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FDA Shuts Down 23andMe #156796
11/26/2013 09:01 AM
11/26/2013 09:01 AM
Joined: Jan 2002
Posts: 23,922
Tulsa
airforce Offline OP
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airforce  Offline OP
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Tulsa
Thinking about having your DNA tested to see if you have any genetically-inherited health concerns? Well, it looks like you're too late. The Food and Drug Administration has forbidden the genetic testing service 23and Me , which identifies more than 240 health characteristics and traits for a cheap $99, from soliciting new customers. Nick Gillespie has the whole infuriating story here.

Quote
In its infinite wisdom, the Food and Drug Administration (FDA) has forbidden the personal genetic testing service 23andMe from soliciting new customers, claiming the company hasn’t proven the validity of its product.

The real reason? Because when it comes to learning about your own goddamn genes, the FDA doesn’t think you can handle the truth. That means the FDA is now officially worse than Oedipus’s parents, Dr. Zaius, and the god of Genesis combined, telling us that there are things that us mere mortals just shouldn’t be allowed to know.

23andMe allows you to get rudimentary information about your genetic makeup, including where your ancestors came from and DNA markers for over 240 different hereditary diseases and conditions (not all of them bad, by the way). Think of it as the H&M version of the haute couture genetic mark-up that Angelina Jolie had done prior to having the proactive mastectomy that she revealed this year....
Read the whole thing. And ask yourself just why the government thinks you aren't grown-up enough to know about your genetic makeup.

Onward and upward,
airforce

Re: FDA Shuts Down 23andMe #156797
11/26/2013 11:48 AM
11/26/2013 11:48 AM
Joined: Sep 2006
Posts: 1,015
washington
mak9030mag Offline
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mak9030mag  Offline
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washington
Because u would be amazed at what u would find


Mak
Re: FDA Shuts Down 23andMe #156798
11/26/2013 12:56 PM
11/26/2013 12:56 PM
Joined: Sep 2002
Posts: 6,705
Western States
Breacher Offline
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Breacher  Offline
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The sinister thing being the government wants to know, the corporations want to know, but they don't want you to know.

I understand those tests are pretty popular in places like NYC where most of the people are of mixed heritage of one kind or another and just want to know, but interestingly, if you can prove to have DNA up to a certain point with certain Indian tribes you can use the test as proof that you are eligible for your share of money from tribal enterprises like the casinos.


Life liberty, and the pursuit of those who threaten them.

Trump: not the president America needs, but the president America deserves.
Re: FDA Shuts Down 23andMe #156799
11/26/2013 01:55 PM
11/26/2013 01:55 PM
Joined: Jan 2002
Posts: 23,922
Tulsa
airforce Offline OP
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airforce  Offline OP
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Here is the "cease and desist" order from the FDA:

Quote
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).

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. For example, your company’s website at www.23andme.com/health (most recently viewed on November 6, 2013) markets the PGS for providing “health reports on 254 diseases and conditions,” including categories such as “carrier status,” “health risks,” and “drug response,” and specifically as a “first step in prevention” that enables users to “take steps toward mitigating serious diseases” such as diabetes, coronary heart disease, and breast cancer. Most of the intended uses for PGS listed on your website, a list that has grown over time, are medical device uses under section 201(h) of the FD&C Act. Most of these uses have not been classified and thus require premarket approval or de novo classification, as FDA has explained to you on numerous occasions....
The "medical device" the letter refers to is a small plastic cup that you spit into, seal, and send back for testing. Um, just how is a plastic cup a "medical device?"

Onward and upward,
airforce

Re: FDA Shuts Down 23andMe #156800
11/26/2013 06:49 PM
11/26/2013 06:49 PM
Joined: Nov 2009
Posts: 729
High Desert
D308cat Offline
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D308cat  Offline
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Posts: 729
High Desert
If this wasn't so disturbing it would be funny, next The Q-tip, The Tooth Brush, those pesky Ear and Nose Hair Trimmers, Curling Irons, Fingernail Clippers. OMG


PSALM 144:01 Blessed be the LORD my Rock, Who trains my hands for war, And my fingers for battle---

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