Transcript

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From Washington State University Extension, this is Food Safety in a Minute

Halloween’s near, and candies’ everywhere but did you know chocolate is sometimes recalled? Here are four common hazards, leading to recalls: 
•	Allergens that aren’t labeled such as milk, nuts, sesame. 
•	Bacterial contamination. 4 million pounds of chocolate wafers were recalled because of Salmonella in May 2024.
•	Undisclosed hazardous substances. And,
•	Foreign Objects or Mislabeling.

If you hear about a recall: 
•	Stop consuming the product immediately. 
•	Next check labels and lot numbers with recall notices to confirm. 
•	Return chocolate to the place of purchase for a refund.
•	Clean and sanitize surfaces possibly contaminated by the product.   

Stay informed and safe, subscribe to FDA recall alerts, or visit FoodSafety.gov. 

I’m Susie Craig for Food Safety in a Minute. 

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Resources

United States Department of Agriculture – Food Safety.gov. Recalls and Outbreaks.
https://www.foodsafety.gov/recalls-and-outbreaks. Accessed online 8/19/25. 

United States Food and Drug Administration. Recalls, Market Withdrawals, and Safety Alerts. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts. Accessed online 8/19/25.

United States Food and Drug Administration. Sign up for Recall Alerts. 
https://public.govdelivery.com/accounts/USFDA/subscriber/new. Accessed online 8/19/25.

FSM 361: Why Does Chocolate Candy Get Recalled?

Medium Article: https://medium.com/@jsmith0475/chatgpt-cant-write-fda-compliant-reports-here-s-what-can-e2154b82c537
"Auditable AI for FDA-Compliant Reports: Cognitive Anchoring,"by Dr. Jerry A. Smith, argues that traditional AI models like ChatGPT cannot meet the Food and Drug Administration's (FDA) requirements for reproducible and predictable documentation in pharmaceutical quality assurance (QA). Dr. Jerry A. Smith identifies the current system of manual report generation as a significant bottleneck in the industry, costing vast amounts of time and money due to bureaucratic overhead. The author proposes a solution called cognitive anchoring, which uses a multi-agent AI system constrained by four mathematical rules (symbolic, temporal, spatial, and symmetry anchoring) to ensure compliance and consistency. This system is auditable because it measures whether outputs rely on Euclidean reasoning (factual retrieval) or hyperbolic reasoning (logical inference), providing a geometric breakdown that satisfies regulatory demands. Ultimately, the piece posits that deploying this production-ready technology is a strategic necessity for Contract Research Organizations (CROs) to achieve massive cost savings, increase report throughput by thousands of times, and lead the future of pharmaceutical QA.

ChatGPT Can’t Write FDA-Compliant Reports. Here’s What Can.

From Crisis to Prevention: How Ambient Monitoring Is Rewiring Healthcare Culture

Join Megan Antonelli as she speaks with Jenice Larmond, RN, BSN, MBA, Clinical Innovation & Excellence Officer at Neteera, about how radar-based ambient monitoring is rewiring clinical culture toward prevention. Discover how FDA-cleared contactless technology continuously monitors heart rate, respiration, and occupancy & motion insights through clothing and bedding—detecting subtle changes before they become crises. Learn why health systems report dramatic reductions in alert fatigue, increased early interventions, and prevention-focused care delivery. If you're building RPM, post-acute care, or aging-in-place programs centered on early detection, this conversation reveals the cultural shift happening now.

Find all of our network podcasts on your favorite podcast platforms and be sure to subscribe and like us. Learn more at www.healthcarenowradio.com/listen/

Digital Health Talks: From Crisis to Prevention

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs explain the reasons for the US Food and Drug Administration’s planned “Simple Reform” of its inspection group, including the move away from specialized teams (:44). They also consider industry’s current thinking on best practices for navigating the agency’s new position on direct-to-consumer ad regulation (18:45).

More On These Topics From The Pink Sheet

US FDA Plans Move Back To More Generalist Inspectorate: https://insights.citeline.com/pink-sheet/compliance/us-fda-plans-move-back-to-more-generalist-inspectorate-5V3573KXHFAJXH6LVC6NSXW37M/ 

Industry Rethinking Visual Elements And Quality-Of-Life Claims After US FDA Drug Ad Crackdown: https://insights.citeline.com/pink-sheet/compliance/marketing-and-advertising/industry-rethinking-visual-elements-and-quality-of-life-claims-after-us-fda-drug-ad-crackdown-WMXPANFVC5B55GZZQ6IWJG4FRE/ 

US FDA Ad/Promo Crackdown Letters Came From OPDP Staff, Not Artificial Intelligence: https://insights.citeline.com/pink-sheet/compliance/marketing-and-advertising/us-fda-adpromo-crackdown-letters-came-from-opdp-staff-not-artificial-intelligence-RKTSXQ5ZV5BPJD4DXGAOS5SS5Q/ 

Drug Fix: Another FDA Inspection Reorg, Industry Navigating New DTC Landscape

The U.S. Food and Drug Administration has conditionally approved a drug for prevention and treatment of New World Screwworm.  Although screwworms are not in the United States, farmers and ranchers will have some tools to fight the screwworms in protection of their cattle herds and other animals if the NWS enters the U.S. in the future. 

11/3/25 - FDA conditionally approves screwworm prevention, treatment drug

Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs consider the impact of the US Food and Drug Administration announcement that a comparative efficacy study is  no longer a prerequisite for biosimilar approval (:35), as well as the upcoming guidance stating the interchangeability switching study requirement will be dropped (11:25). They also discuss agency efforts to clarify the intent of the upcoming inspection force “Simple Reform” (15:13).

More On These Topics From The Pink Sheet

US FDA’s Makary Wants Lower Biosimilar Launch Prices As Clinical Study Mandate Changed: https://insights.citeline.com/pink-sheet/biosimilars-and-generics/biosimilars/us-fdas-makary-wants-lower-biosimilar-launch-prices-as-clinical-study-mandate-changed-5ARJRC6QYBBMTLTQ5S46F5YGXQ/ 

Biosimilar Interchangeability Guidance Eliminating Switching Studies Coming Soon: https://insights.citeline.com/pink-sheet/biosimilars-and-generics/biosimilars/biosimilar-interchangeability-guidance-eliminating-switching-studies-coming-soon-ILNP4IGYJZGZLAJVDZ77URZDNQ/ 

‘Simple Reform’ Not A Step Back From Program Alignment, US FDA’s Elizabeth Miller Argues: https://insights.citeline.com/pink-sheet/compliance/manufacturing/simple-reform-not-a-step-back-from-program-alignment-us-fdas-elizabeth-miller-argues-TCTFWMGBARD6VLRDT7YWUZBJQE/ 

Drug Fix: US FDA Streamlines Biosimilar Development Requirements, Clarifies Inspection Reform

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs take a deep dive into the circumstances of George Tidmarsh’s departure as director of the US Food and Drug Administration’s Center for Drug Evaluation and Research (:30). They also consider the long-term impact on the agency (11:50) and try to place it in context compared to other crises in its history (31:24).

More On These Topics From The Pink Sheet

Breaking: George Tidmarsh Out As US FDA Drug Center Director: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/breaking-george-tidmarsh-out-as-us-fda-drug-center-director-MI2NEWEM6ZFP7GP66ZQJL76N2Q/ 

Former US FDA CDER Director Says He Played Key Role In Stealth’s Elamipretide Approval: https://insights.citeline.com/pink-sheet/product-reviews/drug-review-profiles/us-fda-cder-director-says-he-played-key-role-in-stealths-elamipretide-approval-VAEUL5PU75GBXCMC3QOYTA32WI/ 

Tidmarsh Creates More Instability And Uncertainty For US FDA, Industry: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/tidmarsh-creates-more-instability-and-uncertainty-for-us-fda-industry-DODHAMVW5REBPPHBUUJHV6PZTU/ 

US FDA’s Richard Pazdur Says ‘No’ To CDER Director’s Spot: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/breaking-us-fdas-richard-pazdur-offered-cder-director-spot-said-no-RZK4BW7EX5F5RLG6HG2JSDCKAE/ 

FDA Office of New Drugs Director Mary Thanh Hai Not Interested In CDER Director Job: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/fda-office-of-new-drugs-director-mary-thanh-hai-not-interested-in-cder-director-job-XKOFXETTWVAXFB22BQ3MJ7ONQ4/ 

Drug Fix: Examining George Tidmarsh’s Departure As Head Of US FDA’s Drug Center

Today, we're talking to Dr. David Darrow for a second time. Check out episode 30 for our first discussion. David is a neurosurgeon and assistant professor in the departments of neurosurgery and psychiatry at the University of Minnesota. Many of you will also know that he is a researcher and the primary investigator of the successful and ongoing E-Stand trial, which uses epidural stimulation and optimization protocols for delivering functional outcomes for the SCI community. We discussed the E-Stand trial, how it's progressing, and highlights from its now eight years of running. We also talk about the FDA and the quandary of determining what is meaningful in the eyes of research participants, as well as with regulators. And we get into spinal cord stimulation data sharing, the exciting horizon of combinatorial therapies, and much, much more. As you will hear on this call, David is a smart, innovative, forward-thinking ally of the SCI community. 

More info: https://u2fp.org/get-educated/curecast/episode-135.html

Taking a Stand

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith and Editor-in-Chief Nielsen Hobbs break down the pending retirement of Center for Drug Evaluation and Research Director Richard Pazdur and appointment of Tracy Beth Høeg as the interim replacement (4:51), including the potential impact on sponsors (15:46). They also discuss whether Høeg will take time to learn CDER operations before making changes (19:38), as well as the possibility of yet another CDER director being hired in the coming weeks or months (23:18).

More On These Topics From The Pink Sheet

US FDA Faces Another Leadership Crisis As Drugs Center Director Richard Pazdur Retires: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/breaking-us-fda-cder-director-richard-pazdur-retiring-SUPZZ4JEQ5GVHEEH4RPDLCNIBY/ 

Tracy Beth Høeg Named New Acting US FDA CDER Director: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/tracy-beth-hoeg-named-new-acting-us-fda-cder-director-3AYJZJAMBVG6HNPX3FJ7IBCDHQ/ 

US FDA Sending Pazdur Back To Oncology Office: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-sending-pazdur-back-to-oncology-office-KVBDIDT2RVF4JAZ7FCZHN46XXU/ 

Drug Fix: Understanding the US FDA’s CDER Leadership Shuffle

A hard-hitting, aggressive track built on raw truth and corruption in plain sight. Death Is FDA Approved dives into the toxic marriage between power and profit — where the ones meant to protect you cash in instead. Dark energy, sharp lyricism, heavy bass, and an unfiltered message driving straight through the mix. This isn’t paranoia… In the US, it’s the world we’re living in, carved into sound.

Death is FDA Approved

Citeline places biopharma and medical device professionals, and those who focus on these industries, at the forefront of knowledge and insight, by providing the perfect combination of news and information together with penetrating insight and analysis. Citeline is a leader in the field of healthcare industry information.

In-Depth Explorations of Neuroscience-Inspired Architectures Revolutionizing AI.

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Need answers to your food safety questions? Food Safety in a Minute from Washington State University answers the most commonly asked questions from consumers. Listening is a quick and easy way to learn more about food safety. Subscribe to our weekly podcast and explore online episodes.

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