FDA says DNA testing firm misleads consumers
The U.S. Food and Drug Administration (FDA) ordered a stop to all sales of a genetic testing kit from 23andMe. According to the FDA, the popular product is not effective and could be dangerous by misleading people about their health and their risks of developing certain conditions.
23andMe is a California-based start-up supported by Google that offers a "Personal Genome Service" claiming to detect more than 240 genetic conditions and traits. However, the FDA argues the company failed to provide proper documentation and scientific data proving their services work.
So far, about a half a million consumers have ordered these kits online. The kits require customers to submit a saliva sample via mail and then receive a series of diet or lifestyle recommendations based on their genetic test results.
This act by the FDA sends out a larger message to companies looking to profit from genetic testing. One of the biggest concerns about direct-to-consumer genetic testing is the lack of context provided to consumers to help them clearly understand and respond to test results.
23andMe has 15 days to respond with plans moving forward or it will face additional regulatory actions.