21 CFR 1.1445
§ 1.1445 Under what circumstances may FDA modify or revoke a waiver?
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 1.1445, § 1.1445 Under what circumstances may FDA modify or revoke a waiver?, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/82973
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Full text
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 of the Federal Food, Drug, and Cosmetic Act or misbranded under section 403(w) of the Federal Food, Drug, and Cosmetic Act; or
(c) The waiver is otherwise contrary to the public interest.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.