A US “no questions” letter for a precision-fermented protein is usually reported as a binary: the company has one, or it does not. The letter itself is not binary. It names one substance, one production organism, and a table of food categories with a separate maximum use level in each. What a formulator can actually do with the ingredient lives in that table, and almost nobody prints it.
FDA signed its response to GRAS Notice GRN 001241 on 16 September 2025. The notifier is Verley Food, the Lyon company previously called Bon Vivant SAS. The subject is beta-lactoglobulin produced by Aspergillus oryzae strain “TFB-CLEO75TA”. The letter’s own summary sentence says the substance is notified “for use as a source of protein at levels up to 35% in various foods”, and that phrase is the one that has travelled.
35% is the maximum of twenty-two rows, not the level of any of them except one. It applies to nutritional bars. Yogurt and fermented milk products are capped at 8%. Milk, milk drinks and milk substitutes are capped at 6%. Bread is 10%. Cookies and brownies are 5%.
That gap matters here more than it would for most ingredients, because Verley’s public case for its products is built on exactly the categories with the lowest ceilings.
What the notice actually covers
| Item | Detail |
|---|---|
| Notice number | GRN 001241 |
| Notifier | Verley Food (previously Bon Vivant SAS) |
| Substance | beta-lactoglobulin produced by Aspergillus oryzae “TFB-CLEO75TA” |
| Received | 20 December 2024 |
| Filed | 15 April 2025 |
| Amendments | 23 June, 3 July and 29 July 2025 |
| Response letter | 16 September 2025 |
| Signed by | Susan Carlson, Director, Division of Food Ingredients |
| Excluded | Infant formula, and products under USDA jurisdiction |
The amendments, per the letter, provided “clarifications on the microorganism, manufacturing method, and specifications, as well as the change in the company name of the notifier” — the rebrand from Bon Vivant landed mid-review.
Practical consequence: the excluded uses are as load-bearing as the included ones. A brand planning an infant or toddler formula, or a meat-containing product under USDA jurisdiction, is outside this notice entirely and cannot lean on it in a supplier qualification pack.
The use table
These are the maximum use levels FDA reproduced from the notice. Percentages are of the finished food.
| Food category | Food uses | Max use level |
|---|---|---|
| Nutritional products | Meal replacements and supplements | 15% |
| Nutritional products | Powdered nutritional beverages | 25% |
| Nutritional products | Electrolyte-type sports drinks | 6% |
| Nutritional products | Performance nutritional beverages, high protein | 25% |
| Nutritional products | Nutritional bars | 35% |
| Dairy and dairy-based | Milk, powdered milk, flavored milk, milk-based drinks and drink mixes, milk substitutes | 6% |
| Dairy and dairy-based | Cream, half and half, cream cheese, cheese spread, whipped cream | 15% |
| Dairy and dairy-based | Spreads, dips | 10% |
| Dairy and dairy-based | Cream substitutes | 15% |
| Dairy and dairy-based | Yogurt and fermented milk products | 8% |
| Dairy and dairy-based | Frozen dairy desserts and mixes | 10% |
| Dairy and dairy-based | Cheese used as ingredient | 15% |
| Dairy and dairy-based | Semi-hard cheese | 25% |
| Dairy and dairy-based | Mousses and desserts | 5% |
| Sugar-based products | Confections (including chocolate) | 10% |
| Sugar-based products | Coatings and fillings | 10% |
| Baked goods | Cookies, brownies | 5% |
| Baked goods | Doughnuts, toaster pastries, muffins | 10% |
| Baked goods | French toast, crepes, pancakes, bagels, scones, biscuits, croissants | 10% |
| Baked goods | Bread, rolls, English muffins, pizza crust | 10% |
| Baked goods | Crackers, popcorn, tortilla chips, potato chips, hard pretzels, snack mix | 5% |
| Dressings | Salad dressings | 5% |
| Dressings | Minor entrée sauces (e.g., Alfredo sauce) | 6% |
| Egg products | Egg substitutes | 10% |
Practical consequence: the three highest ceilings — nutritional bars at 35%, and powdered and high-protein performance beverages at 25% — are all in sports and medical nutrition. The clearance is widest exactly where Verley says it is commercialising first, and narrowest in mainstream dairy.
The third product is not in the notice
Verley launched three FermWhey products in March 2025: Native, a beta-lactoglobulin for clear beverages and sports nutrition; MicroStab, a micro-particulated version for heat and acid stability; and Gel, which the company says has gelling properties that let formulators drop stabilisers, gums, carrageenan or modified starch.
FDA’s letter covers one substance. FoodNavigator’s October 2025 report, which is the fullest contemporaneous account of the clearance, attributes it to Native and MicroStab, and states plainly that FermWhey Gel remains in the pipeline, with Verley planning to submit a GRAS notification for it “at a later stage”.
The manufacturing description in the letter is consistent with that. It describes fermentation, separation from biomass by filtration, concentration by a second filtration, “an optional heat-treatment step at 90°C to improve the heat stability and technological properties”, then spray-drying and packaging. A thermal step to improve heat stability is the functionalisation the notice contemplates. No gelation step is described.
Set that against what the company said the gelling product is for. Chief executive Stéphane Mac Millan, in March 2025, said Verley had “enhanced the natural gelling ability of whey proteins, eliminating the need for casein in acid-gelled dairy applications such as yogurt”, allowing manufacturers “to make high-protein, clean-label yogurts and dairy gels using whey alone”.
So the two constraints land in the same place. High-protein yogurt is the application the company names; yogurt is capped at 8% in the notice; and the protein designed to make that application work has not been notified.
Practical consequence: a formulator scoping a spoonable high-protein dairy product on this ingredient should treat the FDA letter as covering the beverage and bar business, and should ask Verley directly for the regulatory basis of anything gelled — self-affirmed GRAS, a filed-but-unanswered notice, or nothing yet. Those are three different risk positions and only one of them is what the letter describes.
The specification is not the marketing number
Trade coverage describes FermWhey Native as “composed of 95% of beta-lactoglobulin”. The specification FDA reproduced is different in kind: protein content of at least 80% by weight, with beta-lactoglobulin at least 90% by weight of that total protein. Also specified: moisture no more than 7%, ash no more than 6%, fat no more than 2%, total carbohydrates no more than 15%, pH 5.0 to 8.0, and limits on arsenic, cadmium, mercury, lead and microorganisms.
These are not contradictory. A batch running at 95% beta-lactoglobulin of total protein comfortably clears a 90% floor. But they are different statements: one is a typical value, the other is the floor the notifier committed to and demonstrated across three non-consecutive batches. A supply agreement should be written against the second.
There is a second detail worth noting for anyone drafting label copy. The letter records that the amino acid sequence is identical to native bovine beta-lactoglobulin variant B “except for two amino acids, which are substituted to the amino acid that occurs in the same position in one of the other beta-lactoglobulin variants”. This is a hybrid of naturally occurring variants rather than a copy of one. FDA also states explicitly that its use of the term “beta-lactoglobulin” in the letter is not a recommendation of that term as the common or usual name for labelling, and that it did not consult its own labelling office on the question.
The use table was inherited, not negotiated
The most useful sentence in the letter for anyone modelling this category is the one where Verley states that its food uses and use levels “are the same as the prior notified uses” of beta-lactoglobulin produced by microbial fermentation, naming GRN 001056 and GRN 001145.
| GRN | Substance | Production organism | FDA response letter |
|---|---|---|---|
| 000863 | beta-lactoglobulin | Trichoderma reesei | 25 March 2020 |
| 001056 | beta-lactoglobulin | Komagataella phaffii | 15 February 2023 |
| 001145 | beta-lactoglobulin | Aspergillus oryzae | 18 December 2023 |
| 001241 | beta-lactoglobulin | Aspergillus oryzae “TFB-CLEO75TA” | 16 September 2025 |
Dates and organisms in this table are taken from the footnotes of the GRN 1241 letter itself, which is the authority for all four. Public reporting attributes GRN 001056 to Remilk and GRN 001145 to Imagindairy; FDA’s letter does not name those companies, and we have kept the attribution and the record separate for that reason.
The pattern is that the exposure envelope for recombinant beta-lactoglobulin in US food was effectively fixed by the 2023 dossiers and has been adopted unchanged since. Verley did not argue for a higher yogurt level; it matched the existing one, which is a rational way to buy a fast review — and Verley’s review was fast, five months from filing to letter.
Verley’s own dietary exposure estimate follows from that inherited table: using NHANES 2017–2020 consumption data, 29 g per person per day at the mean and 55 g at the 90th percentile, eaters-only, for the US population aged two and over. The safety argument rests on substitution — that this protein displaces other added protein rather than adding to total intake.
Practical consequence: the 8% yogurt ceiling is not a Verley-specific constraint and will not move because a supplier asks. It moves when some notifier funds new exposure modelling and files for higher levels. Anyone whose product concept needs more than that should assume the ceiling holds for the current planning cycle, and price the alternative of a self-affirmed position with its own liability profile.
Canada wrote down what FDA left open
Health Canada assessed the same class of ingredient — Remilk’s beta-lactoglobulin from Komagataella phaffii yRMK-66 — and published its Novel Food Information document on 31 January 2024. Comparing the two records is instructive, because the use envelope is recognisably the same and the disclosure around it is not.
| FDA, GRN 001241 (Verley) | Health Canada (Remilk) | |
|---|---|---|
| Use levels | 5% to 35% by category | “5 to 35 % depending on the food” |
| Exposure basis | NHANES 2017–2020, eaters-only, age 2+ | Canadian Community Health Survey 2015, all ages |
| Mean intake | 29 g/person/day | 31.9 g/day |
| 90th percentile | 55 g/person/day | 80.0 g/day |
| Infant formula | Excluded | Not intended for use in infant formula |
| Common or usual name | FDA explicitly declines to recommend one, and did not consult its labelling office | Prescribed: source plus “protein”, e.g. “yeast-derived whey protein” or “yeast-derived r-β-lactoglobulin” |
| Standardized dairy | “may be used in a standardized food only if it is permitted by the applicable standard of identity” | Does not meet the definition of “milk”, “milk product” or “milk solid”, and so is “not permitted to be added to standardized dairy products” |
The exposure figures are not comparable and should not be read as a disagreement: one is eaters-only from a US survey for ages two and over, the other is all-ages from a Canadian survey. That is the point. Two regulators looking at effectively the same use table produced mean intakes 10% apart and 90th percentiles 45% apart, purely from the basis they chose.
The standardized-dairy line is the operationally sharp one. FDA states the general principle and leaves the application to the notifier. Health Canada states the outcome: this ingredient cannot go into a standardized dairy product, and cannot be labelled with dairy ingredient common names or the class names “milk ingredients” or “modified milk ingredients”.
One further difference is worth recording for anyone treating these proteins as interchangeable. Health Canada’s assessment states that the amino acid sequence of Remilk’s protein is identical to bovine beta-lactoglobulin. FDA’s letter records that Verley’s differs from native variant B at two positions. Both are described by their notifiers as equivalent to the milk protein; they are not the same molecule.
Practical consequence: a launch plan that assumes a single global specification and a single global label is wrong on both counts. The Canadian record tells you the naming and standardized-food answer in writing; the US record tells you to go and work it out.
The counter-argument
A GRAS notice is not a licence, and reading the table as a legal cap overstates it. GRAS is a conclusion the manufacturer reaches; FDA’s letter says only that it has no questions about that conclusion under the stated conditions of use. A company may market outside a notified table on a self-affirmed basis, as several precision fermentation firms do — a route the FDA has now proposed to close, as we covered in our analysis of the proposed mandatory notification rule. Verley could also amend or file again.
That is correct, and it is why this is a commercial point rather than a legal one. The value of the letter, in the words of the same executives who obtained it, is as a “springboard” into conversations with large manufacturers whose legal teams will not formulate around a self-affirmed ingredient. That value is bounded by what the letter covers. A buyer that accepts the letter as its assurance is accepting the table with it.
The letter also carries two flags that matter for that conversation. Beta-lactoglobulin is milk-derived protein, so major food allergen labelling applies and, in the letter’s words, the preparation “will likely elicit an allergic response in milk-allergic consumers” — which we examined from the labelling side in our analysis of allergen labelling divergence for animal-free dairy. And FDA notes that an ingredient lawfully added to food may be used in a standardized food only if the applicable standard of identity permits it. Several categories in the table — cheeses in particular — are standardized.
What we could not establish
- Whether FermWhey MicroStab is the optional 90°C heat-treated form described in the notice. The letter names one substance and no brand names. The mapping from FDA’s substance to Verley’s three products comes from trade reporting, not from the letter.
- Whether Verley has since filed a GRAS notification for FermWhey Gel. As of the October 2025 reporting the company said it planned to do so “at a later stage”. We did not find a corresponding notice in the public inventory, and absence from a search is weaker evidence than a filing.
- Whether GRN 001145’s own table is identical row for row. Verley states its uses and levels are the same as GRN 001056 and GRN 001145; we did not obtain the earlier letters’ tables to check each row independently. Two independent records are consistent with it — contemporaneous reporting on GRN 001145 described a 5–35% range across similar categories, and Health Canada’s Remilk assessment describes the same 5–35% envelope — but neither is the GRN 001145 table itself.
- The company attribution of GRN 001056 and GRN 001145. Widely reported as Remilk and Imagindairy respectively; not stated in FDA’s letter.
- Verley’s current published product specifications. The product URLs used in March
2025 trade coverage no longer resolve; the domain
verley.foodis now parked and offered for sale, and the live corporate site is atverley-food.com. Product descriptions here come from trade press quoting the company, not from company pages current at the time of writing.
What to watch
Three things would each move this analysis, and all three are publicly checkable.
A FermWhey Gel notice appearing in the GRAS inventory. That would tell you whether the gelled product is being taken down the notification route at all, and its table would show whether the yogurt ceiling was challenged.
Any notifier filing for a beta-lactoglobulin level above 8% in yogurt. The inherited envelope has held across four notices and roughly five years. The first notifier to fund new exposure work and break it changes the category’s formulation ceiling for everyone behind them.
Whether Verley’s non-US filings mirror the US table. The company said in March 2025 that filings were planned in “multiple other” geographies. Health Canada has already assessed a beta-lactoglobulin from Komagataella phaffii through its novel food process. Where the same ingredient carries different permitted levels in different markets, the launch-market sequencing question we set out in where to launch a precision-fermented protein becomes a formulation question too: the same product specification supports a different finished product depending on the jurisdiction it ships into.