On January 18, USDA published a final rule expanding the criteria of generic label approval for inspected meat, poultry, and egg products. The Expansion of Generic Labeling Rule is largely consistent with the proposed rule published in September 2020, which proposed to discontinue review of generically approved labels and expand the circumstances under which FSIS will generically approve food labels under its jurisdiction. Notably, the final rule does not eliminate the requirement to comply with USDA’s labeling regulations, but instead shifts the burden of compliance for generic labels onto the manufacturer.

Under the current regulations, FSIS evaluates sketches of some labels for approval, and approves others generically without submission to FSIS for sketch approval. To obtain sketch label approval, domestic meat and poultry establishments, egg product plants, and certified foreign establishments that are eligible to export product to the United States, or their representatives, are required to submit sketch labels to FSIS for evaluation, except when the label is generically approved by the Agency under 9 CFR 412.2. FSIS allows certain meat, poultry, and egg product labels that bear all required labeling features and that comply with the Agency’s labeling regulations to be generically approved (9 CFR 412.2(a)(1)). Generically approved labels do not need to be submitted to FSIS for sketch approval before they can be used on products in commerce. Generic label approval requires that all mandatory label features are prominent and conform to FSIS regulations. Although such labels are not submitted to FSIS for approval, they are deemed to be approved and, therefore, may be applied to product in accordance with the Agency’s prior label approval system.

The final rule will expand generic approval to products only intended for export that deviate from domestic labeling requirements and permit generic approval of the labels of products that receive voluntary FSIS inspection. It will also expand generic approval to:

• (1) “Organic” claims that appear in a product label’s ingredients statement;

• (2) Labels of products that receive voluntary FSIS inspection (e.g., exotic species);

• (3) “Geographic landmarks” displayed on a product label (e.g., a foreign country’s flag, monument, or map); and

• (4) “Negative” claims made on product labels that identify the absence of certain ingredients or types of ingredients (e.g., statements such as “No MSG Added,” “Preservative Free,” “No Milk,” “No Pork,” or “Made Without Soy”). However, the final rule does not include negative animal raising claims (e.g., “no antibiotics administered”).

As of the effective date, FSIS will no longer evaluate labels submitted to FSIS that are eligible for generic approval. FSIS will, however, continue to provide industry with relevant resources, including updated generic labeling guidance, and timely answers to generic labeling questions. FSIS has updated the FSIS Guideline for Label Approval and intends to update and reissue FSIS Directive 7221.1.

The final rule will become effective on March 20, 2023. Interested parties may submit comments on the revised FSIS Guideline for Label Approval on or before February 17, 2023 here.