21 C.F.R. § 170.260
Steps you may take before FDA responds to your GRAS notice
(a) You may submit a timely amendment to your filed GRAS notice, to update your GRAS notice or in response to a question from us, before we respond to your notice by letter in accordance with § 170.265(b)(1) or cease to evaluate your notice in accordance with § 170.265(b)(3).
(b) At any time before we respond to your GRAS notice in accordance with § 170.265(b)(1), you may request in writing that we cease to evaluate your GRAS notice. Your request does not preclude you from submitting a future GRAS notice in accordance with this subpart with respect to the notified substance.
Notes of Decisions
Cited in 1
case (1 in the last 5 years), 2021–2021 · leading case: Ctr. for Food Saf. v. Price (S.D.N.Y. 2021).
Ctr. for Food Saf. v. Price (S.D.N.Y. 2021). “21 C.F.R. § 170.260 (b). Under the GRAS Rule, FDA makes publicly available “[a] list of filed GRAS notices, including [certain] information” included in the notice and “[t]he text of any letter” FDA issues, including any letter issued when granting a request to cease evaluating…”
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