Ad description
Two paid-for Facebook ads for NovaFlow, a sinus clearing device, seen on 14 May 2025:
a. The first ad, included an image of a NovaFlow. Overhead text stated, “[strikethrough begins] Congestion [strikethrough ends] gone for GOOD” and “Try the NovaFlow(TM)”. Text overlays appeared over the image, which included “Reduces Sinus Inflammation”,” Restores Natural Breathing” and “Woke Up Feeling Refreshed”.
b. The second ad, included an image of a man holding a NovaFlow. Text next to the image stated “Scientifically Proven To Reach the Deepest Part Of Your Sinuses And Tackle The Root Cause of Clogged Noses.”
Issue
The complainant challenged whether the ads made medical claims for an unlicensed product.
Response
Cleriva t/a NovaFlow acknowledged that the claims “reduces sinus inflammation” and “tackles the root cause" could be interpreted as medical claims under the CAP Code. As a US-based company, they understood, since notification of the complaint, that in the UK such claims could only be made if the product was formally registered with the MHRA (Medicines and Healthcare products Regulatory Agency) as a medical device and held the appropriate conformity marking. They confirmed that they were not aware of these requirements at the time when the posts were made.
They said that their claims were based on scientific literature and provided an example of a study on the potential of low-level red-light therapy in supporting nasal function. They said that their aim was to reflect this research, rather than mislead consumers. They had since taken action to remove the ads in question and said that they would ensure that future ads would avoid medical claims until they had registered with the MHRA. They said they would reframe their marketing to focus on general wellness and comfort rather than claims in relation to medical treatment and reiterated their commitment to comply with the CAP Code.
Assessment
Upheld
The CAP Code stated that medical claims and indications could only be made for a medicinal product that was licensed by the MHRA, the Veterinary Medicines Regulations (VMD) or under the auspices of the European Medicines Agency (EMA), or for a medical device with the applicable conformity marking. In addition, the Medical Devices Regulations required that a medical device was registered with the MHRA before it was placed on the market in Great Britain.
The ASA considered that consumers would understand the claims “Restores natural breathing”, “Reduce sinus inflammation”, “Congestion gone for GOOD” in ad (a) and “Tackle the root cause of clogged noses” in ad (b) to mean that using the NovaFlow device could alleviate symptoms of sinus congestion or breathing problems. We therefore considered that the ads made medical claims, which required that the product met the requirements for medical devices.
We noted NovaFlow’s response, which confirmed that the product was not registered with the MHRA, nor had the applicable conformity marking. Therefore, no medical claims could be made for the product. We welcomed NovaFlow’s willingness to remove the ads. However, because the ads made medical claims for an unlicensed product, we concluded that they breached the Code.
The ads breached CAP Code (Edition 12) rule 12.1 (Medicines, medical devices, health-related products and beauty products).
Action
The ads must not appear again in the form complained of. We told Cleriva t/a NovaFlow not to make medical claims for devices that did not hold the applicable conformity marking and were not registered with the MHRA.
