9 C.F.R. § 412.2

Approval of generic labels

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(a)(1) An official establishment, or an establishment certified under a foreign inspection system in accordance with part 327, or part 381, subpart T of this chapter, is authorized to use generically approved labels, as defined in paragraph (b) of this section, and thus is free to use such labels without submitting them to the Food Safety and Inspection Service for approval, provided the label, in accordance with this section, displays all mandatory features in a prominent manner in compliance with part 317 or part 381, and is not otherwise false or misleading in any particular.

(2) The Food Safety and Inspection Service will select samples of generically approved labels from the records maintained by official establishments and establishments certified under foreign inspection systems, in accordance with part 327 or part 381, subpart T, to determine compliance with label requirements. If the Agency finds that an establishment is using a false or misleading label, it will institute the proceedings prescribed in § 500.8 of this chapter to revoke the approval for the label.

(b) Generically approved labels are labels that bear all applicable mandatory labeling features (i.e., product name, handling statement, ingredients statement, the name and place of business of the manufacturer, packer or distributor, net weight, legend, safe handling instructions, and nutrition labeling) in accordance with Federal regulations and do not bear special statements and claims as defined in § 412.1(e).

[78 FR 66838, Nov. 7, 2013, as amended at 88 FR 2812, Jan. 18, 2023]

Notes of Decisions

Cited in 5 cases (3 in the last 5 years), 2017–2021 · leading case: Robert Cohen v. Conagra Brands, Inc., 16 F.4th 1283 (9th Cir. 2021).

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Robert Cohen v. Conagra Brands, Inc., 16 F.4th 1283 (9th Cir. 2021). “§ 457 (c); 9 C.F.R. § 412.2 (b), (e). The district court found that the United States Department of Agriculture’s Food Safety and Inspection Service (“FSIS”) had approved ConAgra’s poultry labels, and thus Cohen’s claims challenging both the label and ConAgra’s website…”

La Vigne v. Costco Wholesale Corp., 284 F. Supp. 3d 496 (S.D. Ill. 2018). “While the FSIS does not require the submission and pre-approval of certain labels meeting requirements for "generic labels" as defined in 9 C.F.R. § 412.2 , labels that include "[s]pecial statements and claims" are not exempt.”

Phelps v. Hormel Foods Corp., 244 F. Supp. 3d 1312 (S.D. Fla. 2017). “9 C.F.R. § 412.2 . FSIS’s approval process includes a determination of whether labels appear “false or misleading.”

Leining v. Foster Poultry Farms (Cal. Ct. App. 2021). “(9 C.F.R. 412.2.) The exception does not apply in this case.”

Leining v. Foster Poultry Farms, Inc. (Cal. Ct. App. 2021). “(9 C.F.R. 412.2.) The exception does not apply in this case.”

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