Background

This Ruling forms part of a wider piece of work on ads making claims about the treatment of symptoms of the menopause. The ad was identified for investigation following intelligence gathered 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 Facebook ad for Aida Wellbeing, seen on 18 January 2024, featured the text “Revealing I relieved my meno-bloat in 48 hours… 3 steps for the same results with the VolcanicX bundle: 1. Add 2-3 drops of peppermint essential oil to your VolcanicX bracelet 2. Adjust the VolcanicX bracelet to fit you snug 3. Wear it 24/7 for fast bloating relief & appetite control”, followed by “This bundle includes your VolcanicX Bracelet & Peppermint Premium Scented Oil”.

An image of the VolcanicX bracelet and peppermint oil featured the text “MENO-BELLY SOLUTION WHATS THE SECRET? MADE FOR WOMEN. IF YOU KNOW WHAT WE MEAN”.

Issue

The ASA challenged whether the ad breached the Code because it made medicinal or medical claims for an unlicenced product.

Response

GKOnlineCo Pty Ltd t/a Official Aida Store said that they would cease promoting the product and review their advertising. They stated that the product was certified as a medical device, but did not provide the relevant certifications. They further said they would investigate the need for, and if applicable, provide Marketing Authorisation documentation from the Medicines and Healthcare products Regulatory Agency.

Assessment

Upheld

The CAP Code stated that medicinal or medical claims may be made for a medicinal product that was licenced by the Medicines and Healthcare products Regulatory Agency (MHRA), or under the auspices of the European Medicines Agency (EMA), or for a medical device with the appropriate conformity marking. In addition, the Medical Devices Regulations 2002 required that a medical device should be registered with the MHRA before it was placed on the market in Great Britain.

A medicinal product was a substance or combination of substances presented as having properties for treating or preventing disease in human beings. Medical devices included articles, whether used alone or in combination, which were intended by the manufacturer to be used for human beings for the purposes of diagnosis, prevention, monitoring, treatment or alleviation of disease.

The ASA considered that consumers would interpret the claims “relieving meno-bloat in 48 hours” and “fast bloating relief and appetite control” to mean that the VolcanicX bracelet and the peppermint oil supplied with it could in combination treat those symptoms of the menopause. Whilst the menopause itself was not a medical condition, claims regarding the treatment and management of the adverse symptoms of menopause were medicinal or medical claims.

The VolcanicX bracelet was therefore classified as a medical device, and the peppermint oil sold with, and to be applied to, the bracelet was classified as a medicinal product, as the medicinal/medical claims made in the ad were attributed to both. However, we had not seen evidence that the peppermint oil was appropriately licenced as a medicinal product, or that the bracelet was registered with the MHRA and held the appropriate conformity marking. Therefore, no medicinal or medical claims could be made for the products. Because the ad made such claims, we concluded that it breached the Code.

The ad breached CAP Code (Edition 12) rules 1.10 (Legality), 12.1 (Medicines, medical devices, health-related products and beauty products) and 12.11 (Medicines).

Action

The ad must not appear again in the form complained of. We told GKOnlineCo Pty Ltd t/a Official Aida Store not to make medicinal or medical claims for unlicenced medicines, or devices that did not hold the applicable conformity marking and were not registered with the MHRA.

CAP Code (Edition 12)

1.10     12.1     12.11    


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