Background
Summary of Council decision:
Two issues were investigated, one of which was Upheld. The other was informally resolved after the advertiser agreed to amend their advertising.
Ad description
A poster for Puressentiel, an aromatherapy and essential oils retailer, seen on 25 March 2018, on London Underground, featured an image of “REST & RELAX AIR SPRAY”. Text stated “Puressentiel REST &RELAX DREAMING OF GETTING A GOOD NIGHT’S SLEEP1? … 2 IMPROVES THE QUALITY AND DURATION OF SLEEP1”. Small text which was running along the side of the poster stated, “[1] To help preparing a good night’s sleep [2] Usage test - 30 volunteers - 21 days”.
Issue
The ASA received four complaints:
The complainants challenged whether the claim “improves the quality and duration of sleep” was a medicinal claim for an unlicensed product.
Response
Puressentiel UK Ltd said that they did not accept that the product was a medicinal product or medical device and believed that the complaint had no merit and was not in need of further investigation. They said that the spray was a consumer product comprising essential oils derived from plants and that it was not intended, nor did they believe it was perceived by the public, to be a medicinal product or medical device.
Puressentiel said that there were numerous other similar products on the market which were similarly treated as consumer products. Puressentiel provided two scientific studies which assessed improvement in sleep quality and duration for participants who used the product, which they said supported the claims in the ad.
Assessment
Upheld
The CAP Code required that medicinal or medical claims and indications were made only for a medicinal product that was licensed by the Medicines & Healthcare products Regulatory Agency (MHRA) or under the auspices of the European Medicines Agency (EMA) or for a CE-marked medical advice.
The ASA sought the view of the MHRA regarding the claims. They considered that sleep disorders were medical conditions and claims which implied that products were capable of treating such conditions, such as by exerting a sedative action, were medicinal claims. We considered that in the context of the ad as a whole, consumers were likely to interpret the claim “improves the quality and duration of sleep” as being a claim to treat a sleep disorder, and we therefore considered it was a medicinal claim.
We understood that the product did not have the relevant marketing authorisation from the MHRA and we had not seen any evidence to demonstrate that the product was a CE-marked medical device and because of that, no medicinal or medical claims could be made for the product. For those reasons we did not assess the evidence submitted to substantiate the claim in the ad.
Because the ad made medicinal claims for a product which was not licensed or a CE-marked medical device we concluded that the ad breached the Code.
The ad breached CAP Code (Edition 12) rules
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.
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.
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Action
The ad must not appear in its current form. We told Puressentiel UK Ltd to ensure that future ads did not contain medicinal claims for unlicensed products.
