[ExI] FDA Tells Google-Backed 23andMe to Halt DNA Test Service

[BillK]

On Wed, Nov 27, 2013 at 7:14 PM, Dave Sill wrote:
> What evidence is there of that, and that it's resulted in actual harm due to
> people not following 23andMe's disclaimer that their reports aren't intended
> for diagnostic use?
>

That disclaimer is very similar to the fraudulent mediums and
astrologers saying 'for entertainment purposes only'. Their customers
give them money and believe what they are told, knowing that the
disclaimer is just a wheeze to get round the law..

>
> Can you give a hypothetical scenario that demonstrates the unacceptable
> risks presented by 23andMe? Honestly, I want to understand.
>
>

Read the FDA letter. It explains their POV very clearly.
<http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm376296.htm>
Quote:
This product is a device within the meaning of section 201(h) of the
FD&C Act, 21 U.S.C. 321(h), because it is intended for use in the
diagnosis of disease or other conditions or in the cure, mitigation,
treatment, or prevention of disease, or is intended to affect the
structure or function of the body.
-----

The letter continues on to list specific problems.

You are entitled, of course, to disagree with the FDA's opinion. But
they do have a lot of experience fighting the avalanche of medical
fraud in the USA.

BillK