A Fresh Look at the State of Human Foods – FDA Watch
Wayne chats with Brian Sylvester, Partner in Morrison Foerster’s FDA and Healthcare Regulatory and Compliance Group, and Scott Faber, Senior Vice President of Government Affairs for the Environmental Working Group. You’ll hear their thoughts on the recent appointment of Kyle Diamantas to Acting Head of FDA after the resignation of former Commissioner Dr. Marty Makary; the direction and drivers of food regulation; the phase-out of synthetic food dyes amid growing state-level action; where FDA’s interest in overhauling GRAS stands; the potential formal definition of “ultraprocessed” foods and potential labeling and nutrition implications; the balance between precautionary regulation and evidence-based flexibility for industry; how AI is changing the regulatory landscape amid FDA’s rollout of Elsa; and much more.
Headlines
Dr. Marty Makary resigns as FDA Commissioner, Human Foods Deputy Commissioner Kyle Diamantas in as Acting Head
FDA to pilot “one-day inspectional assessments”
Pharma: FDA issues final guidance on the collection of pregnancy safety data for drugs and biologics after approval
Devices: FDA issues recall notice involving heart devices after reports of device malfunctions that could interrupt therapy delivery
Food: FDA announces results from examination on chemical contaminants in infant formula
Cosmetics: PCPC issues statement calling on administration to take more targeted approach in Section 301 investigation into excess manufacturing capacity
Resource Links
About Our Guests
Brian Sylvester
Brian P. Sylvester is a Partner in Morrison Foerster’s FDA & Healthcare Regulatory and Compliance Group. He is the head of Food Regulatory and an influential thought leader and practitioner in the field of food regulation.
Brian counsels clients across the full life cycle of regulated products, serving global brands, startups, life sciences companies, investors, and trade associations. He has been recognized by a number of legal industry awards and publications such as Chambers USA, Bloomberg Law, and The National Law Journal. Chambers USA reports that Brian “is widely noted as an expert in regulatory issues relating to novel food technologies, with significant experience advising on USDA and FDA regulations.”
Brian focuses his practice on Food and Drug Administration (FDA) and U.S. Department of Agriculture (USDA) regulated products, with an emphasis on the food and beverage sector. He additionally counsels early-stage, growth, and global clients on all aspects of cosmetics, over the counter (OTC) human drugs, medical devices, animal food and drugs, and a range of Animal and Plant Health Inspection Service (APHIS) regulated commodities. Across all these regulated product categories, his work spans enforcement actions, audits and investigations, regulatory compliance, labeling and advertising, import and export, due diligence, consumer litigation, comment preparation, public policy advocacy at the federal and state levels, and new product development.
Scott Faber
Scott Faber is the Senior Vice President of Government Affairs for the Environmental Working Group.
Prior to joining EWG, Faber was the Vice President for Federal Affairs for the Consumer Brands Association, formerly known as the Grocery Manufacturers Association.
Faber is also an Adjunct Law Professor at Georgetown University Law Center, where he teaches food and farm law.
FDA Watch Podcast 