On November 22, 2013, the Inquisition collided with the Internet.  On that date, the Food and Drug Administration issued a Warning Letter threatening 23andMe, Inc. with seizure of product, injunctions and civil monetary penalties based on allegations that 23andMe – which provides customers with information about their personal genomes – is selling misbranded and adulterated medical devices.  In plain terms, FDA has sought to restrict dissemination of this information for no other reason than an undocumented fear people might misuse it.  If FDA follows through on its threats of regulatory action, this dispute could provide the forum for defining the First Amendment limits of the FDA’s power to regulate public health by restricting dissemination of information.

By way of brief background, for $99, 23andMe provides a receptacle for a saliva sample and a mailer.  Upon receipt, 23andMe extracts selected genetic information … Read More »