GRAS

Under US food law, a substance intentionally added to food is a food additive that needs premarket review and approval by FDA, unless it is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use [1]. FDA's regulation says that recognition rests only on the views of qualified experts and requires "reasonable certainty that the substance is not harmful under the conditions of its intended use" [2].

There are two routes: scientific procedures, or, for a substance used in food before 1958, experience based on common use in food [1]. The scientific route requires the same quantity and quality of evidence as approval of a food additive [2].

FDA describes its GRAS notification program as "a voluntary mechanism" for telling the agency about a GRAS conclusion (page dated February 9, 2018) [3]. In a proposed rule published August 11, 2026, FDA proposed requiring GRAS notices [4]. A Federal Register search on November 11, 2026, found no final rule, so its final form is not known. FDA's inventory of GRAS notices records the outcome of a closed notice: for one L-theanine notice (GRN No. 209), closed February 5, 2007, the entry for FDA's letter reads "FDA has no questions" [5].

GRAS is a safety status for a stated use in food, tied to its intended conditions of use [2]. A different use, form or amount is a separate question, and GRAS says nothing about whether an ingredient changed attention, memory or sleep in a placebo-controlled trial.

An FDA "no questions" letter answers a notice in which a company reports its own GRAS conclusion, a route the program describes as an alternative to asking FDA to affirm GRAS status [3]. Compound pages on NootropicsWork quote the letter's wording and date rather than calling the ingredient "FDA approved." GRAS is US-only; the nearest EU and UK question is novel food status.

• DSHEA
• Novel food
• Structure/function claim