Background
The ad was identified for investigation following intelligence gathering by our Active Ad Monitoring system, which uses AI to proactively search for online ads that might break the rules.
Ad description
A paid-for Meta ad, seen on 2 July 2024, featured the text “Do you struggle with your child's ADHD? Meltdowns, outbursts, screaming and yelling ... You NEED to try out the Sereni Calming Vest … It uses deep pressure therapy to help: Calm Meltdowns & Outbursts, No More Hyperactivity, Reduce Impulsive Behaviour”. It also contained a video of children wearing the Sereni Calming Vest and voice-over which explained that it could help with the signs of ADHD.
Issue
The ASA challenged whether the ad made medical claims which breached the Code.
Response
Sereni told us their understanding was that class I low-risk medical devices, like their product, did not require certification from a notified body. This guided their advertising.
Assessment
Upheld
The Medical Devices Regulations 2002 required that a medical device should be registered with The Medicines and Healthcare products Regulatory Agency (MHRA) before it was placed on the market in the UK.
Further, the CAP Code (which reflected legislation) stated that 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 medical device with the applicable conformity marking.
The ASA understood that the claims “It uses deep pressure therapy to help: Calm Meltdowns & Outbursts”, “No More Hyperactivity”, “Reduce Impulsive Behaviour”, regarding the treatment and management of adverse symptoms of ADHD, were medical claims for the purposes of the legislation reflected in the Code. The product was therefore required to carry an applicable conformity marking.
We contacted the MHRA to clarify the classification of the product. They told us that, in general, manufacturers of Class I medical devices could self-certify for the conformity marking. However, all medical devices must also be registered with the MHRA in order to be placed on the UK market.
Because Sereni had not demonstrated that the calming vest had the applicable conformity marking to allow for medical claims to be made in the ad, we concluded that it breached the Code.
The ad breached CAP Code (Edition 12) rule 12.1 (Medicines, medical devices, health-related products and beauty products).
Action
The ad must not appear again in its current form. We told Sereni not to make medical claims for products that did not have the applicable conformity marking.
