BOZEMAN, Mont., Sept. 22, 2026 (GLOBE NEWSWIRE) — SciPinion, an independent peer review and risk assessment organization, today launched SciBridge Safety Suite, a set of tools pairing new AI-assisted software with a menu of professional services to measure and document how closely a candidate food ingredient matches a substance generally recognized as safe (GRAS) that the U.S. Food and Drug Administration (FDA) has already reviewed. GRAS status lets an ingredient go to market without full pre-market approval, and a proposed FDA rule would change it from voluntary to mandatory. SciBridge is built to fast-track that process, turning potentially months of manual comparison work into a documented similarity report in minutes.
The FDA’s proposed rule would end the ability to self-affirm GRAS status, preserving only narrow exemptions including ingredients shown to be the same as, or “substantially equivalent” to one FDA has already reviewed with no questions. By SciPinion’s account, the scale of exposure is far larger than published estimates suggest, with potentially tens of thousands of “substitutional” ingredients, where multiple manufacturers rely on substantial equivalence to the same single precedent notice.
“The FDA has acknowledged its own strain here, and the agency’s proposed rule specifically asks for comment on ways to make it easier for notifiers to draw on data from already-submitted GRAS notices, which is exactly what SciBridge is built to do,” said Vanessa Feher Castagna, PhD, Director, Food Safety & Claims at SciPinion. “What companies need, and what FDA is asking for, is a standard, documented method, applied the same way every time.”
The SciBridge Difference
The SciBridge Safety Suite has three tools, built from FDA’s GRAS Notice inventory:
- Browse, a synced, structured index of FDA’s GRAS Notice database with a side-by-side Compare tool.
- Screen, a rapid similarity check that ranks a new substance against precedent notices.
- Bridge, a comprehensive field-by-field substantial similarity evaluation against up to three comparators, with a downloadable report and full audit trail.
The suite’s AI-assisted review process includes human expert review, and the underlying tools were shaped over nearly a year of expert-led quality control and prompt refinement before launch. SciPinion built the program with data security as a core requirement, so confidential ingredient data submitted for review is kept safe. SciBridge’s development incorporated direct feedback and evaluation from FDA, though this does not represent FDA review, endorsement, or use of the software.
“SciBridge is the only tool on the market that can generate a full similarity report against an FDA-cleared precedent in about ten minutes, which is work that can otherwise take months and run into hundreds of thousands of dollars for a ground-up GRAS review,” said Sean Hays, PhD, Chief Executive Officer, SciPinion. “What makes SciBridge’s report something you can put in front of a regulator is the method: our platform fixes the comparison approach before it ever sees your ingredient.”
“FDA’s food ingredient programs, including the GRAS review staff, are severely resource constrained, and the proposed rule, if finalized, will only exacerbate the current review bottlenecks,” said Dennis Keefe, PhD, former Director of FDA’s Office of Food Additive Safety. “A streamlined, systematic, structured data review process is a clear value add for industry to help organize their data in such a way to make it easier for bridging evaluations and benefits FDA to further its public health protection mission.”
SciBridge Availability
SciBridge is built for ingredient and finished-goods manufacturers and distributors, regulatory consultants and law firms, trade associations, and startups. Browse, Screen, and Bridge are available by subscription or via professional services; services are scoped per engagement, beginning with a free 30-minute consultation. More details can be found at bridge.scipinion.com.
Beyond SciBridge
SciPinion also offers a matching menu of GRAS regulatory services, scoped per engagement:
- Gaps Analysis, benchmarking an ingredient against up to three comparator notices
- Dossier Framework Development, assembling a full GRAS-ready dossier
- Expert Panel Validation of Substantial Similarity, routed through an independent, conflict-screened panel
- GRAS Portfolio Strategy Assessment, a prioritized plan for companies moving from self-affirmed to notified status
- Expert Panel Assembly, standalone, for companies running their own review
- Two Specialty Practices, early-life-nutrition ingredients and precision-fermentation proteins
About SciPinion
SciPinion builds trust in scientific decision-making through independent peer review and risk assessment: scientific opinion certification, expert panel engagement, and critical review of emerging chemistries. Expert panels are convened through a modified Delphi process designed to reduce sponsor and social influence. SciPinion has worked with government agencies including the CDC, EPA, and Health Canada. scipinion.com.
Press Contact: Andrew Noyes - Noisemaker Consulting - press@noisemakerconsulting.co
