On 28 October 2026 Formo and Those Vegan Cowboys announced an FDA “no questions” letter for a precision-fermented casein. The notice that letter answers, GRN 1312, covers one use: cheese analogs, at up to 25 g per 100 g. The same-day coverage lists a wider set of applications, including sports nutrition, infant nutrition, coatings, clinical diets and acidic drinks. This piece lays the two side by side and shows where the dates in the coverage cannot be reconciled with the filing.
Our earlier analysis of GRN 1312 read the dossier as a spec sheet, when FDA’s letter status was still “Pending”. This article does not repeat it. It asks a different question that an operator needs answered before signing a supply agreement: what exactly did the letter clear?
One caveat governs everything below. We have not seen the letter. As read on 28 October, FDA’s inventory entry for GRN 1312 still showed the letter as “Pending”. Every statement about what FDA concluded comes from the companies and the trade press. What we can read is the notice itself, which sets the scope any letter responds to.
What the notice covers
The notice’s cover letter is dated 19 December 2025 and is signed by Roman Plewka, CEO of Formo Foods GmbH, and Will van den Tweel, CTO of NewMilkBuzz BV. The notice identifies NewMilkBuzz as trading as Those Vegan Cowboys. FDA’s record lists the notifiers as NewMilkBuzz BV and Formo Foods GmbH, and the substance as recombinant alphaS1-casein from Bos taurus produced by Escherichia coli DSM 35603.
The notice describes its intended use as “intended to be used as a food ingredient in cheese analogs at a maximum use level up to 25 g per 100 g.” FDA’s inventory entry words it as “Intended for use as an ingredient at up to 25g per 100g in cheese analogs.” Both exclude infant formula and products under USDA jurisdiction. The notice’s exclusion names meat, poultry and egg products among them.
Two details matter here. First, the product is a single casein, alphaS1, which the trade coverage describes as about 40% of total bovine casein. Second, the use is a single food category. Nothing in the notice we read refers to beverages or sports products.
Practical consequence: a supplier can tell you honestly that its ingredient has a no-questions letter and still not be cleared, by that letter, to sell into your category. Ask for the notice scope in writing and compare it with your intended use before treating the letter as a clearance.
What the announcements describe
| Application named in coverage | Where it appears | In the GRN 1312 notice? |
|---|---|---|
| Cheese analogs: mozzarella, burger slices, cream cheese, feta, camembert | FoodNavigator, 28 Oct | Yes, within the cheese-analog use, up to 25 g per 100 g |
| Burger cheese with Hochland | FoodNavigator, 28 Oct | Yes, if the product is a cheese analog |
| Sports performance and sports nutrition (XXL Nutrition named as partner) | FoodNavigator, 28 Oct | No. The notice lists only cheese analogs |
| Infant nutrition | FoodNavigator, 28 Oct | No. The notice excludes infant formula; infant nutrition beyond formula is not addressed |
| Coatings and clinical diets | FoodNavigator, 28 Oct | No |
| Chocolate, yogurt, drinks | FoodNavigator, 28 Oct, as areas under exploration | No |
| Clear acidic drinks at pH 3 to 4, up to 6% protein; cold foams; ready-to-drink | Green Queen and Protein Production Technology, 28 Oct | No. Both say Formo plans another GRAS notice for broader uses |
Those Vegan Cowboys’ CTO Will van den Tweel said in FoodNavigator that the product is “not only related to cheese”. That may be a statement about the molecule’s potential, and it is accurate in that sense. It is not a statement about regulatory scope. The coverage is also candid on one point: Green Queen and Protein Production Technology both say Formo intends to file a further notice for beverage-type uses, which tells you the companies themselves treat the beverage uses as outside GRN 1312.
There is a subtlety on the infant line. The notice excludes infant formula. FoodNavigator lists “infant nutrition” among intended applications for the company’s product. Those are different phrases, and we cannot tell from the coverage whether the company means formula, follow-on foods, or something else. The notice we read does not address any of them.
Practical consequence: if your brief is a sports bar, a clear protein drink or an infant product, treat the letter as evidence of a first step and not of a path. The supplier’s next notice, and FDA’s answer to it, are the events that matter.
The timeline does not add up
The dates in the coverage cannot all be true at once.
| Source | What it says about timing |
|---|---|
| GRN 1312 cover letter | Dated 19 December 2025 |
| Protein Production Technology, 2 Jun 2026 | Notice filed in December 2025; no-questions letter expected “later this year” |
| FoodNavigator, 2 Jun 2026 | Issuance of the notice described as the final step before FDA decides whether to release a letter; no filing date given |
| Green Queen, 28 Oct 2026 | Letter came about four months after filing; dossier filed December 2025 |
| FoodNavigator, 28 Oct 2026 | Notice submitted about five months before the announcement |
From 19 December 2025 to 28 October 2026 is 313 days, which is just over ten months. Neither “about four months” nor “about five months” matches that, and Green Queen’s own two statements, filing in December 2025 and a letter four months after filing, conflict with each other. The most plausible reading is that the press is counting from FDA’s filing letter, not from the date the dossier was sent. If so, that implies FDA’s filing came about five months after submission or later. That is our inference, and the coverage does not state it.
The regulation gives a frame. Under 21 CFR 170.265(b)(1), “Within 180 days of filing, we will respond to you by letter based on our evaluation of your notice.” FDA may extend that period by 90 days, with written notice no later than day 180. Filing is a distinct step, confirmed by a letter that gives the date of filing. The section we read sets no deadline for the filing decision itself, so the 180-day clock runs from filing and not from submission.
Practical consequence: when a supplier says a regulatory review took “four months”, ask which clock it means. For a launch plan, the submission-to-letter interval is the one that governed this product’s calendar, and here it exceeded ten months by our count.
Who holds the letter
Both Formo and Those Vegan Cowboys say they received it, and Protein Production Technology reports that Those Vegan Cowboys is now selling its own casein product, Margaret’s Finest, independently of Formo. The two companies began collaborating in 2024, and FoodNavigator reports they will now work independently.
That raises a practical question the notice answers only in part. GRN 1312 names two notifiers, NewMilkBuzz BV and Formo Foods GmbH, and a single substance made by one strain, E. coli DSM 35603. The coverage does not say whether the two companies will each produce the substance, whether they use the same strain, or whether the independent product is the notified one. We could not establish this.
Practical consequence: if you are contracting with either company, ask which entity is the notifier of record, which strain and process produce the lots you will receive, and whether those match the notice.
Context the letter does not change
Both companies are early commercially. Green Queen reports that Those Vegan Cowboys expects first US consumer products in 2027 and plans an EU filing in 2027, and that it has raised €12.25m ($14.2m) plus a €1.2m EU-backed subsidy. It reports Formo has raised over €135m. FoodNavigator reports the Those Vegan Cowboys CTO saying that large-scale production will need cheap feedstock and energy, with no figures given. No production volume, price or capacity appears in any of the coverage or in the notice pages we read.
Demand context is real. Green Queen cites US whey protein isolate above $13 a pound and whey protein concentrate around $10 a pound, both over three times early-2023 prices. FoodNavigator’s 20 October report, citing Expana, put US high-protein whey concentrate at about $12.25 a pound at the end of August, up 134% year on year. The two concentrate figures differ, and neither article specifies the protein grade or the date of its figure, so we do not reconcile them. For how whey benchmarks shift, see our analysis of the whey benchmark split.
The counter-argument
The strongest defence of the announcements is that they are accurate. A no-questions letter is a real regulatory milestone, and the companies have been open that a second notice is planned for beverage uses. Marketing a platform’s potential is not misrepresenting a letter. A cheese-analog clearance is still a meaningful scope, and burger slices and cream cheese are named in coverage as products already developed.
A second reply is legal. A company can in principle conclude on its own that other uses are generally recognised as safe without notifying FDA, which is the route we examine in our piece on the self-affirmed GRAS route. Formo’s global public-affairs lead is quoted in Protein Production Technology’s June report as saying the company “did not stop at self-determined GRAS”, which suggests the firm prefers the notice route where it can. Whether it will self-affirm any beverage use, we do not know.
Neither reply changes the central point. A buyer or investor reading a headline about “FDA clearance” should read the scope line before the headline. The scope line says cheese analogs.
What we could not establish
- The letter itself. FDA’s inventory showed the letter as “Pending” when we read it. We have not seen the letter’s text, its date or any conditions.
- The filing date. The notice is dated 19 December 2025. FDA’s filing letter date is not in any source we read. The press accounts of the elapsed time conflict with that date and with each other.
- Whether “infant nutrition” means formula. The notice excludes formula; the coverage uses the broader phrase without definition.
- Which entity produces what. We could not determine whether both companies will make the notified substance, or in which facility.
- Capacity, price and offtake. None appears in the coverage or the notice pages we read.
- First-ness. Formo describes the letter as the first for a precision-fermented casein. We did not independently verify that claim against FDA’s inventory. Our tracker of precision-fermented clearances predates this letter and our piece on withdrawn and pending casein notices describes the earlier notices.
- Whey price basis. The two whey concentrate figures cited above use unstated grades and dates.
What to watch
- FDA publishing the GRN 1312 response letter. Check that its scope matches the notice: cheese analogs, 25 g per 100 g, no infant formula, no USDA products.
- A second Formo notice covering beverage-type uses, and what use levels it requests. Our earlier article on the OneGo waffle cap shows how far a use level can sit below a marketing claim.
- Any disclosure of production volume, price or a named cheese maker’s purchase commitment. The route-to-market constraint for this ingredient was never only regulatory; see our analysis of the casein route to market.
- Whether Those Vegan Cowboys’ independent product and Formo’s product are the same notified substance.