(a) Labeling of a food, drug, device, cosmetic, or tobacco product shall be deemed to be misleading if it fails to reveal facts that are:
(1) Material in light of other representations made or suggested by statement, word, design, device or any combination thereof; or
(2) Material with respect to consequences which may result from use of the article under: (i) The conditions prescribed in such labeling or (ii) such conditions of use as are customary or usual.
(b) Affirmative disclosure of material facts pursuant to paragraph (a) of this section may be required, among other appropriate regulatory procedures, by
(1) Regulations in this chapter promulgated pursuant to section 701(a) of the act; or
(2) Direct court enforcement action.
(c) Paragraph (a) of this section does not:
(1) Permit a statement of differences of opinion with respect to warnings (including contraindications, precautions, adverse reactions, and other information relating to possible product hazards) required in labeling for food, drugs, devices, cosmetics, or tobacco products under the Federal Food, Drug, and Cosmetic Act.
(2) Permit a statement of differences of opinion with respect to the effectiveness of a drug unless each of the opinions expressed is supported by substantial evidence of effectiveness as defined in sections 505(d) and 512(d) of the act.
[42 FR 15553, Mar. 22, 1977, as amended at 77 FR 5176, Feb. 2, 2012]
Notes of Decisions
Cited in
17
cases (
6 in the last 5 years), 1986–2025 · leading case:
Hadley v. Kellogg Sales Co., 273 F. Supp. 3d 1052 (N.D. Cal. 2017).
Hadley v. Kellogg Sales Co., 273 F. Supp. 3d 1052 (N.D. Cal. 2017).
· cites it 4× “Omission of Material Facts Plaintiff alleges that Defendant’s products are misbranded under 21 C.F.R. § 1.21 because Defendant’s products contain “health and wellness statements” and “fail[] to reveal” the “detrimental health consequences of consuming added sugars” and “the…”
Hadley v. Kellogg Sales Co., 243 F. Supp. 3d 1074 (N.D. Cal. 2017).
· cites it 3× “Omission of Presence of Sugar under 21 C.F.R. § 1.21 Plaintiff alleges that Defendant’s products are misbranded under 21 C.”
James Kroessler v. Cvs Health Corp., 977 F.3d 803 (9th Cir. 2020).
“21 C.F.R. § 1.21 (a). To these ends, the FDCA distinguishes between “disease claims” and “structure/function claims” that manufacturers make about their products, applying different regulatory standards to each.”
Paul Dachauer v. Nbty, Inc., 913 F.3d 844 (9th Cir. 2019).
“21 C.F.R. § 1.21 (a)(2). In other words, if a supplement’s label recommends taking one capsule per day, and that dose actually causes an increased risk of death—a material fact “with respect to consequences which may result from use of the article”—the FDCA would deem it…”
Hurley v. Lederle Labs., Div. of Am. Cyanamid Co., 651 F. Supp. 993 (E.D. Tex. 1986).
“21 C.F.R. § 1.21 expands on the meaning of "misbranded drugs” and provides, in pertinent part: (a) Labeling of a food, drug, device, or cosmetic shall be deemed to be misleading if it fails to reveal facts that are: (1) material in light of other representations made or…”
Motus v. Pfizer, Inc., 127 F. Supp. 2d 1085 (C.D. Cal. 2000).
“9 It is true that 21 C.F.R. § 1.21 (c)(1) states that § 1.21(a) does not “[pjermit a statement of differences of opinion with respect to warnings.”
Henley v. Food & Drug Admin., 873 F. Supp. 776 (E.D.N.Y 1995).
· cites it 2× “Misleading labeling 21 C.F.R. § 1.21 (a) provides that labeling of drug is deemed to be misleading if it fails to reveal facts that are material with respect to consequences which may result from use of the drug.”
Shawn M. Smith v. Hi-Tech Pharm., Inc. (Ga. Ct. App. 2022).
· cites it 2× “21 C.F.R. § 1.21 (a). Thus, “if a supplement’s label recommends taking one capsule per day, and that dose actually causes an increased risk of death — a material fact ‘with respect to consequences which may result from use of the article’ — the FDCA would deem it misleading not…”
Krystofiak v. BellRing Brands, Inc. (N.D. Cal. 2024).
· cites it 2× “23 at 20 (citing 21 C.F.R. § 1.21 (a)). It appears Plaintiffs seek an additional labeling requirement to accompany a “High Protein” label, based on lead content.”
Simien v. C R Bard Inc. (E.D. Tex. 2020).
“§§ 321 , 331, and 352; and 21 C.F.R. §§ 1.21 , 201.128, 801.4, 801.109, 803, 807, and 820.”
Hamzeh v. Pharmavite LLC (N.D. Cal. 2025).
“” 18 Regulations on Statements Made for Dietary Supplements Concerning the Effect of the Product on 19 the Structure or Function of the Body, 65 FR 1000 -01; see 21 C.F.R. § 1.21 (a)(2) (stating that a 20 food label “shall be deemed to be misleading if it fails to reveal facts”…”
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