FSIS Updates Guidance Concerning Labels Not Eligible for Generic Approval

August 23, 2017By Riëtte van Laack

In November 2013, the Food Safety Inspection Service (FSIS) of the USDA issued a regulation expanding the circumstances in which labels were eligible for generic label approval (see our previous post here). Under that regulation, meat and poultry labels need not be submitted for label review unless the labels fall within one of four categories, i.e., 1.) labels for “religious exempt products,” 2.) labels for products for export that are subject to requirements different from those applicable to products for marketing in the United States, 3.) labels that include special statements and claims, and 4.) labels for temporary approval. All other product labels need not be submitted for review but are generically approved provided that they are in compliance with applicable regulations. At the time that it issued the regulation, FSIS also issued guidance with a long list of examples of special statements and claims that needed to be submitted to FSIS for approval and a list of examples of claims that could be generically approved.

On August 18, 2017, FSIS issued the second update to its guidance.  According to its press release, this update “include[s] new examples of special statements and claims that require submitting for approval, factual statements and claims that are generically approved, changes that can be made generically to labels previously approved with special statements and claims, and changes that cannot be made generically to labels previously approved with special statements and claims.”

FSIS asserts that new special statements are marked with an asterisk. New special statements that require approval include egg free, family farm raised, certain implied nutrient content claims (e.g., made with olive oil, protein snack), Paleo Certified, and Paleo Friendly. Some of the information is reorganized. Notably, information about label approvals regarding approval requirements for labels for religious exempt products, export labels that are different from domestic labels, and labels for temporary approval (for labeling errors that do not pose a potential health or safety issue) has been moved to a new Appendix (Appendix 7) making it easier to locate.

FSIS invites comments. The comment period is open for 60 days. Meanwhile, FSIS advises companies to use the updated guidance when determining whether they need to submit a label for approval. Questions regarding labeling statements that are not included in the guidance can be submitted any time via askFSIS.