The Latest in FDA’s Focus on Foods

The Latest in FDA's Focus on Foods – FDA Watch

Shelly and Wayne chat with Dr. Susan Mayne, Adjunct Professor at the Yale School of Public Health and former Director of FDA's Center for Food Safety and Applied Nutrition, and Dr. Peter Lurie, President of the Center for Science in the Public Interest and former Associate Commissioner at FDA. You'll hear their thoughts on what incoming FDA Commissioner Dr. Marty Makary may be prioritizing in the food space, why it took FDA so long to ban Red Dye No. 3, the agency's "healthy" claim final rule, where FDA stands with reducing sodium in human foods, the push to eliminate the self-affirmed GRAS pathway, and much more. In our headlines segment, Shelly and Wayne delve into these major developments: Pharma: Drugs and biologics continue to be reviewed in a timely way, meeting the PDUFA dates, despite recent disruption Medical Devices: CDRH has been busy with device recalls lately, two of which were labeled as Class I Food: HHS Secretary Robert F. Kennedy Directs FDA to Explore Rulemaking to Eliminate Pathway for Companies to Self-Affirm Food Ingredients Are Safe Cosmetics: PCPC Applauds Reintroduction of Humane Cosmetics Act 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 Dr. Susan Mayne, Adjunct Professor at the Yale School of Public Health and former Director of FDA’s Center for Food Safety and Applied Nutrition, and Dr. Peter Lurie, President of the Center for Science in the Public Interest and former Associate Commissioner at FDA. You’ll hear their thoughts on what incoming FDA Commissioner Dr. Marty Makary may be prioritizing in the food space, why it took FDA so long to ban Red Dye No. 3, the agency’s “healthy” claim final rule, where FDA stands with reducing sodium in human foods, the push to eliminate the self-affirmed GRAS pathway, and much more.

Headlines

Pharma: Drugs and biologics continue to be reviewed in a timely way, meeting the PDUFA dates, despite recent disruption

Devices: CDRH has been busy with device recalls lately, two of which were labeled as Class I

Food: HHS Secretary Robert F. Kennedy Directs FDA to Explore Rulemaking to Eliminate Pathway for Companies to Self-Affirm Food Ingredients Are Safe

Cosmetics: PCPC Applauds Reintroduction of Humane Cosmetics Act

Resource Links

Pharma and Devices: Longtime expert and author agree on why so many drugs and treatments fail to make it to market

• Alexander Masters’ op-ed

• Roger Bayston’s letter

Food: From FDA: Both the agency and HHS announced Operation Stork Speed to expand options for safe, reliable, and nutritious infant formula for American families

Cosmetics: PCPC launches webpage with key information on economic achievements in cosmetics industry

About Our Guests

Dr. Susan Mayne

Susan Mayne, Ph.D., is currently Professor (Adjunct) at the Yale School of Public Health, and from 2015-2023 she Directed the FDA Center for Food Safety and Applied Nutrition.  Prior to joining the FDA, she spent nearly three decades at the Yale School of Public Health focusing on food and nutrition.

Dr. Peter Lurie

Peter Lurie, M.D., M.P.H. is President of the Center for Science in the Public Interest.  CSPI publishes a newsletter, Nutrition Action, and conducts advocacy on Capitol Hill, in the regulatory agencies, in the courts, at the state and local level, and through corporate campaigns. Previously, Lurie was the Associate Commissioner at the FDA.