A Shift in Oversight: FDA Launches a New Post-Market Chemical Assessment Program

The US Food and Drug Administration announced a new comprehensive process for the post-market assessment of food additives, signaling a move toward a much more active surveillance and reassessment model. FDA’s process documents make clear that FDA is poised to move swiftly to identify food ingredients for assessment, conduct post-market assessments, and take prompt regulatory action.

This shift in the agency’s stance from passive to active and aggressive post-market oversight carries significant commercial, supply chain, reputational, and litigation risks for food manufacturers, ingredient suppliers, and others working in the food supply chain long before FDA reaches any formal safety determination.

Join a team of Morgan Lewis lawyers with extensive food industry and FDA background as they break down the review process, the tools the FDA will use to evaluate additives, and how companies can position themselves to mitigate potential regulatory, commercial, or litigation risks.

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