# 21 CFR § 1.21: Failure to reveal material facts

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-1.21

## Section

- **Citation:** 21 CFR § 1.21
- **Heading:** Failure to reveal material facts
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** September 22, 2026
- **Source:** Publisher's official text
- **Location:** Title 21—Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER A—GENERAL > PART 1—GENERAL ENFORCEMENT REGULATIONS > Subpart B—General Labeling Requirements

## Text

(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]

## Nearby sections

- [21 CFR § 1.1 § 1.1 General.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1.1.md)
- [21 CFR § 1.3 § 1.3 Definitions.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1.3.md)
- [21 CFR § 1.4 § 1.4 Authority citations.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1.4.md)
- [21 CFR § 1.20 § 1.20 Presence of mandatory label information.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1.20.md)
- [21 CFR § 1.21 § 1.21 Failure to reveal material facts.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1.21.md)
- [21 CFR § 1.23 § 1.23 Procedures for requesting variations and exemptions from required label statements.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1.23.md)
- [21 CFR § 1.24 § 1.24 Exemptions from required label statements.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1.24.md)
- [21 CFR § 1.70 § 1.70 Scope.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1.70.md)
- [21 CFR § 1.71 § 1.71 Definitions.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1.71.md)
- [21 CFR § 1.72 § 1.72 Data elements that must be submitted in ACE for articles regulated by FDA.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1.72.md)
- [21 CFR § 1.73 § 1.73 Food.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1.73.md)
- [21 CFR § 1.74 § 1.74 Human drugs.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1.74.md)
- [21 CFR § 1.75 § 1.75 Animal drugs and veterinary devices.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1.75.md)
- [21 CFR § 1.76 § 1.76 Medical devices.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1.76.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/ecfr-21-1.21. Check the current official text before relying on it. Not legal advice.