Recent Posts

#174: Vaping and the FDA

May 12, 2017

How does an e-vapor business navigate the FDA’s approval process? On August 8, 2016, the Food and Drug Administration’s “Deeming Rule” took effect, starting a...


#111: FDA Cracks Down on E-Cigs

August 9, 2016

Is the FDA putting e-cigs and vapor products out of business? Yesterday, the FDA’s “Deeming Rules” took effect. The rules will force e-cig manufacturers to...


PROTECT Act Would Transfer Regulation of Low-Risk, Non-Diagnostic Health IT from FDA

February 10, 2014

The FDA’s crackdown on 23andMe has called attention to the agency’s ability to apply the most stringent form of regulation to emerging technologies that promise...


Over 10,000 Call for Reversal of FDA’s Actions Against 23andMe

January 22, 2014

Late last year, the FDA ordered home genetics testing company 23andMe to cease marketing its diagnostic service, which informed customers about their predispositions to a...


Larry Downes in Wired: Regulating 23andMe to Death Won’t Stop the New Age of Genetic Testing

January 3, 2014

Larry Downes, author of Big Bang Disruption and one of our major influences, has a great piece in Wired on the FDA’s actions against genetic testing...


FDA oversteps on genetic testing: Berin Szoka in USA Today

December 17, 2013

The FDA recently banned marketing of 23andMe’s genetics home testing kits, effectively stopping sales of the product that has brought the genomics revolution to over...