A new warning letter sent by the US Food and Drug Administration (FDA) to medical device manufacturer RevecoMED regarding the sale and use of its "LipoTRON 30000" device is bringing both praise and scorn from some industry watchers, who say the device and its manufacturer have long flaunted federal regulations without consequence.
The device, also known as the RFLipo System (Model DETCBF140), is technically a "therapeutic massager." Under FDA regulations, the device is a Class I medical device exempt from premarket notification requirements.
"Devices of this generic type work by delivering vibration and contain moving components on them that deliver massage, or knead the tissue," FDA explained.
But despite Revecomed's claim that their device was a therapeutic massager, FDA claims their inspection of the company's Fullerton, CA facility found differently. "[A]ccording to the LipoTRON 3000 User Reference Manual, the LipoTRON 3000 delivers heat to the body via radio frequency energy," FDA said, adding that this difference means the device is no longer exempt from premarket notification procedures.
Other claims added to FDA's perception that the device was not, in fact, a therapeutic massager. Claims on the company's website, for example, noted that the device raises the body's temperature to "remove subcutaneous fat (cellulite) [and] visceral fat at the same time."
"Lipotron-3000 is a revolutionary Radio Frequency Assisted Lipoplasty (RFAL) System to offer a noninvasive procedure substituting traditional lipo-suction," another claim states. "This procedure has no downtime, side effect, fatigue and maintenance."
In total, the claims render the device adulterated and misbranded, regulators said. It will require an approved premarket application (PMA) before being allowed to be marketed, it added.
Industry Critics: What Took You So Long?
But to some industry critics, including public advocacy group Public Citizen, FDA's Warning Letter comes far too late for its tastes, even if it is on point.
"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," it 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."
The group contends that FDA "dragged its feet" to the ultimate detriment of patients. Numerous reports raised in 2012, including by the group FairWarning, noted that the device had "never been cleared or approved by FDA, which would make it illegal under federal law to sell or promote it for weight loss."
"The FDA is aware of the activity," FairWarning's report explained. "But an investigation by FairWarning found that the agency has not taken enforcement action-even though it has known about the situation at least since January, 2010. At that time, two whistleblowers, one a former LipoTron distributor, provided sales records and a trove of other documents to an FDA criminal investigator."
FairWarning's report was released in July 2012. FDA launched a two-week long inspection of RevecoMED starting in August 2012, a month after the report and two months after the health department of Texas announced it would launch its own investigation.
The company had 15 days to respond to FDA's Warning Letter, but as of the time of publication has not removed the violative claims from its website, which will touts the device's ability to introduce a "RF deep endogenous dermal heating method that provides all the advantages of a deep thermal increase to remove subcutaneous fat (cellulite [and] visceral fat at the same time"-the same claim highlighted by FDA as violating federal law.
"We urge the agency to ensure the company responds and to follow up with prompt aggressive enforcement action if it doesn't," said Public Citizen.
Regulatory Focus has reached out to RevecoMED for comment but did not hear back by the time of this articles publication.