Tag: FDA

What price compromise?

When seven Democrat senators and one independent sided with the Republican majority to pass a bill meant to end the government shutdown earlier this week, they did so in full knowledge that they were throwing Affordable Care Act premium subsidies under the bus.

Mike Johnson already has signaled that a vote in the Senate in favour of extending those subsidies would not guarantee a vote in the House.

But, did they realize that, by voting for the Republican bill, they were also throwing food safety under the wheels of that same bus?

According to The Lever, as reposted by Bill Marler (tip of the Petri dish lid for finding and sharing this), the Senate-approved language guts funding for certain current and planned FDA programs and Rules.

The Traceability Rule

Ironically, this Rule was first proposed under Trump 1.0 and is designed to simplify the tracing of a food to its source during a recall or foodborne disease outbreak investigation.

The Rule, which was finalized in 2023, requires food manufacturers, processors, packers, etc., “…maintain records containing information on critical tracking events in the supply chain for these designated foods, such as initially packing, shipping, receiving, and transforming these foods.”

The FDA allowed three years (ie., until January 2026) for those affected by the Rule to come into compliance with its requirements.

Last August, the FDA proposed to extend the compliance deadline by 30 months, to July 2028.

A provision of the Senate bill specifies that no funds “…may be used to administer or enforce the ‘Requirements for Additional Traceability Records for Certain Foods,’ published on Nov. 21, 2022.” 

Produce Safety

In 2016, the FDA issued a Final Rule, “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption” in response to a steady increase in foodborne disease outbreaks linked to contaminated produce.

Compliance dates for this Rule were staggered, with the smallest farms given until 2020 to conform.

The Senate bill just passed PROHIBITS any of the funding made available by the bill from being used to enforce the Produce Safety Rule.

Sodium / Ultraprocessed foods

Finally, in the ultimate irony of the MAHA world, the Senate bill slashes funding for the FDA to develop or administer regulations “…long-term population-wide sodium reduction actions until an assessment is completed on the impact of the short-term sodium reduction targets.” 

Making Americans Sick Again

As it happens, I am in the throes of writing a sequel to my food safety book, TAINTED: From Farm Gate To Dinner Plate, Fifty Years of Food Safety Failures.

The planned title of my new book is, TAINTED II: From Baby Food To Seniors’ Snacks, Making Americans Sick Again.

Watch for it.

TAINTED formats 3
“Reads like a true crime novel” – Food Safety News

Interested in learning more about food safety and the history of foodborne disease outbreaks and investigations?

Click on the link to listen to a short excerpt, then follow the buy links to add a digital, print or audio copy to your personal library.

Chapter 6. Birth of a Pathogen
Order TAINTED now from your preferred on-line retailer

OP-ED: It’s time for states to step up for food safety

Donald Trump and his acolyte, RFK, Jr., vowed to “Make America Healthy Again.”

They lied.

Watch what they do, not what they say.

Rachel Maddow, MSNBC host

Trump, aided by RFK, Jr., is dismantling the US food safety network

  • RFK, Jr. fired every single member of FDA’s media communications team, including its director.
  • The proposed 2026 budget for the FDA outlines plans to shift the responsibility for routine food safety inspections to the states.
  • The 2026 FDA budget also proposes an overall reduction in full-time equivalent staffing for the Human Foods Program of 7.6%, with the Office of Investigations and Inspections reduced by 2.0%, and the Field Laboratory Operations by 54.4%.
  • Staff cuts at the FDA have already put the brakes on the agency’s ability to trace the source of foodborne disease outbreaks. In 2024, the agency investigated a total of 26 outbreaks and identified the source of 20 (77%). In 2025, the FDA has closed its investigation of 11 outbreaks after identifying the source of only 4 (36%); an additional 11 investigations remain under investigation, with a food source having been identified in four (36%).
  • The CDC has reduced its active surveillance of foodborne pathogens from six target organisms to just two, claiming lack of funding.
  • RFK, Jr. and Secretary of Agriculture, Brooke Rollins proposed allowing bird flu to “rip through” infected poultry flocks instead of culling the flocks to prevent further spread.
  • The USDA withdrew its proposed rule that, for the first time, would have placed (very lenient) limits on the presence of certain Salmonella strains in raw poultry.
  • Staff cuts at the USDA’s Animal and Plant Health Inspection Service have reduced the agency’s ability to combat livestock diseases, including bird flu.
  • The US Justice Department unit that used to handle drug and food safety cases on behalf of the FDA has been disbanded.
  • The EPA has rolled back clean air standards and eased limits on pesticide use.

What can US consumers expect as a result of these roll-backs?

  • More foodborne disease, including more hospitalizations and deaths
  • More outbreaks going unreported and unsolved
  • Inconsistent food safety inspection standards from state to state

I have been a food safety microbiologist for more than fifty years. I have worked both in government and in the private sector.

During my entire career, I have advocated for a single agency to oversee food safety—an agency with Cabinet-level representation that would replace the current fragmented regulatory system in the United States.

But desperate times require desperate measures. The federal government is not doing its job. Nor does it plan to in the future.

States can—and must—act

The various states that have the resources to do so must take action to protect their population from the failures of the federal government.

Democrat-led states on both coasts have already acted to counter the CDC vaccine panel’s new recommendations that would restrict access to respiratory (Covid-19, influenza, and RSV), MMRV, and Hepatitis B vaccines.

The West Coast Alliance is comprised of California, Oregon, Washington, and Hawaii. The Northeast Public Health Collaborative includes New York, Pennsylvania, New Jersey, Connecticut, Massachusetts, Maine and Rhode Island, as well as New York City’s Department of Health.

If a state government can override federal recommendations on vaccine access, the state also can superimpose its own food safety regulations on those handed down by the FDA and USDA in order to protect its population from disease.

I propose that the West Coast Alliance be extended to encompass food safety, including the following actions:

  • Develop and implement a common set of inspection standards for produce and processed foods originating in California, Oregon, Washington, and Hawaii.
  • Embargo all shipments of produce and processed foods originating from outside the borders of its member states unless each individual shipment is accompanied by a Certificate of Analysis issued by an accredited laboratory.
  • Regulate discharge emanating from concentrated animal feeding operations (CAFOs) in the member states—discharge that pollutes the soil in which crops are grown and the water used to irrigate those crops.

I am not suggesting these actions will be easy or inexpensive. But, as the federal government no longer appears to be interested in protecting the public from unsafe food, the states that are able to do so must take over.

TAINTED formats 3
“Reads like a true crime novel” – Food Safety News

Interested in learning more about food safety and the history of foodborne disease outbreaks and investigations?

Click on the link to listen to a short excerpt, then follow the buy links to add a digital, print or audio copy to your personal library.

Chapter 6. Birth of a Pathogen
Order TAINTED now from your preferred on-line retailer

10 Listeria monocytogenes illnesses linked to ready-to-eat foods

100% OF PERSONS INTERVIEWED WERE ALREADY HOSPITALIZED BEFORE BECOMING INFECTED

The US Centers for Disease Control and Prevention (CDC) is investigating an outbreak of ten Listeria monocytogenes infections that have been linked to a strain of the pathogen found recently by the US Food and Drug Administration (FDA) in an environmental sample collected during a site inspection at Fresh & Ready Foods, LLC (San Fernando, CA).

The outbreak strain was first recovered from a patient in December 2023, and the most recent confirmed case dates back to September 2024. No cases have been reported in 2025.

The CDC investigated this outbreak in 2024. Epidemiological evidence revealed that the outbreak victims were in healthcare settings such as hospitals prior to becoming sick, and the likely source was a food served in those types of institutions. However, there was not enough information available to link the illnesses to a specific food or supplier.

The CDC reopened its investigation in April 2025, when it learned that the outbreak strain had been found during an FDA site inspection at Fresh & Ready Foods.

Outbreak victims range in age from 41 to 87 years, with a median age of 60. Nine of the ten victims were male. Eight of the ten victims lived in California; the other two resided in Nevada at the time they became ill.

Investigators from state and local public health agencies are interviewing outbreak victims to determine what foods they may have eaten in the weeks before becoming ill. Of the six people with information, all six (100%) were hospitalized before becoming sick. Records reviewed from facilities indicated that ready-to-eat foods made by Fresh & Ready Foods were served in at least three of the facilities.

The company has recalled more than 80 products bearing USE-BY dates from 4/22/2025 to 05/19/2025. The recalled products, which were sold under the brand names Fresh & Ready Foods, City Point Market Fresh Food to Go, and Fresh Take Crave Away, were distributed between 04/18/2025 and 04/28/2025 in vending and breakroom areas within corporate offices, medical buildings, and healthcare facilities located in Arizona, California, Nevada, and Washington. 

Fresh & Ready’s checkered history

Fresh & Ready Foods, LLC is under the joint jurisdiction of the USDA’s Food Safety and Inspection Service (Establishment numbers M39892+P39892+V39892) and the FDA.

The FDA inspected the company’s San Fernando, CA, facility on seven occasions between 2009 and 2022. On six of the seven occasions, the operations were classified as either Voluntary Action Indicated (VAI) or Official Action Indicated (OAI).

No Warning Letter appears to have been issued in response to the 2017 (OAI) inspection.

2009: Voluntary Action Indicated

  • Gloves used in food handling are not maintained in an intact, clean, and sanitary condition
  • Sanitizing agents are unsafe under conditions of use
  • Failure to hold ingredients in bulk or in suitable containers so as to protect against contamination.

2010: Voluntary Action Indicated

  • Suitable outer garments are not worn that protect against contamination of food and food contact surfaces
  • Your HACCP plan lists monitoring frequencies that do not ensure compliance with the critical limit
  • Your HACCP plan includes a corrective action plan that is not in accordance with 21 CFR 123.7(b) to ensure affected producct is not entered into commerce
  • Your verification procedures do not include, at a minimum, reassessment of the HACCP plan whenever modifications to the process are made
  • Your records do not include the date and time of the activitiy the record reflects
  • Your sanitation control records do not accurately document the conditions or practices observed at your firm

2011: No Action Indicated

2015: Voluntary Action Indicated

  • You are not monitoring the sanitation conditions and practices with sufficient frequency to assure conformance with Current Good Manufacturing Practices including protection of food, food packaging material, and food contact surfaces from adulteration.

2017: Official Action Indicated

  • You did not maintain your plant in a clean and sanitary condition and keep your plant in repair
  • You did not implement the monitoring procedures listed in your HACCP plan
  • Your HACCP plan does not list the food safety hazards that are reasonably likely to occur
  • Your HACCP plan does not list one or more critical control points that are necessary for each of the identified food safety hazards

2018: Voluntary Action Indicated

  • You did not implement the monitoring procedures listed in your HACCP plan
  • You are not monitoring the sanitation conditions and practices with sufficient frequency to assure conformance with Current Good Manufacturing Practices including prevention of cross-contamination from insanitary objects

2022: Voluntary Action Indicated

  • Your hazard analysis did not identify a known or reasonably foreseeable hazard that required a preventive control
  • Your process controls procedures did not include appropriate parameters and maximum/minimum values
  • Your HACCP plan does not list the food safety hazards that are reasonably likely to occur
  • Your HACCP plan lists monitoring procedures and frequencies that do not ensure compliance with the critical limit

What you need to know

The joint investigation by the CDC, the FDA, and the USDA is ongoing. Here are the FDA’s recommendations for keeping yourself and your loved ones safe.

Recommendations

  • Consumers, distributors, and foodservice customers, who purchased or received recalled Ready-to-Eat (RTE) foods manufactured by Fresh & Ready Foods, LLC, should not eat, sell, or serve these products. 
  • Foodservice customers, retailers and consumers who purchased or received the recalled products, should carefully clean and sanitize any surfaces or containers that it touched. Follow FDA’s safe handling and cleaning advice to reduce the risk of cross-contamination. Listeria can survive in refrigerated temperatures and can easily spread to other foods and surfaces.
  • If you or your family member have symptoms of listeriosis you should contact your health care provider to report your symptoms and receive care.
     

Recommendations for At-Risk Groups

  • Listeria is most likely to sicken pregnant women and newborns, adults aged 65 or older, and people with weakened immune systems. Other people can be infected with Listeria, but they rarely become seriously ill.
  • Pregnant women typically experience only fever, fatigue, and muscle aches. However, Listeria infection during pregnancy can lead to miscarriage, stillbirth, premature delivery, or life-threatening infection of the newborn.
  • Call your healthcare provider right away if you have symptoms of a Listeria infection.
TAINTED formats 3
“Reads like a true crime novel” – Food Safety News

Interested in learning more about food safety and the history of foodborne disease outbreaks and investigations?

Click on the link to listen to a short excerpt, then follow the buy links to add a digital, print or audio copy to your personal library.

Chapter 6. Birth of a Pathogen
Order TAINTED now from your preferred on-line retailer