Tag Archives: CDC

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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.

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.

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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

Beltway Beat

The CDC quietly scaled back FoodNet from Eight to just Two Pathogens

By Food Safety Tech Staff
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NBC News reported that FoodNet, a federal-state partnership that monitors for foodborne illnesses quietly scaled back its operations in early July of this year.

As of July 1, the Foodborne Diseases Active Surveillance Network (FoodNet) program has reduced surveillance to just two pathogens: salmonella and Shiga toxin-producing E. coli (STEC), a spokesperson for the Centers for Disease Control and Prevention told NBC News.

Before July, the program had been tracking infections caused by six additional pathogens: campylobacter, cyclospora, listeria, shigella, vibrio and Yersinia. Monitoring for the six pathogens is no longer required for the 10 states that participate in the program, though those states aren’t precluded from conducting surveillance on their own.

The change, which hasn’t previously been made public, could make it harder for public health officials to notice whether certain foodborne illnesses are rising and then slow response time to outbreaks.

As of publishing date, the FoodNet page on CDC’s website still states it monitors all eight pathogens.

FoodNet is a collaboration among the CDC, the Food and Drug Administration, the Agriculture Department and 10 state health departments. Its surveillance area covers roughly 54 million people, or 16% of the U.S. population. The network includes Colorado, Connecticut, Georgia, Maryland, Minnesota, New Mexico, Oregon, Tennessee and select counties in California and New York.

A list of talking points the CDC provided to the Connecticut Public Health Department, viewed by NBC News, cites a reason for the change: “Funding has not kept pace with the resources required to maintain the continuation of FoodNet surveillance for all eight pathogens.”

The CDC spokesperson said that other systems conduct national surveillance for the six pathogens that were removed from FoodNet. For instance, state health departments are still able to report cases through the National Notifiable Diseases Surveillance System. And the CDC’s Listeria Initiative collects reports of laboratory-confirmed cases of listeriosis — serious infections from eating food contaminated with listeria.

But FoodNet is the only surveillance system that actively looks for multiple foodborne diseases at the federal level. Other federal surveillance systems are passive, meaning the CDC relies on state health departments to notify it of cases.

The concern is that without active surveillance of all eight pathogens, public health officials won’t be able to adequately compare trends over time or notice whether cases of a particular illness start rising. Scaling back FoodNet’s operations could make it harder to quickly identify and respond to outbreaks.

Barbara Kowalcyk, director of the Institute for Food Safety and Nutrition Security at George Washington University, called the decision to reduce FoodNet surveillance “very disappointing.”

“A lot of the work that I and many, many, many, many other people have put into improving food safety over the past 20 or 30 years is just going away,” she said. Kowalcyk’s son died in 2001 of complications from a foodborne E. coli infection, and since then she has advocated for improvements to U.S. food safety policy.

Kowalcyk said that the federal budget for food safety hasn’t kept up with the cost of inflation and that cuts to federal funding for state health departments have most likely made it harder to maintain FoodNet surveillance. The CDC requested a $72 million budget for food safety for the 2026 fiscal year, about the same as it has requested in years past.

It’s not entirely clear how the changes to FoodNet are affecting surveillance on the state level so far.

The Oregon and Connecticut health departments said they were aware of the changes as of Monday. Meanwhile, the Georgia Public Health Department said that it hadn’t received any official notice from the CDC. And the New Mexico Health Department said it was awaiting notification from the CDC to determine the scope of its future surveillance.

The Maryland Health Department said the state’s health care providers and clinical laboratories are required to report cases of all eight pathogens monitored by FoodNet, so the reporting will continue “regardless of changes to the FoodNet network.”

The Colorado Department of Public Health and Environment said it will need to scale back active surveillance activities for some pathogens if funding is decreased in 2026.

Beltway Beat

Secretary Kennedy Swears in Susan Monarez as CDC Director

By Food Safety Tech Staff
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Susan Monarez, Ph.D., was sworn in today as Director of the Centers for Disease Control and Prevention (CDC) by U.S. Health and Human Services Secretary Robert F. Kennedy, Jr.

Director Monarez, the first Senate-confirmed director of the CDC, brings decades of frontline experience in disaster preparedness, biosecurity, and health innovation.

“Dr. Monarez is a public health expert with unimpeachable scientific credentials,” said Secretary Kennedy. “I have full confidence in her ability to restore the CDC’s role as the most trusted authority in public health and to strengthen our nation’s readiness to confront infectious diseases and biosecurity threats.”

“It is a great honor to join Secretary Kennedy and his HHS leadership team,” said Director Monarez. “I consider it a privilege to work alongside the public servants at CDC. Together we will strengthen and modernize the nation’s public health preparedness and response through science and innovation.”

Director Monarez most recently served as Acting Director of CDC and Deputy Director for the Advanced Research Projects Agency for Health, where she transformed the HHS operating division’s data collection, disease detection and treatment technologies. She has held previous leadership and advisory roles with Biomedical Advanced Research and Development Authority at HHS, the Department of Homeland Security, the White House’s Office of Science and Technology Policy, and the National Security Council.

Director Monarez earned her PhD in microbiology and immunology from the University of Wisconsin–Madison, where she conducted research on developing technologies aimed at the prevention, diagnosis, and treatment of infectious diseases. She completed her postdoctoral research fellowship at the Stanford University School of Medicine.

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Beltway Beat

Update on Outbreak Investigation of Listeria monocytogenes: Ready-to-Eat Foods

By Food Safety Tech Staff
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The FDA and CDC, in collaboration with state and local partners, announced in a press release that they investigated illnesses in a multistate outbreak of Listeria monocytogenes infections linked to recalled Ready-to-Eat (RTE) foods, or products that do not need additional cooking, produced by Fresh & Ready Foods, LLC of San Fernando, CA.

The recalled products were identified by the “Use By” dates from 4/22/2025 to 5/19/2025 and include the following brand names:

  • Fresh & Ready Foods
  • City Point Market Fresh Food to Go
  • Fresh Take Crave Away

These products are no longer available for sale in stores.

CDC announced that the outbreak is over. CDC reports a total of 10 illnesses in two states. There has been a total of 10 hospitalizations and one death attributed to listeriosis.

FDA is working with Fresh & Ready Foods on corrective and preventive actions.

FDA’s outbreak investigation is complete.

To sign up for a free subscription to Food Safety Tech’s weekly Newsletter, click here

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Beltway Beat

FDA, USDA FSIS, CDC and States Collaborate on Outbreak Investigation of Listeria from Chicken Fettuccine Alfredo Meals

By Food Safety Tech Staff
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The U.S. Food & Drug Administration (FDA), U.S. Department of Agriculture Food Safety and Inspection Service (USDA FSIS), and Centers for Disease Control and Prevention (CDC), in collaboration with state and local partners, are investigating illnesses in a multistate outbreak of Listeria monocytogenes infections linked to chicken fettuccine alfredo meals. Recalled product assembled at FreshRealm, Inc.’s San Clemente, California; Montezuma, Georgia; and Indianapolis, Indiana, manufacturing locations may be adulterated with the outbreak strain of Listeria monocytogenes.

As of June 18, 2025, a total of 17 cases have been reported from 13 states. Of the 11 people interviewed, 7 reported eating precooked meals, and 4 (57%) specifically reported eating chicken fettuccine alfredo. Of 17 people with information, 16 (94%) were hospitalized and there are 3 deaths attributed to listeriosis. There is one pregnancy associated illness in a mother that resulted in a fetal loss.

FDA has conducted a thorough investigation in response to this outbreak, including traceback of FDA-regulated ingredients within the assembled product. FDA used specific meal information reported by ill people, and collected by state officials and CDC, and firm records to trace FDA-regulated ingredients through the supply chain to the establishments where those were produced.  FSIS identified the outbreak strain in a routine sample of FreshRealm’s chicken fettuccine alfredo collected on March 19, 2025. This lot of product was not distributed into the food supply. FSIS also used purchase documentation to trace chicken fettuccine alfredo products purchased by two ill people to FreshRealm establishments. An additional two ill people verbally described chicken fettuccine alfredo products they purchased. FSIS identified products produced by FreshRealm that matched the descriptions during follow-up at the retail stores where they shopped.

FDA also initiated multiple inspections, including sample collection, at the manufacturers of some ingredients used to make the chicken fettuccine alfredo product.

Testing of the FDA-regulated ingredients collected to date is complete and the outbreak strain of Listeria was not found. FDA and FSIS have not yet determined a source of contamination for this product; however, both agencies are working closely with each other and CDC to continue to collect information to determine what additional steps are needed to protect public health.

On June 17, 2025, in response to this investigation, FreshRealm, Inc., recalled their pre-made chicken fettuccine alfredo products sold at Kroger and Walmart.

Beltway Beat

Senator Tom Cotton Introduces Bill to Unify Food Safety Agencies

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Senator Tom Cotton (R-Arkansas) introduced the Study And Framework for Efficiency in Food Oversight and Organizational Design (SAFE FOOD) Act, legislation that would direct the Department of Agriculture to conduct a study on the consolidation of federal agencies that have a primary role in ensuring food safety into a single agency.

The Bill states that not later than 60 days after the date of enactment of this Act, the Secretary of Agriculture shall conduct a study on the consolidation of Federal agencies with a primary role in ensuring food safety in the United States (including the Food Safety and Inspection Service, the Food and Drug Administration, and Centers for Disease Control and Prevention) into a single agency.

Not later than 1 year after the date of enactment of this Act, the Secretary of Agriculture shall submit to the appropriate committees of Congress a report containing the results of the study; and any recommendations of the Secretary of Agriculture with respect to the consolidation.

Full text of the bill may be found here.

Beltway Beat

HHS Announces Transformation to Make America Healthy Again

By Food Safety Tech Staff
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The U.S. Department of Health and Human Services (HHS) announced a dramatic restructuring in accordance with President Trump’s Executive Order, “Implementing the President’s ‘Department of Government Efficiency’ Workforce Optimization Initiative.”

The restructuring will address this and serve multiple goals without impacting critical services. First, it will save taxpayers $1.8 billion per year through a reduction in workforce of about 10,000 full-time employees who are part of this most recent transformation. When combined with HHS’ other efforts, including early retirement and Fork in the Road, the restructuring results in a total downsizing from 82,000 to 62,000 full-time employees.

Secondly, it will streamline the functions of the Department. Currently, the 28 divisions of the HHS contain many redundant units. The restructuring plan will consolidate them into 15 new divisions, including a new Administration for a Healthy America, or AHA, and will centralize core functions such as Human Resources, Information Technology, Procurement, External Affairs, and Policy. Regional offices will be reduced from 10 to 5.

Third, the overhaul will implement the new HHS priority of ending America’s epidemic of chronic illness by focusing on safe, wholesome food, clean water, and the elimination of environmental toxins. These priorities will be reflected in the reorganization of HHS.

Finally, the restructuring will improve Americans’ experience with HHS by making the agency more responsive and efficient, while ensuring that Medicare, Medicaid, and other essential health services remain intact.

FDA will decrease its workforce by approximately 3,500 full-time employees, with a focus on streamlining operations and centralizing administrative functions. This reduction will not affect drug, medical device, or food reviewers, nor will it impact inspectors.

“We aren’t just reducing bureaucratic sprawl. We are realigning the organization with its core mission and our new priorities in reversing the chronic disease epidemic,” HHS Secretary Robert F. Kennedy, Jr. said. “This Department will do more – a lot more – at a lower cost to the taxpayer.”

 

Listeria Outbreak Linked to Meats Sliced at Delis

By Food Safety Tech Staff
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The CDC website reported that there is a Listeria Outbreak Linked to Meats Sliced at Delis. Many people in this outbreak are reporting eating meats that they had sliced at deli counters. Investigators are collecting information to determine the specific products that may be contaminated. Products sold at the deli, especially those sliced or prepared at the deli, can be contaminated with Listeria. Listeria spreads easily among deli equipment, surfaces, hands and food.

As of July 19, 2024, a total of 28 people infected with the outbreak strain of Listeria have been reported from 12 states (see map). Sick people’s samples were collected from May 29, 2024, to July 5, 2024 (see timeline). Of 28 people with information available, all have been hospitalized. One person got sick during their pregnancy and remained pregnant after recovering. Two deaths have been reported, 1 in Illinois and 1 in New Jersey. The investigation is still active and there has been no recall.

Public health investigators are using the PulseNet system to identify illnesses that may be part of this outbreak. CDC PulseNet manages a national database of DNA fingerprints of bacteria that cause foodborne illnesses. USDA-FSIS is working to identify the suppliers of deli meats, sliced at deli counters, purchased by people in this outbreak.