US FDA approval boosts Amai Proteins’ sugar substitute commercialization

Israel-based Amai Proteins has received the GRAS (Generally Recognized as Safe) notice from the US FDA for its sweet protein Sweelin — meaning the company can run product trials and speed up US commercialization of the sugar substitute.

The approval comes amid mounting pressure on F&B manufacturers to meet consumers’ sugar reduction demands and tightening sugar regulations worldwide for improving public health.

The notice confirms the US authority has no safety concerns regarding the use of Sweelin as a general sweetener. The precision fermentation-based ingredient supports sugar reduction and replaces conventional sweeteners with a protein-based alternative for clean taste, competitive cost, and improved formulation performance.

Dr. Amir Guttman, CEO of Amai Proteins, tells Food Ingredients First that the FDA notification for Sweelin represents a major commercial milestone — “enabling sales in the US and significantly reducing regulatory friction for food, beverage, and dietary supplements manufacturers.”

“We are leveraging this milestone to accelerate customer onboarding with structured pilot programs and defined technical validation targets. We are also advancing commercial discussions with partners seeking next-generation sweetening solutions.”

The company is also focusing on shortening time-to-market for the sweetener by providing a “comprehensive technical and regulatory package.”

“Active product trials are underway across multiple high-growth categories, including high-protein RTD beverages (including GLP-1 supportive positioning), chocolate products, and functional nutrition and supplement formats,” Guttman adds.

These pilots focus on sweetness equivalence, sensory optimization, sugar reduction targets, and stability under real manufacturing conditions.

Precision fermented proteins

Sweelin is a monellin-based sweet protein inspired by the serendipity berry and is approximately 3,000 times sweeter than sugar weight-to-weight. It can be used in beverages, condiments, confectionery, chewing gum, and dietary supplements.

The FDA GRAS approval for Sweelin unlocks US sales and eases regulatory hurdles for manufacturers, says Amai Proteins CEO Amir Guttman.Serendipity berry (Dioscoreophyllum cumminsii Diels) is an indigenous West African plant, whose fruits are used as sweeteners, and monellin is a protein found in this berry, containing 94 amino acids with sweetness approximately 1500–2000 times higher than sucrose. 

Instead of extracting the protein from fruit, Amai Proteins uses its “Pro3” technology platform to formulate the sweet protein. The process combines AI computational protein design, precision fermentation, and food technology to create scalable and high-performance proteins.

“We apply advanced computational tools to optimize sweet protein variants for sweetness potency, taste quality, stability, solubility, and manufacturability. This enables rapid exploration of protein sequence space and selection of candidates with superior functional performance,” Guttman explains.

Selected proteins are produced via precision fermentation, ensuring scalable, consistent, and high-quality manufacturing — allowing for a “reliable supply while supporting clean label positioning aligned with evolving consumer expectations.”

GLP-1 support

Amai Proteins markets Sweelin as a “high-potential and safe” protein sweetener that aligns with the popular trend of protein-focused and GLP-1-friendly F&B innovations.

“Sweet proteins are emerging as a compelling solution in the global sugar-reduction movement, particularly as GLP-1-driven dietary shifts accelerate demand for high-protein, low-sugar products,” says Guttman.

Legal counsel has confirmed that manufacturers can label Sweelin as “Serendipity Berry Sweet Protein,” the company says. Manufacturers can use the sweetener in products with simple, easily understandable ingredient lists that contain no artificial additives.

Overcoming taste and cost barriers

As sweetener innovation evolves to meet consumer demand, F&B manufacturers are thinking beyond single-sweetener swaps and exploring systems-based sugar reduction solutions that combine rare sugars, stevia blends, and taste modulators.

Amai Proteins is conducting product trials of Sweelin in chocolates and high-protein RTD beverages.With Sweelin, Amai Proteins aims to deliver a “clean sweetness profile” in F&B products. “In many applications, it performs best as part of a carefully balanced sweetener system,” says Guttman.

“Sweelin performs well in high-protein and reduced-sugar systems, where taste masking and sweetness quality are critical. Application performance depends on matrix, pH, and processing conditions, which we address through collaborative formulation trials.”

The ingredient also offers financial benefits since precision fermentation enables “meaningful cost reductions over time through yield and process optimization.”

Manufacturers can evaluate Sweelin on cost-in-use, which factors sweetness potency, sugar reduction, and on-pack differentiation, besides cost per kilogram.

Road to commercialization

Amai Proteins is now connecting with investors and partners to speed up market entry and explore strong growth opportunities for Sweelin.

“As we scale for broader US adoption, we focus on manufacturing scale-up and supply assurance with qualified global partners and robust quality systems and documentation to meet large-brand requirements,” Guttman tells us.

The company plans to expand the sweet protein portfolio for category-specific optimization, advanced sensory performance, and sweetness quality. It is also working on developing integrated sweetener systems for faster customer adoption.