Policy Changes Put Food Innovation Pipelines to the Test

The regulatory environment for food and beverage innovation is shifting quickly, creating both hurdles and openings for R&D teams. At IFT FIRST: Annual Event and Expo, held July 14–16 in Chicago, a Hot Topics Studio session titled “Regulatory Roadmap: How Policy Changes Impact Innovation Pipelines” featured Steve Havlik, consultant at Havlik Consulting LLC, and David Tonucci, senior vice president of regulatory affairs at Bell Flavors and Fragrances. The two offered practical strategies for navigating an increasingly complex landscape.

Mounting Pressure on GRAS and Approvals

Among the most pressing challenges is the U.S. Food and Drug Administration’s (FDA’s) handling of Generally Recognized as Safe (GRAS) submissions. Proposed changes, along with heightened scrutiny of dossiers, are extending timelines for approval. Both speakers emphasized that incomplete data packages are a leading cause of delays. Companies that approach the agency without full safety and manufacturing information risk months of additional questions and reviews.

Tonucci summed it up simply: “Everything has to be buttoned up and tight.”

Post-Market Surveillance

Another shift is the FDA’s new post-market surveillance initiative. For the first time, already-approved substances may be revisited, restricted, or even removed if new safety concerns arise. This creates uncertainty, but also opportunity, as developers could step in with new ingredients to fill gaps left by phased-out materials.

Havlik predicted that the process will move slowly—likely taking six to nine months just to sort through initial comments and pushback—but urged attendees to monitor developments closely.

Global Frameworks and State-Level Hurdles

For companies with global reach, Codex Alimentarius remains a critical starting point for aligning regulatory strategies. Havlik described Codex as the “baseline” for companies entering new markets, while Tonucci pointed out that it provides a foundation on which national and regional regulations build.

Closer to home, state-level regulation in the United States is creating significant complexity. In some cases, companies are avoiding entire markets because of pending or enacted state-level bans. Havlik argued that the food industry should advocate for federal preemption to ensure consistency, saying, “We need to have a national approach as opposed to a state approach.”

Front-of-Pack and Labeling Claims

Labeling changes are also on the horizon. The FDA is exploring front-of-pack requirements, following the lead of countries like Canada. While details are still under development, Havlik’s message was blunt: “It’s coming.”

The panel also reminded attendees that labeling oversight goes beyond the FDA. The Federal Trade Commission actively reviews claims and often demands higher levels of substantiation, including multiple clinical studies for health claims.

Strategies for Success

Against this backdrop, the speakers emphasized several strategies for innovators. Horizon scanning—systematically monitoring emerging regulations—is essential. Trade associations and IFT provide regular updates and are a practical way for smaller companies to keep informed. Pre-notification consultations with the FDA can also smooth the approval process by surfacing potential issues early.

Transparency of safety data is another growing expectation. Tonucci predicted that publishing peer-reviewed safety studies will become a requirement, not just a best practice.

Finally, Havlik underscored the need for greater investment in regulatory preparedness. “To be proactive about it means that you’ve got to expend more effort. It’s going to take more people time. It’s going to take time connecting with other parties.”

The session made clear that the path to innovation is becoming more resource-intensive. From GRAS submissions and post-market reviews to evolving state and federal regulations, developers face rising demands for data, transparency, and foresight. The experts’ message was unequivocal: proactive engagement with regulators, robust scientific support, and early awareness of emerging issues are essential for bringing new products to market.ft