FSIS issues final rule expanding generic label approval

Background

Under FSIS’s label approval regulations, certain categories of product labels must be submitted to the agency for “sketch approval” prior to use. Other categories of product labels are considered “generically approved” and may therefore be used without prior FSIS review, so long as they comply with the agency’s labeling regulations. This marks the third time FSIS has expanded the categories of labeling claims eligible for generic approval since the concept was first introduced in the 1980s.

New Labeling Claims Eligible for Generic Approval

The same general framework for label approval will remain in place, but the final rule¹ modifies the framework such that the labels of the following types of products are now eligible for generic approval:

• Products only intended for export that deviate from domestic labeling requirements;
• Products that receive voluntary FSIS inspection; and
• Products bearing the following special statements and claims:
  • “Organic” claims that appear in a product label’s ingredient statement, which designate an ingredient (but not the product as a whole²) as certified “organic” under the Agricultural Marketing Service’s (AMS’s) National Organic Program;
  • “Geographic landmarks” displayed on a product label, such as a foreign country’s flag, monument, or map; and
  • “Negative” claims made on product labels that identify the absence of certain ingredients or types of ingredients, such as “No MSG Added,” “Preservative Free,” or “Made Without Soy” (excluding claims related to the raising of the animal from which the product is derived or negative claims related to the use of genetically modified ingredients).

The final rule also states that FSIS will no longer evaluate generically approved labels submitted voluntarily to the agency for review. Other generic labeling resources will continue to be available to the industry, including FSIS’s updated generic label approval compliance guideline.³

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We will continue to monitor changes to FSIS’s label approval program. Please do not hesitate to reach out about this or any other matter.

Authored by Brian Eyink and Rachel Buff.

References

1 88 Fed. Reg. 2798 (Jan. 18, 2023), available at: https://www.federalregister.gov/documents/2023/01/18/2023-00693/prior-label-approval-system-expansion-of-generic-label-approval.

2 FSIS will continue to require sketch approval for claims that the product as a whole is organic.

3 Guideline for Label Approval, FSIS (Jan. 2023), available at: https://www.fsis.usda.gov/guidelines/2023-0001.