Homing in on Food Supply, Tariffs & Infant Formula FDA Watch

Shelly and Wayne chat with Martin Hahn, Global Regulatory Partner at Hogan Lovells, and Tony Pavel, Partner at Keller and Heckman. You'll hear their thoughts on global food supply chain vulnerabilities and how FDA is monitoring them; how U.S. tariffs on imported food products influence the availability and safety oversight of essential goods like formula or medical nutrition; how FDA is working with international partners to improve coordination and transparency; FDA measures to ensure a more resilient and responsive infant formula supply; and much more. In our Headlines segment, Shelly and Wayne delve into these major developments:  FDA announces expanded use of unannounced inspections at foreign manufacturing facilities President Trump signs an executive order that aims to reduce drug costs by basing payments for certain medicines on their prices in other countries Pharma: FDA Commissioner Dr. Marty Makary says layoffs won't hinder the agency's target dates for drug reviews Devices: Two U.S. Senators introduce legislation encouraging the use of AI-enabled medical devices Food: HHS, FDA announce plans to phase out synthetic dyes in nation's food supply Cosmetics: ICCS shares case studies and mock dossiers as examples of how new approach methodologies can be utilized  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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Shelly and Wayne chat with Martin Hahn, Global Regulatory Partner at Hogan Lovells, and Tony Pavel, Partner at Keller and Heckman. You’ll hear their thoughts on global food supply chain vulnerabilities and how FDA is monitoring them; how U.S. tariffs on imported food products influence the availability and safety oversight of essential goods like formula or medical nutrition; how FDA is working with international partners to improve coordination and transparency; FDA measures to ensure a more resilient and responsive infant formula supply; and much more.

Headlines

FDA announces expanded use of unannounced inspections at foreign manufacturing facilities

President Trump signs an executive order that aims to reduce drug costs by basing payments for certain medicines on their prices in other countries

Pharma: FDA Commissioner Dr. Marty Makary says layoffs won’t hinder the agency’s target dates for drug reviews

Devices: Two U.S. Senators introduce legislation encouraging the use of AI-enabled medical devices

Food: HHS, FDA announce plans to phase out synthetic dyes in nation’s food supply

Cosmetics: ICCS shares case studies and mock dossiers as examples of how new approach methodologies can be utilized

Resource Links

Pharma: Vinay Prasad, oncologist who previously criticized FDA leadership and COVID-19 mandates, named as Director of the Center for Biologics Evaluation and Research

Devices: UPenn Q&A discusses new study covering AI and medical devices

Food: Tyson Foods and yogurt maker Danone are among companies working to remove artificial dyes from products sold in the U.S.

Cosmetics: PCPC issues statement on New York bill that propose bans on “safe, commonly used ingredients”

About Our Guests

Martin Hahn

Using his background in food technology and his comprehensive understanding of the laws governing the food industry, Martin Hahn helps clients navigate through the countless regulatory and business issues impacting the industry from farm to table.

He recognizes the demands clients face and finds innovative and creative solutions, particularly when responding to observations raised by regulators during inspections. Whether the issue involves obtaining the authorization of a new food or dietary ingredient, complying with manufacturing requirements, labeling or advertising, product recalls, or enforcement, Martin serves as an effective advisor and advocate.

Martin has handled almost every issue impacting the food industry. He has a comprehensive understanding of the laws affecting the labeling and advertising of foods, dietary supplements, infant formulas, medical foods, and foods for special dietary use. He helps anticipate new trends and develops the data needed to distinguish a client’s products from others on the market. Martin uses his understanding of science and technology in the food industry to provide assistance in obtaining regulatory authorizations to market new food ingredients, food packaging materials, and dietary ingredients. He assists in responding to proposed regulations and draft guidance to keep clients informed on the latest trends in class action law suits to help anticipate new regulatory initiatives.

Martin grew up on a farm and worked in food processing plants before going to law school. His hands-on experience in the field and degree in food technology allow him to better understand the challenges his clients face in complying with the laws impacting food manufacturing.

Tony Pavel

Anthony (Tony) Pavel is a partner at Keller and Heckman LLP, in Washington, DC.  Tony guides clients through a comprehensive array of food and drug regulatory matters with his extensive knowledge of U.S. Food and Drug Administration (FDA) regulations related to food, food additives and ingredients, dietary supplements, and cosmetics. In addition to FDA matters, Tony assists clients with issues related to the U.S. Federal Trade Commission (FTC), the U.S. Department of Agriculture (USDA), and other regulatory bodies around the world.

Prior to joining Keller and Heckman, Tony was in private practice at a major international law firm, followed by in-house positions leading a global food law team at a major food, agricultural, and industrial products producer and Deputy General Counsel, Global Food Law for a consumer biology startup. Tony’s in-house corporate experience helped shape his approach to practical, actionable advice and effective solutions for clients.

Tony is frequently invited to speak at domestic and global conferences on food ingredients, food additives, and related policy matters.


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