Beltway Beat

FDA Calls on Infant Formula Industry to Better Safeguard Against Contaminants Introduced through their Supply Chain

By Food Safety Tech Staff
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On July 13, 2026, the U.S. Food and Drug Administration announced on their website that the Agency sent a letter to the infant formula industry and their supply chain partners highlighting multiple recent public health events where risks were introduced through the supply chain and to call for increased vigilance by industry to ensure the safety of ingredients and finished infant formula products.

FDA has investigated two multistate outbreaks of infant botulism associated with two separate brands of powdered infant formula — ByHeart, Inc., and Nara Organics, Inc. — resulting in voluntary recalls and an ongoing FDA investigation into the shared ingredient suppliers. Likewise, a global contamination event occurring in late 2025 through early 2026 resulted in nearly 150 suspected and confirmed cases of cereulide intoxication across 10 countries, traced to contaminated arachidonic acid (ARA) oil used as an ingredient in infant formula. This prompted multiple global downstream recalls, and a supplier of ARA oil being added to multiple import alerts.

Manufacturer Responsibility: Know Your Suppliers

The FDA expects manufacturers to exercise substantive oversight of their suppliers, including understanding where their ingredients come from, how they are produced, what risks they may carry, and whether those risks are effectively controlled. When a contaminated ingredient or supplier concern is identified, whether by FDA or through industry’s own monitoring, manufacturers are expected to act swiftly to assess and address the risk.

The FDA also recommends that infant formula manufacturers and their supply chain partners stay abreast of applicable recall notifications, outbreak investigations and import alerts, which may serve as important safety signals. Experience has shown that ignoring or downplaying these safety signals can lead to increased risks to infants and preventable public health events.

FDA Actions

The FDA acknowledges the challenges in managing the risks related to spore-forming microbes in infant formula ingredents and recognizes there might not be a single approach for addressing them.  The Agency is prepared to work with industry to identify best practices and will continue to solicit advice from experts in academia and international scientific bodies, such as the Codex Committee on Food Hygiene and the International Commission on Microbiological Specifications for Foods.

The FDA also is continuing to investigate the root causes of the 2025 and 2026 infant botulism outbreaks associated with powdered infant formula and has completed initial surveillance to better understand the prevalence of Clostridium botulinum in powdered milk, the results of which are available on FDA’s Post-Outbreak Response Activities: Clostridium botulinum Illnesses Associated with Consumption of Powdered Infant Formula webpage.

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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

 

Farming, sustainability
Beltway Beat

Trump wants to Reduce Pesticides but Glyphosate is ok

By Food Safety Tech Staff
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Farming, sustainability

On Thursday, June 25, SCOTUS (Supreme Court of the United States) sided with the Trump administration and the maker of the weedkiller Roundup in a case brought by a patient who said the pesticide’s key ingredient, glyphosate, caused his cancer.

Later that day, President Trump, facing a backlash from MAHA (Make America Healthy Again) supporters for allying himself with the chemical industry issued an executive order aimed at reducing pesticides in the food supply and studying the health risks they pose. The order discusses regenerative agriculture, the holistic farming system designed to restore soil health, biodiversity, and water cycles while capturing carbon. It focuses on working with nature rather than against it.

Released at 7:30 pm shortly before a dinner Trump hosted for farmers, the order does not include any new federal funding, and does not call for new regulations or legislation.

According to the New York Times, the SCOTUS ruling infuriated MAHA leaders, who held a rally outside the Supreme Court to protest the Trump administration when the case was heard. “This executive order stops short of requiring meaningful action,” said Vani Hari, a close ally of Robert F. Kennedy Jr., Secretary of Department of Health and Human Services who led the protest, adding, “Americans deserve more than another study — they deserve a clear plan with accountability to reduce unnecessary chemical exposures in our food supply.”

Earlier this year, the USDA Regenerative Feedstock Rule, committed $1 billion to invest in farm modernization and “regenerative,” or pesticide-free, agriculture. It instructs the Environmental Protection Agency to “prioritize” the approval of alternatives to pesticides, and asks the Agriculture Department and the Department of Health and Human Services to develop a “research and evaluation framework” to study chemicals in the food supply.

 

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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.

A Greenpeace Study finds microplastics in baby food pouches

By Food Safety Tech Staff
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Greenpeace International announced that a new investigation they commissioned has found microplastics in every baby food pouch it tested, and estimates that a single Gerber pouch contains more than 5,000 microplastic particles and more than 11,000 in a Happy Baby Organics pouch. The study traced the likely source to the plastic lining of the pouches
themselves.

The report, Tiny Plastics, Big Problem: The Hidden Health Risks of Baby Food Plastic Pouches, also detected a range of chemicals in both the food and the packaging, including a potential endocrine-disrupting chemical in the Gerber pouches.

The testing commissioned by Greenpeace International in 2025 found plastic particles in the baby food products of two global consumer goods companies – Danone and Nestlé. The study suggests a link between the type of plastic the pouches are lined with – polyethylene – and some of the microplastics found. Tests also suggest a range of plastic-associated chemicals in the packaging and food of both products. Key findings are:

  • In every gram of baby food tested, researchers found up to 54 microplastic
    particles in Gerber pouches and up to 99 particles in Happy Baby Organics
    pouches, on average. That’s equivalent to as many as 270 (Gerber) and 495
    (Happy Baby Organics) microplastics per teaspoon.
  • The study also identified a range of plastic-associated chemicals present in
    both the packaging and the food, including a chemical in the Gerber samples
    that is a known endocrine disruptor.
  • The study suggests a link between polyethylene, the plastic lining the pouches,
    and some of the microplastics found in the baby food tested.

The study was conducted by SINTEF Ocean in Norway in 2025 and commissioned by Greenpeace International. It tested three pouches each of two baby food products, Nestlé’s Gerber brand yogurt puree and Danone’s Happy Baby Organics brand fruit puree. Products were analyzed as sold (not heated).

A Nestlé spokesperson told Food Safety Tech  “We understand the concerns raised in this report. We want to reassure all consumers that our products are safe to consume. We take our responsibility in feeding babies extremely seriously and apply strict controls across our entire value chain, including the rigorous selection and management of packaging.” materials.”

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Beltway Beat

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.

Food Packaging
Ask The Expert

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

By Food Safety Tech Staff
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Food Packaging

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

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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.

Hygiena ZymoSnap ALP

Hygiena® Secures U.S. Trademark for One Health Diagnostics®

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Hygiena ZymoSnap ALP

The United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for the trademark application of One Health Diagnostics®.

“We are thrilled to receive this Notice of Allowance from the USPTO,” said Amanda Manolis, VP Global Marketing, Scientific Affairs, Product & Program Management at Hygiena. “The One Health Diagnostics® mark reinforces our leadership in the category we are building and leading as the authority in rapid diagnostics. This recognition reinforces Hygiena’s role in advancing diagnostics beyond food safety into a fully integrated system that protects global health through data-driven insight and end-to-end visibility.

The global diagnostics market is undergoing a structural shift from isolated testing methods to integrated, intelligence-driven platforms. Hygiena’s One Health Diagnostics® portfolio is designed to meet this shift by delivering capabilities across the entire food safety and environmental monitoring value chain, from ATP hygiene and sanitation verification with UltraSnap®, AquaSnap® and KLEANZ®, to molecular, pathogen detection workflows with BAX® and foodproof® RT-PCR Systems. Our portfolio, which includes allergen and gluten detection with GlutenTox®, GMO and supply chain transparency testing to public health and environmental surveillance, empowers data-driven decision-making at every stage. More than just testing, our solutions protect public health, food security and sustainability.

Through platforms including SureTrend® Food Safety Management Software along with the newest addition to the Hygiena portfolio, KLEANZ® Sanitation Management, transform ATP, PCR, sanitation, and environmental data into real-time operational decisions, strengthening compliance, improving quality programs, and supporting continuous improvement.

Our One Health Diagnostics® ethos places Hygiena among the few organizations worldwide with a comprehensive portfolio covering the entire food safety value chain. At the core of One Health Diagnostics® is a shift from testing alone to connected diagnostics ecosystems, delivering actionable insights that drive smarter, faster and more sustainable decision-making.