CIRS Assist Client in Receiving "No Questions" FDA GRAS Notice

Recently, Guilin Layn Natural Ingredients Corp. (hereinafter referred to as "Layn"), with the support of CIRS, received a "no questions" letter from the FDA for its enzymatically converted rebaudioside M2 (hereinafter referred to as RebM2). This indicates that RebM2 has been successfully notified under the FDA GRAS (Generally Recognized as Safe) notification program. The official FDA GRAS notice, unlike a self-affirmed GRAS, carries greater authority and market recognition.

The entire process, from obtaining the GRN number to receiving the final "no questions" letter, took only five months. This notice not only underscores Layn's global recognition for its strong research and development capabilities and product quality but also paves the way for the company to expand into global markets. Additionally, this achievement strongly validates CIRS's professional capabilities in food compliance services.

Basic information of the notified substance

Product Name: rebaudioside M₂

Production process: enzymatic conversion

Product introduction: RebM2 is a rare and high-value monomer among steviol glycoside sweeteners. Compared to other rare monomers like RebD and RebM that are currently popular in the market, RebM2 offers superior sweetness characteristics, a purer taste, greater stability, and improved solubility. When combined with other sweeteners, RebM2 enhances overall sweetness, making it highly adaptable to various applications. It has broad market potential in food, beverages, dietary supplements, and animal nutrition, aligning well with modern consumers' pursuit of healthy eating.

Impact of the FDA GRAS notice on Layn

The FDA GRAS notification for Layn’s RebM2 produced via enzymatic conversion signifies that the product has passed the FDA’s rigorous safety and quality review, granting it access to the US food and beverage market. This recognition will not only facilitate deeper market penetration and sales in the US but also significantly enhance Layn’s competitive differentiation and overall industry strength. The notification is expected to have a highly positive impact on the company’s future growth.

RebM2 is a premium and rare monomer among steviol glycoside sweeteners, yet traditional production methods fail to meet market demand due to low yields, complex processes, and high production costs. Layn’s enzymatic conversion method provides significant advantages in efficiency, cost, and quality, effectively addressing market needs for high-performance sweeteners while driving the development of a sustainable synthetic biology production model.

With established large-scale production capabilities for RebM2, Layn is well-positioned to expand the product’s global market presence. The notification will help accelerate the company’s commercial production capacity, supporting further promotion and sales worldwide. Given RebM2’s excellent taste profile, physicochemical properties, and high compatibility with other ingredients, Layn will continue to focus on deepening research, driving application innovations, and expanding its product portfolio. By enhancing service capabilities, the company aims to empower global food and beverage brands in their product innovation and upgrades.

About CIRS

The Food Division of CIRS Group was established in 2012 and it has a professional team specializing in US GRAS notice. The CIRS Food Division has extensive experience in various fields, covering GRAS, new food ingredients, new food additives, food contact materials, synthetic biology foods, EU Novel Foods, dietary supplements, and special dietary foods.

CIRS operates a fully-owned subsidiary in the US. By leveraging the expertise of the CIRS USA and the international team, it is able to provide enterprise various US food services, including but not limited to:

• US FDA GRAS Notice;
• US FDA Dietary Supplement Structure/Function Claim Notification;
• US New Dietary Ingredient (NDI) Notification;
• US FDA Registration of Food Facilities; and
• US Food Label/Advertisement Information Review.

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.