FDA WARNING_LETTER - Meditherm Inc.

This FDA Warning Letter, addressed to Dr. Joseph Mercola of Dr. Mercola’s Natural Health Center and Thermography Diagnostics Centers, identifies the unlawful marketing of the Meditherm Med2000 Telethermographic camera. The FDA found that the device is being marketed for uses lacking marketing clearance or approval, violating the Federal Food, Drug, and Cosmetic Act. Specifically, Dr. Mercola's website promotes the device for stand-alone diagnosis and screening of various diseases and conditions, including breast cancer, arthritis, and digestive disorders. These claims exceed the device's 510(k) clearance (K003332), which permits its use only for viewing and storing thermal patterns, not for independent diagnostic purposes. Consequently, the device is deemed adulterated under section 501(f)(1)(B) of the Act, as no approved premarket approval application or investigational device exemption exists for these new intended uses. The FDA mandates immediate cessation of all such promotional claims. Dr. Mercola must submit a written response within 15 working days, detailing compliance, listing similar promotional materials, and outlining a plan to discontinue their use. Failure to correct these violations promptly may result in regulatory actions, including seizure, injunction, and civil money penalties.