23andMe bows to FDA, drops all medical information from new tests

Wisconsin.edu

After a partial attempt to get the Food and Drug Administration to ease up on its complaints, the personal genetics company 23andMe took a rather substantial step yesterday: it pulled all medically relevant information from its site, replacing its normal home page with a disclaimer. This move doesn't meet the FDA's original demand—that the company stop selling testing kits entirely—but it does suggest that 23andMe is now taking the issue seriously.

In late November, the FDA sent an open letter to 23andMe, noting that the company is offering a service that fits the legal definition of a medical device and is therefore subject to regulatory oversight. In fact, the company and agency had been negotiating for years regarding how best to bring the genetic tests into compliance. However, it seems that 23andMe stopped returning the agency's calls sometime earlier this year, and it then launched a new advertising campaign in which it promoted the medical relevance of its tests.

The FDA's letter seemed to alternate between disappointment and annoyance at these developments, but its proposed solution came down clearly in the annoyance end of the spectrum: it gave the company two weeks to stop offering its product. As a conciliatory gesture, 23andMe announced that it would stop promoting its products through advertising. Yesterday, it followed that up with a more dramatic step by removing all medical information from the Web portal that helps users interpret the results of the tests. Today, a visit to the company's website will bring up a dialog that asks the visitor to acknowledge the following: