Breast thermography marketing: FDA warnings, mammogram claims and screening wording

Thermography is offered by integrative, naturopathic and wellness clinics, and its marketing often leans on the same few lines: “radiation-free breast screening,” “finds cancer up to 10 years earlier,” “better than mammograms for dense breasts,” “FDA-approved.” FDA has addressed those lines directly, in a safety communication, a consumer update and a string of warning letters.

This guide covers how FDA classifies thermography devices, what its warnings say about breast cancer screening claims, what the current federal screening recommendation says, and how FTC rules apply to the rest of a thermography page. We do not name any device, brand, clinic or company. For screening outreach built on mammography, see our guide to mammogram outreach marketing. For imaging businesses in general, see our guide to imaging center marketing.

The short version

• Thermography is cleared only as an adjunct. FDA’s regulation splits it into adjunctive systems (Class I) and systems for use alone in screening (Class III, which need FDA approval). openFDA shows 41 510(k)s for the adjunctive code and no approval for the stand-alone code.
• FDA says it is not a mammogram substitute. Its 2019 safety communication says thermography should not be used in place of mammography for breast cancer screening or diagnosis.
• FDA has called out specific claims. “Finds cancer years earlier” and “better for dense breasts” are named in FDA’s warnings as claims it knows no evidence for.
• Facilities, not only makers, received warning letters. FDA’s 2019 notice lists warning letters from 2011 to 2019, sent to device makers and to clinics that promoted thermography.
• The federal screening recommendation is mammography. The USPSTF recommends screening mammography every other year for women 40 to 74 (grade B, April 30, 2024).

How FDA classifies thermography

21 CFR 884.2980 covers telethermographic systems, the infrared cameras that measure heat given off by the body’s surface without touching the skin. The regulation has two parts:

• 884.2980(a), adjunctive use. A system “intended for adjunctive diagnostic screening for detection of breast cancer or other uses.” Class I, general controls. The product code is LHQ.
• 884.2980(b), use alone. A system “for use as the sole diagnostic screening tool for detection of breast cancer or other uses.” Class III. The regulation says an approval under section 515 of the act is required before such a device may be commercially distributed. The product code is LHP.

21 CFR 884.2982 has the same split for liquid crystal systems that are placed on the skin, with the adjunctive version described as an adjunct to physical palpation or mammography.

openFDA’s records (device data last updated October 19, 2026) show 41 510(k) clearances under LHQ, from July 28, 1984 to May 20, 2026, and no 510(k) or PMA record under LHP. A third code under the same regulation, IYM (infrared telethermographic system), has eight 510(k)s from 1981 to 1986, before the current two-part rule, and no PMA record. In other words, no thermography system in these records has FDA approval as a stand-alone breast cancer screening tool. The most recent LHQ clearance, K253911, is a prescription device whose indications say it is for adjunctive use in addition to other clinical methods, provides relative surface temperature information only and does not identify anatomical structures, with interpretation left to a qualified professional.

What FDA’s warnings say

FDA’s safety communication of February 25, 2019 was addressed to women, people getting breast cancer screening and health care providers, and it is specific about advertising. It says:

• Thermography devices have been cleared only for use with another screening or diagnostic test like mammography, not as a standalone diagnostic tool.
• Thermography is not an effective alternative to mammography and should not be used in place of mammography for breast cancer screening or diagnosis.
• There is no valid scientific data showing thermography, alone or with another test, is an effective screening tool for any medical condition, including early detection of breast cancer.
• FDA was aware of health spas, homeopathic clinics, mobile health units and other facilities using thermography as a standalone screening tool and making claims that it finds breast cancer years before other methods or improves detection in dense breasts. FDA said none of these claims are true or have valid scientific evidence behind them.
• Providers should educate patients about thermography’s limits, including high false negative and false positive rates, and discourage its use to screen for or diagnose breast cancer.

FDA’s consumer update on the same subject (content current as of October 6, 2023) repeats the core points: thermography has not been shown to be effective as a standalone test for breast cancer screening, patients who have thermography alone should not be reassured by the findings, and FDA is not aware of evidence for claims of earlier detection or better detection in dense breasts. It also says FDA has taken, and will continue to take, regulatory action against manufacturers who market thermography as an alternative to mammography.

The 2019 notice lists FDA warning letters issued from January 2011 to February 2019. The recipients include device makers and also clinics and practitioners who promoted thermography, which tells a clinic that FDA’s attention is not limited to manufacturers. In those letters, according to the notice, FDA told the recipients to stop making inappropriate claims about thermography devices immediately.

Which claims to drop

• “Alternative to mammograms” or “instead of a mammogram.” Directly contrary to FDA’s safety communication.
• “Detects cancer up to 10 years earlier.” Named by FDA as a claim with no valid evidence.
• “Ideal for dense breasts” or “sees what mammograms miss.” Also named by FDA. The USPSTF found the evidence insufficient even for supplemental ultrasound or MRI in dense breasts, which are not thermography.
• “FDA-approved thermography.” openFDA shows no approval for the stand-alone code, and 21 CFR 807.97 says a 510(k) clearance does not denote official approval. A representation that creates that impression is misleading and constitutes misbranding.
• “Normal results, no need for further screening.” FDA says people who have thermography alone should not be reassured by the findings.
• “Breast health risk score” or “cancer risk assessment.” A screening or diagnostic claim in other words.
• “Safe, painless, no radiation” as the lead benefit. True for the scan itself, but on a page that offers it as screening, it invites the comparison FDA warns against. The FTC reads ads for their net impression.

Wording that stays closer to the record

If a clinic offers thermography at all, the page should say what it is and what it is not, near the top, not in a footer. An example:

“Thermography is an infrared image of skin surface temperature. FDA has cleared thermography devices only for use alongside other tests, and FDA advises that it should not be used in place of a mammogram to screen for or diagnose breast cancer. It does not replace your mammogram. Talk with your clinician about breast cancer screening.”

Two practical points. First, the interpretation goes through a qualified professional; the recent clearance leaves interpretation to them. A report signed by a non-clinician technician and sent straight to a client is hard to square with that. Second, if a client reports a lump, nipple change or other symptom, the right message is to see their clinician, which is also FDA’s advice to patients.

Why this is also an FTC question

Section 5 of the FTC Act declares unfair or deceptive acts or practices unlawful (15 USC 45(a)), and section 12 makes it unlawful to disseminate a false advertisement to induce the purchase of devices or services (15 USC 52). Under 15 USC 55(a)(1), whether an ad is misleading depends partly on what it fails to reveal, which matters here: a thermography page that never mentions mammography leaves out the fact FDA thinks a reader most needs. The FTC Health Products Compliance Guidance says health claims need competent and reliable scientific evidence, and FDA’s own position is that it knows of none for the claims above.

On the FDA side, 21 USC 352(a)(1) treats a device as misbranded if its labeling is false or misleading in any particular, and the 2019 notice shows FDA sent warning letters to clinics as well as makers. A clinic that promotes a cleared adjunctive camera as a stand-alone screen is promoting a use that would need FDA approval under 21 CFR 884.2980(b).

Screening recommendations to point readers to

The USPSTF final recommendation (April 30, 2024) is for biennial screening mammography in women aged 40 to 74 (grade B). It applies to cisgender women and all other persons assigned female at birth who are 40 or older at average risk, including those with a family history of breast cancer or dense breasts, but not to people with a genetic marker or syndrome associated with high risk. For women 75 and older, and for supplemental ultrasound or MRI screening in women with dense breasts on an otherwise negative mammogram, the USPSTF found the evidence insufficient (I statements).

A thermography page that links to mammography information, or a clinic that refers clients for mammograms, is easier to defend than one that positions itself as the screening. Our guide to cancer center advertising covers how cancer-related claims are read more broadly.

Testimonials, images and packages

• Testimonials. “My thermogram caught my cancer early” is an early-detection claim made by the clinic through the client. Under 16 CFR 255.2(a), an advertiser needs substantiation for what an endorsement conveys, and under 255.2(b) a result is likely to be read as typical unless the generally expected results are clearly disclosed. Do not use such stories.
• Heat map images. Color thermal images marked “abnormal” or “high risk” imply a diagnostic finding. Use them, if at all, to show what the image looks like, not what it detects. Get written authorization for any client image; see patient photo consent for marketing.
• Annual plans. “Yearly breast thermography plan” frames it as a screening schedule. Describe the service, not a screening interval.
• Former prices. “Was $350, now $199” needs a former price you actually offered in good faith for a reasonably substantial period (16 CFR 233.1(a)).
• Insurance. Say “covered” only for plans you have confirmed.

An example (made up)

This illustration is invented. A wellness clinic posts: “FDA-approved, radiation-free breast screening! Thermography finds cancer up to 10 years before a mammogram and works better for dense breasts. Skip the squeeze. Annual scan $199 (reg. $350).”

Fixes: “FDA-approved” comes off; openFDA shows no approval for stand-alone thermography and a clearance is not approval (21 CFR 807.97). “Breast screening” and “skip the squeeze” come off; FDA says thermography should not be used in place of mammography. “10 years before a mammogram” and “better for dense breasts” come off; FDA names both as claims without valid evidence. “Annual scan” stops implying a screening schedule. The former price stays only if clients actually paid $350 for a reasonable period. A version that holds up: “Thermography is an infrared image of skin temperature. FDA has cleared it only for use alongside other tests, and it does not replace a mammogram. Ask your clinician about breast cancer screening. Thermal imaging session $199.”

Checklist

• No mammogram substitution or comparison claims (FDA safety communication, February 25, 2019; FDA consumer update, October 6, 2023).
• No early detection, “years earlier” or dense breast claims (same sources; 15 USC 45, 52).
• No “FDA-approved”; adjunctive clearance described as adjunctive (21 CFR 884.2980; 21 CFR 807.97).
• A plain statement near the top that thermography does not replace a mammogram (15 USC 55(a)(1)).
• Interpretation by a qualified professional, and symptoms routed to a clinician.
• Link to mammography and screening information (USPSTF, April 30, 2024).
• No cancer-detection testimonials or diagnostic-looking images (16 CFR 255.2).
• Prices, former prices and insurance wording real and clear (16 CFR 233.1).

How we help

We build pages for integrative, wellness and imaging practices with claims checked against the sources above: website design, healthcare SEO that does not chase “thermography instead of mammogram” searches, and lead generation campaigns that describe services without screening, approval or detection overclaims. We do not decide which test fits a patient, we do not give legal opinions, and we are not a law firm. Related guides: naturopathic doctor marketing and integrative medicine marketing claims.

Sources

• 21 CFR 884.2980: Telethermographic system
• 21 CFR 884.2982: Liquid crystal thermographic system
• 21 CFR 807.97: Misbranding by reference to premarket notification
• openFDA device classification data (last updated October 19, 2026)
• openFDA device 510(k) data (last updated October 19, 2026)
• openFDA device PMA data (last updated October 19, 2026)
• FDA 510(k) database: K253911 (May 20, 2026)
• FDA: Breast Cancer Screening: Thermogram No Substitute for Mammogram (content current as of October 6, 2023)
• FDA safety communication: thermography should not be used in place of mammography (February 25, 2019; Internet Archive copy, June 17, 2022)
• USPSTF: Breast Cancer: Screening (April 30, 2024)
• 21 USC 352: Misbranded drugs and devices
• 15 USC 45: Unfair methods of competition unlawful
• 15 USC 52: Dissemination of false advertisements
• 15 USC 55: Additional definitions
• FTC: Health Products Compliance Guidance (December 2022)
• 16 CFR 255.2: Consumer endorsements
• 16 CFR 233.1: Former price comparisons

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