Regulatory Update: A New Era at FDA

There’s been a significant turnover at FDA with Commissioner Scott Gottlieb resigning, Ned Sharpless taking over as Acting Commissioner and former Walmart VP of Food Safety Frank Yiannas becoming Deputy Commissioner of Food Policy and Response. What can we expect from this new era of leadership? A reading of Sharpless’ remarks at his First All-Hands Meeting provides some insight.

While there is a definite focus on technological advancement (See The Rise of Technology), the general feel is one of continuation – with modernization. That is, Sharpless intends to steer the priorities of his tenure through “the commitment to science-based decision-making and prioritizing our efforts for the benefit of the public health.” At the same time, he said that the agency will grow and respond to the changing needs of society; deal with the regulatory challenges of new products, such as CBD oil, genetically modified animals, and cell-cultured meat and pet food; and assess food safety uses of “modern technology like blockchain and artificial intelligence in a way that is maximally protective to the consumer, but also not onerous and debilitating to industry.”

Thus, while continuing to focus on food safety modernization, there will be a decided shift from it being that of a regulated Act to being overall industry culture – and it has already begun. As Sharpless said, “I plan to maintain FDA’s current course of action in every area and proceed full speed ahead.”