Background
Summary of Council decision:
Two issues were investigated, both of which were Upheld.
Ad description
A paid-for Facebook ad for Noozier, an online retailer, for an at-home fetal [sic] doppler, seen on 18 February 2023 stated “’It was so reassuring to be able to hear my baby’s heartbeat whenever I wanted during my pregnancy’ – Lesley. USA”. Further text stated “Provides peace of mind”, and “Helps with early detection of issues”.
The ad included a video with the superimposed text “No more pregnancy or anxiety worries”, which featured pregnant women and couples using the doppler in home settings, listening to the sound of a heartbeat, and reacting positively. Further superimposed text stated “This fetal doppler let’s you hear your babies heartbeat”, “Enjoy peace of mind knowing your baby is well”, “It helps with early detection and eases anxiety”, “Its 100% baby safe!”, “Check up on your baby whenever you like” and “Say goodbye to pregnancy anxiety!”.
Issue
The complainant, a midwife, who understood that heartbeat readings from foetal dopplers could only be interpreted safely and effectively by trained medical professionals, challenged whether the claims that pregnant women could use the product for “early detection of issues”; to “Check up on your baby”; to “Enjoy peace of mind knowing your baby is well”; and to “Say goodbye to pregnancy anxiety”:1. were misleading; and2. discouraged pregnant people to seek essential treatment for which medical supervision should be sought, particularly in instances of concern about reduced movements of unborn babies.Response
Person(s) unknown t/a Noozier did not respond to the ASA’s enquires.Meta said they had investigated the matter and the content was no longer available in United Kingdom.
Assessment
The ASA was concerned by Noozier’s lack of response and apparent disregard for the Code, which was a breach of CAP Code (Edition 12) rule 1.7 (Unreasonable delay). We reminded them of their responsibility to provide a response to our enquiries and told them to do so in the future.
1. 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 medical device with the applicable conformity marking, and that objective claims must be backed by evidence, if relevant consisting of trials conducted on people.
The ad for the home doppler device featured the claims “Helps with early detection of issues”, “It helps with early detection and eases anxiety”, “Check up on your baby whenever you like” and “Its 100% baby safe!”. It also included claims about providing reassurance and alleviating anxiety for parents, such as “Enjoy peace of mind knowing your baby is well”, “Say goodbye to pregnancy anxiety!”, “No more pregnancy or anxiety worries”. A testimonial in the ad also stated “It was so reassuring to be able to hear my baby’s heartbeat […]”.
The ASA considered the statements in the ad relating to early detection of issues and reassurance implied that the device could help to alert parents immediately about any health complications or emergencies that their baby was affected by during pregnancy. Plus, it could be used for checking that the baby was healthy and well. We considered those statements were medical claims which required the device to hold an applicable conformity marking.
In order to support the medical claims in the ad, we would need to see evidence that the device was CE-marked as a medical device, and also relevant substantiation. In the absence of engagement from Noozier, we had seen neither. We therefore concluded the claims that suggested the advertised device could detect health issues early, and provide reassurance that an unborn baby was healthy and well, were likely to mislead.
On that point, the ad breached CAP Code (Edition 12) rules 3.1 (Misleading advertising), 3.7 (Substantiation), and 12.1 (Medicines, medical devices, health-related products and beauty products).
2. Upheld
The CAP Code stated that marketers must not discourage essential treatment for conditions for which medical supervision should be sought. Advertisers must not offer specific advice on diagnosis of or treatment for such conditions, unless that advice, diagnosis or treatment was conducted under the supervision of a suitably qualified medical professional.
As referenced above, we considered the claims “Enjoy peace of mind knowing your baby is well”, “helps with early detection and eases anxiety”, and “Check up on your baby whenever you like”, suggested expectant parents could use the doppler device at home to detect or monitor their unborn baby’s heartbeat and to check that their baby was healthy and well. We considered the ad particularly emphasised the reassuring nature of the product and implied it could help to relieve parental concern or anxiety about a baby’s health or pregnancy generally.
The NHS recommended that pregnant people should immediately contact a midwife or maternity unit in the event of reduced baby movements, and specifically advised against the personal use of home dopplers to check a baby's heartbeat. They said home dopplers were not a reliable way to check a baby's health, and that the presence of a heartbeat was not necessarily an indication of good health. We therefore understood that medical supervision should be sought for all monitoring during pregnancy, especially for any concerns about an unborn baby’s health or heartbeat, and it was particularly important that parents sought immediate medical advice from a midwife or maternity services if their baby’s movements were reduced. We therefore considered any advice, diagnosis or treatment relating to pregnancy should be conducted under the supervision of a suitably qualified health professional.
Because the ad suggested that parents could use the product to check their baby’s heartbeat and health themselves at home, we concluded that the ad discouraged essential treatment for conditions for which medical supervision should be sought, and had therefore breached the Code.
On that point, the ad breached CAP Code (Edition 12) rule 12.2 (Medicines, medical devices, health-related products and beauty products).
Action
The ad must not appear again in the form complained of. We told Person(s) unknown t/a Noozier to ensure their future ads for medical devices did not make medicinal claims unless the device was appropriately licensed. We also told them to ensure their future ads did not state or imply the device could help to detect health issues early, or provide parents with reassurance that an unborn baby was healthy and well, and must not discourage essential treatment for conditions for which medical supervision should be sought. We referred the matter to CAP’s Compliance team.
