Tag: FDA

FDA, CDC investigating Salmonella outbreak linked to sprouts

The US Food and Drug Administration (FDA), the US Centers for Disease Control and Prevention (CDC) and their state and local partners are investigating a three-state outbreak of Salmonella Typhimurium infections.

To date, the outbreak has sickened fifteen people in Nebraska (8), South Dakota (6), and Oklahoma (1), according to information provided by the CDC. Two people have been hospitalized.

The Nebraska Department of Health and Human Services has reported sixteen illnesses among individuals who consumed SunSprouts alfalfa sprouts between December 4–13. Eight of these have been confirmed genetically to be part of this outbreak. Results are pending on seven other cases.

Tracing the source

Epidemiological evidence collected by the CDC and its state partners identified alfalfa sprouts as a likely source of this outbreak.

Two outbreak victims specifically reported having purchased SunSprouts alfalfa sprouts at their local grocery stores. Others reported having consumed alfalfa sprouts at local restaurants.

A traceback investigation carried out by the FDA identified SunSprouts brand alfalfa sprouts grown by CW Sprouts Inc., doing business as (DBA) SunSprout Enterprises of Fremont, NE as the probable source of the outbreak.

The company has recalled four batches of alfalfa sprouts, identified as Lots ##4211, 5211, 3212, and 4212.

The recalled SunSprouts brand alfalfa sprouts were packaged in 4-ounce clamshells and 2.5 lb packages with best sold by dates between 12/10/2022 and 1/7/2023. The sprouts were supplied directly to restaurants and grocery stores in Nebraska, Kansas, and Iowa.

Inspection history

According to the FDA’s Inspection Database, CW Sprouts, Inc. has been inspected on at least seven occasions since 2009. Although some of its earlier inspections were classified “Voluntary Action Indicated,” there are no posted citations listed for the past ten years.

The most recent FDA inspection was completed in August 2021.

What you need to know

Consumers, restaurants, and retailers

  • Do not eat, sell, or serve recalled SunSprouts brand alfalfa sprouts.
  • Check your refrigerators for recalled SunSprouts brand alfalfa sprouts with best by dates between 12/10/2022 and 1/7/2023, and discard these items.
  • If you purchased or used recalled alfalfa sprouts, use extra vigilance in cleaning and sanitizing any surfaces that may have come in contact with these products, to reduce the risk of cross contamination.
  • If you or someone in your household ate SunSprouts alfalfa sprouts and have symptoms of salmonellosis, contact your healthcare provider.

Suppliers and Distributors

  • Do not use, ship or sell recalled alfalfa sprouts grown by SunSprout Enterprises.
  • Do not use any comingled and potentially cross-contaminated product if there has been potential cross-contamination or mixing of recalled alfalfa sprouts with products from other sources, and use extra vigilance in cleaning any surfaces and storage areas that may have come into contact with recalled alfalfa sprouts.
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Food Safety Administration: A too-modest proposal

Senator Richard Durbin (D-IL) and Representative Rosa DeLauro (D-CT) have proposed bicameral legislation to split the US Food and Drug Administration (FDA) into two separate entities: the Food Safety Administration (FSA) and the Federal Drug Administration.

The new Food Safety Administration would remain a part of the US Department of Health and Human Services and would be led by a food safety expert whose appointment would require Senate confirmation.

The proposed restructuring of the FDA came in response to agency shortcomings revealed during the recent Abbott Nutrition infant formula recalls and investigations.

Divide and conquer

While the intentions of Senator Durbin and Congresswoman DeLauro are to be lauded, I believe their proposed solution does not address a major underlying flaw in the US food safety regulatory system.

I am referring to the divided and overlapping jurisdictions of the current FDA and the Food Safety and Inspection Service (FSIS) of the US Department of Agriculture.

As now constituted, the FDA is responsible for ensuring the safety of approximately 80% of the US food supply. The FSIS oversees most of the balance, including meat, poultry, eggs and siluriformes (catfish and other related species).

This split jurisdiction has led to some strange and arbitrary divisions of authority. For example, the USDA oversees inspection of open-faced sandwiches containing meat or poultry, while the FDA is responsible for all other open-faced sandwiches as well as for all closed-face sandwiches, regardless of the filling.

Pizzas containing more than 2% meat are regulated by the FSIS; other pizzas come under the purview of the FDA.

As I wrote in TAINTED. From Farm Gate to Dinner Plate, Fifty Years of Food Safety Failures, “[a] fragmented inspection system is expensive, inefficient and unfair to the industry it regulates.”

In addition to the jurisdictional jigsaw puzzle, the FSIS is in a potential conflict of interest vis-à-vis other agencies within the USDA that are responsible for marketing US food commodities domestically and around the world.

Show me the money

The combined discretionary food safety budget allocated to FSIS and the current FDA for 2022 is $2.766 billion.

The FDA’s share of this budget is $1.6 billion, or ~58% of the total amount.

Yet, the FDA is responsible for regulating ~80% of the food supply. The Durbin/DeLauro proposal does nothing to address the funding imbalance between the two principal federal food safety agencies.

In 1998, a joint committee of food safety experts within the US Institute of Medicine and the National Research Council recommended that the US consolidate food safety into a “single, unified agency headed by a single administrator.“

Several US trading partners have done just that.

Canada, the United Kingdom, Ireland, Australia, New Zealand and Denmark, to name just a few, have successfully consolidated their food safety programs. In doing so, these countries have reduced duplication of efforts, streamlined jurisdictions, and removed the appearance of a conflict of interest between agricultural marketing and food safety.

The solution

The United States should have taken the advice of its own experts decades ago.

Representative DeLauro and Senator Durbin, the US food safety system is badly broken. What you are proposing is to apply a Band-Aid when what is needed is an organ transplant.

Instead of splitting the current FDA into two separate components, you should be proposing a single, unified, stronger Food Safety Administration. One with enough muscle to claim a seat at the cabinet table.

It’s time to “go big or go home.”

Learn more about a variety of food safety issues in TAINTED. From Farm Gate to Dinner Plate, Fifty Years of Food Safety Failures, now available in digital, print and audiobook editions.

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

Nine baby deaths reported to FDA during Abbott Nutrition investigation

Between December 1, 2021, and March 3, 2022, the US Food and Drug Administration (FDA) received nine (9) reports of infant deaths among babies who were fed powdered infant formula manufactured by Abbott Nutrition in Sturgis, Michigan.

The infant death reports were included in a list of 128 consumer complaints supplied to eFoodAlert by the FDA in response to a Freedom of Information Act (FOIA) request. (see: Abbott Nutrition consumer complaints file, Redacted)

Two of the deaths were numbered among the four confirmed outbreak cases of Cronobacter sakazakii identified by the US Centers for Disease Control and Prevention (CDC).

The other seven deaths were reported to the FDA via the agency’s consumer complaint system. Two of those reports mentioned Salmonella in the complaint description.

In addition to the nine deaths, consumers described twenty-five (25) incidents categorized as “Life Threatening Illness/Injury” and eighty (80) instances of “Non-Life Threatening Illness/Injury.”

Fourteen consumers contacted the FDA to obtain information or clarifications on the Abbott recall.

The complaints were lodged with FDA District Offices across the continental USA.

Salmonella was present in two of the dead babies, and was mentioned in seventeen other illness complaints.

One of the surviving infants was infected with both Salmonella and E. coli.

The symptoms suffered by the infants were mostly consistent with a gastrointestinal infection: fever (31 babies), vomiting (42 babies), diarrhea (47 babies), and blood in stool (6). Most babies suffered from multiple symptoms.

Other reported symptoms included loss of appetite, rash (either localized or spread over entire body), lethargy, dehydration, irritability, weight loss, and difficulty breathing.

Some of the infants suffered from multiple infections:

The FDA did not respond to eFoodAlert‘s request for comment on what was done to follow up on the seven infant death reports that did not involve Cronobacter sakazakii, or on the non-fatal illnesses not involving Cronobacter.

According to an agency spokesperson, the FDA, along with the CDC and state and local partners, investigated consumer complaints and/or reports, received from September 20, 2021 to February 24, 2022, of infant illness.

The spokesperson did not address any of the more than thirty complaints–including three reported deaths–received by FDA district offices between February 25, 2022 and March 3, 2022.

Two of those three reported deaths referred to Salmonella.

The FDA investigation uncovered multiple instances of Cronobacter sakazakii in the environment of Abbott’s manufacturing facility.

None of the cultures retrieved from environmental samples were a genetic match for the strain that infected the two babies for which the CDC received cultures. The CDC did not receive cultures from the other two infected babies for genetic analysis.

Although there is no direct evidence in the form of genome sequencing to link any of the illnesses unequivocally to Abbott’s infant formulas, all of the complaints have one element in common.

Every one of the sick babies was fed an Abbott powdered formula.

The FDA has established an Incident Management Group (IMG) under Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response.

The IMG is tasked with managing the ongoing investigation and monitoring the infant formula supply chain, and will remain in place at least until the current supply shortage is over, according to the FDA spokesperson.

In Memoriam

With production now having resumed–under close supervision–at the Abbott Nutrition plant in Sturgis, the time has come to acknowledge the lives that were lost.

We know very little about the nine infants who died. For privacy reasons, their names, ages, genders, where they lived, and when they died have been withheld. They are identified only by their unique Complaint ID numbers.

  • Complaint ID #171222, reported December 1, 2021. Infant arrived to the ER in cardiac arrest. Cronobacter sakazakii and Proteus mirabilis. Infant had consumed Similac Pro-Total Comfort (Powder) infant formula, Lot #23495K80.
  • Complaint ID #172435, reported February 22, 2022. Vomiting, swollen organs, trouble breathing. Infant had consumed Similac Advance, Lot #34875K80.
  • Complaint ID #172477, reported February 22, 2022. Screaming. Infant had consumed Similac Total Comfort Easy-to-Digest Gentle Protein & Prebiotics, et al, infant formula powder, Lot #34869K80.
  • Complaint ID #172479, reported February 23, 2022. Fever, diarrhea, loss of appetite, vomiting. Infant had consumed Similac Advanced infant formula. Lot number not available.
  • Complaint ID #172541, reported February 24, 2022. Tested positive for Cronobacter sakazakii. Infant had consumed Similac PM 60/40, Lot #27032K800.
  • Complaint ID #172585, reported February 24, 2022. No details available. Infant had consumed EleCare infant formula, Lot number not available.
  • Complaint ID #172607, reported February 28, 2022. Cause of death and opinion pending further studies (Congenital). Infant had consumed Similac Elecare powdered infant formula, Lot #34771Z21 1306305
  • Complaint ID #172632, reported March 2, 2022. Salmonella meningitis, ventriculitis, vomit, diarrhea, seizures, bradycardia. Infant had consumed Similac Pro Advance infant formula, Lot #25598SHO 0557 015 SIMESPWD.
  • Complaint ID #172636, reported March 2, 2022. Salmonella. Infant had consumed Similac Total Comfort, Lot #26834K80.

May they rest in peace.