This is a CRN Associate Member Spotlight. Learn more: www.sgsnutrasource.com
Increases in the time and cost required to bring new ingredients to market could be on the horizon, with FDA exploring potential rulemaking to revise its GRAS Final Rule and legislative proposals in both the U.S. Senate and House in play to eliminate the self-affirmed GRAS pathway and require all GRAS determinations to be formally submitted to the agency, and mandate the reassessment of food-related substances, including additives and food contact materials, respectively.
CRN Associate Member GRAS Associates, a Nutrasource company, advises companies developing new ingredients or considering future launches to make sure they are prepared for these changing dynamics.
What they’re saying: “If your ingredient is supported by strong safety data, the way to mitigate risk and ensure your ingredient gains market access in a timely manner is to prepare a quality GRAS dossier that is ready for FDA notification, should this become a requirement,” advised Amy Mozingo, vice president of U.S. nutra regulatory sciences for Nutrasource Pharmaceutical and Nutraceutical Services, and director of operations for GRAS Associates.
“A properly designed dossier contains the same rigor and information for both self-affirmed and notified pathways,” Mozingo said. “GRAS Associates has always prepared filings in this manner and brings more than 20 years of experience helping brands navigate both self-affirmed and notified GRAS pathways.”
The GRAS Associates team can:
- Rapidly assess whether your data supports self-affirmed GRAS
- Build a complete and compliant dossier
- Help you prepare for a future where notified GRAS may be the only route
In addition to preparing dossiers, the team of board-certified toxicologists will also recommend and oversee the safety testing that is necessary to support these dossiers.
See the recent Q&A on LinkedIn for more and contact Amy Mozingo at amozingo@gras-associates.com to get started on your regulatory roadmap.