FDA's handling of infant formula crisis raises questions about agency's ability to protect public health

The newly installed deputy commissioner for human foods faces the tough task of reforming the embattled agency, yet some senators and other industry leaders are not convinced that it will be enough to improve its culture.

Cindy Hazen, Contributing writer

September 15, 2023

4 Min Read

At a Glance

  • FDA acknowledged that it should do more to reduce foodborne illness, but it's unclear how much progress the agency has made.
  • GAO is being asked to investigate FDA's food safety efforts and to recommend ways to improve the agency's effectiveness.
  • The senators are committed to working with FDA to improve food safety in the United States.

Preventing foodborne illness is a bipartisan goal. Senators from the Democratic and Republican parties are demanding accountability from FDA, in part due to the agency’s handling of the 2022 infant formula crisis. On Sept. 12, Sen. Richard Blumenthal (D-CT) and Senate Majority Whip Dick Durbin (D-IL) sent a letter to the U.S. Government Accountability Office (GAO) questioning FDA’s effectiveness. On Sept. 11, four Republican senators sent a letter to FDA with a similar theme. All four Republicans are members of the Health, Education, Labor and Pensions (HELP) committee that has oversight of FDA. 

Blumenthal and Durbin referenced an evaluation of FDA by an independent panel. The Reagan-Udall report, issued in December 2022, cited issues with the current culture at FDA, “including the lack of a clear vision and mission; a disparate structure and a consensus governance model; competing priorities; and the lack of a strong, supportive leader and, when the situation requires, an ultimate decision-maker, who is responsible for the Human Foods Program.” The panel found the agency’s organizational structure reinforces duplicative roles and responsibilities, siloed work and inadequate internal and external engagement. Additionally, resources are inadequate, the report stated. 

Related:California Senate passes bill to ban four food additives

FDA has since proposed a unified Human Foods Program run by a deputy commissioner for Human Foods. On August 23, the agency announced the appointment of James “Jim” Jones as the first-ever deputy commissioner.  

Republican Senators Cassidy et al. acknowledged FDA’s recent efforts to reorganize into one organization, but noted in their letter to the agency: “We are concerned that FDA has not provided specific details about how it will foster an improved culture within the Human Foods Program.” 

The senators are seeking specific details from FDA that include: 

  • A clear vision and strategic goals for the program 

  • Concrete metrics to measure whether the program is achieving its goals 

  • Greater detail on how the Office of Critical Foods will operate and ensure safety 

  • More information on efforts to improve interagency coordination. 

In the letter to GAO, the Democratic senators acknowledged FDA has taken steps to address some of the issues raised in the panel’s report, including proposals to restructure the agency. “Given the importance of FSMA to FDA’s goal of reducing foodborne illness in the United States, as well as the increases in funding for food safety and the recent changes at the agency, we request that GAO undertake a review that focuses on the following questions:” 

Related:FDA issues warning letters to three infant formula manufacturers

1.      What have been the key trends in foodborne illness since FSMA was enacted in 2011? 

2.      To what extent has FDA assessed its own effectiveness in implementing FSMA to reduce foodborne illness in the United States, and what metrics, if any, does FDA use to measure FSMA’s success? 

3.      What challenges, if any, does FDA face as it implements FSMA, and what barriers, if any, does FDA face in achieving its goal of further reductions in foodborne illnesses? 

4.      What impact, if any, have the recommendations in the Reagan-Udall report and FDA’s subsequent proposed changes had on the agency’s food safety efforts? 

5.      What new resources or authorities does FDA require from Congress to more effectively reduce foodborne illness in the United States? 

In the same letter to GAO, data from the Centers for Disease Control and Prevention (CDC) was provided. "Each year, roughly 1 in 6 Americans (or 48 million people) get sick, 128,000 are hospitalized, and 3,000 die as a result of foodborne illness.”  

Possibly because the CDC is also underfunded, the agency’s data may be lacking. “The oft cited 48 million number is quite dated, and we need to be able to gauge, if not in real time, at least more quickly, where foodborne illness stands in the U.S.,” said Dr. Jennifer McEntire, former chief food safety officer at International Fresh Produce Association and founder of Food Safety Strategy. “Plus, we know that almost half of these are due to norovirus, often associated with food preparation (home, restaurants, institutions, etc., Norovirus Burden and Trends | CDC). CDC's FoodNet data and other sources of data that track illness become difficult to interpret when you consider improvements in detection and diagnostics.  

Related:White House Proposes Single Food Safety Agency Under USDA

Still, McEntire wondered if a difference has been made with the investments the food industry has made in food safety.  

“Is food safer?” she continued. “We don't have a good way to trend rates of foodborne illness since FSMA was passed. If GAO is able to investigate, maybe they will reveal some insights. We're more than a dozen years past FSMA, and a review of the impact on public health is warranted. With FDA's new leadership in the Human Foods Program, questions about how FDA can measure success are timely.”  

About the Author(s)

Cindy Hazen

Contributing writer

Cindy Hazen has more than 25 years of experience developing seasonings, dry blends, beverages and more. Today, when not writing or consulting, she expands her knowledge of food safety as a food safety officer for a Memphis-based produce distributor.

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