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September 29, 2020

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September 28, 2020

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USDA-FSIS Issues Updated Guidelines for Premarket Label Approval

  • The labeling of meat and poultry products primarily falls under the jurisdiction of the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS). FSIS administers the Federal Meat Inspection Act (FMIA) and the Poultry Products Inspection Act (PPIA). Both the FMIA and the PPIA require food manufacturers to obtain prior approval for labels of meat and poultry products before such products may be marketed in commerce. Prior approval is granted in one of two ways:

    • “Sketch approval” which entails Agency review of food labels; and

    • “Generic approval” which is label approval obtained by virtue of the label being in compliance with applicable regulations.

  • On Friday, August 18, 2017, FSIS issued an updated FSIS Compliance Guideline for Label Approval to clarify when meat and poultry companies must submit labels to FSIS for approval. In particular, FSIS updated the guidelines to provide clarification on:

    • Special statements or claims in labels which require submission to FSIS for approval.

    • Changes to labels approved with special statements and claims that require FSIS approval.

    • Changes that can be made to labels approved with special statements and claims without additional FSIS review.

    • How companies can ask FSIS for “blanket approval” so that they can use a special claim for an entire line of products or multiple products without having to submit every single label to FSIS for approval.

  • FSIS has opened up a 60-day comment period on the guidelines. Comments may be submitted via or by mail to USDA-FSIS, Patriots Plaza 3, 1400 Independence Avenue SW, Mailstop 3782, 8-163A, Washington, D.C. 20250-3700. Detailed summary of the updated compliance guideline is forthcoming. 

© 2020 Keller and Heckman LLPNational Law Review, Volume VII, Number 234


About this Author

Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...