February 26, 2019 — The U.S. Food and Drug Administration (FDA) issued a warning letter to Total Thermal Imaging Inc., of La Mesa, Calif., and its president and co-owner, Linda Hayes, for illegally marketing and distributing an unapproved thermography device as a sole screening device for breast cancer and other diseases. The FDA also issued a safety communication to warn patients that thermography is not cleared by the FDA as an alternative to mammography and should not replace mammography for breast cancer screening or diagnosis.
Thermography is a noninvasive tool that uses an infrared camera to produce images that show the patterns of heat and blood flow on or near the surface of the body. Thermography devices, also known as digital infrared imaging devices, have been cleared by the FDA only as an adjunctive tool, meaning it should only be use alongside a primary diagnostic test like mammography, not as a standalone screening or diagnostic tool.
The FDA said it is aware that health spas, homeopathic clinics, mobile health units, and other healthcare facilities are using thermography inappropriately as a standalone tool for breast cancer screening or diagnosis. The agency said it has received reports that these types of facilities provide false information that can mislead patients into believing that thermography is an alternative or better option than mammography. Some facilities make inaccurate, unsupported and misleading claims, such as thermography can find breast cancer years before it would be detected through other methods or thermography improves detection of cancer in dense breasts.
None of these claims are true or have any valid scientific evidence to support them, according to the FDA. In addition, the Society for Breast Imaging notes a lack of evidence that thermography has any effective role in breast cancer screening. Mammography is the most safe and effective tool for screening and diagnosis of breast cancer, and the only method proven to increase the chance of survival through earlier detection, the agency said.
The FDA is concerned that people will believe the misleading claims about thermography and not get mammograms to screen for breast cancer. People who choose thermography instead of mammograms may miss the chance to detect cancer at its earliest and most treatable stages.
Total Thermal Imaging Inc. markets and distributes the Thermography Business Package, an unapproved device which includes a FLIR Systems Inc. thermographic camera and proprietary software, to individuals and clinics as a sole screening tool for breast cancer and other diseases. Such a device would require premarket approval by the agency. Total Thermal Imaging Inc. illegally marketed the unapproved device via a website and promotional materials claiming that its device can enable the early detection or the diagnosis of many disorders including breast cancer, inflammatory breast cancer, pre-stroke, heart disease, deep vein thrombosis and other diseases.
In addition, the warning letter discusses the FDA’s recent inspection of Total Thermal Imaging Inc., in which investigators observed several significant deviations from the agency’s quality systems regulations, such as:
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Failure to establish procedures for taking corrective or preventive actions to address any defective products; and
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Failure to establish procedures for receiving and evaluating complaints (including a procedure for determining whether a complaint should be submitted to the FDA as a medical device report).
The warning letter requests that Total Thermal Imaging Inc. immediately cease distributing the Thermography Business Package. It also asks the firm to respond, within 15 working days from the date the warning letter was received, with details of how the violations noted in the warning letter will be corrected. Any violations not corrected could lead to enforcement action such as seizure, injunction or civil money penalties.
This warning letter is not the first time the FDA has cited firms for illegally marketing and promoting thermographic devices. In the Feb. 25 safety communication, the FDA lists five warning letters issued to manufacturers for marketing unapproved thermographic devices and/or making misleading claims about thermography.
“Advancing and protecting women’s health is a priority for the FDA. As part of these efforts, we will not tolerate individuals or companies who attempt to take advantage of patients by marketing unapproved devices that deceive patients and put them at risk,” said FDA Commissioner Scott Gottlieb, M.D. “The FDA is concerned that patients will rely on unapproved claims that thermography may be used as a sole screening device for breast cancer and not get screened with mammography, which is proven to save lives by detecting cancer and prompting patients to seek appropriate treatment. People who substitute thermography for mammography may miss the chance to detect breast cancer in its earliest and most treatable stages. We’ll continue our efforts to protect patients from those individuals or companies who ignore the FDA’s requirements intended to keep patients safe.”
For more information: www.fda.gov
April 18, 2024 
