C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION › PART 101—FOOD LABELING › Subpart F—Specific Requirements for Descriptive Claims That Are Neither Nutrient Content Claims nor Health Claims

21 C.F.R. § 101.95

“Fresh,” “freshly frozen,” “fresh frozen,” “frozen fresh.”

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The terms defined in this section may be used on the label or in labeling of a food in conformity with the provisions of this section. The requirements of the section pertain to any use of the subject terms as described in paragraphs (a) and (b) of this section that expressly or implicitly refers to the food on labels or labeling, including use in a brand name and use as a sensory modifier. However, the use of the term “fresh” on labels or labeling is not subject to the requirements of paragraph (a) of this section if the term does not suggest or imply that a food is unprocessed or unpreserved. For example, the term “fresh” used to describe pasteurized whole milk is not subject to paragraph (a) of this section because the term does not imply that the food is unprocessed (consumers commonly understand that milk is nearly always pasteurized). However, the term “fresh” to describe pasta sauce that has been pasteurized or that contains pasteurized ingredients would be subject to paragraph (a) of this section because the term implies that the food is not processed or preserved. Uses of fresh not subject to this regulation will be governed by the provisions of 403(a) of the Federal Food, Drug, and Cosmetic Act (the act).

(a) The term “fresh,” when used on the label or in labeling of a food in a manner that suggests or implies that the food is unprocessed, means that the food is in its raw state and has not been frozen or subjected to any form of thermal processing or any other form of preservation, except as provided in paragraph (c) of this section.

(b) The terms “fresh frozen” and “frozen fresh,” when used on the label or in labeling of a food, mean that the food was quickly frozen while still fresh (i.e., the food had been recently harvested when frozen). Blanching of the food before freezing will not preclude use of the term “fresh frozen” to describe the food. “Quickly frozen” means frozen by a freezing system such as blast-freezing (sub-zero Fahrenheit temperature with fast moving air directed at the food) that ensures the food is frozen, even to the center of the food, quickly and that virtually no deterioration has taken place.

(c) Provisions and restrictions. (1) The following do not preclude the food from use of the term “fresh:”

(i) The addition of approved waxes or coatings;

(ii) The post-harvest use of approved pesticides;

(iii) The application of a mild chlorine wash or mild acid wash on produce; or

(iv) The treatment of raw foods with ionizing radiation not to exceed the maximum dose of 1 kiloGray in accordance with § 179.26 of this chapter.

(2) A food meeting the definition in paragraph (a) of this section that is refrigerated is not precluded from use of “fresh” as provided by this section.

[58 FR 2426, Jan. 6, 1993]
Notes of Decisions
Cited in 8 cases (1 in the last 5 years), 1993–2023 · leading case: Campbell v. Freshbev LLC, 322 F. Supp. 3d 330 (E.D.N.Y. 2018).
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Campbell v. Freshbev LLC, 322 F. Supp. 3d 330 (E.D.N.Y. 2018). · cites it 6× “" The parties agree that 21 C.F.R. § 101.95 governs use of the word "fresh" on a label but disagree as to its implications.”
Mladenov v. Wegmans Food Markets, Inc., 124 F. Supp. 3d 360 (D.N.J. 2015). · cites it 2× “¶¶ 76-79; ACME Amend. Compl. ¶¶71-77). Since the Court finds that Plaintiffs’ have failed to state viable CFA claims, Plaintiffs’ TCCWNA claims cannot survive to the extent they rely on the alleged CFA- violations.”
Brazil v. Dole Food Co., 935 F. Supp. 2d 947 (N.D. Cal. 2013). “54 (g); “fresh” claims, 21 C.F.R. § 101.95 ; “sugar free” and “sugarless” claims, 21 C.”
Abruzzi Foods, Inc. v. Pasta & Cheese, Inc., 986 F.2d 605 (1st Cir. 1993). “6, 1993) {to be codified at 21 C.F.R. § 101.95 ) (since “consumers recognize that milk is nearly always pasteurized,” there is no danger of deception in calling pasteurized milk “fresh”).”
Sarr v. BEF Foods, Inc., No. 1:18-cv-06409, 2020 WL 729883 (E.D.N.Y. Feb. 13, 2020). “]” 21 C.F.R. § 101.95 (a); see FAC ¶ 72. However, according to the plaintiffs, consumers believe that “fresh” means “just prepared.”
Lumbra v. Suja Life, LLC, 674 F. Supp. 3d 7 (N.D.N.Y. 2023). “21 C.F.R. § 101.95 . The regulation expressly allows processed foods to use the word "fresh," so long as "the term does not suggest or imply that a food is unprocessed or unpreserved.”
Abruzzi Foods, Inc. v. Pasta & Cheese, No. 92-1597 (1st Cir. Mar. 2, 1993). “" One might, for example, accurately call pasteurized milk "fresh," in order to distinguish it from condensed or powdered or long-life milk.”
Abruzzi Foods, Inc. v. Pasta & Cheese, No. 92-1597 (1st Cir. Mar. 2, 1993). “" One might, for example, accurately call pasteurized milk "fresh," in order to distinguish it from condensed or powdered or long-life milk.”
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