Get All Access for $5/mo

FDA Tells 23andMe to Quit Selling Genetic Testing Kits The Food and Drug Administration said the popular genetics testing kits are being sold without 'marketing clearance or approval.'

By Karma Allen

This story originally appeared on CNBC

paulstamatiou.com

The Food and Drug Administration has issued a warning to genetics testing company 23andMe to immediately halt sales of its Saliva Collection Kit and Personal Genome Service (PGS).

In a letter, the FDA said the DNA-testing products were being sold without "marketing clearance or approval" in violation of the Food, Drug and Cosmetic Act.

"FDA is concerned about the public health consequences of inaccurate results from the PGS device; the main purpose of compliance with FDA's regulatory requirements is to ensure that the tests work," the agency said.

According to 23andMe's website, the saliva kit can determine details about the user's health, including susceptibility to certain diseases, as well as about ancestry.

"We recognize that we have not met the FDA's expectations regarding timeline and communication regarding our submission," 23andMe said in a statement. "Our relationship with the FDA is extremely important to us, and we are committed to fully engaging with them to address their concerns."

Anne Wojcicki, who recently separated from Google co-founder Sergey Brin, co-founded 23andMe in 2006. Google is an investor in the company.

Since 2010, the FDA has required that all services claiming to evaluate a user's risk of disease must be approved by U.S. regulators for direct-to-consumer sales.

News Associate for CNBC

Want to be an Entrepreneur Leadership Network contributor? Apply now to join.

Side Hustle

This Mom Started a Side Hustle on Facebook — Now It Averages $14,000 a Month and She Can 'Work From a Resort in the Maldives'

Heather Freeman was searching for a way to make some extra cash — and her cousin gave her a great idea.

Starting a Business

He Turned His High School Science Fair Project Into a Product That Solves a $390 Billion Problem: 'This Has Not Been Done Before'

Vasya Tremsin was just 18 years old when he came up with the idea for outdoor fire sensor company Torch Sensors.

Business News

Why Does Taylor Swift Keep Stopping Her Shows Mid-Song? It's Actually a Great Lesson in Leadership.

Taylor Swift has paused nearly half of her shows while on the European leg of her Eras tour, and the reason is something leaders can learn from.

Side Hustle

This 26-Year-Old's Side Hustle That 'Anybody Can Do' Grew to Earn $170,000 a Month. Here's What Happened When I Tested It.

Stephen Alvarez was working at a dental supply company and following his passion for cars on the side — then an Instagram ad changed everything.

Business News

Melinda French Gates Says This Mindset Hack Helped Her Overcome Imposter Syndrome

Melinda French Gates said she faced (and conquered) imposter syndrome while working at the Bill and Melinda Gates Foundation. Here's how.