23andMe's genetic testing results are for informational purposes only and should not be used to make medical decisions about diagnosis, medication, or treatment.
This analysis describes what 23andMe's agreement states, permits, or reserves. It does not constitute a legal determination about enforceability. Regulatory applicability and practical outcomes may vary by jurisdiction, enforcement context, and individual circumstances. Read our methodology
This provision disclaims medical applicability of the genetic results, which limits the company's liability for health decisions made on the basis of its reports while also communicating a genuine limitation of the scientific scope of consumer genetic testing.
The updated Terms now apply only to users who live outside the United States, Canada, EEA, UK, and Switzerland, or who access the Services from outside those regions. US, Canadian, EEA, UK, and Swiss…
The updated Terms of Service now apply exclusively to users in the United States, narrowing the geographic scope from the prior version that addressed users in multiple regions. The terms now contain…
The updated terms now apply only to users who live outside or access services outside the United States, Canada, EEA, UK, and Switzerland. Previously, the terms applied to US-based users. The terms a…
Users receive genetic information that the Terms explicitly state should not be used as the basis for medical decisions, meaning that if a user changes medications or treatment based on 23andMe results without consulting a physician, the Terms disclaim company responsibility for any resulting harm.
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"23andMe's Services are not intended to diagnose any condition or disease. The Services are not intended to tell you anything about your current state of health, or to be used to make medical decisions, including whether or not you should take a medication, how much of a medication you should take, or determine any treatment.— Excerpt from 23andMe's 23andMe Terms of Service
REGULATORY LANDSCAPE: The FDA regulates direct-to-consumer genetic tests as medical devices in certain categories, including those reporting on disease risk, carrier status, and pharmacogenomics. The disclaimer that services are not intended for diagnosis does not automatically remove FDA jurisdiction; regulatory classification depends on the nature of claims made in the reports. The FTC evaluates the accuracy and substantiation of health-related marketing claims. State medical practice laws may also be relevant if the service's health reports are interpreted as medical advice. GOVERNANCE EXPOSURE: High. The tension between marketing health-related genetic reports (including disease risk and pharmacogenomics) and disclaiming medical applicability creates regulatory exposure under both FDA and FTC frameworks. The disclaimer is common in the direct-to-consumer genetic testing industry, but its adequacy depends on whether the actual report content makes claims that go beyond what the disclaimer covers. JURISDICTION FLAGS: California's medical practice and consumer protection laws may impose additional disclosure requirements on health-related genetic reports marketed to consumers. States with telehealth regulations, particularly those addressing the boundary between health information and medical advice, should be considered given that 23andMe also offers telehealth services under incorporated Telehealth Terms. CONTRACT AND VENDOR IMPLICATIONS: Healthcare organizations or benefits administrators who might refer employees to 23andMe services should evaluate whether the medical disclaimer is consistent with their own duty-of-care obligations. The disclaimer does not affect the company's obligation to maintain accuracy in its laboratory processes or reporting. COMPLIANCE CONSIDERATIONS: Legal teams should evaluate whether the reports offered by 23andMe, particularly those covering pharmacogenomics or specific disease risk, have received FDA authorization and whether the disclaimers are consistent with FDA-authorized labeling. Any marketing materials that imply medical utility should be reviewed against this disclaimer for consistency.
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This provision disclaims medical applicability of the genetic results, which limits the company's liability for health decisions made on the basis of its reports while also communicating a genuine limitation of the scientific scope of consumer genetic testing.
Users receive genetic information that the Terms explicitly state should not be used as the basis for medical decisions, meaning that if a user changes medications or treatment based on 23andMe results without consulting a physician, the Terms disclaim company responsibility for any resulting harm.
No. ConductAtlas is an independent monitoring service. We are not affiliated with, endorsed by, or sponsored by 23andMe.