The U.S. food regulatory landscape is changing, and GRAS (Generally Recognized as Safe) is at the center of it.
Under a policy shift being pushed by Robert F. Kennedy Jr., the Food and Drug Administration is proposing to eliminate the long-standing self-affirmed GRAS pathway. If finalized, companies would no longer be able to independently determine that a food ingredient is GRAS without notifying FDA.
What’s Changing?
Historically, companies could rely on internal expert panels to self-affirm GRAS status and bring ingredients to market without FDA review. Additives such as corn syrup, corn solids, maltodextrin, dextrose, xylose, and high fructose corn syrup are recognized as GRAS in the U.S.. With the FDA’s proposed rule, FDA would review these GRAS determinations, significantly increasing oversight, documentation expectations, and regulatory risk for manufacturers and importers.
For importers, this is not just a formulation issue — it’s a border compliance issue. Ingredients previously considered “low-risk” could suddenly face FDA holds, requests for information, or even refusal if GRAS status cannot be clearly demonstrated.
Why This Matters for Importers and Brokers
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Ingredients may be “taken off the table” if GRAS status cannot be supported
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FDA scrutiny at entry may increase
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Documentation gaps can trigger delays, detention, or enforcement action
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Importers remain legally responsible — even when relying on foreign suppliers
This is where experienced FDA compliance guidance becomes critical.
How Ken Lehat and Associates Can Help
As FDA consultants and licensed customs brokers, Ken Lehat and Associates sits at the intersection of regulatory strategy and real-world import execution.
They help companies:
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Assess GRAS risk exposure for ingredients already on the market
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Evaluate supplier documentation to ensure GRAS determinations meet FDA expectations
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Identify when a GRAS notice or alternative regulatory pathway may be required
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Prepare for FDA inquiries or entry reviews before they become enforcement issues
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Coordinate FDA compliance with customs clearance, reducing shipment delays
In a regulatory environment moving away from self-certification and toward FDA review, having advisors who understand both FDA policy shifts and import operations is no longer optional — it’s essential.