genetic testing, direct-to-consumer, food and drug law, FDA, regulation

Document Type



A decade after the complete sequencing of the human genome, we have seen a proliferation of genetic testing services marketed directly to the consumer and purporting to use genetic information to generate individualized health information. These tests have been subject to only minimal regulation, despite the fact that scientists and policymakers have serious concerns about both the clinical effectiveness of the tests and the safety of releasing certain types of health information to the public without the supervision of a health care professional. Proponents of minimal regulation argue that the tests allow for patient autonomy and privacy of genetic information, while unburdened marketing of the tests encourages increased development and innovation of testing services. This article explores in depth both the benefits of direct to consumer genetic testing and the concerns arising from such tests, and concludes that particular safety and accuracy concerns warrant increased oversight of these tests. The article then goes on to evaluate the current regulatory framework under which direct to consumer genetic testing services operate, and finds that it is insufficient in light of these concerns. The article concludes that recent steps by the Food and Drug Administration (FDA) to exercise increased regulation over direct to consumer genetic tests are warranted and will provide the optimal amount of regulation for these tests.


67 Food & Drug L. J.

Publication Title

Food & Drug Law Journal