Twelve. That is the current count of precision-fermented proteins the FDA has told a company it has “no questions” about since the pathway’s first use in 2018 — and four of the twelve arrived in a single eight-month stretch of 2025.
Our earlier analysis of why Europe has approved none of these ingredients put the US total at seven, current as of that piece’s reporting. Five more have cleared since: Vivici’s whey protein in February, TurtleTree’s lactoferrin in March, and both Onego Bio’s egg protein and Verley’s whey proteins in September. This is the fuller, current list, the pace behind it, and what the pace itself tells you.
Methodology
The FDA does not tag its GRAS Notice Inventory by production method, so there is no single query that returns “precision-fermented proteins.” This list was assembled from GRAS Notice (GRN) filings identifiable by ingredient and organism — a fermentation host such as Komagataella phaffii, Trichoderma reesei or Saccharomyces cerevisiae producing a named protein — cross-referenced against company announcements and trade press coverage of each clearance.
That means two things worth stating plainly. First, this covers the FDA GRAS notification pathway specifically, not the separate premarket consultation process FDA and USDA run for cultivated meat — the two use similar “no questions” language but are different dockets governing different products; conflating them is a common error. Second, a notice that generated no company announcement and no trade coverage could exist unflagged in a database of more than 1,300 entries. Treat this as the complete list of publicly documented clearances, not a mathematically verified census of the full inventory.
Every clearance, in order
| Company | Protein | Organism | GRN | Filed | Cleared | Time to clearance |
|---|---|---|---|---|---|---|
| Impossible Foods | Soy leghemoglobin | Pichia pastoris | 737 | Not stated in sources reviewed | Jul 2018 | Not stated in sources reviewed |
| Perfect Day | β-lactoglobulin (whey) | Trichoderma reesei | 863 | May 2019 | Apr 2020 | ~11 months |
| Clara Foods / The EVERY Co. | Soluble egg-white protein | Komagataella phaffii | 967 | 2020 | Sep 2021 | ~12 months |
| Remilk | β-lactoglobulin (whey) | Komagataella phaffii | 1056 | 2022 | Feb 2023 | ~11 months |
| The EVERY Co. (2nd notice) | Egg-white protein, expanded use | Komagataella phaffii | 1104 | Sep 2022 | Late 2023* | ~14 months* |
| Oobli | Brazzein (sweet protein) | Komagataella phaffii | 1142 | Not stated in sources reviewed | Mar 2024 | Not stated in sources reviewed |
| New Culture | Casein | Not disclosed | Self-affirmed | N/A | 2024 | No FDA notification filed |
| Geltor | Collagen peptides | Not disclosed | 1171 | 2023 | Oct 2024 | ~11 months |
| Vivici | β-lactoglobulin (whey), “Vivitein BLG” | Not disclosed | Not disclosed | Jul 2024 | Feb 2025 | ~7 months |
| TurtleTree | Lactoferrin, “LF+” | Not disclosed | 1219 | Sep–Dec 2024 | 8 Mar 2025 | ~3–5 months |
| Onego Bio | Ovalbumin, “Bioalbumen” | Not disclosed | Not disclosed | 19 Dec 2024 | 22 Sep 2025 | ~9 months |
| Verley | β-lactoglobulin (whey), “FermWhey” | Not disclosed | 1241 | Early 2025 | Sep 2025 | Not disclosed |
*EVERY’s second notice: amendments concluded September 2023; the exact response-letter date was not confirmed in company or trade coverage — see “What we could not establish.”
Perfect Day’s brazzein notice (GRN 1167, reported earlier this year) does not appear above because it could not be independently corroborated with a clearance date at the time of writing; it is a candidate 13th entry, not yet confirmed.
The pace roughly tripled
Group the same table by year and the finding sharpens.
| Period | Years covered | Clearances | Rate |
|---|---|---|---|
| 2018–2022 | 5 years | 3 | ~0.6/year |
| 2023–2024 | 2 years | 5 | ~2.5/year |
| 2025 (through September) | 0.75 years | 4 | ~5.3/year |
Four clearances in the first nine months of 2025 is more than the entire 2018–2022 period produced in five years, and more than any other single year on record. The practical consequence: a formulator who assumed precision-fermented protein was a niche, single-supplier category as recently as 2023 is now working from stale information. By September 2025, five different companies held FDA clearance across three protein types — whey, egg white and lactoferrin — with viable, if young, commercial supply.
Three forces plausibly explain the acceleration, though none is confirmed by FDA itself, which does not publish reasoning for review speed. Later filers can model their dossiers on earlier ones — Verley’s own CEO described its review as a “remarkably fast turnaround,” crediting the quality of the submission but also filing into a pathway four other companies had already used successfully. That is easier to achieve when a structurally similar protein has already cleared the same route. Contract fermentation capacity that came online through 2023–2024 gave newer entrants a faster route from lab result to the pilot-scale production data a GRAS notice requires. And four companies clearing in one year is itself a signal to the next cohort that the pathway is tractable within a normal venture timeline, which should — on this logic — keep the pace up rather than revert it.
Self-affirmed GRAS: the path that skips this table entirely
New Culture’s casein does not have a GRN because the company never filed one. Under US law, a company may determine independently that an ingredient is Generally Recognized As Safe, using the same category of scientific evidence FDA would review, and go to market without ever notifying the agency. Vivici did the same for a period — it declared self-affirmed GRAS for Vivitein BLG in February 2024, a full year before its FDA “no questions” letter arrived in February 2025.
This means the twelve-entry table above understates how many precision-fermented proteins are commercially available in the US. It only counts the ones whose makers chose FDA review. The practical consequence for a buyer: absence from this list is not evidence an ingredient lacks a safety basis, and presence on it is not the only mark of market readiness — but it is the only mark that is independently, publicly verifiable against a federal record rather than a company’s own claim.
Why file at all, if self-affirmation is legal and faster? The companies that have done so are consistent on the reasoning: an FDA “no questions” letter is a credibility signal to risk-averse enterprise buyers, retailers and their legal teams, in a category still being explained to the average grocery shopper. Verley’s CEO called the letter a “springboard for growth” specifically because it unlocks conversations with larger manufacturers who will not formulate around a self-affirmed ingredient alone. Self-affirmation is the faster legal path; FDA notification is the faster sales path.
What actually varies in review time
The clearances above range from roughly three months (TurtleTree, though this measures from formal filing rather than initial submission) to fourteen months (EVERY’s second notice). Reading the table for a pattern in that spread finds one plausible but unproven correlate: dossiers built on a protein type the FDA has already reviewed once — a second whey protein, a second ovalbumin — tend toward the shorter end. TurtleTree’s lactoferrin was a genuinely novel protein to the pathway and still moved in roughly three months from its formal filing (about five from FDA’s initial receipt of the notice), which cuts against a simple first-of-kind-is-slower rule. With the small number of data points available and no published FDA methodology, this is an observation to watch, not a conclusion to plan around.
The counter-argument
A table of successes is not a complete picture, and it is worth naming what it leaves out. FDA does not publish notices a company withdrew before a response letter issued, or filings still active and unresolved. A company whose notice has been under review for two years with no public update would not appear here, and there is no way to distinguish “still in normal review” from “quietly stalled” using only public information. The twelve-company success list, in other words, sits on top of an unknown number of attempts that have not yet succeeded or that failed silently. Readers using this piece to gauge how tractable the GRAS pathway is in general, rather than to track the specific companies that have cleared it, should weight it accordingly.
What we could not establish
The exact response-letter date for EVERY’s second notice (GRN 1104) — amendments ran through September 2023, and the agency response letter exists as a public FDA document, but no company announcement or trade coverage found during research stated the letter’s date directly.
GRN numbers for Vivici, Onego Bio, TurtleTree’s precise number is confirmed (1219) but Vivici’s and Onego Bio’s were not disclosed in the sources available at the time of writing, despite both companies issuing public announcements about the clearance itself.
Whether Perfect Day’s more recent brazzein notice (GRN 1167) has received a response letter, and when — flagged above as an unconfirmed candidate rather than included in the count of twelve.
Filing dates and review durations for Impossible Foods’ GRN 737 and Oobli’s GRN 1142 — both clearance dates are confirmed, but no source reviewed stated when either notice was filed, so those cells are marked as not stated rather than estimated.
What to watch
Whether 2026 sustains or exceeds 2025’s pace. A single strong year could be a backlog clearing rather than a trend. A second year at four-plus clearances would confirm the pathway has become a normal part of go-to-market planning for this category rather than an occasional event.
Whether any company’s timeline breaks meaningfully past fourteen months. Every clearance so far has landed inside roughly a year, give or take three months. A filing that runs two years or more — or one that fails publicly — would be the first real test of whether the pathway holds up as volume increases.
Whether self-affirmation becomes the default rather than the exception. If more companies follow New Culture’s route and skip FDA notification entirely, this table will increasingly undercount the real state of the market, and the credibility premium Verley and others are currently paying for will erode.