The affair held sway for several weeks but, now, it has come to an end. The U-Mask masks, seen on the faces of many VIPs, can no longer be sold. It was established on Ministry of Health, which notified the existence of potential health risks due to a non-compliant evaluation process.
U-Mask, what you need to know
When U-Masks were launched on the market, they seemed like a real revolution. The much disputed hour Model 2, produced by U-Earth Biotech (London company with branch in Milan), everyone wore it: sportsmen, influencers, actors, various celebrities. Described as "the first biotech goggle," the Model 2 was all about its own five layers: recycled nylon, non-woven fabric, nano-filtration system, non-woven fabric, bio-layer. And it is the latter that is the key to the innovation of U-Mask masks. Or rather, so the company claimed. A self-sanitizing layer, capable of reducing the bacterial load thanks to an unspecified one natural and non-toxic molecule. There are no patents, there are no publications. Above all, there are no certifications judged to be "real". In Italy, the masks they need to be certified by a accredited and registered laboratory. Only when they get the green light from the Ministry of Health can they be sold. This is where the criticality arises: the Clodia laboratory (Bolzano) which carried out the tests is not accredited and operates without authorization.
The decision of the Ministry of Health
Due to the absence of the required evaluation test, or rather its invalidity, the Ministry of Health has decided to ban the sale of U-Mask masks. The safety and efficacy of Model 2 are not certified, hence the wording "potentially dangerous to health". Not knowing their real effectiveness, people who wear them may think they are protected without - in fact - being protected. Also because, U-Masks were sold as class 1 medical device. And it was a contradiction. Devices of this type have a very limited duration, while the company promoted use of 200 hours. But what is the real one filtering capacity U-Mask? The company speaks of 99%, Altroconsumo of 97-98%, the laboratories contacted by Strip The News (from which everything started) stop at 95%. Indeed, a competitor claims to have found an effectiveness of 70-80%. The Model 2 are therefore not ineffective from the point of view of filtering: the problem lies in the misleading communication, and in the irregularity of the evaluation process.
U-Mask's answer
At the heart of the investigation there are several information deemed misleading: the bio-technology never verified, the 200 hours of use, the comparison with the Ffp3 masks, the ambiguity regarding the right of withdrawal. In recent weeks, the Milan prosecutor had seized samples of masks from some pharmacies to be analyzed. L'investigation for fraud focused on the figure of Betta Maggio, legal representative of U-Earth Biotech. Subsequently, the proceeding of the Antitrust Authority (AGCM) for misleading advertising began. In the face of all this, the U-Mask can no longer be sold. “We are appalled by the precautionary measure announced yesterday by the Ministry of Health regarding U-Mask. We radically contest the provision e we will defend ourselves in the appropriate places. We will defend the quality of our products, the reputation and the work of our company in every location, certain of our reasons and the transparency of our conduct ”said U-Earth Biotech.
