FSIS Issues Final Rule Expanding Category of Labeling That Does Not Require Prior Approval

By Riëtte van Laack –

On November 7, 2013, the Food Safety and Inspection Service (FSIS) amended its prior label approval system regulations to expand the circumstances in which certain types of labels and labeling are generically approved and do not need specific FSIS approval. 

Under the final rule, companies need not submit the label for approval if the label bears all required mandatory labeling features and includes only claims that are defined in FSIS’s regulations, the Food Standards and Policy Book (with the exception of natural and negative claims), and allergen statements in compliance with the Food Allergen Labeling and Consumer Protection Act.

Labels that cannot be generically approved include temporary approvals, labels for export only that bear labeling deviations, religious exemption (e.g., Buddhist exemption), and labels bearing special statements and claims.  With the exception of the child-nutrition box, which is reviewed by the Agricultural Marketing Service, claims that have been reviewed by other Government agencies (e.g., organic claims and health claims) are considered special statements and claims. 

FSIS issued a guidance providing additional information regarding the final rule. The guidance includes a long list of examples of statements that are not eligible for generic approval  and a list of examples of claims that are eligible.

The final rule is intended to reduce the time for approval of labels that do not qualify for generic approval.  Although the Agency will continue to review all label applications, labels that do not qualify for generic approval will receive first priority for review.  Applications for labels that qualify for generic approval will receive lower priority and may take longer to be reviewed.

The final rule also consolidates the regulations regarding approval of labels for meat and poultry (9 C.F.R. §§ 317.4, 317.5, 381.132, 381.133) into a new single part, 9 C.F.R. Part 412.

The rule will become effective on January 6, 2014, and, unfortunately, will not provide any relief to those affected by the backlog that resulted from the government furlough in October 2013.