When Your Life Sciences Are on the Line: FDA Policy

Morrison Foerster partners Kate Driscoll and Nate Mendell, both former federal prosecutors and members of the firm’s Investigations + White Collar Defense Group, hosted the eleventh episode of When Your Life Sciences Are on the Line, where leading practitioners and thought leaders share the insights and advice needed to manage business and legal risk in the life sciences sector.

In this episode, Kate and Nate speak with Brian Sylvester, a partner in Morrison Foerster’s U.S. Food and Drug Administration (FDA) & Healthcare Regulatory and Compliance Group and an influential thought leader and practitioner in food law. Together, they delve into the evolving regulatory landscape for food and beverage companies under the Trump administration. Their discussion highlights significant policy shifts impacting the industries regulated by the FDA and the United States Department of Agriculture (USDA), including the revocation of synthetic color additives such as Red No. 3, increased scrutiny of added sugars, and the recent request for information that could potentially lead to a federal definition of “ultra-processed foods.” Brian addresses the implications of these changes for food manufacturers and retailers, the growing momentum behind reformulation and transparency, and the potential for lasting impact regardless of future political leadership. The episode also explores challenges and opportunities in food innovation, such as “Generally Recognized as Safe” or “GRAS” determinations and the regulation of cell-cultured (cultivated), precision fermentation-derived ingredients and plant-based foods, providing practical insights for industry stakeholders navigating a rapidly changing regulatory environment. Listen to the podcast.