Navigating 2025: What Regulatory Shifts and Industry Insights Mean for Food Safety Programs

 As we settle into 2025, the food safety landscape is evolving with regulatory overhauls by the FDA to industry-wide challenges faced by food producers and QA teams. It is clear that staying compliant — and competitive — requires a deeper understanding of both policy direction and real-world execution.

Priorities for the FDA: Modernization, Accountability and Traceability 

The FDA's Human Foods Program was introduced to create a more specialized and focused approach to food safety regulation, distinct from the agency's oversight of pharmaceuticals and other products. This initiative aims to enhance the effectiveness of food safety protocols by dedicating resources and expertise specifically to human food products. As the FDA is entering a post- Food Safety Modernization Act (FSMA) phase (1), the agency is focusing on

• Restructuring the Human Foods Program. This move is designed to unify food safety, nutrition, and outbreak response efforts under clearer leadership — a long-awaited change that aims to reduce internal silos and improve agility.
• Traceability. One of the most pressing changes is FSMA 204, the new food traceability rule. Set to take effect in January 2026, this rule requires end-to-end tracking of certain high-risk foods. While it promises better outbreak response, many in the industry are still unclear about its technical requirements and are concerned about the burden of compliance.
• Emphasis on Technology. The FDA is leaning into data — smart tools, digital traceability, and predictive analytics are becoming the backbone of inspections and outbreak prevention.
• Stronger Enforcement. The agency is also signaling a tougher stance on companies that repeatedly fall short of preventive controls or fail to act on past violations.
  

Industry Perspectives: Audits and Budget Constraints

To gauge industry sentiment, a survey was conducted involving approximately 150 food processors from 35 countries, with a significant portion based in the U.S. and Canada (2).

• Among respondents from the U.S. and Canada, over two-thirds produce products regulated by the FDA, the U.S. Department of Agriculture (USDA), or both. This underscores the importance of understanding and adapting to regulatory changes within these agencies.
• A notable 70% of respondents expressed optimism about the success of the Human Foods Program. Many believe that separating food regulation from other FDA responsibilities allows for more specialised training and a dedicated focus on food-related issues.
• Respondents highlighted the necessity for specialised expertise in food safety. They emphasise that the knowledge required to inspect and regulate food production differs significantly from that needed for pharmaceuticals, making the creation of a dedicated program both logical and timely.

Whilst they understand the need for tighter food safety controls, there are a number of challenges they are facing. Food companies are overwhelmed by audits, from regulatory inspections to GFSI and they are finding staffing shortage and training gaps unmanageable. Additionally, budget constraints usually mean that they are lagging behind in technology adoption too.

Bridging the Gap: Alignment Between Policy and Practice, and the Role of Innovative Technologies

It’s clear that the intentions behind regulatory change are sound, but execution at the ground level remains complex. For companies to align with the FDA’s evolving priorities, there must be better support — whether that’s in the form of guidance, funding, or collaborative tools that reduce the burden rather than add to it - but there is also a need for regulators and industry professionals to open their minds to innovative technologies.

At this crossroad, adoption of such technologies is crucial. If we want to see better control of the food value chain, and safer food on our plates, we need new technologies that can transform the industry. The year ahead presents the opportunity to bridge the gaps between policy and practice and to build a more resilient, tech-enabled, and sustainable food safety system.

Technologies that can enhance sensitivity and accuracy in food testing, that are easy to use, have digital readouts and sustainable designs are ideal for food testing and environmental monitoring (3).

At SWIFTR Bio we are developing transformative technology for food pathogen testing that will contribute to bridge some of these gaps. Our molecular diagnostics for the food industry deliver fast and accurate results through our affordable tests. Our products allow for data collection and predictive analytics to help industry professionals maintain compliance whilst preventing outbreaks.

Interested? Look at current innovations in this space (4). 

References:

(1) https://www.food-safety.com/articles/10019-regulatory-changes-impacting-your-food-safety-program-part-1what-should-fdas-priorities-be.

(2) https://digitaledition.food-safety.com/february-march-2025/column-food-safety-insights/

(3) https://news.swiftr.bio/blog/mission-critical-protecting-safety-with-paid-reliable-testing

(4) https://news.swiftr.bio/blog/innovations-in-the-lateral-flow-test-market-driving-precision-and-usability-forward