Berlin-based Formo and Dutch company Those Vegan Cowboys announced on 28 October that the US Food and Drug Administration has no questions about their conclusion that a precision-fermented casein is generally recognised as safe. Food Ingredients First reports it is the first such letter for this type of ingredient. The two companies filed the notice together in December 2025 under a research collaboration that ended in 2025, and now sell separately: Formo as Enhanced Casein, Those Vegan Cowboys as Margaret’s Finest.
At a glance
- GRN 1312 recombinant αS1-casein produced by E. coli DSM 35603
- 25 g per 100 g: the maximum use level, in cheese analogs only
- 2 exclusions: infant formula and products under USDA jurisdiction
- 2 notifiers sharing one dossier: NewMilkBuzz BV and Formo Foods GmbH
FDA GRAS Notices inventory; Food Ingredients First, 28 October 2026.
What the letter covers
The FDA inventory entry lists one intended use: cheese analogs at up to 25 g per 100 g. The review covered identity, composition, manufacturing, allergenicity, toxicology and dietary exposure. A no-questions letter is the agency’s response to a company’s own GRAS conclusion; it is not an approval and does not extend to other food categories. The casein is a milk allergen and must be labelled as one.
Formo says it will file a further notice for wider food and nutrition uses. Its own tests show the casein staying soluble at pH 3–4 at protein concentrations of up to 6%, which points at clear high-protein drinks, a use the current letter does not cover. Those Vegan Cowboys names Hochland (burger cheese) and XXL Nutrition (sports nutrition) as partners, Cheese Reporter reports.
What this means for investors
The letter removes the largest US regulatory question for casein in cheese, the protein FoodNavigator describes as responsible for texture, melt and stretch. It does so for two competitors at once, so neither gains an exclusive position from it. Value now moves to cost per kilogram, contracted volumes with cheese makers, and speed on the second notice: Green Queen notes the FDA has proposed ending the self-affirmed GRAS route, which would make FDA-reviewed dossiers a requirement for later entrants.
Checklist: reading a GRAS letter in a data room
Read the intended use and maximum level on the FDA inventory page, not in the press release.
List the exclusions; infant formula and USDA-regulated products need separate work.
Check who else is named as notifier and can use the same dossier.
Ask for the filing date and status of the next notice.
Sources and reporting
- FDA: GRAS Notice GRN 1312, recombinant αS1-casein from Bos taurus produced by Escherichia coli DSM 35603, accessed 4 November 2026
- Food Ingredients First: Formo secures first FDA “no questions” letter for precision-fermented casein, 28 October 2026
- Cheese Reporter: Formo, Those Vegan Cowboys get “no questions” letter from FDA on fermentation-derived casein, 30 October 2026
- Green Queen: Formo, Those Vegan Cowboys secure FDA GRAS letter to sell cow-free casein in US, October 2026
- FoodNavigator: Those Vegan Cowboys get FDA letter for animal-free casein, 28 October 2026
Reporting note: Desk report on the FDA GRAS inventory, company statements and trade coverage. FoodEdge has not seen the letter text or the dossier. FoodEdge published an R&D brief on precision-fermented casein for cheese on 3 November; this story covers the regulatory and investment side.
AI tools supported source research and drafting during the editorial process.
