Search the FDA’s GRAS Notice Inventory for “casein” and five records come back. Two of them are recombinant caseins made by precision fermentation. Neither has an FDA no-questions letter.
The first, GRN 1228, was filed by Fermify GmbH of Vienna for β-casein produced by E. coli DSM 35048. Its date of closure is 13 June 2025, and the entry in the agency’s letter column reads: At the notifier’s request, FDA ceased to evaluate this notice. The inventory’s “Resubmitted as GRN No.” column is blank.
The second, GRN 1312, was filed by NewMilkBuzz BV and Formo Foods GmbH for recombinant αS1-casein from Bos taurus produced by E. coli DSM 35603. Its letter column reads Pending. The inventory page was last updated on 18 August 2026.
That is the whole federal record for recombinant casein in the United States. It is worth setting against the coverage from early June, when the Formo filing became public and was reported under headlines including “Formo Cleared to Sell Cow-Free Casein in US”. Those headlines are not wrong about what a self-determined GRAS conclusion permits. They are a poor guide to what the FDA has actually said, which so far is nothing.
What each notice actually claims
The two dossiers took opposite bets on scope, and the difference is the most decision-relevant thing in the record.
| GRN 1228 | GRN 1312 | |
|---|---|---|
| Substance | β-casein produced by E. coli DSM 35048 | Recombinant αS1-casein from Bos taurus produced by E. coli DSM 35603 |
| Notifier | Fermify GmbH, Vienna, Austria | NewMilkBuzz BV and Formo Foods GmbH, Berlin, Germany |
| Basis | Scientific procedures | Scientific procedures |
| Maximum level | Up to 15% | Up to 25g per 100g |
| Food categories | Cheese and cheese analogs, non-alcoholic beverages, dairy product analogs, frozen dairy desserts, milk products, plant protein products | Cheese analogs only |
| Stated exclusions | None stated in the inventory entry | Infant formula; products under USDA jurisdiction |
| Date of closure | 13 June 2025 | — |
| FDA’s letter | Ceased to evaluate at notifier’s request | Pending |
Fermify asked for six food categories at up to 15% inclusion. Formo and NewMilkBuzz asked for one category at up to 25g per 100g — a higher ceiling in a much narrower box, with infant formula and USDA-jurisdiction products written out on the face of the record.
The practical consequence: a formulator evaluating Formo’s αS1-casein is looking at an ingredient whose notified intended use is cheese analogs. Everything else discussed around it — high-protein beverages, barista milks, recovery and satiety formats, GLP-1 adjacent nutrition — sits outside the scope of GRN 1312 as the inventory describes it. Those applications are not prohibited; they are simply not what this notice covers, and a buyer’s regulatory affairs function will ask which document supports them.
“Cleared to sell” and “Pending” are both true, and they are not the same thing
The confusion here is structural rather than anybody’s error, and it is worth stating precisely because it recurs across every precision-fermented ingredient.
A company may conclude for itself that a substance is GRAS, on scientific procedures, and begin selling on that basis. Formo did exactly that, and Green Queen’s 1 June report describes the self-determination as the milestone that “enables the firm to sell the animal-free dairy protein to food manufacturers in the US”. Notifying the FDA is voluntary. It does not confer permission, because permission was never the agency’s to grant under this pathway.
What notification buys is a documented federal review and, if it goes well, a letter saying the agency has no questions. Protein Production Technology International’s account of the same filing put the boundary plainly: publication of the dossier “does not constitute regulatory clearance”, and both companies said they expect a no-questions letter later in 2026.
Formo’s own public affairs lead, Christian Poppe, framed the choice as deliberate. “We did not stop at self-determined GRAS,” he told PPTI. “We submitted for FDA notification review because that is the right standard for innovative food ingredients made through precision fermentation.”
That is a defensible position and, on the evidence of the inventory, an unusual one. It is also the position that produces a public record which can be checked — including by people who would prefer it said something else.
The practical consequence: treat “self-affirmed GRAS” and “FDA has no questions” as two different assets on a supplier’s regulatory balance sheet. The first is the supplier’s own conclusion. The second is a federal letter. Only the second survives a hostile procurement review, and only the second is unaffected by the rulemaking discussed below.
Why the withdrawal matters more than it looks
Withdrawing a GRAS notice is not a company failure and should not be read as one. The FDA’s own inventory introduction notes that notifiers often resubmit notices the agency previously ceased to evaluate at the notifier’s request, and that resubmitted notices commonly receive a no-questions letter after deficiencies are addressed. Withdrawal is frequently the cheapest way to fix a dossier without a formal adverse finding on the record.
The detail that carries weight is that GRN 1228 was not resubmitted. Fourteen months after closure, the inventory shows no successor notice for Fermify’s β-casein, and no other recombinant casein notice exists.
It is also the second fermentation-protein notice we have found that closed at the notifier’s request rather than reaching a decision. The other came nine months later: GRN 1268, withdrawn in March 2026 after the agency identified deficiencies, which we covered in The Protein Brewery cleared the EU in six years; its US notice closed with no decision. Two withdrawals do not make a pattern, but they do undercut the widely repeated claim that the US GRAS route is the fast and predictable one. Our count of every FDA GRAS clearance for fermentation-derived protein reached twelve; the casein subset of that field has produced zero.
The timing problem
Notification is voluntary today. The FDA has proposed to make it mandatory. We examined the proposal in FDA counts 2,000 self-affirmed GRAS conclusions; its proposed rule gives them a one-year window, which found no grandfathering clause and a single one-year streamlined-submission window after any final rule takes effect.
Both trade reports place the Formo filing against that backdrop. Green Queen notes the proposed rule to scrap self-affirmation and a New York state bill to close the same route for products sold in that state. Poppe’s argument to PPTI — that “precision fermentation will earn long-term public trust by exceeding oversight, not minimizing it” — reads as a company positioning itself ahead of a rule change rather than defending the status quo.
If that rule is finalised in anything like its proposed form, a filed notice with a pending letter is a materially better position than a self-determination held in a drawer. On that reading, GRN 1312 is less a marketing milestone than a hedge.
The practical consequence: if you are underwriting a supply agreement that runs past the likely effective date of a mandatory-notification rule, ask which of your suppliers’ ingredients appear in the GRAS inventory at all. Absence from the inventory is not a safety signal. It is a signal about what happens to that ingredient’s paperwork if the pathway changes.
The route-to-market picture, updated
Earlier this month we found that four companies commercialising precision-fermented casein had each picked a different owner of the route to market, and that none of them held an FDA no-questions letter. That remains true. What has changed is that the federal record is now legible: one casein notice has been through the process and come out without a decision, and one is in it.
The narrowness of GRN 1312’s intended use also reframes the Leprino–Fooditive arrangement described in that piece, where exclusivity was granted for cheese and non-exclusive rights everywhere else. Formo’s notified scope is cheese analogs. The category everybody is fighting over is the category the regulator is being asked about first, and for good reason: it is where casein’s functional case is strongest and where an inclusion level of 25g per 100g is technically plausible.
The counter-argument
The strongest case against reading much into this record is that it is simply young. GRN 1312 was filed in December 2025 and published in mid-2026; a pending letter after a few months is unremarkable, and FDA review timelines for novel fermentation-derived proteins have historically run well past a year. On this view the inventory is telling us nothing except that a normal process is at a normal stage.
That is fair, and nothing here forecasts an adverse outcome. But two claims in circulation are testable against the record today and do not survive it: that a precision-fermented casein has been cleared by the FDA, and that the US pathway reliably delivers a decision. Neither the withdrawn notice nor the pending one supports either claim.
A second counter-argument is that intended-use scope in a GRAS notice is a floor rather than a ceiling — companies routinely file narrowly and broaden later. True, and Formo has said its R&D pipeline points at a wider platform of casein variants. But each broadening is its own regulatory work, and a buyer signing today is buying the scope on today’s record.
What we could not establish
- Whether Fermify’s withdrawal was strategic or remedial. The inventory records only that the agency ceased evaluation at the notifier’s request. The FDA’s linked letter for GRN 1228 is titled accordingly. We did not obtain a statement from Fermify explaining the decision, and we make no inference about the company’s commercial position from it.
- The date GRN 1312 was filed with the agency. The inventory detail page does not display a filing date. PPTI reports a December 2025 submission and Green Queen refers to a self-determination “last December” without giving a year; we have used PPTI’s December 2025 for the submission and have not asserted a date for the self-determination itself.
- The corporate relationship between NewMilkBuzz BV and Those Vegan Cowboys. The FDA lists NewMilkBuzz BV as a co-notifier at Formo’s Berlin address. Both trade reports describe the notice as jointly filed by Formo and Those Vegan Cowboys. We could not confirm the entity relationship from a primary corporate registry and have used the FDA’s names where the record is what matters.
- Fermify’s current regulatory position. No successor notice appears in the GRAS inventory. We could not verify from a source we fetched what route the company has taken since June 2025.
- Volumes and manufacturing partners for Formo’s casein. Green Queen reports that Wohlgensinger declined to disclose specific volume numbers or contract manufacturing partners, saying only that production is split between Formo’s own Frankfurt pilot capability and qualified contract partners. No tonnage figure is on the public record.
What to watch
Three testable claims, all checkable against the same inventory page:
- GRN 1312’s letter column changes before 31 December 2026. Both companies have said they expect a no-questions letter this year. The record will show it, or show a closure, or continue to read Pending.
- A successor notice appears for Fermify’s β-casein. The FDA’s own guidance says resubmission after withdrawal is common and usually successful. Fourteen months of silence is the anomaly to watch.
- The notified scope broadens. If casein is to reach protein beverages, barista systems and metabolic-health formats in the US on a notified basis rather than a self-determined one, a second notice with wider intended use has to appear. It has not yet.
We will revisit this record when any of the three changes. The same discipline applied to Helaina’s lactoferrin and the infant-formula question applies here: the useful figure is not the one in the announcement, it is the one on the file.