FDA's Fight Against Ultraprocessed Foods FDA Watch

Wayne chats with Claudia Lewis, Co-Chair of the FDA Group at Venable, and Ricardo Carvajal, Director at Hyman, Phelps & McNamara. You'll hear their thoughts on FDA's focus and direction on ultraprocessed foods; GRAS regulation and former FDA Commissioner Dr. David Kessler's citizen petition; potential agency updates to food nutrition labeling; inspections and food safety; FDA's use of AI in food decision-making; and much more. In our headlines segment, Wayne delves into these major developments: Pharma: Substantial publicity surrounds firing of CDC Director Susan Monarez Devices: FDA launces Regulatory Accelerator for digital health devices Food: HHS and Secretary Kennedy to issue second MAHA report Cosmetics: FDA issues warning letters to sunscreen companies making mousse products In our Resource Links segment, we list key documents in our four core areas. To view these links, subscribe, or find out more information about our podcast, visit FDAWatch.net. Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at info@fdawatch.net.  Music by Dvir Silver from Pixabay.

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Wayne chats with Claudia Lewis, Co-Chair of the FDA Group at Venable, and Ricardo Carvajal, Director at Hyman, Phelps & McNamara. You’ll hear their thoughts on FDA’s focus and direction on ultraprocessed foods; GRAS regulation and former FDA Commissioner Dr. David Kessler’s citizen petition; potential agency updates to food nutrition labeling; inspections and food safety; FDA’s use of AI in food decision-making; and much more.

Headlines

Pharma: Substantial publicity surrounds firing of CDC Director Susan Monarez

Devices: FDA launces Regulatory Accelerator for digital health devices

Food: HHS and Secretary Kennedy to issue second MAHA report

Cosmetics: FDA issues warning letters to sunscreen companies making mousse products

Resource Links

Pharma: Axios breaks down newly updated COVID-19 vaccine guidance

Devices: FDA, Health Canada, and MHRA issue five guiding principles machine learning-enabled medical devices can safely adapt through Predetermined Change Control Plans

Food: FDA tracks which food companies making pledges to remove “petroleum-based” food dyes

Cosmetics: British Beauty Council joins coalition pushing for tougher regulation of digital marketplaces

About Our Guests

Claudia Lewis

Claudia Lewis, Co-Chair of Venable’s FDA Group, counsels clients on matters involving FDA regulation, labeling, and marketing of foods, over-the-counter (OTC) drugs, medical devices, and other products. With deep knowledge of dietary supplement labeling regulations, Claudia represents scientists, physicians, nutritionists, healthcare associations, and citizen groups. She has also aided international clients in establishing a U.S. market for their products. She has prepared and presented constitutional and administrative law cases before the FDA, Federal Trade Commission (FTC), Department of Justice (DOJ), Bureau of Land Management (BLM), and Environmental Protection Agency (EPA).

Ricardo Carvajal

Ricardo Carvajal is a Director at Hyman, Phelps & McNamara, PC, a law firm based in Washington, D.C. He counsels food companies on the regulatory requirements that apply to the formulation, manufacture, labeling, and advertising of food. He previously served as an Associate Chief Counsel for foods at FDA.


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