21 CFR 170.205
§ 170.205 Opportunity to submit a GRAS notice.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 170.205, § 170.205 Opportunity to submit a GRAS notice, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/84898
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Full text
Any person may notify FDA of a view that a substance is not subject to the premarket approval requirements of section 409 of the Federal Food, Drug, and Cosmetic Act based on that person's conclusion that the substance is GRAS under the conditions of its intended use.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.