Food safety and the FDA.

Plus: There’s no transparency in healthcare.


Food Safety And The FDA

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If you asked, most people would likely say they consider the U.S. food supply to be pretty safe. However, the reality is that foodborne illnesses remain a significant public health concern. 

The solution? The FDA is hoping to finish implementing a new rule aiming to enhance the traceability of certain high-risk foods. This type of policy is a long time coming and represents a crucial step towards mitigating the risks of foodborne illness in the future (READ MORE)

The new rule, which will be fully effective by January 20, 2026, would require detailed record-keeping across the supply chain for specific foods known to be frequent sources of outbreaks, such as fresh produce and seafood.

This measure is part of the FDA’s ongoing efforts to modernize and strengthen the nation’s food safety system. The enhanced traceability will enable quicker identification of outbreak sources, thereby reducing the spread of illness and expediting responses to public health risks. The sooner we know where an outbreak started, the sooner we can act to mitigate damages and stop any potential spread. 

Under this rule, businesses handling listed items must maintain specific records, including a detailed traceability plan, at various points in the item’s supply chain journey. The FDA’s methodology in selecting which foods require enhanced record-keeping was primarily based on criteria like the history and severity of past outbreaks. 

While several stakeholders agree with the FDA’s approach, others believe the list of foods is too inclusive. In response, the FDA has clarified its rationale, explaining that foods grouped in categories share similar risk characteristics and associated hazards.

But it’s not like this new rule will solve everything at once. Implementing such a comprehensive rule poses challenges for the industry and regulators alike. As of late 2023, the FDA has begun planning for the rule’s implementation but hasn’t finalized or documented a comprehensive implementation plan. 

This is kind of a big deal since having a plan would address various challenges identified by stakeholders, including the roles of non-federal regulators, enforcement strategies, necessary resources, and additional guidance and training for everyone involved.

This implementation plan must be detailed and clear to effectively prepare the industry and regulators for compliance. It should cover inspection procedures, enforcement plans, and resources needed to ensure smooth compliance.  It should provide necessary guidance, training, and tools to all involved parties, assuring they are well-equipped to meet the rule’s requirements.

The problem is that the FDA is still nowhere near completing this detailed plan. 

This is why the Government Accountability Office (GAO) has recommended that the FDA finalize and document this implementation plan. The U.S. Department of Health and Human Services (HHS), under which the FDA operates, has agreed with this recommendation. In other words, it is time the FDA gets its act together and puts pen to paper on moving things in the right direction. 

The key takeaway? Foodborne illness, a significant concern in the U.S., can be better managed with efficient product tracing during outbreaks. The FDA’s efforts in implementing the food traceability rule are a vital step in enhancing public health protections and reducing the impact of foodborne illness outbreaks. The only hold-up is the lack of a comprehensive implementation plan, so someone please tell the FDA to start making some moves, 

If we can get this across the goal line, there’s hope for a more robust and responsive food safety system that would safeguard public health more effectively than ever before.


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