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Self-affirmed GRAS determinations made by the food industry are being called into question at federal and state levels, even without health or safety concerns associated with substances that are designated as GRAS.

This guidance provides the agency’s current thinking on establishing a routine sanitation program for low-moisture, ready-to-eat foods that can help prevent pathogen contamination events and also sets forth recommendations for corrective actions.

FDA’s FSMA Section 204(d) rule requires traceability for critical high-spoilage foods, which have been known to carry foodborne illnesses. If you’re not prepared for the new rule, your competition will be.

The FDA’s draft guidance includes plant-based alternatives to eggs, seafood, poultry, meat and dairy products (excluding plant-based milk alternatives) that fall under FDA jurisdiction.

FDA considers the following action levels to be achievable by the food industry when control measures are taken to minimize the presence of lead.

FSIS will consider, on a case-by-case basis, GOIs for official import inspection establishments outside the 50-mile geographic radius of a U.S. land or sea port of entry.

Manufacturers who choose to use the “healthy” claim have three years to conform but can use the new criteria sooner. 

FSIS will consider, on a case-by-case basis, GOIs for official import inspection establishments outside the 50-mile geographic radius of a U.S. land or sea port of entry.

The FDA is implementing a revised inspection approach, strategically designed to optimize program efficiency by leveraging other oversight activities, which may reduce user fees.

This request is part of the FDA's continued work to increase its understanding of the potential for PFAS exposure from seafood and to reduce dietary exposure to PFAS that may pose a health concern.