On 9 September 2026 Onego Bio announced that it will supply Bioalbumen, its precision-fermented egg protein, to Zen Waffles, a Brooklyn maker of high-protein frozen waffles. It is the first named food-manufacturer customer in the coverage we found for an ingredient that received an FDA “no questions” letter a year earlier. The announcement gives no volume, price, launch date or list of which waffles will contain it.
The FDA record gives the number the announcement leaves out. Under GRN 1249, the use level for “Pastries, pancakes, waffles, biscuits, French toasts, pies and cobblers” is 5%. Zen sells its waffles on 23 grams of protein each. Set those two facts beside each other and the likely role of Bioalbumen in a Zen waffle is a partial replacement for the egg’s structure and browning, not the protein source. That distinction is what a formulator needs from this deal.
What FDA cleared, category by category
FDA’s response letter, dated 10 September 2025, says the agency has “no questions at this time regarding Onego’s conclusion that ovalbumin preparation is GRAS under its intended conditions of use”. It lists maximum use levels by food category. Selected rows:
| Food category (as listed by FDA) | Maximum level |
|---|---|
| Breads and rolls, English muffins, cookies, batter mixes, graham crackers | 3% |
| Pastries, pancakes, waffles, biscuits, French toasts, pies and cobblers | 5% |
| Cakes | 6% |
| Soufflés | 8% |
| Quiches; egg products and analogs | 12% |
| Breakfast cereals (ready-to-eat) | 10% |
| Plain pasta and noodles | 10% |
| Meat analogs | 10% |
| Ice cream, frozen yogurt, sherbet | 8% |
| Breakfast, granola and cereal bars | 10% |
| High-protein breads | 25% |
| Protein bars | 25% |
| Nutritional beverages; protein and nutritional powders | 25% |
| Marshmallows; soft candy | 3% |
The pattern is that FDA’s highest levels, 25%, sit in categories defined as protein vehicles: protein bars, protein and nutritional powders, nutritional beverages, smoothies with added protein and high-protein breads. The ordinary baked-goods categories (breads, pastries and waffles, cakes) are capped at 3% to 6%. The letter also states, “Ovalbumin preparation requires labeling under the FD&C Act because it contains protein derived from egg.”
Practical consequence. A formulator reading “cleared for baked goods” should read the category line, not the headline. The same ingredient can be a 25% protein source in a bar and a 5% functional ingredient in a waffle.
The arithmetic of a 5% cap in a waffle
FoodNavigator, reporting the 2025 clearance, describes Bioalbumen as having 90 grams of protein per 100 grams, which is a company-reported figure and which we have not checked against the notice. If that is right and the cap is applied to the preparation, then at the 5% waffle level the most protein the ingredient can contribute is 4.5 grams per 100 grams of waffle.
| If the waffle weighs | Maximum protein from Bioalbumen at 5% and 90% protein | Share of a 23 g claim |
|---|---|---|
| 75 g | 3.4 g | 14.7% |
| 100 g | 4.5 g | 19.6% |
| 125 g | 5.6 g | 24.5% |
These weights are illustrations, not Zen’s product weight, which is not published on the pages we read. The point is robust to the choice: even a 125 g waffle would need the ingredient at the cap and every other protein source to supply three quarters of the claim. To deliver all 23 grams from Bioalbumen at 5% would take a waffle of about 511 g.
Zen’s own pages are consistent with that reading. The classic waffle’s listed ingredients are “Cottage Cheese, Organic Eggs, Almond Flour, Monkfruit Extract with Erythritol Extract, Casein Proteion, Baking Powder”, with the allergen statement “CONTAINS: MILK, EGG, ALMOND”. Bioalbumen does not appear in that list. The classic is 23 g of protein and 190 calories per waffle; the blueberry is 23 g of protein and 250 calories; Food Business News and Baking Business report that the chocolate chip carries 28 g. We cannot say whether the product page predates the reformulation, or whether Bioalbumen enters only some varieties.
Two consequences follow for the labelling. Because FDA requires the ovalbumin preparation to be labelled as containing egg protein, and the classic waffle already carries an egg allergen statement, the allergen panel would not change for that product. And if Bioalbumen replaces part of the whole egg, the deal is about price stability and supply security rather than about a new protein claim, which is the argument Protein Production Technology’s coverage of the clearance makes, citing supply-chain volatility and avian influenza.
The calendar: twelve months from letter to first named customer
| Date | Event | Source |
|---|---|---|
| 19 December 2024 | GRAS notification submitted | Business Wire; FDA letter |
| 10 April 2025 | Notice filed by FDA | FDA letter |
| 10 September 2025 | FDA response letter: no questions | FDA letter |
| 16 September 2025 | Notice closed on the inventory | FDA inventory page |
| 23–24 September 2025 | Company announcement and trade coverage | Protein Production Technology; FoodNavigator |
| 9–10 September 2026 | Zen Waffles supply agreement announced | Onego/Zen release; vegconomist |
Twelve months from clearance to a named customer is not slow for a regulated novel ingredient. The harder question is supply. FoodNavigator reports that Onego acquired a 25.9-acre site in Wisconsin, expected to come online in 2028, with 2 million litres of fermentation capacity per manufacturing unit. vegconomist lists the Jefferson County, Wisconsin site as the company’s selected first flagship manufacturing facility. Neither the Zen announcement nor Onego’s Q3 2025 newsletter says where the Bioalbumen for Zen is being made today, or in what quantity.
That gap matters because the 2028 plant is two years after the supply deal. A customer announcement in September 2026 is therefore either supplied from an existing, undisclosed production route, or a commitment ahead of capacity. For the other precision-fermented egg protein, see how EVERY’s OvoPro capacity is stated, which is also a multiple without a published base.
The record contains small discrepancies
Two details differ between sources, and each affects how a formulator would read the clearance.
- Use levels. FDA’s inventory page summarises the levels as 3 to 25 g per 100 g, and the letter’s table runs from 3% to 25%. FoodNavigator reports a range of 3 to 35 grams of ovalbumin per 100 grams. We follow FDA.
- Approved uses. vegconomist describes the approved uses as baked goods, beverages and confectionery. The FDA table includes ice cream, pasta, sauces, meat analogs and egg analogs, and puts confectionery categories such as marshmallows and soft candy at 3%.
Practical consequence. Cite GRN 1249 and the category line in a formulation brief, not a trade article’s summary of it. If your product sits between two categories on FDA’s list, as a high-protein waffle arguably does, treat the lower level as the working limit until FDA or counsel confirms otherwise.
The case for the deal
The strongest counter-argument is that a 5% cap is enough. Ovalbumin is the main egg-white protein, and the functions listed on FDA’s inventory page are foaming, gelling and binding. In a waffle those are the jobs an egg does: it holds the batter, helps it set and browns the crust. Onego’s own Q3 2025 newsletter reports sampling feedback, including a comment that it whipped better than standard egg white; these are remarks the company collected, not a published trial. A manufacturer replacing a share of whole eggs with an ingredient that the trade coverage describes as insulated from egg-market volatility has a commercial reason that does not depend on the protein claim.
That reasoning is sound and it is the likelier reading of the deal. It is also a different story from the one the announcement tells. The press release frames the deal around demand for “high-protein” foods, citing US high-protein packaged-food sales of approximately $24 billion in 2025, while the FDA’s own level for this category limits how much of that protein claim the ingredient can carry. A reader could come away thinking Bioalbumen is the protein in the waffle. The record does not say that.
What we could not establish
- Whether Bioalbumen is in any Zen waffle yet. The product pages we read list whole eggs, cottage cheese and casein and do not mention it. Launch timing is not stated.
- Waffle weight and Bioalbumen inclusion. Zen does not publish the weight on the pages we read, and no source gives the inclusion rate. Our table is an illustration.
- Whether FDA would treat a high-protein waffle under the 5% line. The 25% level is reserved for named protein categories; a waffle sold for its protein is not listed separately.
- Where the Zen supply is made, and how much. No source says. The Wisconsin plant is described as expected in 2028.
- Price. No source gives a price per kilogram for Bioalbumen or the deal terms.
- The 90 g per 100 g protein content. FoodNavigator reports it; we did not find it in the FDA documents we read.
- Why FoodNavigator reports a 35 g upper use level when FDA’s letter tops out at 25%.
What to watch
- Ingredient declarations on Zen’s packs. A label that lists “ovalbumin” or “Bioalbumen” is the first evidence the ingredient has reached the product.
- A supply source and volume. Contract manufacturing, a pilot run, or the 2028 plant: each implies a different cost and risk.
- A second named customer in a category with a higher cap, such as a protein bar, nutritional beverage or high-protein bread, where the ingredient could carry the protein claim.
- Any FDA clarification on mixed-category products. It would settle which line a high-protein waffle belongs to.