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by dragonwriter 4580 days ago
> This doesn't answer the question of why FDA bans products and services instead of simply informing consumers of possible dangers and letting them decide for themselves.

To the extent that it does this, it does it because the FD&C Act set standards by which they are required to. Why Congress did that is a different question.

But, it must be noted, that what they are doing here is not banning a product, they are prohibiting the marketing of a product for a particular set of advertised uses without meeting particular standards of proof that it is effective for those marketed uses.

> If the government really cared about consumers, it would go after homeopathy dealers, religious leaders and other charlatans. Never gonna happen. Why do you think that is?

In the case of homeopathy, which is regulated by the FDA, it is less regulated to less stringent standards than traditional medical products and devices largely due to public pressure.

> but a startup that actually provides some value to people, suddenly is a threat that needs to be shut down?

23andMe is "suddenly" a "threat that nees to be shut down". They were notified years ago of the requirements they needed to meet to market the product the way they do, they initiated the application process to meet those requirements in 2012, and haven't responded to FDA requests for further information necessary to move forward on those applications for over a year.

You act as if the FDA noticed the existence of 23andMe and immediately moved to destroy them. That is very much not what has happened.

1 comments

The question is not whether they were notified or not. The question is whether you believe that you yourself, as a taxpayer who funds the FDA, have the right to order people what to spend their money on and how to live their lives. It doesn't matter if a person is going to hurt himself or not. Why should it be in your power to take away someone else's freedom in the name of safety this person might not even want?

Looking at this particular case of 23andme I will tell you this. It's ridiculous. The claim is that somehow consumers might act in a way that can hurt them based on the information they received from the company. That sounds a lot like censorship to me. In Russia now people are prevented to look at sites that promote suicide or drug use. It's essentially the same thing: sites are notified, if they refuse to remove the information, they are banned within Russia. Hey, we want to protect our people.

> The question is not whether they were notified or not. The question is whether you believe that you yourself, as a taxpayer who funds the FDA, have the right to order people what to spend their money on and how to live their lives.

If I didn't believe that, I couldn't believe in the existence of government at all, which is nothing but a means by which the people whom the government works for direct the people who are subject to it (largely overlapping sets) what to spend their money on and how to live their lives.

So, yes, I'll agree that that question -- which is equivalent to "do you believe government should exist at all" -- is a threshold question here. But I don't really think its the interesting question here.

> Why should it be in your power to take away someone else's freedom in the name of safety this person might not even want?

The only "freedom" even arguably being denied here is 23andMe's freedom to market their product with particular claims. The issue is not whether they can sell the product, but the manner in which they are marketing it.

The manner in which they are marketing it is entirely their own business. If american people are smart enough to choose a politician to lead the country - and political campaigns are full of lies and deceit - then how come they are not smart enough to tell whether a marketing campaign of a product that has the potential to directly affect their life - is honest enough? How come no agency oversees what a politician says during a campaign and then just suspends this politician immediately if he does anything out of line?