Tag Archives: FDA

By Food Safety Tech Staff

FDA’s Human Foods Program (HFP) released its priority deliverables for 2026. As part of HFP’s comprehensive plan, these targeted deliverables represent more than incremental progress; they signal a transformation in how HFP fulfills its mission to protect and enhance public health.

According to a press release, in 2026, HFP will build on accomplishments in 2025, guided by the three risk pillars, to strengthen and shape the next phase of FDA’s efforts. Throughout this year, FDA intends to provide periodic updates on their progress.

The planned activities include:

Food Chemical Safety: Improving the safety of food ingredients by systematically reviewing and, where appropriate, banning additives from the food supply.
Nutrition: Helping to reduce the prevalence of diet-related chronic disease by increasing transparency and empowering consumers to make informed choices through enhanced food labeling, such as front-of-package nutrition labeling; and expanding options for safe, reliable, and nutritious infant formula for American families through Operation Stork Speed initiatives.
Microbiological Food Safety: Enhancing food safety by advancing strategies and best practices for preventing contamination in human foods, strengthening protection by leveraging state oversight to complement FDA’s resources, and improving transparency of FDA’s regulatory and enforcement decisions.

In line with these 2026 priorities, HFP is also publishing its proposed 2026 guidance agenda to increase transparency of their work and processes, enhance food safety, and empower consumer nutrition choices, including the following impactful public health actions:

Establishing action levels for cadmium and inorganic arsenic in infant and young children’s foods, plus issuing guidance on preventive controls for chemical hazards.
Issuing guidance to assist industry in implementing effective sanitation controls consistent with the Preventive Controls for Human Food rule.
Issuing guidance to assist with food labeling for online grocery store platforms to give consumers access to nutrition information wherever they shop.

FDA states its goals for 2026 are ambitious, but claims HFP has the dedication, knowledge, and experience to tackle them.

January 21, 2026

Allergen Alley

FDA Takes Steps to Improve Gluten Ingredient Disclosure in Foods

By Food Safety Tech Staff

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The U.S. Food and Drug Administration issued a Request for Information (RFI) regarding labeling and preventing cross-contact of gluten in packaged food. The FDA is taking this action as a first step to improve transparency in disclosures of ingredients that impact certain health conditions, such as gluten for those with celiac disease, and other established food allergens.

The agency is seeking information on adverse reactions due to “ingredients of interest” (i.e., non-wheat gluten containing grains (GCGs) which are rye and barley, and oats due to cross-contact with GCGs) and on labeling issues or concerns with identifying these “ingredients of interest” on packaged food products in the U.S.

The agency has received a citizen petition on this matter and has reviewed available data and reports including the most recent reports by the Food and Agriculture Organization of the United Nations expert consultation. The FDA’s review of this information indicates that there are several serious data gaps limiting the agency’s ability to fully evaluate the public health importance of these ingredients which includes limited U.S. data on adverse reactions to the “ingredients of interest.”

The FDA seeks detailed information such as the prevalence of products where rye or barley are not currently disclosed; information on the severity of and potency of immunoglobulin E-mediated food allergy to rye and barley; concerns around the gluten content of oats due to cross-contact and other questions related to these issues.

The FDA is taking this action to help enhance transparency for consumers and inform the agency’s gluten-related labeling priorities and next steps. The FDA intends to use the information to support a determination on what type(s) of future regulatory actions we should take to better protect consumers with celiac disease.

How to Submit Comments

Electronic Submissions Comments can be submitted via the Federal eRulemaking Portal to Docket No FDA-2023-P-3942 (open for 60 days). Follow the instructions for submitting comments.

Written Submissions Written comments may be mailed to:
Dockets Management Staff (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

Ensure that all comments include Docket No. FDA-2023-P-3942. Confidential submissions should be appropriately marked.

January 13, 2026

Beltway Beat

DeLauro, Durbin Reintroduce the Federal Food Administration Act

By Food Safety Tech Staff

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On December 10, 2025, Congresswoman Rosa DeLauro (CT-03) and Senate Democratic Whip Dick Durbin (D-IL) reintroduced the Federal Food Administration Act, legislation that would streamline our food safety system by consolidating food oversight into a single agency dedicated to keeping the foods Americans eat safe.

“We need a single food safety agency to ensure the food Americans eat is safe,” said DeLauro. “Currently, food safety oversight is scattered across multiple agencies with the bulk of the responsibility falling to the Food and Drug Administration – where food safety has often been treated like a second-class citizen. This legislation would put one agency clearly in charge with the singular mission of protecting our food supply with the resources, staff, and focus to achieve that goal. I am proud to partner with Senator Durbin in this effort, because Americans deserve peace of mind that the government is keeping companies accountable with clear, consistent safety standards.”

“The sad reality is that FDA has failed to protect Americans from preventable foodborne illnesses and death. In recent years, the FDA has failed to protect babies from bacterial infections in their infant formula and lead-tainted applesauce pouches,” said Durbin. “This is why Congresswoman DeLauro and I are introducing legislation to create a Federal Food Administration. With the Federal Food Administration Act, we hope our nation will have greater success in protecting the foods in our kids’ lunch boxes and on our dining room tables.”

FDA regulates approximately 80 percent of our food supply. Consumers and companies depend on FDA to perform its regulatory role effectively. Yet, despite increased authorities included in the Food Safety Modernization Act (FSMA) and the creation of the Human Foods Program at FDA, the agency has failed to make significant inroads in reducing rates of foodborne illness and death in the U.S.

About one in six Americans—or 48 million people—get sick from a foodborne illness each year. According to the Centers for Disease Control and Prevention (CDC), 128,000 Americans also are hospitalized and 3,000 Americans die of foodborne diseases each year.

A single food safety agency, with a Senate-confirmed Commissioner, will strengthen oversight of the food supply, improve the health and well-being of Americans, and ensure companies that cut corners on food safety are properly held accountable.

Joining Durbin and DeLauro as original cosponsors of this legislation is Sen. Richard Blumenthal (D-CT) and U.S. Representative Sara Jacobs.

The legislation is endorsed by Consumer Reports, Consumer Federation of America, Environmental Working Group, and STOP Foodborne Illness.

December 31, 2025

Beltway Beat

FDA Opens VQIP Application Portal for FY2027

By Food Safety Tech Staff

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The FDA’s Voluntary Qualified Importer Program (VQIP) application portal for fiscal year 2027 opens on January 1, 2026, providing food importers with an opportunity to streamline their import processes through expedited review and importation benefits.

VQIP is a voluntary, fee-based program that offers expedited review and importation benefits for human and animal foods when importers demonstrate control over their supply chain safety and security. To participate, importers must ensure their foreign supplier facilities are certified through FDA’s Accredited Third-Party Certification Program.

Key Application Details:

• Application Window: January 1 – September 1, 2026

• Program Year: FY2027 benefits

Getting Started:

• Create an account on the FDA Industry Systems website (https://www.access.fda.gov/)

• Contact FSMAVQIP@fda.hhs.gov for an informational meeting

• Review eligibility requirements and certification needs, as foreign supplier facilities must be certified by FDA-accredited third-party certification bodies.

VQIP supports FDA’s Strategy for the Safety of Imported Food by incentivizing importers to use certified suppliers and maintain robust processes to help ensure imported food meets U.S. food safety requirements.

Resources and Support:

For questions or assistance, contact the VQIP Importers Help Desk:

• Email: FSMAVQIP@fda.hhs.gov

• Phone: 301-796-8745

• Program Information: https://www.fda.gov/food/importing-food-products-united-states/voluntary-qualified-importer-program-vqip

November 12, 2025

Beltway Beat

FDA and CDC Leading Multistate Outbreak Investigation of Infant Botulism from Infant Formula

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The FDA and CDC, in collaboration with the California Department of Public Health (CDPH), Infant Botulism Treatment and Prevention Program (IBTPP) and state and local partners, are investigating a multistate outbreak of infant botulism. Epidemiologic and laboratory data show that ByHeart Whole Nutrition infant formula might be contaminated with Clostridium botulinum, which is causing infant illness in multiple regions of the country.

As of November 10, 2025, a total of 15 infants with suspected or confirmed infant botulism and confirmed exposure to Byheart Whole Nutrition infant formula (various lots) have been reported from 12 states. Laboratory confirmation for some cases is ongoing. For 14 cases with illness onset information available, illnesses started on dates ranging from August 9 to November 10, 2025. All 15 infants were hospitalized. No deaths have been reported to date. For 14 infants with age and sex information available, they range in age from 16 to 157 days and 7 (50%) are female.

The company posted a letter on the company’s website. https://byheart.com/ that stated It’s important that you know that neither we, nor the FDA or CDC, have found Clostridium botulinum spores or toxins in any unopened can of ByHeart formula. The decision to broaden our recall to all ByHeart products comes after a call with the FDA late last night, informing us that they found two more cases of infant botulism in babies that had also consumed ByHeart at some point. The FDA’s investigation into infant botulism in the U.S. is still ongoing, and we feel that there are still too many unanswered questions. Your baby’s safety is, and always will be, our biggest priority. Upon learning about this outbreak on Friday evening, we immediately began conducting our own extensive testing on all ByHeart batches. Additionally, we are providing the FDA complete and unrestricted access to all of our facilities and products for their investigation, which has been done regularly at our owned facilities.

State and local public health officials are interviewing caregivers about the foods the infants were fed in the month before they got sick. Fifteen infant botulism cases have been identified that were fed ByHeart Whole Nutrition powdered infant formula before getting sick.

According to information shared by IBTPP, since August 1, 2025 through November 10, 2025, 84 infants nationwide have received treatment for infant botulism. Notably, more than 40% (15) infants who had consumed ByHeart Whole Nutrition infant formula.

This information shows that ByHeart brand formula is disproportionately represented among sick infants in this outbreak, especially given that ByHeart represents an estimated 1% of all infant formula sales in the United States. Investigations remain ongoing, but have not identified any other infant formula brands or shared exposures that pose a risk to infants.

As part of this investigation, officials in several states have collected leftover infant formula for testing. On November 8, 2025, preliminary laboratory results reported by the California Department of Public Health suggest the presence of the bacteria that produce botulinum toxin in a can of ByHeart infant formula (lot 206VABP/251131P2) that was fed to an infant with infant botulism. Additional testing is underway, and results are expected in the coming weeks. Detection of Clostridium botulinum in infant formula is difficult, and a negative test result does not rule out the presence of the bacteria in the product.

FDA contacted the firm and requested a recall expansion to include all ByHeart infant formula on the market. On November 11, 2025, ByHeart expanded its recall to include all ByHeart formula nationwide, including cans and single-serve sticks. All ByHeart Whole Nutrition Infant Formula products have been recalled. This includes all unexpired lots of formula cans and single-serve “anywhere” sticks.

FDA’s Commissioner, Dr. Marty Makary, interviewed on CBS News on Nov.12, stated that the FDA did find one positive case of the bacteria that produce botulinum toxin in a can of ByHeart infant formula.

Update: The New York Times reported that a Pennsylvania plant run by the company, ByHeart, was shut down this year after inspectors found mold, a leaking roof and more than 2,500 dead insects in a food production area.

According to the Times article, FDA inspection reports detailed significant problems at the company’s site in Reading, Pa. Although the reports did not involve the plants that made the formula recalled in the botulism outbreak, the findings raise concerns about the company’s safety record.

For example, in July and August 2022, ByHeart found cronobacter sakazakii, a bacterium that can be deadly to infants, in the processing area of the plant. When the company also found the bacteria in a can of finished formula weeks later, it faulted the laboratory that discovered it.

Months later, FDA inspectors returned to the Pennsylvania manufacturing site, detecting mold in a tank meant to contain clean water, finding more than 2,700 dead insects in a food production area and learning the plant had dealt with several roof leaks. The FDA classified the inspection at its highest tier of concern.

October 3, 2025

Beltway Beat

FDA Announces First Use of Import Certification Authority for Certain Shrimp and Spices Potentially Contaminated with Cesium-137

By Food Safety Tech Staff

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The FDA announced today that, effective October 31, 2025, the agency will require import certification for shrimp and spices from certain regions of Indonesia, based on the risk of potential contamination of the food with Cesium-137. This represents the first use of this Congressional authorized tool to address ongoing food safety problems while keeping trade flowing for products which meet the certification requirements. In addition to issuing Import Alert #99-52 which outlines FDA’s risk-based determination and notice of the implementation of the new requirements, the FDA published a new webpage explaining its import certification authorities.

Congress gave the FDA import certification authority under section 801(q) of the Federal Food, Drug, and Cosmetic Act through the Food Safety Modernization Act. This tool allows the FDA to require certification or other assurance that imported food meets U.S. requirements before the food can leave the port of export for shipment to the U.S. The FDA may use this authority to address ongoing and repeated food safety problems through additional oversight before shipment. This approach works alongside current tools to cover larger volumes of trade while maintaining safety oversight. Import certification supports foreign firms’ abilities to bring compliant products to U.S. markets while keeping potentially contaminated products out of the U.S.

The FDA is taking this action to require import certification after U.S. Customs and Border Protection detected high levels of Cesium-137 in multiple shipments of shrimp and in a sample of cloves from certain regions of Indonesia and the FDA’s laboratory confirmed contamination in food samples, in addition to other evidence and information reviewed by the FDA.

October 3, 2025

Beltway Beat

FDA Human Foods Program: Outbreak Investigations & Safety Advisories

By Food Safety Tech Staff

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CORE Outbreak Investigation Table

The CORE Outbreak Investigation Table is a list of outbreak and adverse event investigations primarily being managed by FDA’s CORE Response Teams. The investigations are in a variety of stages, meaning that some outbreaks have limited information, and others may be near completion. The table will be updated weekly.

This week’s updates are:

Due to the absence of either a fiscal year 2026 appropriation or a Continuing Resolution, only certain government activities will continue. While FDA will continue to conduct foodborne outbreak surveillance and response activities, the CORE Investigation Table will not be updated weekly during this time. FDA will continue to issue public warnings if there is actionable information to protect consumers from foodborne illness.
For the outbreak of Salmonella Lomalinda (ref #1339), the case count has increased from 35 to 37 cases.
For the outbreak of Listeria monocytogenes (ref #1309), the case count has increased from 25 to 26 cases.
For the outbreak of Salmonella Enteritidis (ref #1329), the case count has increased from 40 to 45 cases.
For the outbreak of Salmonella Anatum (ref #1312), the outbreak has ended and FDA updated the outbreak a dvisory on September 25, 2025.
For the outbreak of Listeria monocytogenes (ref #1290), FDA updated the advisory to include additional product recall information related to this outbreak. See the advisory for additional information.

CORE Outbreak Investigation Table

September 18, 2025

Ask The Expert

Seeing the Forest Through the Trees: Advancing Integration in the U.S. Food Protection System

By Rick Biros

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Calls to integrate the regulatory oversight of the U.S. food system have been echoed for decades through studies, reports, and policy forums—yet meaningful change has remained elusive. While the FDA’s recent creation of the Office of Inspections and Investigations marks an important step toward more coordinated oversight, the USDA’s FSIS still lacks a parallel structure, and significant gaps persist across the broader food protection landscape.

From food safety and quality to food defense, food integrity, and physical and digital security, the farm to fork system continues to operate in silos. This fragmentation not only creates regulatory confusion for industry stakeholders but also fuels inconsistent enforcement and mixed messages for consumers potentially leading to negative public health impacts and loss of consumer trust due to confusing recall messages—exemplified by the widely cited disparity in how cheese and pepperoni pizzas are regulated by different federal agencies.

This topic will be discussed at the Food Safety Consortium conference in Alexandria VA., October 19-21. Panelists include Benjamin Reading, Ph.D. Interim Assistant Director, NC Agricultural Research Service (NCARS) Associate Professor & University Faculty Scholar, North Carolina State University and Jason Bashura, M.P.H., RS, a 25+ yrs. public health and food protection professional. Ben and Jason discuss the need for truly unified, risk-based U.S. food protection system in this 26 minute recorded webinar. To watch the video, click on the image below or this link: Watch the Webinar.

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

After watching the video, we invite you to take a quick 5 question survey on this topic. You can win a chance to receive a complimentary registration to the Food Safety Consortium by correctly identifying the number of times Jason says the two words “Food Protection” in the webinar. Click here to take the Survey.

The session at the Food Safety Consortium will convene leaders from regulatory agencies, industry, academia, and NGOs to explore the structural and operational challenges that continue to hinder integration. Through their collective insights, attendees will gain a deeper understanding of what a truly unified, risk-based food protection system could look like, why such a system is needed now more than ever, and how emerging solutions—both policy-based and practical—can help close longstanding gaps.

By moving beyond agency silos and outdated jurisdictional lines, this session challenges participants to rethink what it means to protect the food supply and to consider how collaboration can turn complexity into clarity. This is the next step in seeing the forest through the trees—and laying the groundwork for a smarter, more resilient food protection system.

The Food Safety Consortium, presented by Food Safety Tech and the American Frozen Food Institute (AFFI) will take place October 19-21, 2025, at the Crystal Gateway Marriott, Arlington VA directly across the Potomac River from Washington, DC. The Program starts with several pre-conference workshops and training which leads into two full days of high-level panel discussions and educational presentations that will be sure to open your mind and expose you to a variety of topics, ideas and like-minded Food PROTECTION professionals who will be in attendance.

For a limited time, you can receive a 10% discount off registration by entering the discount code FoodProtection. Visit FoodSafetyConsortium.org

September 16, 2025

Allergen Alley

FDA to Open Registration for the Virtual Public Meeting and Listening Sessions on Food Allergen Thresholds and Their Potential Applications

By Food Safety Tech Staff

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The FDA invites the public to attend a virtual public meeting on November 18, 2025 and listening sessions on November 19 – 20, 2025 regarding food allergen thresholds and their potential applications in the U.S. Recent scientific developments in food allergen thresholds have prompted the FDA to explore how these thresholds can improve food safety, enhance labeling practices and help consumers make more informed choices. The purpose of the public meeting and listening sessions is to discuss strategies for approaching food allergen thresholds to benefit public health.

During these events, there will be presentations to provide background on the food allergen landscape and risk-based food allergen thresholds. The two days of facilitated listening sessions (November 19 – 20, 2025) will offer participants the opportunity to provide feedback on the following topics:

Risk-based food allergen thresholds concepts,
Risk communications and labeling,
Potential applications of food allergen thresholds; and
Challenges with food allergen thresholds in the U.S.

Questions for consideration during the public meeting and listening sessions, should be submitted through the registration. Registration for the November 18, 2025 public meeting will remain open until the start of the meeting. In order to attend the listening sessions, participants are required to register by November 3, 2025. There will be a maximum number of participants for each session.

Beginning November 18, 2025, a Regulations.gov docket will open for comments related to the event topic. The FDA will provide future communications on the comments process and timeline.

August 11, 2025

Beltway Beat

Kyle Diamantas, Deputy Commissioner for Human Foods, FDA To Present at the Food Safety Consortium

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Donna Garren, Ph.D., Executive Vice President of Science & Policy at AFFI who co-chairs the Food Safety Consortium program committee confirmed that Kyle Diamantas, Deputy Commissioner for Human Foods, FDA will present at the Food Safety Consortium Conference, October 19-21 in Washington DC.

Mr. Diamantas will join Dr. Denise Eblen, Administrator, U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) in a plenary session called “Regulators in the Spotlight: FDA & USDA’s Vision for Safer Food.” They discuss FDA and FSIS’ vision for advancing food safety through science-based policymaking, enhanced surveillance, and streamlined regulatory frameworks.

Equally important, this session will emphasize the critical role of stakeholder engagement. Attendees will hear how industry leaders, state regulators, consumer advocates, and academic partners can actively participate in shaping policy—ensuring that new regulations are practical, effective, and rooted in collaboration.

Dr. Emilio Esteban, Chief Scientific Officer for Mérieux NutriSciences’ North America division, and Head of its Global Analytical Hub and former Undersecretary for Food Safety at USDA is the opening keynote speaker. The closing keynote speaker is Ricky Dickson, Author and Former CEO of Blue Bell Creameries.

The full program is available at FoodSafetyConsortium.org

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