin had not been substantiated and therefore breached the Code.

On that 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).

3. Upheld

We noted that the certificate BetterYou provided showed that the producer’s address was in the northeast of the Netherlands, while the producer’s own website stated that the magnesium source was located near to its facilities and provided additional information on the source itself. However, the certificate, which was dated June 2014, related to the analysis of one wholesale product by the producer and was therefore not an independent assessment of the purity of its magnesium more generally. It also did not include any information on comparator magnesium products. We therefore considered the certificate and the information we located on the producer’s website were not sufficient to demonstrate that the magnesium was from the most naturally pure source available, as claimed. In addition, we did not receive any documentary evidence relating to the aspects of the claim that referred to the source seam being one mile below ground, the magnesium chloride being naturally condensed and purified for over 250 million years, or open water sources containing elevated man-made pollutants and heavy metals. We again concluded that the claim had not been substantiated and therefore breached the Code.

On that 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 ad must not appear again in its current form. We told BetterYou Ltd not to make efficacy claims about their product, for example in relation to use in sport or absorption through the skin, in the absence of adequate evidence. We similarly told them not to make claims about the purity of the magnesium they used, or its source, including in comparison to other sources or products, if they did not hold documentary evidence for those claims.

CAP Code (Edition 12)

12.1     3.1     3.7    


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