LipoTron, Lipo-Ex Weight Loss Machine Marketed Illegally: Report
A machine heralded for literally melting body fat away appears to have been marketed illegal in the United States, leading to calls for the FDA to take immediate action to end the distribution, sale and promotion of the unapproved medical device.
Known as the LipoTron 3000, or Lipo-Ex, the machine targets fat with radiofrequency waves. While spas across the country have promoted the device as “revolutionary” and “innovative,” there is one problem: it has not been approved by the FDA, which makes it illegal under federal law to sell or promote it for weight loss.
According to an investigation by the nonprofit publication FairWarning, the FDA has known about the product for months, but has not taken action.
The manufacturer of the device, RevecoMED, reportedly first sought a green light from the FDA to market the device in 2007. It chose the FDA’s market clearance procedure, which is less demanding than the formal approval process, but failed due to a lack of information provided.
In 2011, the company classified the device as a massager, which can be sold without FDA approval. However, promotional materials suggest that the device is a medical device and the company appears to have sold the LipTron3000 in the United States since 2007.
RevecoMED’s website describes the LipoTron3000 as being able to increase the body’s core temperature to a point of dissolving fat cells, without causing damage to other internal organs. The company also claims that the device causes the disruption of fat cell membranes, causing the fatty content to leak out into the interstial tissue. The fat is then absorbed by the lymphatic system and eventually eliminated naturally via the urine and feces. RevecoMED also states on its website that it’s the first technology to melt the unhealthy and dangerous fat linked to heart disease and diabetes.
Public Citizen, a prominent consumer advocacy group, sent a letter (PDF) to the FDA July 18, encouraging the agency to “[e]xpeditiously complete its criminal investigation of the distribution, sale, and promotion of the LipoTron device and take appropriate legal action against those individuals, companies, and user facilities that are found by the agency to have engaged in any illegal marketing or promotion of this device.”
At least two whistleblowers have reportedly come forward about the product, providing sales records and other documents to an FDA criminal investigator, but the federal regulatory agency has not taken steps to stop the sale and promotion of the LipTron or Lipo-Ex machines.
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Mary J.December 31, 2012 at 4:28 pm
Asked in several online sites but received no clear answer.. Some sources say that it is FDA approved for medical use ( http://www.lipoadvisor.com/lipo-ex/ ) ! what is this supposed to mean? Does FDA provide different approvals for Medical use, Weight loss effect etc?
BelindaOctober 5, 2012 at 11:27 pm
Department of Justice press release regarding off-label promotion, dated Tuesday October 2, 2012, that may help clarify some of the issues in these postings: http://www.justice.gov/opa/pr/2012/October/12-civ-1195.html FDA contacts tell me that the rules are the same for devices as for drugs. I've been corrected by these FDA/OCI/DOJ contacts about the following important distinctions: 1. FDA re[Show More]Department of Justice press release regarding off-label promotion, dated Tuesday October 2, 2012, that may help clarify some of the issues in these postings: http://www.justice.gov/opa/pr/2012/October/12-civ-1195.html FDA contacts tell me that the rules are the same for devices as for drugs. I've been corrected by these FDA/OCI/DOJ contacts about the following important distinctions: 1. FDA registration refers to a company, not a device. Once a device is exempted, cleared, or approved, it is listed under its registered company and there are annual fees and requirements associated with a registration. 2. Exempted devices do not have a "label", only an "intended use". 3. Only "cleared" (by successful 510(k) process) and "approved" (by successful PMA process) devices have a "label". 3. If an exempted device is promoted outside its narrowly defined "intended use", its manufacturer must go through either the 510(k) or PMA process so the device may be properly and adequately classified and appropriately "labeled". 4. There is no "off-label" promotion nor use allowed for "exempted" devices because, by definition, they do not have a "label". An exempted device can be promoted and used only for its "intended use" as specifically defined in its exemption. 5. If you are marketing, selling, and training end-users on an exempted device outside its narrowly defined "intended use" it is "misbranding" and illegal to do so. As I've encouraged many times, don't take my word, or anyone else's. Do your own reading and research. All that is at stake is your business, livelihood, medical license, and reputation.
JillDAugust 27, 2012 at 2:40 pm
Actually, there are dozens of peer-reviewed medical articles showing the technology is safe and effective (go to PubMed and do a little research for yourself). There’s a range of results, of course, so some people are inevitably at the low end, but overall satisfaction is good. As for the machine, it is registered with the FDA and complaints on the web originated with a disgruntled ex-distributor [Show More]Actually, there are dozens of peer-reviewed medical articles showing the technology is safe and effective (go to PubMed and do a little research for yourself). There’s a range of results, of course, so some people are inevitably at the low end, but overall satisfaction is good. As for the machine, it is registered with the FDA and complaints on the web originated with a disgruntled ex-distributor who is the one who produced most of the off-label marketing that she complains about. The new distributor was perhaps too slow in revising the marketing, but has done so. The machine itself has been in use for years and is very similar to other devices in use that work the same way. Complications have been been few and minor and comparable to other such non-invasive treatments. Doctors who use the machine for body contouring are using it off-label but, unlike manufacturers, physicians are totally free to do so (up to half of all medical care is off-label; it’s legal and ethical). Basically, a bitter ex-rep combined with an attention seeking “advocacy” group that appears to many to be using hyperbolic fear-mongering to grow its contribution base are creating a lot of noise over very little.