GAO Disappointed in Foodborne Illness Prevention, Calls Out FDA in Recent Report

The Government Accountability Office (GAO) has officially called out deficiencies in foodborne illness prevention results, as described in the Food Safety Modernization Act (FSMA) enacted in 2011. While a good portion of the plans were met, there are at least five points that remain unaddressed and much of what exists is insufficient.

With 15 years passing between its inception and looming deadlines on the horizon, the GAO accurately deemed a study on their progress necessary.

What prompted a need for FSMA and foodborne illness prevention in the first place? Why did GAO revisit their progress? What has the FDA done so far, and what do they still need to complete for compliance?

Let’s explore the GAO’s report, “Further Action Needed to Implement Foodborne Illness Prevention Law and Assess Its Results.”

What Prompted FSMA and the Need for Official Foodborne Illness Prevention?

The FSMA was created to shift the focus from responding to foodborne illness to a system designed to prevent it.

The Centers for Disease Control and Prevention (CDC) estimates that around 48 million people get sick with a foodborne illness each year.

That is one in six people in the country!

Of those, around 128,000 people are hospitalized for severe illnesses. Each year 3,000 people die because of them.

Foodborne illness is a “significant public health burden.” One that is preventable and should not be ignored.

With about 80% of the U.S. food supply governed by the U.S. Food and Drug Administration (FDA), this organization was the most likely to impact foodborne illness prevention.

Several new Programs were formed to achieve this goal. Additionally, certain “rules” were created to standardize activities. All of which are managed by the FDA.

Much of what was asked of the FDA has been addressed.

But not everything.

Why Did GAO Revisit FDA Progress on Foodborne Illness Prevention?

Despite a 15-year span, large-scale multi-state outbreaks persist. Tens of millions of Americans and thousands of deaths persist.

Recently, major outbreaks have caught attention of GAO.

The GAO specifically noted two specific outbreaks in 2024 and one in 2023.

In 2024, E. coli outbreaks involving onions and organic carrots sickened over 100 individuals across 24 states. Reports indicate at least two deaths in these outbreaks.

The year before, lead contamination linked to cinnamon apple puree and applesauce pouches resulted in elevated blood levels in children. At least 566 children across 44 states, the District of Columbia, and Puerto Rico were impacted. Even more egregious, samples obtained during this investigation contained 200 times more lead than is allowed in food.

The system is still not working.

This is what prompted GAO to perform a study on how the FDA is doing on their foodborne illness prevention goals. What they have done so far and what they still need to do to become compliant if they are not. Also, the study was formed to determine if the desired actions are sufficient to achieve the goal.

What Has the FDA Done So Far?

First, let’s look at what the FDA has managed to do in 15 years.

Several “Final Rules” have been published to address different parts of the global supply chain.

Some set standards for imported products and how those standards are verified. Essentially making imported products meet or exceed the requirements for food produced in the United States.

Other Final Rules set standards for businesses that “grow, harvest, pack, or hold fruits and vegetables.” Things like conditions, required testing, good manufacturing practices.

Others involve hazards that impact human health or economic disruption of the U.S. food supply.

One of the newer Final Rules implemented in May 2024 involves agricultural water. Specifically, testing requirements for surface irrigation.

In all, the FDA has completed 41 of the 46 requirements the GAO identified in the FSMA. The number of completed items is significant. However, the job is far from done.

So, what is left?

What Does FDA Still Need to Do to Become Compliant?

According to GAO study, five major points are still lacking.

These include:

• “issue guidance on hazard analysis and prevention controls for human food;
• issue guidance to protect against the intentional adulteration, or tampering, of food;
• report on the progress of implementing a national food emergency response laboratory network;
• publish updated good agricultural practices for fruits and vegetables; and
• establish a system to improve FDA’s capacity to track and trace food that is in the U.S.

FDA Claims Organizational Restructuring Impacted Progress

According to the GAO report, FDA officials claim that “competing priorities and an October 2024 agency reorganization” were the reasons the agency has been unable to complete these requirements. A hiccup occurring 13 years into the FSMA.

In March 2025, GAO was notified that the FDA plans to establish a system for tracking and tracing food by July 2028. However, time frames for completing other deliverables were not specified.

Another issue identified in the GAO study involved the FDA’s efforts appearing to focus more on implementing rules over assessing whether the rules are effective. Both are necessary to ensure effective foodborne illness prevention.

Can We Have a System Where No One Experiences Foodborne Illness?

In a perfect world, everyone does what they are supposed to do. Food is safe. Our food supply is closely monitored. Nobody gets sick.

In a perfect world.

But, we do not live in a perfect world.

There will always be a human factor. Mistakes are inevitable. No system is 100% fool-proof.

However, if enough safety measures are in place we can expect better outcomes. Fewer foodborne illnesses. Issues can be caught before they make their way to the public. Testing activities and better surveillance can keep potentially harmful products from leaving manufacturing facilities. Issues are caught more quickly so potentially adulterated food can be recalled before an outbreak grows.

In a perfect world.

Personally, I would love to see that world. I believe we can all see that world.

We just have to keep striving to focus on foodborne illness prevention.

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If you’d like to know more about food safety topics in the news, like “FAO Disappointed in Foodborne Illness Prevention, Calls Out FDA in Recent Report,” check out the Make Food Safe Blog. We regularly update trending topics, foodborne infections in the news, recalls, and more! Stay tuned for quality information to help keep your family safe, while The Lange Law Firm, PLLC strives to Make Food Safe!

By: Heather Van Tassell (contributing writer, non-lawyer)