For the second time in as many weeks, the US Food and Drug Administration (FDA) has released a warning letter sent to a company marketing a cleared therapeutic massage device as something for which it has not received regulatory approval.
The first of these devices, marketed by RevecoMED, is the LiptoTRON 3000, a therapeutic massager that an FDA warning letter claimed was actually being marketed as a heating device used to "remove subcutaneous fat (cellulite) and visceral fat."
While the device was cleared under the 510(k) premarket notification system as a Class I medical device, its new labeling indications rendered it misbranded, and the claims required a premarket approval (PMA) application and FDA approval before it may be legally marketed, FDA said.
But the deficiencies prompted a sharp response from public advocacy group Public Citizen as well, which chided FDA for its response time to the company.
"FDA is doing the right thing by warning RevecoMED International, the maker of the LipoTron 'fat-burning' device, to stop marketing the device, which has not been FDA-approved for 'fat-burning,'" Public Citizen said in a statement.
"However, the action comes years too late. The illegal distribution and promotion of the LipoTron device was first brought to the FDA's attention in January 2010. It should not have taken the agency so long to respond."
But FDA's 26 March 2013 warning letter to Toronto-based Body, Mind & Soul, Inc makes clear that RevecoMED isn't the only company to have engaged in off-label marketing of a therapeutic massage device.
The company's Celluderm therapeutic massager, unlike RevecoMED's device, has received no clearance or approval via either the 510(k) or PMA regulatory pathways, rendering it misbranded and adulterated. FDA investigators said the product claimed a number of prohibited and unproven claims, including that it could boost the immune system, treat the effects of fibromyalgia and restless leg syndrome, reduce breast cysts and relieve headaches.
Like RevecoMED, the company also claimed the device could be used to reduce fat, this time by "breaking up the congestion that contributes to sluggish lymphatic flow" and by acting to "break up fat congestion."
As with the other company, FDA demanded that Body, Mind & Soul cease marketing the devices until the company is able to obtain a PMA.
The company was also cited for failing to register its manufacturing facility with FDA, even as it marketed its products within the US. This oversight means that every device marketed by the company is misbranded under section 502(o) of the Federal Food, Drug and Cosmetic Act in that they were manufactured or otherwise processed at an unregistered facility. The company's website only mentions its manufacture of the Celluderm device, however.
FDA's letter did not indicate whether the devices are subject to seizure or refused entry into the country.