Tag Archives: FDA

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FDA Shares Recording of Traceability Public Meeting

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On June 15, 2026 The FDA held a public meeting to give the public an opportunity to share information on continued implementation of the Food Traceability Rule and areas of remaining concern, specifically as they relate to lot-level tracking and flexibilities for compliance. The Agency is now making the video recording of the meeting available for stakeholders. 

The FDA final rule on Requirements for Additional Traceability Records for Certain Foods (Food Traceability Rule) requires persons who manufacture, process, pack, or hold food on FDA’s Food Traceability List to maintain and (in some cases) provide to their supply chain partners key data elements (KDEs) for certain critical tracking events (CTEs) in the food’s supply chain. The requirements in the rule will allow for faster identification and rapid removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses and deaths.

The original compliance date for all persons subject to the recordkeeping requirements of the Food Traceability Rule was January 20, 2026. The FDA proposed to extend the compliance date for the rule by 30 months to July 20, 2028. Subsequently, the Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act of 2026 (the Continuing Appropriations Act) directed FDA not to enforce the Food Traceability Rule prior to that same date of July 20, 2028. The FDA  intends to comply with this Congressional directive.

The Continuing Appropriations Act also required FDA to engage quarterly with regulated entities, including farms, restaurants, retail food establishments, and warehouses distributing to retail food establishments and restaurants, to identify and implement, as appropriate, additional flexibilities for satisfying the Food Traceability Rule’s lot-level tracking requirement. This public meeting is the second of these quarterly engagements.

The recording, and related transcripts, can be found on the public meeting webpage. 

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Beltway Beat

Foods Program Guidance Under Development

By Food Safety Tech Staff
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FDA announced a list of guidance topics includes possible new topics for guidance documents or revisions to existing guidance documents that the FDA’s Human Foods Program is considering. The announcement states that “We currently intend to develop guidance on each topic; however, the FDA’s Human Foods Program is neither bound by this list of topics, nor required to issue every guidance document on this list.”

Several factors may impact FDA’s ability to issue the listed guidances, including, for example, new Administration priorities, emerging public health issues, or other extenuating circumstances. FDA claims they are not precluded from issuing guidance documents on topics not on this list.

You may submit comments on the guidance topics at www.regulations.gov at Docket FDA-2022-D-2088.

Guidance for Industry

Food Chemical Safety, Dietary Supplements, and Innovation

Title of Guidance

Action Levels for Cadmium in Processed Food Intended for Babies and Young Children; Draft
Guidance for Industry
Action Levels for Inorganic Arsenic in Food Intended for Babies and Young Children; Draft Guidance for Industry
Action Level for Opiate Alkaloids on Poppy Seeds; Draft Guidance for Industry
Fruit Juice and Vegetable Juice as Color Additives in Food; Draft Guidance for Industry
Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 12: Preventive Controls for Chemical Hazards; Draft Guidance for Industry
New Dietary Ingredient (NDI) Notifications and Related Issues: Identity and Safety Information About the NDI; Guidance for Industry

Microbiological Food Safety

Title of Guidance

Preventing Contamination of Low-Moisture Ready-to-Eat Human Foods and Remediating a Pathogen Contamination Event if Prevention Fails; Revised Draft Guidance for Industry
Guide to Minimize Biological Hazards in Ready-to-Eat Fresh-Cut Produce; Guidance for Industry
Hazard Analysis and Risk-Based Preventive Controls for Human Food: Chapter 10: Sanitation Program; Draft Guidance for Industry
The Accredited Third-Party Certification Program: Questions and Answers; Guidance for Industry
Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories: Guidance for Industry

 

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Beltway Beat

FDA Announces Updates to Modernize, Strengthen Pesticide Monitoring Compliance Program

By Food Safety Tech Staff
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The FDA’s Human Foods Program announced in a press release several key enhancements designed to modernize and strengthen the agency’s monitoring of pesticides in domestic and imported human foods through revisions to Compliance Program 7304.004, last updated in 2011.

According to the press release, these updates strengthen the FDA’s regulatory pesticide residue monitoring program, through which the agency selectively monitors approximately 3,500 domestic and import samples yearly for residues of approximately 780 different pesticides. The FDA also monitors pesticides in human foods through focused surveys and the FDA’s Total Diet Study, and works with states through the Laboratory Flexible Funding Model Program to conduct additional monitoring.

The updated compliance program will focus exclusively on monitoring pesticide residues in foods. To reflect this, the program has been renamed “Pesticides in Human Foods – Domestic and Import.”  The updates streamline the program and clarify specific objectives such as:

  • Risk-based Sampling Priorities 
    The updates include a focus on sampling foods highly consumed by infants and children among more than 150 raw agricultural commodities the FDA samples as part of its responsibility to enforce EPA-established tolerances. These procedural enhancements ensure resources are directed toward the areas of greatest potential risk.
  • Enhanced Operational Procedures
    Instructions for laboratory, compliance, and enforcement staff have been revised to align with updated FDA procedures. Updates to the laboratory testing methods reflect the transition by FDA regulatory laboratories to a harmonized multi-analyte gas- and liquid-chromatography tandem mass spectrometry method for determination of pesticide residues and elimination of separate, analyte-specific methods, improving throughput and consistency of results. All activities related to industrial chemicals, including dioxins, will now be conducted under their own programs and references in the compliance program will be removed.
  • Strengthened Collaboration with Regulatory Partners
    New information has been added that outlines interactions and partnerships with FDA centers, related FDA compliance programs, other federal agencies, and U.S. state and local counterparts, highlighting the FDA’s commitment to a collaborative approach to food safety.

Information on the FDA’s pesticide residue monitoring program, including annual summary reports and the newly released Pesticide Report Data Dashboard, visit FDA’s Pesticides webpage.

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FDA Releases Discussion Paper Ahead of Traceability Public Meeting in June

By Food Safety Tech Staff
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The FDA has released a discussion paper to promote deeper and more productive engagements with stakeholders on potential flexibilities regarding the lot-level tracking requirements in the final rule, “Requirements for Additional Traceability Records for Certain Foods” (Food Traceability Rule). The discussion paper includes information and questions to help inform FDA’s engagements with stakeholders, including the upcoming virtual FDA-led public meeting on June 15th.

The FDA encourages those attending and speaking at the public meeting to consider the topics in the discussion paper. The public meeting is free and open to the public, but registration is necessary to attend. If you would like to speak during the public comment period, please register by June 5. All others can register until June 14th. More information about registration and how to request to speak during the public comment period are available on our meeting page.

In addition to the public meeting, the FDA wants to provide all stakeholders with an opportunity to actively engage with the Agency on this topic. Therefore, all interested parties are encouraged to submit feedback on the discussion paper to https://www.regulations.gov, Docket No. FDA-2014-N-0053. Feedback does not need to cover every question that is asked in the document; you are encouraged to focus on whichever aspects of the discussion paper are of the most interest to you. To ensure that we can fully consider your feedback as we continue our stakeholder engagements and work to expeditiously identify flexibilities to help implement the lot-level tracking requirements of the Food Traceability Rule, provide feedback by July 15, 2026.

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FDA Advances Post-Market Review of Phthalates Used in Food Contact Materials

By Food Safety Tech Staff
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The FDA announced on its website that it released a scientific evaluation of the eight ortho-(o)-phthalates (“phthalates”) currently authorized as plasticizers for food contact use to determine if they should be grouped together for the purpose of a cumulative risk assessment. This work will inform the agency’s upcoming post-market safety assessment of the food contact uses of phthalates, which is part of the agency’s commitment to ensuring that chemicals in the U.S. food supply remain safe as new scientific information becomes available. FDA is encouraging the public to comment by June 26, 2026, through docket FDA-2026-N-5776.

Specifically, FDA analyzed the scientific literature to understand if phthalates should be considered chemically or pharmacologically related (CPR) substances. Grouping similar chemicals as CPR enables assessment of their combined risk to consumers in a cumulative risk assessment.

The FDA evaluated the following eight phthalates:

  • diisononyl phthalate (DINP)
  • diisodecyl phthalate (DIDP)
  • di(2-ethylhexyl) phthalate (DEHP)
  • dicyclohexyl phthalate (DCHP)
  • butylphthalyl butyl glycolate (BPBG)
  • diethyl phthalate (DEP)
  • ethylphthalyl ethyl glycolate (EPEG)
  • diisooctyl phthalate (DIOP)

The evaluation proposes science-based inclusion and exclusion criteria for CPR grouping of these phthalates. The FDA’s findings support CPR grouping for DEHP, DCHP, DIOP and DINP for a future cumulative risk assessment. The FDA will consider stakeholder input on the use of this grouping for a future cumulative risk assessment.

To better understand the eight phthalates still authorized as plasticizers, the FDA previously issued a request for information seeking data on current uses, use levels, and safety to support an updated post-market assessment. The FDA received and reviewed approximately 24,000 comments in response to the RFI. This information was considered when conducting the evaluation released today.

Beltway Beat

Dr. Donald A. Prater has been named as the Acting Deputy Commissioner for Food at FDA

FDA announced that Kyle Diamantas, J.D. is now the Acting Commissioner of Food and Drugs, replacing Dr. Martin (Marty) Makary who resigned as the 27th Commissioner of the U.S. Food and Drug Administration (FDA) in May 2026. Dr. Donald A. Prater has been named as the Acting Deputy Commissioner for Food.

As the Acting Deputy Commissioner for Food, Dr. Prater leads the agency’s Human Foods Program, overseeing all FDA nutrition and food safety activities. In this role, Dr. Prater exercises authority over all Human Food Program entities and operations, including resource allocation, risk-prioritization strategy and decision making, policy initiatives, and major response activities involving human foods. Dr. Prater also oversees food resources in the agency’s Office of Inspections and Investigations.

Dr. Prater has presented at both the Food Safety Consortium Conference and as recently at the Food Safety Hazards Conference, in April in St. Louis.

Dr. Mindy Brashears, USDA, Brian Ronholm, CR and Dr. Don Prater FDA at the Food Safety Hazards Conference April 2026

Prior to this role, he served as the agency’s Principal Deputy Associate Commissioner for Food since 2024 and was previously Acting Director of the FDA’s Center for Food Safety and Applied Nutrition, a role he took on in 2023. He adeptly helped lead the Center during a time of transition, prioritizing nutrition and the safety of the food supply, dietary supplements, and cosmetics while helping to re-envision the organization.

Previously he had been the Associate Commissioner for Imported Food Safety in Office of Food Policy and Response, providing direction to and management of imported food safety programs. In addition, he served as a senior scientific advisor and technical expert on matters related to human and animal food safety and the implementation of the FDA Food Safety Modernization Act. Earlier in his FDA tenure, Dr. Prater was Director of the FDA’s Europe Office in Brussels, Belgium and the Department of Health and Human Services Country Representative to the European Union.

Dr. Prater received a Doctor of Veterinary Medicine from the Virginia-Maryland Regional College of Veterinary Medicine (government and corporate track) in 1996. Following a three-year residency in anatomic pathology, he joined the FDA’s Center for Veterinary Medicine (CVM) in 1999 as a Veterinary Medical Officer. There he served in several roles including leader of the Aquaculture Drugs Team, CVM Pathologist, and Director of the Division of Scientific Support.

Beltway Beat

Trump Planning to Fire FDA Commissioner Marty Makary

By Food Safety Tech Staff
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According tho the Wall Street Journal, President Trump has signed off on a plan to fire Food and Drug Administration Commissioner Marty Makary.

Top administration officials have become increasingly convinced Makary has to go because, in addition to months of turmoil, complaints from some in the pharmaceutical industry have continued to mount, people familiar with the matter said. Kennedy last year had considered installing someone else to run the FDA while Makary remained a figurehead.

The Wall Street Journal reported that Trump recently became frustrated with Makary for not moving fast enough to approve flavored vapes and other nicotine products. Makary in February refused to authorize blueberry and mango vape flavors from Los Angeles manufacturer Glas, worried that fruit flavors would encourage youth vaping. After the pressure from Trump, he reversed course and authorized the flavors. Makary has also run into criticism from biotech companies with rare-disease drugs, as well as patients and their advocates.

Marjorie Dannenfelser, the influential president of antiabortion group Susan B. Anthony Pro-Life America, recently renewed her call for Makary to be fired. The Wall Street Journal reported that Makary said he could have stalled approval of a generic form of the abortion pill, but didn’t.

Trump tapped Makary for the FDA post in November 2024, as Kennedy and other health department leaders bonded in meetings at Dr. Mehmet Oz’s oceanfront Florida mansion. Kennedy described Makary, along with Oz and National Institutes of Health Director Jay Bhattacharya, as “friends” who stayed in each other’s homes and vacationed together, in a Fox News interview last year.

Beltway Beat

UPDATE: Outbreak Investigation of E. coli O157:H7 in Raw Cheddar Cheese. Was it from RAW FARM or Not??

By Rick Biros
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Update March 30, 2026: Since the last FDA announcement on March 15, 2026, two (2) additional illnesses have been reported. A total of nine (9) people infected with the outbreak strain of E. coli have been reported from three (3) states. Illnesses started on dates ranging from September 1, 2025, to February 20, 2026. Three (3) people have been hospitalized and one (1) person developed hemolytic uremic syndrome (HUS), a serious condition that can cause kidney failure. No deaths have been reported. Over half of the illnesses are in children under five (5) years old.

State and local public health officials are interviewing people or their caregivers about the foods they ate in the week before they got sick. Of the eight (8) people interviewed, all eight (8) (100%) in this outbreak reported consuming or being served raw dairy products.

Of the eight (8) people interviewed, seven (7) had brand information available. One (1) person drank raw milk but didn’t know the brand. Of the seven (7) people interviewed who knew a brand, seven (7) (100%) reported RAW FARM-brand dairy products. In 2026, five (5) people reported consuming or being served RAW FARM-brand raw cheddar cheese. In 2025, two (2) sick people reported consuming RAW FARM-brand raw milk. Affected RAW FARM-brand raw milk from 2025 should no longer be for sale.

Whole genome sequencing (WGS) analysis of E. coli isolates from ill people shows that they are all closely related genetically to each other. This means that people in this outbreak are likely to share a common source of infection.

FDA has initiated an onsite inspection at RAW FARM, LLC in coordination with state partners. To date, FDA is not aware of any positive E. coli tests in RAW FARM-brand raw cheddar cheese products from this time period. FDA will update this advisory should additional information become available.

Original News Story March 19, 2026: The FDA and CDC, in collaboration with state and local partners, are investigating a multistate outbreak of E. coli O157:H7 infections as reported on FDA’s website

As of March 14, 2026, a total of 7 confirmed infections have been reported from three states, including CA (5), FL (1), and TX (1). Known illness onset dates range from September 1, 2025 to February 13, 2026. Whole genome sequencing analysis of E. coli isolates from ill people shows that they are all closely related genetically to each other. This means that people in this outbreak are likely to share a common source of infection. Additionally, 4 of 7 cases are 3 years old or younger. Two patients have been hospitalized. No deaths or HUS cases have been reported.

State and local public health officials have interviewed 3 ill people about food exposures of interest in this outbreak. All 3 people (100%) reported eating RAW FARM- brand raw cheddar cheese. State and local officials are working to gather additional data for the 4 other illnesses, including 2 illnesses that occurred in 2025. Epidemiologic evidence indicates that RAW FARM-brand raw cheddar cheese products made by RAW FARM, LLC are the likely source of this outbreak.

FDA has recommended that RAW FARM, LLC voluntarily remove their raw cheese products from the market, and the firm has declined.

On the company’s website, RAW FARM issued their official statement “We 100% disagree with FDA’s false possible link and extreme allegations.” Aaron McAFee, President of RAW FARM is filmed in a 2:13 minute YouTube video explaining their position.

FDA states, the investigation is ongoing to determine the source of contamination and whether additional products are linked to illnesses. To date, to FDA’s awareness, no RAW FARM-brand cheddar cheese products from this time period have tested positive for E. coli. As part of this investigation, state partners initiated collection of product samples for testing and analysis, but results are not yet available.

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Beltway Beat

FDA Releases the CORE 2024 Annual Report: Investigations of Foodborne Outbreaks and Adverse Events in FDA-Regulated Foods

By Food Safety Tech Staff
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On March 17, 2026, the U.S. Food and Drug Administration’s (FDA) Office of Coordinated Outbreak Response, Evaluation, & Emergency Preparedness (CORE+EP) released its annual report summarizing the investigations of foodborne illness outbreaks and certain adverse events in FDA-regulated human foods for the 2024 calendar year.

The FDA’s CORE+EP, originally established in 2011 as the CORE Network, expanded in October 2024 to include an emergency preparedness team focused on food defense, traceability, and supply chain management. One of CORE+EP’s missions is to find, stop, and aid in the prevention of foodborne illness outbreaks. This is accomplished through disease surveillance, outbreak response, post-response activities, and collaboration with the U.S. Centers for Disease Control and Prevention (CDC), state and local public health agencies, and international public health partners. Every year, CORE teams evaluate and respond to numerous foodborne outbreaks and certain adverse events linked to FDA-regulated products.

In 2024, CORE teams evaluated 72 incidents, responded to 26, and issued advisories for 10. These numbers remain similar to those from recent years, with 69 incidents evaluated, 25 responses, and 10 advisories issued in 2023. In 2024, CORE investigations resulted in numerous public health actions, including recalls, public health advisories, a Warning Letter, a consent decree of permanent injunction, and FDA prevention strategies.

The 2024 annual report highlights a few noteworthy outbreaks: a large outbreak of E. coli linked to carrots, a historical outbreak of illnesses associated with cheese, and a novel series of adverse events linked to certain chocolate bars, cones, and gummies.

Beltway Beat

Achieving Goals: Integrating the Fragmented United States Federal Food Safety System into a Food Protection System

By Allen R. Sayler, Benjamin J. Reading, Ph.D., Jason Bashura, MPH, R.S., Mehrdad Tajkarimi, DVM, MPVM, Ph.D.
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The United States (U.S.) food protection system is fragmented across federal, state, and local jurisdictions, resulting in duplication, inefficiency, and systemic failures that undermine public health and erode consumer trust. Foodborne pathogens such as Listeria, Salmonella, and E. coli do not respect institutional boundaries, yet responsibility for oversight is divided among more than 15 federal agencies, 75 state entities, and thousands of local jurisdictions, operating under more than 30 laws and 70 interagency agreements. This structure has proven incapable of reducing the persistent burden of foodborne illness in the U.S. The Centers for Disease Control and Prevention (CDC) estimate one in six Americans is affected annually, causing 10 million illnesses, 53,000 hospitalizations, and more than 900 deaths.

The term food protection, in use since at least 1924, conceptually unifies food safety, defense, authenticity, and infrastructure protection. However, the lack of an integrated federal entity has perpetuated disjointed responses. The 2025 recall of chicken fettuccine alfredo meals—linked to 17 illnesses, 16 hospitalizations, three deaths, and one fetal loss (as of this date)—illustrates the shortcomings of the system. Oversight was split between the Department of Health and Human Services (DHHS) Food and Drug Administration (FDA), which regulated the non-meat components, and the U.S. Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS), which oversaw the chicken ingredient. Despite involvement from CDC, the outbreak was not contained in time to prevent fatalities. Similarly, the 2024 deli meat Listeria outbreak, responsible for 10 deaths and 61 illnesses, highlighted the failure of FSIS to enforce corrective actions despite documented ongoing sanitation-based violations. These preventable events underscore the limitations of the current model.

The Government Accountability Office (GAO) has repeatedly called for consolidation—in 2005 and again 20 years later in 2025—emphasizing that inefficiencies, regulatory conflicts, and siloed data hindering effective food protection, resulting in preventable public health impacts. Reports also document how FSIS’s 6,500-employee continuous inspection program expends enormous resources without measurably improving outcomes. Decentralized data management further impedes trend analysis, predictive modeling, and risk-based decision-making that could anticipate and prevent outbreaks.

A unified federal food protection entity would provide structural and scientific coherence, resulting in the desired outcomes described herein. By consolidating regulatory authority, streamlining enforcement, and centralizing data, such an entity could accelerate response times, enhance accountability, and foster consistent risk-based regulation. Integrating modern technologies such as artificial intelligence and predictive analytics would strengthen surveillance, while harmonized training and inspections would maximize public health protections and reduce duplication and industry burden. Examples from Canada and the United Kingdom—both of which have lower per-capita illness rates—demonstrate the effectiveness of nationally unified food protection systems.

Congressional recognition of these systemic weaknesses has spurred legislative proposals in 2025 to establish a single food protection authority. This initiative reflects both scientific necessity and policy urgency. A consolidated approach would align regulatory practice with the realities of microbial ecology, supply chain complexity, and consumer demand for safe and wholesome foods.

In conclusion, the U.S. food protection system requires modernization and unification. Reform should focus on five core directives:

  1. Improving public health through risk-based regulation
  2. Eliminating overlap and duplication
  3. Streamlining enforcement and compliance
  4. Increasing accountability and modernizing governance
  5. Strengthening food protection as a component of national security

A unified federal food protection entity would provide a vision forward with four prime outcomes:

  1. Protect public health more effectively
  2. Reduce regulatory and economic burden
  3. Improve resilience against both natural and intentional threats
  4. Deliver a modern, science-based food protection system for the 21st century and beyond

One system, one standard, one mission: Protecting America’s food supply from farm to fork.

—Guiding principle for U.S. food safety efforts, FSIS

Click on the image to download the complete 45 page Whitepaper:

ICYMI: Click on the image to watch this recorded webinar with two of the Whitepaper Authors, Jason Bashura and  Ben Reading:

Ben and Jason discuss the need for truly unified, risk-based U.S. food protection system in this 26 minute recorded webinar