In accordance with section 403(d) of the act, a food shall be deemed to be misbranded if its container is so made, formed, or filled as to be misleading.
(a) A container that does not allow the consumer to fully view its contents shall be considered to be filled as to be misleading if it contains nonfunctional slack-fill. Slack-fill is the difference between the actual capacity of a container and the volume of product contained therein. Nonfunctional slack-fill is the empty space in a package that is filled to less than its capacity for reasons other than:
(1) Protection of the contents of the package;
(2) The requirements of the machines used for enclosing the contents in such package;
(3) Unavoidable product settling during shipping and handling;
(4) The need for the package to perform a specific function (e.g., where packaging plays a role in the preparation or consumption of a food), where such function is inherent to the nature of the food and is clearly communicated to consumers;
(5) The fact that the product consists of a food packaged in a reusable container where the container is part of the presentation of the food and has value which is both significant in proportion to the value of the product and independent of its function to hold the food, e.g., a gift product consisting of a food or foods combined with a container that is intended for further use after the food is consumed; or durable commemorative or promotional packages; or
(6) Inability to increase level of fill or to further reduce the size of the package (e.g., where some minimum package size is necessary to accommodate required food labeling (excluding any vignettes or other nonmandatory designs or label information), discourage pilfering, facilitate handling, or accommodate tamper-resistant devices).
(b) [Reserved]
[59 FR 537, Jan. 5, 1994]
Notes of Decisions
Daniel v. Mondelez Int'l, Inc., 287 F. Supp. 3d 177 (E.D.N.Y 2018).
· cites it 6× “" 21 C.F.R. § 100.100 (a). Recognizing the inevitability and value of slack-fill in many products, the FDCA only considers " non-functional " slack-fill to be misleading when placed in a package where consumers are unable to fully view the contents.”
Clarisha Benson v. Fannie May Confections Brands, 944 F.3d 639 (7th Cir. 2019).
· cites it 2× “21 C.F.R. § 100.100 (a). Slack-fill is nonfunctional if it cannot be justified by any of the following reasons: (1) protec- tion of the contents of the package; (2) the requirements of the machines used to enclose the contents in such package; (3) un- avoidable product settling…”
Bautista v. Cytosport, Inc., 223 F. Supp. 3d 182 (S.D.N.Y. 2016).
· cites it 4× “§ 343 (d), and its implementing regulations at, 21 C.F.R. § 100.100 , a food is misbranded “[i]f its container is so made, formed or filled as to- be misleading.”
Stemm v. Tootsie Roll Indus., Inc., 374 F. Supp. 3d 734 (E.D. Ill. 2019).
· cites it 3× “Stemm further alleges that the empty space within the Product's packaging (commonly referred to as the "slack-fill") is non-functional, because it does not protect the candies, is not required for enclosing the candies, did not substantially result from product settling into the…”
Waldman v. New Chapter, Inc., 714 F. Supp. 2d 398 (E.D.N.Y 2010).
· cites it 3× “” 21 C.F.R. § 100.100 (a). 6 Drawing reasonable inferences in Plaintiffs favor, the Complaint pleads both of these prongs.”
Hawkins v. Nestle U.S.A. Inc., 309 F. Supp. 3d 696 (E.D. Mo. 2018).
· cites it 2× “") Specifically, in the Amended Complaint, Plaintiff cites 21 C.F.R. § 100.100 , a Federal regulation which provides: "A container that does not allow a consumer to fully view its contents shall be considered to be filled so as to be misleading [in violation of 21 U.”
Witte v. Gen. Nutrition Corp., 104 F. Supp. 3d 1 (D.D.C. 2015).
“¶ 14; see also 21 C.F.R. § 100.100 (a) (“Slack-fill is the difference between the actual capacity of a container and the volume of product contained therein.”
Diesel v. Mariani Packing Co., Inc. (E.D. Mo. 2024).
· cites it 7× “Specifically, Plaintiff argues that: (1) her actions were consistent with a “reasonable consumer”; (2) her testimony shows that the Product’s packaging misled her; (3) there is 2 Under 21 C.F.R. § 100.100 (a), a container that does not allow the consumer to fully view its…”
Stuve v. Kraft Heinz Co., The (N.D. Ill. 2023).
· cites it 5× “argued that the NLEA and 21 C.F.R. § 100.100 (a)(3)(iii) expressly preempted the plaintiffs’ claims.”
Clarisha Benson v. Fannie May Confections Brands (7th Cir. 2019).
· cites it 2× “21 C.F.R. § 100.100 (a). Slack-fill is nonfunctional if it cannot be justified by any of the following reasons: (1) protec- tion of the contents of the package; (2) the requirements of the machines used to enclose the contents in such package; (3) un- avoidable product settling…”
— 21 C.F.R. § 100.100(a) — 1 case
Daniel v. Mondelez Int'l, Inc., 287 F. Supp. 3d 177 (E.D.N.Y 2018).
“" 21 C.F.R. § 100.100 (a). Recognizing the inevitability and value of slack-fill in many products, the FDCA only considers " non-functional " slack-fill to be misleading when placed in a package where consumers are unable to fully view the contents.”
— 21 C.F.R. § 100.100(a)(1) — 2 cases
Daniel v. Mondelez Int'l, Inc., 287 F. Supp. 3d 177 (E.D.N.Y 2018).
“" 21 C.F.R. § 100.100 (a). Recognizing the inevitability and value of slack-fill in many products, the FDCA only considers " non-functional " slack-fill to be misleading when placed in a package where consumers are unable to fully view the contents.”
Diesel v. Mariani Packing Co., Inc. (E.D. Mo. 2024).
“Specifically, Plaintiff argues that: (1) her actions were consistent with a “reasonable consumer”; (2) her testimony shows that the Product’s packaging misled her; (3) there is 2 Under 21 C.F.R. § 100.100 (a), a container that does not allow the consumer to fully view its…”
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