By using this site, you agree to the Privacy Policy and Terms of Use.
Accept
Health Works CollectiveHealth Works CollectiveHealth Works Collective
  • Health
    • Mental Health
    Health
    Healthcare organizations are operating on slimmer profit margins than ever. One report in August showed that they are even lower than the beginning of the…
    Show More
    Top News
    bowl of vegetable salad
    Raw Foods: benefits and harms
    November 9, 2021
    pros and cons of the keto diet
    Read This Before You Follow the Keto Diet
    May 18, 2022
    spinal cord injuries
    4 Potential Causes of Spinal Cord Injuries (and How to Seek Compensation)
    May 25, 2022
    Latest News
    5 Steps to a Promising Career as a Healthcare Administrator
    July 31, 2025
    Why Custom Telemedicine Apps Outperform Off‑the‑Shelf Solutions
    July 20, 2025
    How Probate Planning Shapes the Future of Your Estate and Family Care
    July 17, 2025
    Beyond Nutrition: Everyday Foods That Support Whole-Body Health
    June 15, 2025
  • Policy and Law
    • Global Healthcare
    • Medical Ethics
    Policy and Law
    Get the latest updates about Insurance policies and Laws in the Healthcare industry for different geographical locations.
    Show More
    Top News
    Effective Healthcare Requires a Social Approach
    June 15, 2015
    CCBHCs
    2016 Excellence in Behavioral Health Program Design
    February 23, 2016
    conducting Clinical Trial
    5 Tips for Conducting a Clinical Trial
    April 21, 2024
    Latest News
    How IT and Marketing Teams Can Collaborate to Protect Patient Trust
    July 17, 2025
    How Health Choices and Legal Actions Intersect After an Injury
    July 17, 2025
    How communities and healthcare providers can address slip and fall injuries with legal awareness
    July 17, 2025
    Let Your Lawyer Handle the Work Before You Pay Medical Costs
    July 6, 2025
  • Medical Innovations
  • News
  • Wellness
  • Tech
Search
© 2023 HealthWorks Collective. All Rights Reserved.
Reading: 23andWho?
Share
Notification Show More
Font ResizerAa
Health Works CollectiveHealth Works Collective
Font ResizerAa
Search
Follow US
  • About
  • Contact
  • Privacy
© 2023 HealthWorks Collective. All Rights Reserved.
Health Works Collective > Policy & Law > Medical Ethics > 23andWho?
BusinessMedical EthicsMedical InnovationsPolicy & LawTechnology

23andWho?

Anne Weiler
Anne Weiler
Share
8 Min Read
SHARE

Jacquie Scarlett, Wellpepper Director of Customer Experience, and I were some of the last people to get full genomic testing using the $99 personal genomic testing kits from 23andMe before the FDA “cease and desist” letter on November 22, 2013. We had sent in our saliva samples and were waiting for results, when the following letter was published by the FDA.

Jacquie Scarlett, Wellpepper Director of Customer Experience, and I were some of the last people to get full genomic testing using the $99 personal genomic testing kits from 23andMe before the FDA “cease and desist” letter on November 22, 2013. We had sent in our saliva samples and were waiting for results, when the following letter was published by the FDA.

WARNING LETTER
 
Dear Ms. Wojcicki,
The Food and Drug Administration (FDA) is sending you this letter because you are marketing the 23andMe Saliva Collection Kit and Personal Genome Service (PGS) without marketing clearance or approval in violation of the Federal Food, Drug and Cosmetic Act (the FD&C Act). Read the full letter here. 

What was fascinating to us about the letter is that it hinted pretty clearly to the strategy of 23andMe: try to ignore the FDA as long as possible. The letter references many prior letters and meetings during which 23andMe had apparently made some promises to get back to the FDA but didn’t. Many health and technology writers commented that the strategy was in keeping with both Silicon Valley arrogance and modeled after Google’s belief that data trumps all. They posited that 23 and Me was racing to get to the magic 1 million record number at which point their data alone would prove whether the tool provides valid genetic results so that they would not get bogged down in what are usually lengthy FDA approval processes. While it does make sense for a start-up to try to avoid the FDA route if possible based on their technology and business model, 23 and Me is definitely well-funded enough to survive an FDA approval process. And, they’ve been having these conversations with the FDA for 5 years, which is actually enough for some FDA approvals to get through.

[M]ore than 5 years after you began marketing, you still had not completed some of the studies and had not even started other studies necessary to support a marketing submission for the PGS. 

The letter calls for 23andMe to discontinue marketing the PGS until it receives FDA marketing authorization.

There’s a saying that if you’re not paying, you’re the product. It seems that this can be true even if you are paying, or if what you’re paying, for example $99 is such a nominal amount that it doesn’t cover the full value you are receiving, or when the value you are providing the organization, for example, your DNA or buying habits is the most valuable of all. After this FDA letter and related editorials were published, we waited to see what would happen. It took 6 days from the time of the FDA letter for 23andMe founder and CEO Anne Wojciki to send a letter to paying customers to explain what was going on, and that letter really did not say anything at all. This is the type of letter that PR and legal typically send within 24 hours of an incident: we know there’s an issue and we’re working on it. 6 days later, it felt like too little to late for us to believe they really cared about us as consumers. (Contrast that to last week when New Balance sent  a number of customers, including me, some erroneous emails and had corrected them within an hour and also had updated their call center line.)

More Read

healthcare entrepreneurs
How To Engage Your Clients To Achieve Their Goals
Mobile Health Technology: Results of HIMSS Survey on Usage
Selecting a File Transfer Solution: The Five Most Important Points Healthcare Providers Should Consider
To Up Patient Satisfaction, Hospital Supply Chain Units Need Better IT and Technology
What To Know About How mHealth Apps Benefit Heart Patients

Dear 23andMe Customers,

I wanted to reach out to you about the FDA letter that was sent to 23andMe last Friday.

It is absolutely critical that our consumers get high quality genetic data that they can trust. We have worked extensively with our lab partner to make sure that the results we return are accurate. We stand behind the data that we return to customers – but we recognize that the FDA needs to be convinced of the quality of our data as well.

23andMe has been working with the FDA to navigate the correct regulatory path for direct-to-consumer genetic tests. This is new territory, not just for 23andMe, but for the FDA as well. The FDA is an important partner for 23andMe and we will be working hard to move forward with them.

I apologize for the limited response to the questions many of you have raised regarding the letter and its implications for the service. We don’t have the answers to all of those questions yet, but as we learn more we will update you.

I am committed to providing each of you with a trusted consumer product rooted in high quality data that adheres to the best scientific standards. All of us at 23andMe believe that genetic information can lead to healthier lives.

Thank you for your loyalty to 23andMe. Please refer to our 23andMe blog for updates on this process.

Anne Wojcicki
Co-founder and CEO, 23andMe

 

A full 15 days later, we found out that since we’d purchased our kits before the November 22nd letter from the FDA, we would receive both genetic and ancestry results.

“If you are a customer whose kit was purchased before November 22, 2013, your 23andMe experience will not change. You will be able to access both ancestry and health-related information as you always have.

So first off, they didn’t have the most basic customer targeting capabilities to determine when I purchased to send a more personalized letter, and it doesn’t seem like any concessions were made to people who would only be receiving half of what they paid for as they received the same letter. When we signed up for 23andMe we did know what we were getting into: they are a start-up with some pretty lofty aspirations. However, this experience made it pretty clear that the consumer is not the customer for this company. That said, would we do it again? Yes. The process, whether 100% accurate or not has been extremely interesting. Our next blog post will talk about 1. the things we learned. 2. how 23andMe drives a highly sticky and engaging experience for end-users. We’ll also touch a bit on the ethical aspects and how this type of testing can help and also create potential risks for the empowered patient.

TAGGED:23andMegenetic testinggenomics
Share This Article
Facebook Copy Link Print
Share
By Anne Weiler
Follow:
Anne Weiler is CEO and co-founder of Wellpepper, a clinically-validated and award winning platform for patient engagement that enables health systems to track patient outcomes in real-time against their own protocols and personalize treatment plans for patients. Wellpepper patients are over 70% engaged. Prior to Wellpepper, Anne was Director of Product Management at Microsoft Corporation.

Stay Connected

1.5kFollowersLike
4.5kFollowersFollow
2.8kFollowersPin
136kSubscribersSubscribe

Latest News

5 Steps to a Promising Career as a Healthcare Administrator
5 Steps to a Promising Career as a Healthcare Administrator
Health
July 31, 2025
holistic dental
Holistic Dentist Services Are Natural and Safe
Dental health Specialties
July 28, 2025
botox certification
Help Improve People’s Skin Health Via Botox Certification
Skin Specialties
July 22, 2025
Telemedicine Apps
Why Custom Telemedicine Apps Outperform Off‑the‑Shelf Solutions
Health
July 20, 2025

You Might also Like

Why Apple Could Win in the Digital Health “Battle for the Wrist”

August 20, 2013
2016-02-17 09_44_20-_ 2
Technology

EMR, EHR, PACS & VNA: Looking Beyond the Acronyms

March 1, 2016

How Healthcare Reform Will Change Healthcare Communication Forever

November 6, 2011
DiagnosticsMedical InnovationsSpecialtiesTechnology

New Technology Will Catch Alzheimer’s in the Early Stages

December 28, 2016
Subscribe
Subscribe to our newsletter to get our newest articles instantly!
Follow US
© 2008-2025 HealthWorks Collective. All Rights Reserved.
  • About
  • Contact
  • Privacy
Welcome Back!

Sign in to your account

Username or Email Address
Password

Lost your password?