23andMe acts on FDA’s warning letter by suspending health risk information service to its customers and will offer only ancestry information. The new policy is valid for customers who bought 23andMe’s Personal Genome Service on or after November 22, 2013, the date of the Warning Letter from the FDA. However, the customers who bought kits before November 22, 2013 will still receive health-related results.
Here is the blog post announcing the suspension of health risk testing.
If you go to 23andMe website, it welcomes you with the following consent form.
Welcome to 23andMe.
At this time, we have suspended our health-related genetic tests to comply with the U.S. Food and Drug Administration’s directive to discontinue new consumer access during our regulatory review process.
We are continuing to provide you with both ancestry-related genetic tests and raw genetic data, without 23andMe’s interpretation.
If you are an existing customer please click the button below and then go to the health page for additional information. If you are a customer who purchased before November 22, 2013, you will still have access to your health-related results.
We remain firmly committed to fulfilling our long-term mission to help people everywhere have access to their own genetic data and have the ability to use that information to improve their lives.
Upon entering the site, please confirm you understand the new changes in our services.
I understand that 23andMe only sells ancestry reports and raw genetic data at this time. I understand 23andMe will not provide health-related reports. However, 23andMe may provide health-related results in the future, dependent upon FDA marketing authorization.