USDA Food Safety and Inspection Service (FSIS) Label “Approval Process”

By Jon Morse, EAS Consulting Group Independent Consultant

What Must Appear on an FSIS Label

USDA Food Safety Inspection Service (FSIS) requires that meat, poultry, and egg product labels are truthful, not misleading, and approved by the USDA.

Essential elements include:

Most labels are “generically approved” in-house, though special claims require approval. Without approved labels, meat, poultry, and egg products may not be sold, offered for sale, or otherwise distributed in commerce.

Generic Label Approval

Many labels qualify for in-house generic approval without direct submission to FSIS, provided they meet all regulatory requirements. Generically approved labels are those that do not fall under the specific categories requiring Labeling and Program Delivery Staff (LPDS) sketch approval, such as products with special statements (e.g., “natural”) or temporary approvals. This reduces the amount of time for approval of labels. Establishments do not need to submit generically approved labels to LPDS for evaluation prior to use so long as they meet all applicable labeling requirements. However, all labels, including generically approved labels, are subject to routine verification by FSIS field inspectors. Establishments must maintain an approved label file on premises for both generic and FSIS approved labels. Even though generic labels do not have to be submitted, establishments must maintain records of these labels (e.g., product formulation, label proofs) for FSIS inspector review. Establishments are responsible for ensuring the label complies with all FSIS regulations.

When FSIS Approval Is Required

A temporary label approval may be granted for labels with a regulatory deviation that does not pose any potential health, safety, or dietary problems to the consumer. Temporary approvals will be granted for up to 180 days, and establishments can apply for one extension of up to an additional 180 days. Temporary label approval is granted on a case-by-case basis.

Labels with special statements (e.g., “organic,” “low fat,” “raised without antibiotics”) must be submitted to the FSIS Labeling and Program Delivery Staff (LPDS) for approval. Labels with certified claims (e.g., “humanely raised” or certified organic) must include the certifying organization’s name, website, and logo and submitted to LPDS for approval.

Label Recordkeeping Requirements

Establishments are required to keep records of all labeling, both generically approved, and sketch approved by LPDS, along with the product formulation and processing procedures. For establishments that are making changes to labels previously approved by LPDS, they must update the labeling records and labels to reflect the changes made. This also applies to generically approved labels.

Final Thoughts

In a nutshell, most labels can be generically approved. Labels with special claims must have approval from FSIS LPDS. Establishments must maintain an approved label file and make updates add needed. The labels in the approved file must match the label applied to products. Although the approval process appears straightforward, determining whether a label qualifies for generic approval or requires LPDS review can be more complex than many establishments expect. Careful documentation and regulatory review before production can help avoid delays, label revisions, and compliance issues.

EAS consultants assist companies with USDA label reviews, claim evaluations, and regulatory compliance before products reach the marketplace.

Additional Resource

• Food Standards and Labeling Policy Book