FSIS issues Proposed Rule to expand generic labeling approval

The United States Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS or the agency) has issued a Proposed Rule to expand the circumstances in which FSIS will generically approve the labels of meat, poultry, and egg products (1).   FSIS is also proposing to cease evaluating generically approved labels voluntarily submitted to FSIS for review.  The Proposed Rule would expand generic approval to cover additional claims and would expand the type of products eligible for generic approval.  Whereas FSIS’s last expansion of generic label approval, in 2013, marked a significant shift in the agency’s approach to generic approval, the current proposal reflects iterative changes within the existing framework.  Comments are due by November 13, 2020.

Background and Overview

Under FSIS’s current regulations, certain categories of labels must be submitted to FSIS for review and approval before being used (called sketch approval).  However, 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 used under generic approval.   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 be present and conform to FSIS regulations.  Although such labels are not submitted to FSIS, they are deemed to be approved and may be applied to product in accordance with the prior label approval system. 

Proposed Changes

FSIS is proposing several expansions in labels eligible for generic approval:

  • Products Intended for Export:  Extend generic label approval to products only intended for export that deviate from domestic labeling requirements.  FSIS will no longer verify whether product for export meets labeling requirements listed in the Export Library when certifying products for export.
  • Special Statements and Claims.  Make certain additional product claims eligible for generic approval:
    • Organic Claims.  ‘‘Organic’’ claims that appear in a label’s ingredients statement (which designate a specific ingredient as certified “organic” under the Agricultural Marketing Service’s National Organic Program) would no longer require verification by FSIS that such ingredients are indeed certified as organic and could be used under generic approval.  Importantly, however, labels certifying a total product as organic (e.g., a “USDA Organic” claim on the front panel) will still require sketch approval.
    • Geographic Landmarks Such as Flags, Monuments, or Maps.  Geographic landmarks or symbols used on logos would be generically approved.  For example, the following claims would no longer require sketch approval: A Polish flag depicted on a Polish sausage product label, or an outline of the State of Nevada depicted on a product label for beef produced in Nevada.
    • Negative Claims Identifying the Absence of Ingredients.  Negative claims highlighting the absence of a specific ingredient would be eligible for generic approval.  For example, statements such as “No MSG Added,” “Preservative Free,” “No Milk,” “No Pork,” or “Made Without Soy,” on labels that do not list these ingredients in the ingredients statement would no longer require sketch approval.  Importantly, however, negative animal-raising claims (e.g., “no antibiotics administered”) or negative claims relating to the use of genetically modified ingredients would still require sketch approval.
  • Labels for Products Under Voluntary Inspection.  FSIS would extend the generic approval rules to labels for products produced under voluntary FSIS inspection (e.g., rabbits, elk, bison, and migratory water fowl) on the same basis as amenable meat, poultry, and egg products.  These products historically have not been eligible for generic approval.  
  • Cease Evaluation of Generic Labels Submitted Voluntarily.  FSIS currently allows companies to voluntarily submit for review labels eligible for generic approval.  Under the proposed rule, FSIS would stop reviewing labels eligible for generic approval, requiring companies to properly implement labeling regulations for these products.  

FSIS stated that it will continue to provide comprehensive labeling guidance in the form of guidance documents, PowerPoint presentations, webinars, industry group meetings, training for inspectors, askFSIS questions, and industry outreach to assist label submitters with labeling compliance.

Comments are due on the Proposed Rule by November 13, 2020. 

We will continue to monitor the Proposed Rule.  Should you have any questions or if we can be of assistance in submitting comments, please do not hesitate to contact us. 



Authored by: Gary Kushner, Brian Eyink, Chris Forgues


  1.  FSIS Proposed Rule, Prior Label Approval System: Expansion of Generic Label Approval, 85 Fed. Reg. 56538 (Sept. 14, 2020), https://www.govinfo.gov/content/pkg/FR-2020-09-14/pdf/2020-17340.pdf [hereinafter “Proposed Rule”].


Gary Kushner
Washington, D.C.
Brian Eyink
Washington, D.C.


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