| Public Health Service Food and Drug Administration |
10903 New Hampshire Aveune |
Department of Health and Human ServicesMarch 22, 2011
WARNING LETTER
VIA UNITED PARCEL SERVICE
Dr. Joseph Mercola
Dr. Mercola’s Natural Health Center
Thermography Diagnostics Centers
3200 W Higgins Road
Hoffman Estates, IL 60169
Re: Meditherm Med2000 Infrared cameras
Dear Dr. Mercola:
The Food and Drug Administration (FDA) has learned that you are marketing the Meditherm Med2000 Telethermographic camera at your Thermography facility in Hoffman Estates, Illinois, and endorse for other thermography centers outside of Illinois for uses that have not received marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
Under section 201(h) of the Act, 21 U.S.C. § 321(h), a telethermographic camera is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body. The FDA’s Center for Devices and Radiological Health (CDRH) has reviewed your website at: http://naturalhealthcenter.mercola.com. Your website promotes the Meditherm Med2000 Telethermographic camera for uses for which you have not obtained marketing approval or clearance, which is a violation of the law.
A review of our records indicates that a premarket notification (510(k)) [K003332] for the Meditherm Med2000 Telethermographic camera was cleared on February 21, 2001 “[f]or viewing and digitally storing thermal patterns generated by the human body in the clinical, hospital, acute care settings, surgery, healthcare practitioner facilities or in any environment where healthcare is provided by a qualified healthcare professional. . . .” The Meditherm Med2000 Telethermographic camera is not intended to be used as a stand-alone device to diagnose or screen any disease or condition. However, your website makes claims that the Meditherm Med2000 Telethermographic camera can be used alone to diagnose or screen for diseases and conditions.
For example, your website contains the following statements that represent or suggest that the Meditherm Med2000 Telethermographic camera is intended to be used as a stand-alone device to diagnose or screen for various diseases or conditions associated with the breast:
• “Revolutionary and Safe Diagnostic Tool Detects Hidden Inflammation: Thermography”
• “The Newest Safe Cancer Screening Tool”
• “[b]ecause measuring inflammation through thermal imaging is a proactive, preventative method you can use for detecting disease, which significantly improves your chances for longevity and good health.”
• “Additionally, thermograms provide:
Reliable and accurate information for diagnosis, treatment, and prognosis…”
• “Yes, it’s true. Thermograms provide you with early diagnosis and treatment assistance in such problems as cancer, inflammatory processes, neurological and vascular dysfunction, and musculoskeletal injury.”
Not only do the statements made on your website and the content of the video that appears on your site, as well as other sites that you endorse, state or imply that the Meditherm Med2000 Telethermographic camera can be used alone to diagnose or screen for various diseases or conditions associated with the breast, they also represent that the sensitivity of the Meditherm Med2000 Telethermographic camera is greater than that of machines used in mammography.
In addition, your website claims that thermography can benefit patients by detecting conditions including: Arthritis: “[d]ifferentiate between osteoarthritis and more severe forms like rheumatoid.” Immune Dysfunction, Fibromyalgia and Chronic Fatigue, “Digestive Disorders: Irritable bowel syndrome, diverticulitis, and Crohn’s disease…” and “Other Conditions: including bursitis, herniated discs, ligament or muscle tear, lupus, nerve problems, whiplash, stroke screening, cancer and many, many others.”
These claims all indicate that the Meditherm Med2000 Telethermographic camera can be used alone to diagnose or screen for various diseases or conditions and are therefore outside the 510(k) clearance of the device. For this reason, the Meditherm Med2000 Telethermographic camera is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B) because you do not have an approved application for premarket approval in effect pursuant to section 515(a) of the Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. 360j(g), for the new intended uses. The kind of information you need to submit in order to obtain approval or clearance for the new intended uses for this device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
The FDA requests that you immediately cease making claims, identical or similar to those described above, for this product. You should take prompt action to correct these violations. Failure to correct these violations promptly may result in the initiation of regulatory action by the Food and Drug Administration without further notice. These actions include, but are not limited to seizure, injunction, and/or civil money penalties.
Please submit a written response to this letter within 15 working days from the date you receive this letter, describing your intent to comply with this request, listing all promotional materials that are the same as or similar to those described above, for this product, and explaining your plan for discontinuing use of such materials. Please direct your response to Toni M. Stifano, Office of Compliance, Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, Maryland 20993-0002, facsimile at (301) 847-8138. We remind you that only written communications are considered official.
The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for this product comply with each applicable requirement of the Act and FDA implementing regulations.
Sincerely,
/s/
Steven Silverman
Director
Office of Compliance
Center for Devices and Radiological Health
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