(a) Among representations in the labeling of a food which render such food misbranded is a false or misleading representation with respect to another food or a drug, device, or cosmetic.
(b) The labeling of a food which contains two or more ingredients may be misleading by reason (among other reasons) of the designation of such food in such labeling by a name which includes or suggests the name of one or more but not all such ingredients, even though the names of all such ingredients are stated elsewhere in the labeling.
(c) Among representations in the labeling of a food which render such food misbranded is any representation that expresses or implies a geographical origin of the food or any ingredient of the food except when such representation is either:
(1) A truthful representation of geographical origin.
(2) A trademark or trade name provided that as applied to the article in question its use is not deceptively misdescriptive. A trademark or trade name composed in whole or in part of geographical words shall not be considered deceptively misdescriptive if it:
(i) Has been so long and exclusively used by a manufacturer or distributor that it is generally understood by the consumer to mean the product of a particular manufacturer or distributor; or
(ii) Is so arbitrary or fanciful that it is not generally understood by the consumer to suggest geographic origin.
(3) A part of the name required by applicable Federal law or regulation.
(4) A name whose market significance is generally understood by the consumer to connote a particular class, kind, type, or style of food rather than to indicate geographical origin.
Notes of Decisions
Chavez v. Blue Sky Nat. Beverage Co., 268 F.R.D. 365 (N.D. Cal. 2010).
· cites it 3× “21 CFR § 101.18 (c). Plaintiff identifies another FDA regulation that governs specification of the name and place of business: (a) The label of a food in packaged form shall specify conspicuously the name and place of business of the manufacturer, packer, or distributor.”
Hi-Tech Pharm., Inc. v. HBS Int'l Corp., 910 F.3d 1186 (11th Cir. 2018).
“" 21 C.F.R. § 101.18 (b). But HexaPro's name does not include the name of any of the product's ingredients, so the object of Hi-Tech's state-law claim cannot be to enforce this regulation.”
Bohr v. Tillamook Cnty. Creamery Assn., 516 P.3d 284 (Or. Ct. App. 2022).
· cites it 4× “” Finally, plaintiffs’ complaint alleged a theory of loss that plaintiffs characterize as “prohibited transaction” claims: “Plaintiffs and the class purchased ‘misbranded goods’ as defined by 21 CFR 101.18 (False Statement of Geographic Origin).”
O'Hara v. Diageo-Guinness, USA, Inc., 370 F. Supp. 3d 204 (D.D.C. 2019).
· cites it 7× “46 , and 21 C.F.R. § 101.18 . Id . Plaintiff included a proposed Second Amended Complaint as an exhibit to his memorandum in support of the Motion to Amend, with Count IV of the proposed second amended complaint constituting the new claim plaintiff proposes.”
Kennard v. Kellogg Sales Co. (N.D. Cal. 2022).
· cites it 8× “§ 343 (a), which deems misbranded any food whose “label is false or misleading in any 9 particular”; (2) violating 21 C.F.R. § 101.18 (b), by describing the Products as VEGGIE despite 10 that they are primarily composed of non-vegetable ingredients, like wheat, gluten, and oil;…”
Johnston v. Kashi Sales, L.L.C. (S.D. Ill. 2022).
· cites it 2× “Kashi explains that “[Johnston] alleges that Kashi’s use of the phrase ‘Ripe Strawberry’ violates 21 C.F.R. § 101.18 (b), as that phrase ‘includes strawberries but does not include pears or apples, even though pears and apples are stated in the fine print on the ingredient list.”
Lima v. Post Consum. Brands, LLC (D. Mass. 2019).
· cites it 2× “See 21 C.F.R. § 101.18 (b). That regulation provides that a label “which contains two or more ingredients may be misleading by reason .”
Bohr v. Tillamook Cnty. Creamery Assn. (Or. 2025).
· cites it 2× “Third, the Tillamook products that plain- tiffs bought had been “misbranded” in violation of federal law, 21 CFR §101.18 and 21 USC § 331 , and had been falsely advertised in violation of ORS 616.”
Bohr v. Tillamook Cnty. Creamery Assn. (Or. 2025).
· cites it 2× “Third, the Tillamook products that plain- tiffs bought had been “misbranded” in violation of federal law, 21 CFR §101.18 and 21 USC § 331 , and had been falsely advertised in violation of ORS 616.”
Figueredo v. Tropicale Foods, LLC (S.D. Fla. 2024).
“¶ 43 (citing 21 C.F.R. § 101.18 (c)(2)(ii)). But, as Judge Bernal pointed out, “‘Helados Mexico’ does not translate into ‘Mexican Ice Creams’.”
Lima v. Post Consum. Brands, LLC (D. Mass. 2019).
“22 , which provides requirements for identifying food’s “primary recognizable flavors(s),” and 21 C.F.R. § 101.18 , which provides guidance on misbranding of food, such as when packaging references an ingredient that the food does not contain.”
— 21 C.F.R. § 101.18(b) — 1 case
Johnston v. Kashi Sales, L.L.C. (S.D. Ill. 2022).
“Kashi explains that “[Johnston] alleges that Kashi’s use of the phrase ‘Ripe Strawberry’ violates 21 C.F.R. § 101.18 (b), as that phrase ‘includes strawberries but does not include pears or apples, even though pears and apples are stated in the fine print on the ingredient list.”
— 21 C.F.R. § 101.18(c) — 2 cases
Chavez v. Blue Sky Nat. Beverage Co., 268 F.R.D. 365 (N.D. Cal. 2010).
“21 CFR § 101.18 (c). Plaintiff identifies another FDA regulation that governs specification of the name and place of business: (a) The label of a food in packaged form shall specify conspicuously the name and place of business of the manufacturer, packer, or distributor.”
Bohr v. Tillamook Cnty. Creamery Assn., 516 P.3d 284 (Or. Ct. App. 2022).
“” Finally, plaintiffs’ complaint alleged a theory of loss that plaintiffs characterize as “prohibited transaction” claims: “Plaintiffs and the class purchased ‘misbranded goods’ as defined by 21 CFR 101.18 (False Statement of Geographic Origin).”
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