C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION › PART 170—FOOD ADDITIVES › Subpart E—Generally Recognized as Safe (GRAS) Notice

21 C.F.R. § 170.205

Opportunity to submit a GRAS notice

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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.

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).
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Ctr. for Food Saf. v. Price (S.D.N.Y. 2021). “” 21 C.F.R. § 170.205 . The GRAS Rule provides two ways for demonstrating GRAS status.”
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