SciPinion Launches AI Tool to Streamline GRAS Process for Food-Tech Firms
SciPinion, a specialist in scientific risk assessment, unveiled its AI-led solution designed to assist food-tech startups in navigating the Generally Recognized as Safe (GRAS) approval process more efficiently. The new platform, named SciBridge, integrates AI-assisted software with a selection of professional services aimed at matching a candidate food ingredient with substances already approved by the United States Food and Drug Administration (FDA).
The introduction of SciBridge comes at a critical time, as the FDA is considering changes to the GRAS process—which allows ingredients to be marketed without full pre-market approval—shifting it from a voluntary to a mandatory framework. This change means food-tech companies, particularly those developing alternative protein ingredients, would need to seek external verification of GRAS status unless their ingredient closely matches one already reviewed by the FDA.
SciBridge offers three main tools based on the FDA’s GRAS Notice inventory: Browse, which is a synced index of the FDA’s GRAS database with a compare function; Screen, a rapid similarity evaluation of a new substance against existing notices; and Bridge, which provides a comprehensive similarity analysis against up to three comparators, complete with a report and audit trail. These tools are complemented by human expert review to ensure accuracy.
The company asserts that SciBridge can transform months of manual work into a computerized similarity report within minutes. It is particularly advantageous as the FDA seeks input on methods to better utilize data from existing GRAS notices, aligning with SciBridge's objectives.
A significant aspect of the platform is its ability to assist both ingredient manufacturers and distributors, as well as being applicable for use by regulatory consultants, law firms, and trade associations. The tool was refined over the course of a year with insights from the FDA, although the agency does not officially endorse or use the software.
Aletta Schnitzler, the chief scientific officer at TurtleTree, a company working on animal-free lactoferrin, highlighted the platform’s utility, noting that previously there was no structured way to demonstrate substantial similarity of new ingredients. Meanwhile, Dennis Keefe, former director of the FDA’s office of food additive safety, emphasized the resource constraints faced by the FDA's GRAS review staff and the need for systematic data review processes to alleviate these pressures.
