FSIS experiencing 21-day delay for label approval process

FSIS is currently experiencing a delay of about 20-21 business days in evaluations for labels that require review prior to use. By providing industry with label application submission tips and suggestions via the Constituent Update, FSIS is hopeful that it will achieve a faster, more efficient label evaluation process.

TIP: The fastest way to obtain a label approval is to ensure the application includes a label with all of the required features and documentation necessary to support any statements or claims on the label.

FSIS receives and reviews a high volume of labels every week. Accurate and complete label application submissions will ensure that reviews are carried out in a timely manner. When only minor modifications are needed, labels may be approved by FSIS as “sketch modified” rather than returned to the submitter. However, if the label modifications necessary for FSIS to approve a label are too numerous or complex, or if the modification cannot be made by FSIS without additional information (e.g., the product formula in the application does not match the ingredients statement on the label), then the label application must be returned to the submitter. FSIS must also return label applications submitted without the necessary supporting documentation for special statements or claims on the label.

NOTE: A label application that is resubmitted, after being returned by FSIS during initial review, will automatically be placed at the top of the label evaluation queue and FSIS will review them within a few days. Even so, the quickest way to obtain label approval is by initially submitting a complete label application, which would include a fully compliant label and any necessary supporting documentation.

FSIS will continue to provide weekly updates regarding the label turnaround time, as well as suggestions to assist industry to streamline label submissions. For more information about the mandatory label features and considerations relating to each feature, please see the following guidance: https://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/labeling/labeling-procedures/label-submission-checklist

Source: FSIS

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