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?

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, and senior editors Sue Sutter and Cathy Kelly consider the impact of the government shutdown on the US Food and Drug Administration, as well as industry (:21), and discuss the future of drug pricing after Pfizer completes its deal with the White House to embrace its Most Favored Nation plan (10:29). 

More On These Topics From The Pink Sheet

Shutdown Approaches: US FDA Would Retain Most Of Recently Trimmed Staff: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/shutdown-approaches-us-fda-would-retain-most-of-recently-trimmed-staff-DTVAHLBI5VGZBPHD76TLNDIBGU/ 

Shutdown Day One: US FDA Hiring, MFN Demos Delayed?: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/shutdown-day-one-us-fda-hiring-mfn-demos-delayed-7LGCITF2WVCJNEVUTWZV5MOZSE/ 

Closing The Gap? Pfizer Will Set Same US, Foreign Launch Prices In MFN Deal: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/closing-the-gap-pfizer-will-set-same-us-foreign-launch-prices-in-mfn-deal-ZRSNU56KTFGRBBX4Y5OJKLFV6Y/ 

Questions Persist About How Pfizer’s US Agreement Lowers Prices: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/questions-persist-about-how-pfizers-us-agreement-lowers-prices-T2TEWMKVMVHGJHPXDKIFDF2GWA/

Drug Fix: Government Shutdown’s Impact On US FDA, Pfizer Inks Drug Pricing Deal

Join host David Wild as he speaks with Stacie Bell, chief clinical research officer at Lupus Therapeutics, about the dramatic transformation happening in lupus drug development. From a field once avoided by pharma companies to one generating unprecedented excitement, Bell discusses how her organization's 62-center network is revolutionizing clinical trials through patient engagement and scientific innovation.
 
Learn about promising oral therapies, Genentech's cancer drug Gazyva under FDA review for lupus nephritis, cell therapy approaches offering potential long-term remission and how combination treatments may become the new standard. Bell shares insights on overcoming clinical trial barriers, advancing biomarker research and ensuring representative participation from lupus communities.
 
A must-listen for anyone interested in autoimmune disease research, clinical development innovation, and patient-centered drug development.

Lupus Clinical Development Enters a New Era of Innovation

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith and Editor-in-Chief Nielsen Hobbs discuss the reasons US Food and Drug Administration Commissioner Martin Makary could have helped negotiate the Most Favored Nation drug pricing deal with Astra Zeneca (:30) and the deal’s potential impact on the 340B program (16:35). They also consider the Justice Department’s alternative interpretation of off-label promotion regulations and the effect on the scientific exchange of information about drugs (19:16).

More On These Topics From The Pink Sheet

US FDA Commissioner’s Involvement In AstraZeneca Pricing Deal Raises Ethical, Legal Questions: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/us-fda-commissioners-involvement-in-astrazeneca-pricing-deal-raises-ethical-legal-questions-IJV4LMTDA5E65KCOFQUQM76GCA/ 

EMD Serono IVF Candidate Among First US FDA Priority Voucher Recipients As Part Of MFN Deal: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/emd-serono-ivf-candidate-among-first-us-fda-priority-voucher-recipients-as-part-of-mfn-deal-LKHA6VRTKRE6DJERGNCWCGMBF4/ 

Manufacturer Most Favored Nation Deals: How They Could Be Protected From 340B: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/manufacturer-most-favored-nation-deals-how-they-could-be-protected-from-340b-FALSG7GHM5GQBFN3I5SPERJIYU/ 

Off-Label Promotion: DOJ May Take New Look At Scientific Information Exchange: https://insights.citeline.com/pink-sheet/legalandip/litigation/off-label-promotion-doj-may-take-new-look-at-scientific-information-exchange-R62PQJFQTRBCVGCZE57GWM3Q3Q/ 

Drug Fix: US FDA Involved In Astra Zeneca’s Drug Pricing Deal, DOJ’s Off-Label Promotion Policy

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

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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