Test type
Wellness and traits tests: what FDA reviews
For people who want to know: fitness, diet, sleep or traits.
What FDA says
Generally not reviewed by FDA
FDA: “In general, direct-to-consumer tests for non-medical, general wellness, or low risk medical purposes are not reviewed by the FDA before they are offered.” (U.S. Food and Drug Administration)
A "wellness" or "trait" label on a product doesn't decide its regulatory status. FDA ties review to the test's purpose and risk: “Direct-to-consumer tests for moderate to high risk medical purposes, which may have a higher impact on medical care, are generally reviewed by the FDA to determine the validity of test claims.” (U.S. Food and Drug Administration)
FDA's page on general wellness tests:
Some tests are offered for purposes the FDA considers general wellness, such as tests that predict athletic ability. The FDA generally does not review low risk general wellness products.
FDA records for this type: none. There is nothing to match a product against.
What every home DNA result has in common
FDA: “No test is 100% accurate.” (U.S. Food and Drug Administration) MedlinePlus adds that “additional testing through a healthcare provider is usually required before direct-to-consumer test results can be used to diagnose a medical condition or make healthcare decisions.” (MedlinePlus)
Other test types
- Carrier screening: exempt from premarket notification, with conditions (FDA's wording and conditions are on that page)
- Genetic health risk: first test reviewed; later tests exempt, with conditions (FDA's wording and conditions are on that page)
- Cancer predisposition: FDA reviews before sale (FDA's wording and conditions are on that page)
- Pharmacogenetics: FDA reviews before sale (FDA's wording and conditions are on that page)
- Ancestry: not reviewed by FDA (FDA's wording and conditions are on that page)