On July 16th, during keynote address by Jim Jones, Deputy Commissioner for Human Foods at the FDA, during IFT 2024. As a regulatory scientist with a focus on human food safety in the United States, several of Jones’ remarks were particularly illuminating regarding the FDA’s future.

The FDA is in the midst of a significant reorganization, a move that Jones confirmed has been officially approved and will take effect on October 1st, 2024. This restructuring will focus on three critical areas: microbiological safety, nutritional safety, and chemical safety. The reorganization is designed to enhance risk management and surveillance capabilities, addressing some of the indecision that has characterized the FDA’s recent years. With emergent technologies like cultivated meat facing delays due to policy stagnation, this overhaul promises to provide much-needed clarity and direction. In my view, the shift towards a more predictable and decisive FDA is a positive development for the industry.

In his speech, Jones highlighted the FDA’s renewed emphasis on traceability within microbiological safety. He noted that while the technology for traceability is already in use within the industry for business purposes, the FDA is now looking to enhance regulatory measures and utilize artificial intelligence to focus enforcement on high-risk imports. An intriguing aspect of this initiative is the FDA’s plan to monitor social media to expedite the detection of foodborne illness outbreaks.

Regarding chemical safety, Jones pointed out two key areas of innovation: gene editing in plants, and cultivated meat. While the agency released guidance earlier this year addressing advances in gene editing, Jones acknowledged ongoing challenges in evaluating new ingredients for cell culture media. Additionally, the FDA is concerned about the proliferation of state-level food additive regulations. Jones expressed a desire for the FDA to play a more prominent role in this space but noted that significant post-market surveillance improvements are necessary, despite expected resource constraints. My prediction is that given the likelihood of limited additional funding for the FDA from Congress, it seems the trend of state-level regulation will persist, but we shall see if the FDA can be creative in how they acquire funding and allocate resources.

On the topic of pre-market assessment reforms, Jones discussed the FDA’s cautious approach towards New Approach Methodologies (NAMs) as replacements for traditional animal toxicology studies. Although the agency is supportive of NAMs, Jones mentioned their current use is primarily for corroborating animal data rather than as a standalone assessment tool.

In the realm of nutritional safety, Jones outlined the FDA’s ongoing commitment to voluntary sodium reduction targets and the forthcoming introduction of a new FDA logo for qualifying healthy products. This initiative, along with a proposed rule for front-of-package nutrition labeling, aims to enhance consumer trust and offer tangible benefits to genuinely healthy products on the market.

Jones also addressed the topic of ultra-processed foods (UPFs). He emphasized that the FDA requires robust scientific evidence demonstrating causality before considering regulatory action on substances associated with UPFs. This approach aligns with the agency’s core principle of a science-based, risk-focused strategy. The FDA will continue to collaborate with NGOs, states, and industry stakeholders on this complex issue.

In the subsequent Q&A session, when asked about the potential impact of the Chevron case on the FDA, Jones dismissed the concern, suggesting that food laws are clear and the case would not have a significant effect. I suspect this remark might reflect an attempt to sidestep potential challenges in administrative decision-making.

Overall, I thought Jones’ keynote provided valuable insights into the FDA’s strategic priorities and forthcoming changes, offering a glimpse into how the agency plans to navigate the evolving landscape of food safety and regulation.

We at Global Standards continue to monitor developments in the U.S. food regulatory landscape and adapt to emerging priorities. Our mission is to help companies comply with the ever-changing regulatory landscape and ensure the swift and safe market entry of effective, industry-defining products.

Do you have questions about food regulatory compliance in the U.S. or other parts of the world? Are you interested in learning about a given state-level regulation for a food market of interest, or do you need assistance seeking regulatory approval for an innovative food technology? Contact the experts at Global Standards —we’re here to help.

Disclaimer: This blog was prepared by Karam Malkawi in his personal capacity. The opinions expressed in the article are the author’s own and do not reflect the views of Global Standards or the Food & Drug Administration.