According to the FDA’s website, Fresh-cut produce can be particularly susceptible to contamination, which can be introduced in the environment where it’s grown, during transport, during manufacturing, when it’s commingled with other products or at retail, and the opportunity for contamination can be amplified through each of these steps as it makes its way to consumers. Fresh-cut produce does not receive a kill step to eliminate pathogens that may be introduced during these processes and most are sold ready-to-eat. The guidance provides recommendations and examples of how the PCHF requirements can be implemented to protect fresh-cut ready-to-eat produce from contamination with biological hazards.
Fresh-cut produce includes any fruit or vegetable that has been physically altered from its whole state (e.g., by chopping, dicing, peeling, shredding) without additional processing (such as freezing or cooking) and distributed in fresh form. Examples of fresh-cut produce include chopped lettuce, cut cantaloupe, diced onions, and shredded carrots.
The final guidance reflects public comments received on the October 2018 draft guidance and replaces the 2008 FDA fresh-cut produce guidance. This guidance represents the agency’s current thinking on the issues related to preventing contamination in fresh cut produce. The agency encourages the industry to continue advancing and improving food safety practices, including through the development and implementation of Best Practice documents tailored to their specific commodities and processes.
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidance documents describe the agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidance means that something is suggested or recommended but not specifically required.
On August 10, 2026, HHS proposed a rule requiring food manufacturers to notify the U.S. Food and Drug Administration (FDA) when concluding that the use of a substance added to human or animal food is Generally Recognized as Safe (GRAS) and, alongside the U.S. Department of Agriculture (USDA), submitted for final review the federal government’s first proposed definition of ultra-processed foods (UPFs).
“Nearly 60% of the American diet is made up of ultra-processed foods, and childhood obesity now affects more than one in five American children,” said HHS Secretary Robert F. Kennedy, Jr. said within the press release “We cannot reverse America’s chronic disease epidemic without transforming our food system.”
Acting FDA Commissioner Kyle Diamantas, J.D. added “By proposing mandatory GRAS notifications, we are closing critical information gaps and giving the FDA greater visibility into substances entering the food supply. By advancing a proposed definition of ultra-processed foods, we seek to create a stronger foundation for future nutrition research. Together, these reforms represent a significant step toward a more transparent and modern food safety system.”
FDA Proposes Stronger Oversight of Food Ingredients
The FDA issued a proposed rule that would require manufacturers to notify the agency whenever they conclude that the use of a substance added to human or animal food is Generally Recognized as Safe (GRAS). The proposal would modernize the GRAS framework, increase transparency, and give the FDA greater visibility into substances entering the food supply.
Since Congress established the GRAS exemption in 1958, manufacturers have been permitted to reach their own conclusions that certain substances are generally recognized as safe under the conditions of their intended use. Although the FDA has long operated voluntary notification programs, companies have not been required to notify the agency when making these determinations.
The proposed rule would modernize that framework by making GRAS notifications mandatory and expanding the public-facing inventory of submitted notices, significantly improving transparency while strengthening the FDA’s ability to oversee ingredients entering the food supply.
For substances already on the market based on industry self-GRAS conclusions, the proposal would establish a time-limited streamlined submission pathway that would allow manufacturers to provide the FDA with information about existing uses. This enables the agency to prioritize post-market safety evaluations while minimizing unnecessary regulatory burden.
Consumer Reports Chimes in on the Announcement
Consumer Reports issued a statement regarding the proposed rule today pointing out that while the rule would require manufacturers to notify the FDA when they determine a new food substance is GRAS, manufacturers would still self-determine that safety conclusion themselves. Substances introduced into the market before the regulations go into effect, would be eligible for a separate, time-limited streamlined submission pathway.
“Considering the out-of-control, self-regulatory system we currently have for food ingredients, it’s disappointing that today’s announcement lacks substance and doesn’t propose anything meaningful,” said Brian Ronholm, Director of Food Policy at Consumer Reports. “Given the lack of any real enforcement under the proposed rule for failing to submit a GRAS notice, combined with the fact that it would not apply to chemicals already in our foods, it risks maintaining the status quo that allows secret ingredients and chemicals to remain on the market without FDA review.“
“The absence of a meaningful proposed rule demonstrates how budget cuts and years of underfunding have created a system where we may never fully know all the ingredients and chemicals in some of our foods. If the process for this proposed rule gets drawn out, it may be years before anything is implemented, if at all, so this should not preclude states from passing laws that protect consumers more quickly.”
Consumer Reports (CR) has called for closing the GRAS loophole in a recent petition with Yuka, which urges the FDA to end the practice of allowing companies to introduce new food additives without notifying the agency or undergoing federal safety review.
Definition of Ultra-Processed Foods
HHS and USDA submitted for final review the federal government’s first proposed definition of UPFs. Although research has linked high consumption of UPFs to preventable chronic diseases, including type 2 diabetes and heart disease, the absence of a standardized federal definition has limited research consistency across the federal government. The proposed definition incorporates feedback from thousands of stakeholders, including industry, consumer organizations, researchers, and members of the public.
August 10 update to this article: Apparently, there has been some confusion when the Simple Reform info went out because it is not affecting food, according to Dr. Stephen Ostroff, in a follow up email. Also, Steven Mandernach, J.D. Executive Director of Association of Food and Drug Officials (AFDO) told FST, he spoke with his food program contacts at the FDA last week, and they confirmed that the Human Foods Program is not affected by Simple Reform.
Originally reported: The Trump administration approved FDA’s reorganization proposal, according to an internal agency announcement. In the announcement, Melanie Keller, the FDA’s deputy commissioner for operations and chief operating officer, said the reorganization proposal known as “Simple Reform” will go into effect on Oct. 1 of this year.
The FDA’s “Simple Reform” reorganization primarily changes internal agency administration rather than regulatory standards, meaning current compliance rules and quality system requirements remain legally unchanged for industry facilities. However, shifting to a generalist inspectorate heavily reshapes how inspections will play out in practice.
Under the revised structure, individual centers like the Human Foods Program (HFP) will no longer conduct their own administrative affairs like human resources, finance and information technology services. Instead, the agency will operate under a “shared service” model in which the FDA Office of Operations controls those functions across the agency.
The agency will end deep technical specialization for field inspectors, merging food & beverage, medical devices and clinical research inspectorates into a mixed pool of generalists. Investigators will handle inspections across multiple industries instead of focusing exclusively on one narrow technical product field.
The food and beverage industry should expect a shift in audit dynamics, meaning audits will likely focus less on highly specific, niche technical processes and more on foundational, broad-spectrum quality systems.
In 2017, FDA moved to place inspectors within specific programs of expertise, rather than requiring them to work across multiple programs. Simple Reform will reverse that.
Food Safety Tech reached out to Dr. Stephen Ostroff, who was the Deputy Commissioner for Foods and Veterinary Medicine at FDA a position he assumed in May 2016.
Rick Biros: “Steve, I’m curious to learn your opinion on Simple Reform and the impact you think it will have on food safety. I’ve reached out to Mike and Frank as well.”
FDA’s Stephen Ostroff, M.D. answers audience questions at the 2017 Food Safety Consortium Conference
Steve Ostroff: “I was the Acting Commissioner of FDA when Program Alignment was finalized after several years of work. I recall celebrating in Chicago (after your conference) at the district office downtown. Program alignment was an effort to better vertically and horizontally align inspection activities – vertically within the inspectorate and horizontally between the Office of Regulatory Affairs inspectors and the headquarters programs. It recognized that having generalist inspectors was inefficient and failed to take into account how technically sophisticated FDA regulated products had become (and were rapidly becoming). It wasn’t possible for an inspector to be technically proficient in medical devices, gene therapies, regenerative medicine, infant formula, synthetic foods, etc. etc. It also wasn’t helpful to have an inspector principally working on foods be supervised by someone with expertise in medical devices. It was an effort that recognized the need for specialization and it was right then and it continues to be right.
The idea that inspectors would return to being generalists is a step in the wrong direction. The significant loss of inspectors since early 2025 may in part explain why this is being proposed. But this won’t solve that problem and won’t address the significant backlog of inspections in the food program, especially international inspections. It’s more likely to exacerbate it.
As for centralizing administrative functions like HR, finance and IT, this is like a pendulum that swings back and forth. It’s been tried over the years and there’s little evidence that it works or helps. In addition, given the resource imbalances at FDA between the medical products programs and the food program, it’s a recipe for the interests of the food program and needs of the food program to end up at the back of the line. As is so often the case, unfortunately. “
Frank Yiannas, who followed Dr. Ostroff as the next Deputy Commissioner for Food at FDA added “Don’t think it will achieve better results.”
“Simple Reform” will go into effect on Oct. 1 of this year. Dr. Donald A. Prater, Acting Deputy Commissioner for Food, U.S. Food and Drug Administration (FDA) will be presenting at the Food Safety Consortium Conference. October 21-23, 2026 in Washington DC. More info at FoodSafetyConsortium.org.
On July 19, 2026, FDA provided an update on the Cyclospora investigation regarding the sample of lettuce supplied by Taylor Farms de Mexico which was reported positive on July 18. “Due to the complexity in detection of Cyclospora, FDA laboratory experts re-reviewed the sample results and have concluded that the finding does not represent true amplification and should be considered a false positive.”
Information about the sample has been removed from the July 18, 2026, update. FDA has notified Taylor Farms and continues working with the firm to ensure product implicated in this outbreak has been removed from the market. FDA and state partners continue to collect and analyze product samples. As of July 19, 2026, there are no confirmed positive sample results for product testing for Cyclospora.
On July 19, 2026, Taylor Farms posted on the company’s website that “today, FDA apologized to us. Yesterday, FDA informed Taylor Fresh Foods that one of its iceberg lettuce products from central Mexico tested positive for cyclospora. Today, we were informed that FDA made a mistake, and this was a false positive. To be clear, at this moment, FDA has not identified a single positive product test result for Cyclospora.
Based on initial information provided by health officials, in an abundance of caution, we completed a voluntary recall of iceberg lettuce from central Mexico. Recalled product was limited to iceberg lettuce grown and processed in central Mexico.”
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.
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.
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
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.
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.
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.
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.
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