The company Innovative Medical Products was very aggressive in promoting its KN95 Mask. It paid for newspaper advertisements, television commercials, direct mail pieces, and billboards to inform the public of the product’s potential to remove and prevent signs of aging. Knoll was so well known in the U.S. that many newspapers, which accept advertising from companies, ran ads announcing, “Knoll is the world’s leading creator of medical equipment.” Although it is true that Knoll has produced a host of other medical devices, the line of industrial medical devices produced by Knoll is typically divided between two: surgical tools and therapeutic gear.
Innovative Medical Products was the manufacturer of the KN95 Mask, and it also produced a variety of other industrial and therapeutic medical devices. Knoll is an example of a public relations campaign aimed at persuading consumers that the company’s consumer products are highly recommended. Unfortunately, those consumers who used their KN95 Mask were told that they could not be trusted, because it had not been approved by the FDA as an OTC medical device.
If you live in the United States, or know someone who does, there is every reason to think twice about buying a KN95 Mask. Contrary to the claims made in the TV and print ads, the new mask does not qualify as an OTC medical device, which means that it cannot be sold without a doctor’s prescription. Indeed, even those who see a doctor may be unable to purchase the new medical device without a prescription.
The reason for this is that the Knoll mask was designed and manufactured for use only by physicians. All other consumers are not allowed to use it, for the same reason. The FDA does not permit manufacturers to market their products for non-medical purposes. This includes, for example, selling goods intended for cosmetic surgery, like the new KN95 Mask.
The Federal Trade Commission recently issued a formal complaint against Knollfor violating the Federal Trade Act. In a complaint filed with the FTC, the FTC charged that Knoll made and sold its medical equipment devices only to doctors, and that the medical devices were not to be used by consumers.
According to the complaint, Knoll represented that the product was FDA approved and that it was “the worlds leading creator of medical equipment”. However, the FDA charges that it never received any formal notification from Knoll about these claims. The complaint says that, “The Center for Medicare and Medicaid Services never reviewed a submission by Knoll for medical device approval. A submission for a ‘FDA investigational device exemption’ for the KN95 Mask would have triggered this review.”
Furthermore, according to the complaint, the FTC says that, “KNoll manufactured and sold the KN95 Mask to medical professionals as a device used by doctors to quickly remove facial hair. Knoll also marketed the KN95 Mask to consumers as a device that effectively prevents and treats aging signs.” As noted above, neither the FTC nor the FDA to require manufacturers to disclose any of the marketing claims they make about their products to the general public.
If you want to buy a KN95 Mask and do not plan to purchase it from a doctor, you should be very careful about which manufacturer you select. You should be very suspicious if your favorite store shows advertising touting that their product is approved by the FDA, and that it is “the world’s leading creator of medical equipment”. You should be especially suspicious if you see those advertising claims on TV, in print ads, and on billboards. And, remember, the device has never been cleared by the FDA for use by the general public.