Medicinal claims are not permitted for unlicensed products and medical devices need to be appropriately certified before medical claims are permitted.
That seems pretty clear-cut but what makes a product a medical device? In rulings on products that were, on the face of it, intended for beauty, the ASA considered some claims medicinal.
Behind the mask
The ASA considered claims that LED face masks could treat or prevent acne - a medical condition - to be medicinal claims. Such claims therefore required that the products met the requirements for medical devices, but Luyors Retail Inc provided no evidence that their device was registered with the Medicines & Healthcare products Regulatory Agency (MHRA) or had the appropriate conformity marking. Their ad thus breached CAP Code (Edition 12) rule 12.1 (Medicines, medical devices, health-related products and beauty products).
Related claims
The MHRA told the ASA that, while they reviewed products on a case-by-case basis, in general claims to treat redness related to acne were also medicinal claims. The ASA therefore considered that a claim by Invention Works BV that their LED mask would reduce acne-related redness was a claim to treat a medical condition and also meant the product would need to meet the requirements for medical devices.
Know your conditions
The ASA considered claims regarding rosacea to be claims that an LED mask could treat or prevent a medical condition. In the Beautaholics Ltd ruling, while the ASA understood that the product was UKCA certified, and therefore had the applicable conformity marking, they saw no evidence that it was registered with the MHRA. No medicinal claims could therefore be made for the product. Marketers should ensure products meet all the requirements to make medical claims. Even if you have the necessary registration and conformity marking, you still need to hold robust documentary evidence to support the claims you make for a device.
Testimonials
Presenting medical claims in a testimonial does not remove the need to meet those requirements (see Project E Beauty LLC and Invention Works BV). The Code applies to claims in testimonials and endorsements in the same way that it applies to claims elsewhere in advertising.
Check out the Medical Devices AdviceOnline to establish if your product is a medical device and, while we’re talking beauty, don’t forget the level of evidence required to substantiate efficacy for those claims too.
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