Food Safety Inspection Services Updates Label Approval Guidelines

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FSIS Updates Guidelines for Label Approval

by: Food and Drug Law at Keller and Heckman of Keller and Heckman LLP - The Daily Intake

Tuesday, April 2, 2024

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In March 2024, USDA’s Food Safety Inspection Service (FSIS) issued a revised guidance document to help establishments determine whether their labels must be submitted for approval. The revised guidance includes information about voluntary U.S.-origin labeling claims based on a final rule defining the conditions under which FSIS-regulated products may bear these claims.
On March 18, 2024, FSIS published the final rule “Voluntary Labeling of FSIS-Regulated Products with U.S.-Origin Claims.” The final rule amends FSIS labeling regulations at 9 CFR Parts 317, 381, and 412 by specifically defining the claims “Product of USA” and “Made in the USA.” These two claims will be generically approved for use on single ingredient FSIS-regulated products derived from animals born, raised, slaughtered, and processed in the U.S., as well as on multi-ingredient products if all FSIS-regulated products are (1) derived from animals meeting the U.S. origin requirement, (2) all other ingredients other than spices or flavorings originate in the U.S., and (3) the preparation and processing steps occur in the U.S. In addition, other label claims that indicate a preparation or processing step of a FSIS-regulated product occurred in the U.S. will be generically approved for use as long as they indicate the steps upon which the claim is made. Use of the U.S. flag or a U.S. State or Territory flag will be deemed to be a claim indicating the product’s origin and must meet the same requirements.
The revised guidance document includes a new section that explains the requirements for voluntary use of the defined claims, as well as other U.S.-origin label claims related to the product’s preparation and processing.
In addition to U.S.-origin labeling guidance, the document includes new label examples with special statements and claims that require FSIS approval before they can be used on labels of products in commerce, such as claims about verification programs, animal production methods, and breed claims, as well as factual statements that do not require approval, such as “authentic,” “gluten free,” and certain negative claims.