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 from the sample and provides on-line access to the results, including information about genealogy and a short synopsis of selected publically-available, non-patient specific research on medical conditions associated with those genes. The company's terms of service caution that:
You should not change your health behaviors solely on the basis of information from 23andMe. Make sure to discuss your Genetic Information with a physician or other health care provider before you act upon the Genetic Information resulting from 23andMe Services. For most common diseases, the genes we know about are only responsible for a small fraction of the risk. There may be unknown genes, environmental factors, or lifestyle choices that are far more important predictors. If your data indicate that you are not at elevated genetic risk for a particular disease or condition, you should not feel that you are protected. The opposite is also true; if your data indicate you are at an elevated genetic risk for a particular disease or condition, it does not mean you will definitively develop the disease or condition. In either case, if you have concerns or questions about what you learn through 23andMe, you should contact your physician or other health care provider. 1
23andMe thus makes clear the information it provides is not intended as a diagnostic tool or for use in making medical decisions, but merely as a starting point for dialog and investigation with health care professionals.
FDA's pretext for regulation is a self-serving classification, first...
