---
kind: "section"
citation: "21 C.F.R. § 1.1445"
title: "21"
number: "1.1445"
heading: "Under what circumstances may FDA modify or revoke a waiver?"
url: "https://uscodex.org/cfr/21/1.1445"
---

# §1.1445. Under what circumstances may FDA modify or revoke a waiver?


FDA may modify or revoke a waiver if we determine that:

- (a) Compliance with the waived requirements would no longer impose a unique economic hardship on the individual entity or type of entity to which the waiver applies;
- (b) The waiver could significantly impair our ability to rapidly and effectively identify recipients of a food to prevent or mitigate a foodborne illness outbreak or to address credible threats of serious adverse health consequences or death to humans or animals as a result of such food being adulterated under [section 402](/cfr/21/402.md) of the Federal Food, Drug, and Cosmetic Act or misbranded under [section 403(w)](/cfr/21/403.md?p=w) of the Federal Food, Drug, and Cosmetic Act; or
- (c) **The waiver is otherwise contrary to the public interest.**

## Notes

### Source

Source: 87 FR 71077, Nov. 21, 2022, unless otherwise noted.

### Authority

Authority: 15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C. 1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 342, 343, 350c, 350d, 350j, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362, 371, 374, 381, 382, 384a, 387, 387a, 387c, 393, and 2223; 42 U.S.C. 216, 241, 243, 262, 264, 271.

### Source

Source: 42 FR 15553, Mar. 22, 1977, unless otherwise noted.