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Good Move, But Years Late: FDA Warns Maker of ‘Fat-Burning’ Device to Stop Marketing Unapproved Product

Statement of Dr. Michael Carome, Deputy Director of Public Citizen’s Health Research Group

Note: Note: On July 18, 2012, Public Citizen sent a letter to the U.S. Food and Drug Administration, urging the agency to act immediately to end the distribution, sale and promotion of the LipoTron medical device because it had not been approved for the use for which it was being promoted and it could harm patients. Earlier this month, the FDA sent the manufacturer a letter, telling it that the device needs FDA approval and should not be marketed until that approval has been given.

The Food and Drug Administration (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.”

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. While the FDA dragged its feet, patients were in harm’s way and likely wasted money on an unproven treatment. The agency is supposed to protect the public, not allow it to be exposed to potentially harmful and ineffective products.

The LipoTron device has been promoted for use in removing subcutaneous and visceral fat, and has been sold as the major component of a weight loss program called Lipo-Ex. However, it poses a risk of burns, and sufficient data have not been submitted to the FDA documenting that the device is effective for its intended uses.

The FDA’s March 1 letter to the company admonishes it to take prompt actions to correct the violations and bring the device into compliance with the law.

We urge the agency to ensure the company responds and to follow up with prompt aggressive enforcement action if it doesn’t.