Event Recap – Tapping into FDA: Regulatory Hot Topics

At the Saison-al Session hosted by Gardner Law, three of the firm’s regulatory experts—Nathan Downing, Rebecca Zadaka, and Brynn Stanley—delivered a high-impact, fast-paced update on what’s shifting at the U.S. Food and Drug Administration. Their 30-minute session, titled “Tapping into FDA: Regulatory Hot Topics,” covered key enforcement trends, food ingredient oversight, global inspections, advertising scrutiny, and deregulation efforts—providing practical insights for FDA-regulated companies navigating compliance challenges in an uncertain environment.

A Shifting FDA Landscape

Nathan Downing opened by characterizing today’s FDA as “evolving but unpredictable,” especially in light of recent staffing changes and the downstream effects on review timelines, meeting availability, and consistency in agency communication. These changes, he explained, have started to erode some of the informal but critical communication touchpoints industry has come to rely on.

The loss of these "optional" engagement opportunities isn't the result of disinterest or reduced demand from regulated companies. Instead, it’s a consequence of the agency’s limited capacity to maintain the full range of support it once offered. The impact is more than procedural—companies are encountering greater uncertainty and less predictability in submission timelines, both of which can compromise strategic planning and delay product launches.

As the conversation unfolded, it became clear that this operational strain is not isolated. It intersects with a broader trend of policy shifts, emerging enforcement practices, and structural adjustments in how the agency communicates and collaborates with regulated industry.

GRAS: Transparency vs. Innovation

Rebecca Zadaka turned the spotlight on the GRAS (Generally Recognized as Safe) regulatory pathway. While designed to support innovation in food ingredients, GRAS’s self-affirmation process has increasingly come under fire for its lack of transparency and FDA oversight.

“When manufacturers self-determine safety without alerting FDA, it opens the door to conflicts of interest and regulatory blind spots,” said Zadaka.

Proposed reforms—which we have written about previously—would mandate formal FDA notifications—shifting GRAS from optional to obligatory review. That change could dramatically increase FDA’s oversight load, giving rise to further feasibility questions unless matched with new resources.

Inspection Readiness: No Time to Slack

Next, Brynn Stanley focused on FDA’s renewed enforcement focus on global operations, including the return of unannounced foreign inspections. The COVID-era backlog and perception of uneven treatment between domestic and foreign firms triggered this escalation.

Stanley advised manufacturers to increase internal audit rigor, update training protocols, and ensure supplier compliance readiness—especially for companies with international vendors.

“It’s not just about passing an inspection. A failed inspection can upend your business plans overnight,” she noted.

Advertising Enforcement: HCP Materials Are Not Exempt

Zadaka returned to address a surprising shift: FDA’s recent untitled letter targeting material aimed at healthcare professionals (HCPs), not just consumers. This reflects growing concern that HCP-targeted promotional decks and presentations may still mislead—and with potentially dangerous consequences, as Nathan has discussed in a previous article.

The trend underscores the importance of aligning promotional claims with data and ensuring rigorous internal review, no matter the target audience.

Deregulation: Opportunity or Uncertainty?

Stanley closed with a discussion of the HHS’s aggressive new deregulation directive, which requires the agency to eliminate ten rules for every new one issued. While this might sound like relief for overburdened companies, the potential for rapid change—and regulatory gaps—demands vigilance.

The team urged stakeholders to participate in the comment period, flag regulations that hinder innovation, and prepare for both loosening and tightening of rules in unexpected places.

Final Takeaway: Adaptability Is the Strategy

All three speakers concluded that the core compliance strategy right now is adaptability. Companies must stay proactive, not reactive. As Downing concluded:

“In a volatile regulatory environment, readiness isn’t optional—it’s the edge.”

If your team needs support interpreting regulatory shifts or preparing for increased FDA scrutiny, Gardner Law is here to help. Contact us to discuss how your organization can adapt its compliance strategy and stay ahead of emerging risks.