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.

TAINTED formats 3
“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.

Organic strawberries behind hepatitis A outbreak

The FDA, the CDC, the Public Health Agency of Canada (PHAC) and the Canadian Food Inspection Agency, in cooperation with their partner agencies, are investigating a cross-border outbreak of hepatitis A illnesses linked to organic strawberries.

A total of 27 outbreak cases have been confirmed in all, including ten in Canada and seventeen in the United States.

Canadian cases are reported in Alberta (4) and Saskatchewan (6), in individuals between 10 and 75 years of age. Four of the ten victims have been hospitalized.

Cases in the United States have occurred in California (15), Minnesota (1) and North Dakota (1), with 12 hospitalizations reported.

Illness onset dates range from March 28 to April 30, 2022 in the US, and between early and mid-April in Canada.

Patient interviews conducted in both countries linked the outbreak to consumption of fresh organic strawberries sold in the United States between March 5th and April 25th, and in Canada between March 5th and March 9th.

The strawberries, which have passed their shelf life, were sold in Co-op stores in Alberta and Saskatchewan and at the following retailers in the United States under FreshKampo and HEB brand names:

  • Aldi
  • HEB
  • Kroger
  • Safeway
  • Sprouts Farmers Market
  • Trader Joe’s
  • Walmart
  • Weis Markets
  • WinCo Foods

The strawberries were distributed across the United States, but only sold in the two Canadian provinces where hepatitis cases were reported.

Neither the FDA nor the PHAC have indicated in what country the strawberries were grown.

Consumers who may have frozen the strawberries for later use should check their freezer and throw away any suspect product.

What consumers should do

  • Check your freezer for these fresh organic strawberries purchased between March 5 and 9, 2022 at Co-op stores in Alberta and Saskatchewan or between March 5 and April 25th at one of the US retailers listed above. If you froze them to eat later, do not eat them. Throw away any remaining organic strawberries. If you don’t know where the strawberries came from, throw them out.
  • Wash and sanitize any drawers, shelves, or containers where the products were stored using a kitchen sanitizer (follow the directions on the container) or prepare a bleach solution in a labelled spray bottle (you can use a ratio of 5 ml of household bleach to 750 ml of water) and rinse with water.
  • If you have eaten these organic strawberries, purchased fresh and later frozen, or have symptoms consistent with hepatitis A, see your health care provider immediately. Vaccination can prevent a hepatitis A infection if given within 14 days of exposure.
  • Wash your hands before and after preparing or eating food, and after using the washroom or changing diapers.
  • If you have been diagnosed with hepatitis A, do not prepare or serve food and drinks to others.