The FDA has issued a warning to Joseph Mercola, MD, that he has violated the Federal, Food, Drug, and Cosmetic Act by marketing the Meditherm Med2000 Telethermographic camera as a breast cancer screening tool.
According to the FDA, neither Mercola nor Meditherm have obtained marketing approval or clearance to market the camera as a stand-alone system to diagnose or screen breast disease. However, Mercola’s natural health website touts the camera as a stand-alone device to diagnose or screen for various diseases or conditions of the breast, the FDA wrote in a March 22 warning letter. These include: “Revolutionary and safe diagnostic tool detects hidden inflammation: thermography” and “The newest safe cancer screening tool.”
The FDA also charged that Mercola’s website implies that the Meditherm Med 2000 camera provides sensitivity greater than mammography.
In its warning letter, the FDA requested that Mercola cease making these and similar claims and noted that failure to correct “the violations promptly may result in the initiation of regulatory action [which may include] seizure, injunction, and/or civil monetary penalties.”
The initial 510(k) notification for Meditherm Med2000 Telethermographic camera, issued on Feb. 21, 2001, cleared the system “[f]or viewing and digitally storing thermal patterns generated by the human body in the clinical, hospital, acute care setting, surgery, healthcare practitioner facilities or in any environment where healthcare is provided by a qualified healthcare professional.”