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It is only reasonable in the context of the standard operating procedures of the FDA. As this is essentially prior restraint upon speech and/or trade, it is unreasonable, but no more unreasonable than anything else the FDA does.

Ideally, the FDA would have independently-generated evidence indicating that the product in question is unreasonably dangerous or ineffective for some intended purpose before issuing a cease and desist order. Instead, they simply assume guilt and place the burden of proof upon the vendor.

Given that the FDA has vastly more resources than 23andMe, and companies like it, this makes the FDA seem like bullies against microbusinesses, and like the captured servants of agricultural and pharmaceutical megabusinesses.



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