Amai Proteins secures FDA ‘no questions’ letter for ‘sweelin’ sweet protein, clearing path to US commercialization

Amai Proteins has received a ‘no questions’ letter from the US Food and Drug Administration in response to its Generally Recognized as Safe notification for sweelin, the company’s lead sweet protein ingredient.

• Amai Proteins has received an FDA “no questions” letter for sweelin under GRN No. 1269, supporting its conclusion that the ingredient is safe under intended conditions of use.
• sweelin has been developed as a general sweetener produced via precision fermentation and designed for broad food and beverage applications.
• The regulatory milestone has supported Amai’s transition toward US commercialization and engagement with food and beverage partners.

The letter, issued in response to GRN No. 1269, supported Amai’s conclusion that sweelin is safe for use as a general sweetener under its intended conditions of use and in accordance with good manufacturing practices.

The regulatory development marked a significant step for the Rehovot, Israel-based food technology company as it advanced toward commercialization in the US market. With the FDA review process completed without further questions, sweelin can now be evaluated more broadly by food and beverage manufacturers considering new approaches to sugar reduction.

Receiving FDA GRAS notification for sweelin is a pivotal step for Amai, said Amir Guttman, CEO of Amai Proteins. “This milestone validates our regulatory strategy and allows us to move forward with commercialization discussions with partners who are looking for clean-label, next-generation sweetening solutions.”

Amai has developed sweelin as a protein-based sweetener designed to deliver sugar-like sweetness with minimal caloric contribution. The ingredient has been engineered to maintain performance across a wide range of food and beverage applications, including beverages, dairy products, condiments, confectionery, chewing gum, and dietary supplements.

The company has described increasing industry demand for ingredients that enable meaningful sugar reduction without compromising taste, cost, or processing compatibility. sweelin has been positioned as a solution intended to address those formulation challenges.

According to Amai, sweelin has been evaluated in a randomized, double-blind, controlled clinical study, where it demonstrated no effect on blood glucose or insulin levels. The findings have supported its characterization as a metabolically neutral sweetening solution.

In the USA, sweelin can be labeled as “serendipity berry sweet protein,” a name derived from the fruit that inspired its development. The company has indicated that this labeling option may appeal to consumers seeking recognizable, protein-based ingredients aligned with health-focused formulations.

sweelin is based on monellin, a naturally occurring sweet protein originally identified in serendipity berries. Amai has reported that the ingredient is approximately 3,000 times sweeter than sugar by weight. Through its Pro3 Technology Platform, the company has combined AI-driven computational protein design, precision fermentation, and food technology to engineer the protein for improved stability, affordability, and compatibility with industrial processing conditions.

The protein is produced via precision fermentation, enabling scalable manufacturing without reliance on agricultural extraction of the source fruit. Amai has built a patent portfolio around its engineered sweet proteins and has focused on aligning molecular design with commercial production requirements.

The FDA’s ‘no questions’ letter does not constitute formal approval of the ingredient but indicates that the agency has reviewed the company’s GRAS notice and has no further questions at this time regarding the notifier’s safety conclusion. Such letters are widely regarded within the food industry as an important regulatory milestone, particularly for companies seeking to enter the US market with novel ingredients.

For Amai, the outcome has supported its move from development and validation into commercial engagement. The company has reported that it is working with leading food and supplement manufacturers to enable sugar reduction of up to 70% in certain applications, with the aim of supporting healthier product reformulations without sacrificing taste, cost, or sustainability considerations.

As manufacturers continue to navigate consumer demand for reduced-sugar products alongside regulatory and labeling scrutiny, protein-based sweeteners have attracted growing interest as an alternative to traditional high-intensity sweeteners and bulk sugar replacers. With the GRAS process completed and FDA review concluded without objection, sweelin has entered the next phase of market evaluation in the USA.