Summary of Council decision:
Two issues were investigated, both of which were Upheld.
A website, www.freestepsuperfix.co.uk, for a horse supplement supplier Freestep, seen on 20 October 2015. A page for a calming spray product titled 'INSTAMAG (300ML)' included text that stated "... Over 4 times faster acting than any other magnesium calmer on the market, closest comparison - 90 mins. Trans-dermal application is the fastest way to deliver magnesium into the tissues/blood and onto the brain". The page for a supplement titled 'LAMALERT C.S.H. (500G)' contained text that stated "Formulated to provide support for horses with Cushings, an alternative choice to a synthetic medicine ... LAMALERT C.S.H assist [sic] ponies and horses in retaining natural hormone levels giving a healthy life ... suitable to be fed to horses and ponies prone to laminitis. LAMALERT C.S.H IS A LEGAL ALTERNATIVE !!".
The ASA received two complaints from a member of the public and Rumenco Ltd:
1. the member of the public challenged whether the claim "Over 4 times faster acting than any other magnesium calmer on the market, closest comparison - 90 mins" was misleading and could be substantiated;
2. both the member of the public and Rumenco challenged whether the claim "Transdermal application is the fastest way to deliver magnesium into the tissues/blood and onto the brain" was misleading and could be substantiated; and
3. Rumenco also challenged whether the page for 'LAMALERT C.S.H. (500G)' made medicinal (veterinary) claims for an unauthorised product.
1. & 2. Freestep Ltd stated that the claim “over 4 times faster acting than any other magnesium calmer on the market, closest comparison - 90 mins” was based on claims stated on competitors’ websites, in relation to the time that their magnesium would take to absorb through the gut onto the brain. Freestep also submitted a document produced by the research and development arm of their company, which they stated contained details of the latest research regarding the transdermal application of magnesium.
3. Freestep provided a veterinary document that showed the comparison to veterinary drugs prescribed for Laminitis, Equine Metabolic Syndrome (EMS) and equine Cushing’s disease, such as Prascend. They stated that their evidence had been welcomed by vets who were searching for alternatives for horses that competed and which had been diagnosed with previous complications, but the drugs that would otherwise be prescribed would not pass the doping tests under Federation Equestre Internationale regulations.
Freestep stated that prominent insurers had been paying out on their products based on the results that they had experienced with Lamalert and they believed that this demonstrated the product was not only a legal alternative, but also a cheaper and effective alternative.
1. & 2. Upheld
The ASA considered that consumers were likely to expect from the claims that Instamag was effective in calming horses in under 20 minutes, and that it acted four times faster than all other magnesium calmer products in the market. We further considered that consumers were likely to view both claims as being capable of objective substantiation and therefore we expected to see adequate documentary evidence, consisting of clinical trials to support those claims.
We did not consider that examples of claims relating to the rate of absorption taken from competitors’ websites were adequate in supporting the comparative claim that implied Instamag was four times faster acting than other magnesium calmer products on the market. We noted that the document produced by Freestep’s research and development team provided some explanation, with references to a number of academic sources, on how magnesium might be absorbed through skin and on the use of magnesium chloride hexhydrate for faster and more efficient delivery. The document also included comments from Freestep’s previous findings on the absorption of magnesium through skin, compared to absorption through the digestive tract. However, we had not seen any evidence, such as clinical trials, that showed the efficacy of the product in calming horses; that it would be effective in under 20 minutes; or that Instamag acted four times faster than alternative magnesium calmer products. We also had not been provided with detailed studies or general literature that examined the physiological effects and benefits of transdermal application of magnesium over oral ingestion. For those reasons, we considered that the evidence provided by Freestep were insufficient to substantiate the comparative claims in relation to the product’s efficacy. We therefore concluded that they were likely to be misleading.
On those points, 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 3.33 3.33 Marketing communications that include a comparison with an identifiable competitor must not mislead, or be likely to mislead, the consumer about either the advertised product or the competing product. (Comparisons with identifiable competitors).
The CAP Code required medicines to have a marketing authorisation from the relevant regulatory body before they were marketed, including veterinary claims made for animal products. The relevant regulatory body for veterinary claims was the Veterinary Medicines Directorate (VMD).
We understood from the VMD that any claims for efficacy against an adverse condition would be deemed a medicinal claim and that they considered the efficacy claims made in the ad against equine Cushing’s disease and laminitis were medicinal claims. We also understood that the product Lamalert had not been assessed by the VMD for efficacy, safety or quality and that it did not hold a marketing authorisation. Because the efficacy claims made for Lamalert were medicinal and that Freestep did not hold a marketing authorisation, we concluded that the claims breached the Code.
On that point, the ad breached CAP Code (Edition 12) rules
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. and 12.6 12.6 Marketers should not falsely claim that a product is able to cure illness, dysfunction or malformations. (Medicines, medical devices, health-related products and beauty products), and 12.11 12.11 Medicines must have a licence from the MHRA, VMD or under the auspices of the EMA before they are marketed. Marketing communications for medicines must conform with the licence and the product's summary of product characteristics. For the avoidance of doubt, by conforming with the product's indicated use, a marketing communication would not breach rule 12.2.
Marketing communications must not suggest that a product is "special" or "different" because it has been granted a licence by the MHRA, VMD or under the auspices of the EMA. (Medicines).
The ad must not appear again in its current form. We told Freestep Ltd to ensure that they did not make efficacy claims in future advertising unless they held adequate evidence to substantiate the claims. We also told them to ensure that they did not make medicinal claims unless they could demonstrate that they held marketing authorisation from the VMD.