The GRAS (Generally Recognized as Safe) designation is a U.S. FDA classification that allows food ingredients—including probiotics—to be legally marketed when qualified experts determine they are safe for their intended use. Probiotics are live microorganisms that can support gut health, immunity, and other beneficial functions. When added to foods or beverages in the U.S., GRAS status is often required to confirm their safety and enable lawful market access. Under the current U.S. regulatory framework, probiotics are not a separate FDA category—they’re regulated according to intended use and claims. Novel probiotic strains without a history of dietary use may be regulated as food additives, requiring either a Food Additive Petition (FAP) or GRAS status before entering the market.

There are two primary GRAS pathways for probiotics:

• Self-Affirmed GRAS – A safety assessment reviewed by a panel of qualified experts. No FDA notification is required; documentation is kept on file for compliance.
• FDA-Notified GRAS – A GRAS dossier submitted to the FDA for review. A “no questions” letter and public listing in the FDA GRAS Inventory provide added transparency and marketing credibility.

• Regulatory Pathway Assessment: Determine if your probiotic qualifies for self-affirmed GRAS, requires an FDA-Notified GRAS, or must pursue a Food Additive Petition (FAP).
• Expert Panel Coordination: Recruit and manage a panel of independent qualified experts (toxicologists, microbiologists, clinicians) to review your safety data for self-affirmed GRAS.
• GRAS Dossier Development: Prepare compliant dossiers for both self-GRAS and FDA-Notified GRAS pathways, including all supporting safety data.
• Probiotic Strain Characterization: Perform or coordinate strain-level identification, including genomic sequencing, in silico assessments (antibiotic resistance, virulence factors), and safety profiling.
• Safety Data Compilation: Aggregate published and proprietary data—historical use, toxicity, allergenicity, and human clinical studies.
• Manufacturing & Quality Compliance: Document GMP processes, product specifications, stability, allergens, and provide Certificates of Analysis (COAs).
• FDA Liaison & Support: Guide communications during FDA review for notified GRAS, addressing inquiries to ensure timely resolution.
• Strategic Market Readiness: Support marketing, investor, and retailer confidence by leveraging GRAS outcomes—whether self-affirmed or FDA-notified.