a device within the meaning of section 201(h) of the [Food, Drug and Cosmetic] Act ["FDCA"], 21 U.S.C. 321(h), because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body.In its letter, the FDA orders 23andme to take its product off the market immediately:
23andMe must immediately discontinue marketing the PGS until such time as it receives FDA marketing authorization for the device. The PGS is in class III under section 513(f) of the FD&C Act, 21 U.S.C. 360c(f). Because there is no approved application for premarket approval in effect pursuant to section 515(a) of the FD&C Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the FD&C Act, 21 U.S.C. 360j(g), the PGS is adulterated under section 501(f)(1)(B) of the FD&C Act, 21 U.S.C. 351(f)(1)(B). Additionally, the PGS is misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because notice or other information respecting the device was not provided to FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k).This federal regulatory enforcement action is sure to galvanize the human genomics industry into action. One possibility is to spur efforts to comply better with the FDCA. Another is that 23andme will challenge the FDA's allegations, perhaps by disputing whether the FDCA does, in fact, apply to genomics testing. It is not a foregone conclusion that the federal courts will side with the FDA, even though they do tend to give federal agency decisions considerable deference.
Regardless of the outcome of this particular FDA enforcement action, human genomics is certain to play an acceleratingly-important role in human health. As the avid Tudorian, Allison Plowden, once wrote, "The laws of genetics apply even if you refuse to learn them."