The rule, “Voluntary Labeling of FSIS-Regulated Products with U.S.-Origin Claims,”1 finalizes FSIS’s March 2023 proposal.² FSIS positioned the final rule as prohibiting false or misleading U.S.-origin labeling in the marketplace and helping ensure that the information consumers receive about the source of their food is truthful. In announcing the finalized rule, USDA emphasized how the rule better aligns “Product of USA” and “Made in the USA” claims for meat, poultry, and egg products with consumer expectations, as reflected in a consumer-perception study that FSIS commissioned in 2022.³ Finalizing the rule has been a priority for the Biden Administration and is responsive to three petitions FSIS has received since 2018 on the issue.⁴

In tandem with the final rule, FSIS published an updated version of its labeling guidance, “Guideline for Label Approval,” to reflect the changes from the final rule on the use of voluntary U.S.-origin label claims and provide additional examples of permissible claims and the types of documentation that establishments may maintain to support the use of the claims.⁵ We outline the key components of the final rule and updated guidance below.

Overview of the Final Rule

General Requirements

Under the final rule, the voluntary label claims “Product of USA” and “Made in the USA” may be used on FSIS-regulated products that meet the following criteria:

• Single ingredient products that are derived from animals born, raised, slaughtered, and processed in the United States; and
• Multi-ingredient products, if
  1. All FSIS-regulated products within the multi-ingredient product are derived from animals born, raised, slaughtered, and processed in the United States;
  2. All other ingredients, except for spices and flavorings, are of domestic origin; and
  3. The preparation and processing of the product occurred in the United States.

Images of the U.S. flag are considered U.S.-origin claims.

U.S.-origin claims under the final rule are eligible for generic approval.

Consistent with the proposed rule, the new requirements apply to products marketed in the United States. Products exported from the United States remain subject to the requirements provided in the FSIS Export Library, which may specify different requirements for U.S. origin marking for international trade purposes.

Additional Permutations

In addition to the general requirements for U.S.-origin claims, the final rule allows for several additional origin-claim permutations:

• Qualified U.S.-origin claims. The final rule permits qualified U.S.-origin label claims focusing on specific components or processing steps, but the claim must specify the preparation and processing steps that occurred in the United States. In the accompanying labeling guidance, FSIS explains that the description of the processing step must “provide meaningful consumer information about the specific type of preparation and processing steps that occurred in the United States.”

By way of example, FSIS indicates that a generic statement such as “manufactured in the United States” is not specific enough, but a statement such as “sliced and packaged in the United States” on a single-ingredient pork tenderloin would be an appropriately phrased claim. FSIS similarly identifies as appropriate a claim such as “beef raised, slaughtered, and processed in the United States” made on a multi-ingredient product of mixed origin.

• State and locality-origin claims. The final rule permits claims focused on state or locality origin, provided the product meets the same criteria as set for U.S.-origin claims, with the state or locality substituted for the U.S. For example, FSIS identifies a “Product of Montana” claim as being appropriate for a single-ingredient beef cut derived from an animal born, raised, harvested, and processed in Montana. FSIS similarly would allow a “Sliced and packaged in Oklahoma” claim for a single-ingredient product that was imported but then sliced and packaged in the state of Oklahoma. Similarly to the U.S. flag, a depiction of a state flag would be considered a state-origin claim.

In keeping with existing policy, the rule specifies that labels that have geographic significance to a location other than where the animal originated must be qualified by the word “style,” “type,” or “brand.” The final rule outlines several requirements for these qualifying terms, including that they are printed in the same font and size as the geographical reference and are accompanied by a clear statement identifying the locality.

Recordkeeping Requirements

The final rule requires establishments to maintain written documentation supporting U.S.-origin claims. Like the proposal, the final rule does not require specific documentation, but lists the following general examples of the types of documents that may be maintained:

• A written description of the controls used in the birthing, raising, harvesting, and processing of the source animals and eggs, and in the preparation and processing of other regulated ingredients;
• A written description of the controls used to trace and segregate source animals, eggs, and other ingredients through the supply chain;
• A signed and dated document describing how the claim is not false and misleading;
• A written description of the controls used in each applicable preparation and processing step to support a U.S.-origin claim, including potentially traceability and segregation controls.

FSIS’s new labeling guidance provides the following additional examples of the types of documentation that may be maintained:

• For a “Product of USA” label claim on a single ingredient product, records from a ranch demonstrating that the source animal was born, then raised until slaughter, on the ranch.
• For a “Sliced and Packed in New Jersey” label claim on a meat sausage product, records from a processing facility located in New Jersey demonstrating that the product was sliced and packaged in that facility.

Next Steps

FSIS has not yet published the final rule in the Federal Register. An advance copy is available on its website here.⁶ Establishments voluntarily using a U.S.-origin claim subject to the final rule will need to comply with the new regulatory requirements by FSIS’s next uniform compliance date for new labeling regulations, January 1, 2026.⁷ Companies should begin reviewing their product portfolios to identify claims that may need to be revised or removed and to ensure that they possess appropriate supporting documentation for any claims they intend to make after January 1, 2026.

Additionally, FSIS is seeking public comment on the revised labeling guidance. The agency will accept comments for 60 days following the publication of the final rule in the Federal Register.

We will continue to monitor changes to FSIS policy on U.S.-origin claims and other labeling regulatory requirements. Please contact us if you have any questions about this final rule or the revised guidance.