Of the 1,316 GRAS notices in FDA's public database, 1,304 (99.1%) cite "scientific procedures" as their basis for safety — the self-affirmed evidentiary track where the notifying company, not an independent FDA panel, assembles and evaluates the safety data. Only 10 notices (0.8%) rely on "common use in food," the older, harder-to-satisfy basis reserved for ingredients with a documented history of consumption before 1958. That 99-to-1 ratio is the whole story of how GRAS has evolved: it is now almost exclusively a company-run safety review that FDA merely receives and, in most cases, does not object to.
The mechanism is procedural. Since 1997, FDA has run GRAS as a voluntary notification program (21 CFR 170.36): a company convenes its own panel of qualified experts, decides the ingredient is safe, and can market it immediately — notifying FDA is optional, and even when a company does notify, FDA's 180-day review ends in a "no questions" letter, not an approval. That single design choice explains why science-based self-assessment so overwhelmingly dominates the ratio above: it is the path of least resistance, and it is the one industry associations have defended and regulators have increasingly challenged.
A pipeline that spans genome-edited enzymes to longevity supplements
Filing volume by year tracks the categories: it rose from roughly 20-30 notices/year in the early 2000s to a peak of 69 in 2014, driven heavily by industrial enzymes and functional-food ingredients. Novozymes North America (18 notices), DSM Food Specialties (17), Cargill (15), and Glycom A/S (15, human-milk oligosaccharides for infant formula) top the notifier list — a small, repeat-filer bench that treats GRAS as routine regulatory infrastructure, not a one-off event.
The notices also work as an early-warning system for ingredient trends before they hit shelves. GRN 791, filed by Amazentis SA in June 2018, sought GRAS status for Urolithin A — a postbiotic marketed for cellular/mitochondrial health — for use in protein shakes, bars, and yogurts [1]. Nestlé Health Science took a strategic equity stake in Amazentis the following year, in April 2019, gaining global rights to Urolithin A across supplements, foods, and medical nutrition [2], and Urolithin A is now a mainstream longevity-supplement ingredient. Reading GRAS filings in real time is, in effect, reading a year or more ahead of the commercial and investment activity that follows in the supplement aisle.
What the data does not show
Two limitations matter. First, this index only captures notices companies chose to file — the fully self-affirmed track, where a company never tells FDA at all, is invisible here and, by FDA's own admission, unquantifiable. Second, 638 of 1,316 records (48.5%) have no filing date, and the dated records run out after 2019 even though the live FDA inventory continues past GRN 1,000+ today — so this snapshot is a lagging, partial view of a program that has kept growing.
That gap is now a live policy fight. In March 2025, then-HHS Secretary Robert F. Kennedy Jr. directed FDA to pursue rulemaking to eliminate the self-affirmed GRAS pathway entirely [3]. FDA listed the mandatory-notification rule on its spring 2025 Unified Agenda, and by September 2025 stakeholders expected a formal Notice of Proposed Rulemaking within weeks [4]; as of the rule's most recent public update, FDA sent the draft proposal to the White House Office of Management and Budget for review in December 2025, with publication not expected before early-to-mid 2026. If finalized, the 99%-self-affirmed pattern this index shows would become the target of the rule, not just a description of it — worth watching for anyone tracking how new food ingredients actually reach market.