Approval of U.S.-origin generic label claims.

9 C.F.R. § 412.3
in effectEffective: 2024-07-01
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(a) The claims “Product of USA” and “Made in the USA” may be used under generic approval on labels to designate single ingredient products derived from animals born, raised, slaughtered, and processed in the United States. (b)(1) The claims “Product of USA” and “Made in the USA” may be used under generic approval on labels to designate multi-ingredient products if: (i) All ingredients that are produced under FSIS mandatory inspection or voluntary inspection services in the product are derived from animals born, raised, slaughtered, and processed in the United States; (ii) All other ingredients in the product are of domestic origin; and (iii) The preparation and processing steps for the multi-ingredient product have occurred in the United States. (2) For purposes of this paragraph (b), spices and flavorings need not be of domestic origin for claim use, but all other ingredients of the product must be of domestic origin. (c) Claims other than “Product of USA” and “Made in the USA” may be used under generic approval on labels to designate the U.S.-origin component of single ingredient and multi-ingredient products' preparation and processing only if the claim includes a description of the preparation and processing steps that occurred in the United States upon which the claim is being made. Such labels must be truthful and not misleading. (d) Claims may be used under generic approval on labels to designate the U.S. State, Territory, or locality-origin of single ingredient and multi-ingredient products or components of a product's preparation and processing, only if the claim meets the requirements for use of U.S.-origin claims under paragraphs (a) through (c) of this section with regards to the U.S. State, territory, or locality origin. (e) Display of the U.S. flag, or a U.S. State or territory flag, may be used under generic approval on labels to designate the United States, U.S. State, or U.S. territory origin of single and multi-ingredient products or components of a product's preparation and processing, only if the display of the flag meets the requirements for use of U.S.-origin claims under paragraphs (a) through (d) of this section. For the purposes of the display of a flag that meets the requirements for use of U.S.-origin claims other than “Product of USA” and “Made in the USA” under paragraph (c) or (d) of this section, the display must be accompanied by a description of the preparation and processing steps that occurred in the United States, or in the U.S. State or territory, upon which the claim is being made. (f) In addition to the requirements in § 412.2, official establishments using and facilities choosing to use labels that bear the claims “Product of USA” or “Made in the USA” to designate products of U.S. origin must maintain records to support the U.S.-origin claim. Examples of the types of documentation that may be maintained to support the U.S.-origin claims “Product of USA” or “Made in the USA” include: (1) A written description of the controls used in the birthing, raising, slaughter, and processing of the source animals and eggs, and for multi-ingredient products the preparation and processing of all additional ingredients other than spices and flavorings, to ensure that each step complies with paragraphs (a) and (b) of this section. (2) A written description of the controls used to trace and, as necessary, segregate, from the time of birth through packaging and wholesale or retail distribution, source animals and eggs, all additional ingredients other than spices and flavorings, and resulting products that comply with paragraphs (a) and (b) of this section. (3) A signed and dated document describing how the product is prepared and processed to support that the claim is not false or misleading. (g) In addition to the requirements in § 412.2, official establishments using and facilities choosing to use a U.S.-origin label claim other than “Product of USA” or “Made in the USA” to designate the U.S.-origin preparation and processing steps of a product must maintain records to support the qualified U.S.-origin claim. Examples of the types of documentation that may be maintained to support the qualified U.S.-origin claim include: (1) A written description of the controls used in each applicable preparation and processing step of source animals and eggs, all additional ingredients other than spices and flavorings, and resulting products to demonstrate that the qualified U.S.-origin claim complies with paragraph (c) or (d) of this section. The described controls may include those used to trace and, as necessary, segregate, during each applicable step, source animals and eggs, all additional ingredients other than spices and flavorings, and resulting products that comply with the U.S.-origin claim from those that do not comply. (2) A signed and dated document describing how the qualified U.S.-origin claim regarding the preparation and processing steps is not false or misleading.

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