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CIRS Supports Kingdomway in Obtaining a “FDA Has No Questions” Letter for Brazzein
On October 7, with comprehensive support from CIRS Group, Inner Mongolia Kingdomway Pharmaceutical Limited (hereinafter referred to as “Kingdomway”) officially received a “FDA Has No Questions Letter” from the U.S. Food and Drug Administration (FDA) for its fermentation-derived brazzein (GRAS Notice No. 001305). This milestone marks the successful completion of the FDA’s review of the company’s GRAS notice for the product.
United States
Food Ingredients
Food and Food Related Products
GRAS
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CIRS Supports Kingdomway in Obtaining a “FDA Has No Questions” Letter for Brazzein
United States
Food Ingredients
Food and Food Related Products
GRAS
Our Cases
Global First! Shandong Weiyan’s β-carotene Secured FDA GRAS Notification and No Questions Letter
This successful FDA evaluation marks a major breakthrough in the product’s international compliance capabilities, providing a solid foundation for the company’s overseas business expansion and the implementation of its global strategy.
United States
Food Ingredients
Food and Food Related Products
GRAS
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Global First! Shandong Weiyan’s β-carotene Secured FDA GRAS Notification and No Questions Letter
United States
Food Ingredients
Food and Food Related Products
GRAS
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CIRS Assists Zhongda Hengyuan’s D-psicose in Achieving GRAS Notice
On July 6, Henan Zhongda Hengyuan Biotechnology Stock Co., Ltd. (Hengyuan) received a "no questions" letter from the FDA regarding the GRAS (Generally Recognized as Safe) notice for its D-psicose. Produced via an enzymatic bioconversion process, the ingredient's safety has now been officially recognized by the FDA.
United States
Food and Food Related Products
GRAS
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CIRS Assists Zhongda Hengyuan’s D-psicose in Achieving GRAS Notice
United States
Food and Food Related Products
GRAS
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CIRS Helps Shandong Freda’s SAMe-DT Successfully Complete FDA NDI Notification
Recently, S-adenosyl-L-methionine disulfate tosylate (SAMe-DT), independently developed by Shandong Freda Biotechnology Co., Ltd. (hereinafter refered to as Shandong Freda), has successfully completed FDA New Dietary Ingredient (NDI) notification, with the NDIN number being 1473, marking the ingredient’s compliance for entry into the U.S. dietary supplement market. CIRS Group provided full support throughout the notification process.
United States
Food Ingredients
Food and Food Related Products
Our Cases
CIRS Helps Shandong Freda’s SAMe-DT Successfully Complete FDA NDI Notification
United States
Food Ingredients
Food and Food Related Products
Our Cases
CIRS Supports Enhe Aiju’s ZeaVida® Zeaxanthin Obtain FDA GRAS Notice
Recently, Enhe Aiju (Hangzhou) Science and Technology Co., Ltd. (Enhe Aiju) has completed the FDA GRAS notice for its self-developed zeaxanthin, produced via fermentation using production strain Yarrowia lipolytica CGMCC 39021 (GRN No. 1300). This is the world’s first high-concentration crystalline zeaxanthin product manufactured at commercial scale using cell factory technology to receive GRAS, fully under the support of CIRS Group.
United States
Food Ingredients
Food and Food Related Products
GRAS
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CIRS Supports Enhe Aiju’s ZeaVida® Zeaxanthin Obtain FDA GRAS Notice
United States
Food Ingredients
Food and Food Related Products
GRAS
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CIRS Assists Shandong Weiyan in Obtaining GRAS Status for Its Astaxanthin
Recently, Shandong Weiyan Biotechnology Co., Ltd. (“Shandong Weiyan”) achieved a milestone in its international compliance journey for its product, astaxanthin. With comprehensive professional support from CIRS Group, the company’s astaxanthin has been concluded by GRAS Panel as Generally Recognized as Safe (GRAS).
United States
Food and Food Related Products
GRAS
Our Cases
CIRS Assists Shandong Weiyan in Obtaining GRAS Status for Its Astaxanthin
United States
Food and Food Related Products
GRAS
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CIRS Assisted Meihua Group in Securing First NHC Approved 3’-SL
On February 5, 2026, China’s NHC issued the No.1 Announcement of 2026. 3’-SL was approved as a new food nutrition enhancer, becoming the third officially authorized human milk oligosaccharide (HMOs) following 2’-FL and LNnT.
China
Food Ingredients
Food and Food Related Products
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CIRS Assisted Meihua Group in Securing First NHC Approved 3’-SL
China
Food Ingredients
Food and Food Related Products
Our Cases
CIRS Assists Runhan in Obtaining GRAS Status for Its GlcNac
Earlier in September 2025, Shandong Runhan Biotechnology Co., Ltd. (“Runhan”) achieved a milestone in its international compliance journey for its core product, GlcNac. With comprehensive professional support from CIRS Group and its U.S. subsidiary, the company’s GlcNac has been concluded by GRAS Panel as Generally Recognized as Safe (GRAS).
China
United States
Food and Food Related Products
GRAS
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CIRS Assists Runhan in Obtaining GRAS Status for Its GlcNac
China
United States
Food and Food Related Products
GRAS
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CIRS Assists VDK in Securing GRAS Status for β-carotene
Recently, VDK’s synthetically produced β-carotene, manufactured using synthetic biology technology, obtained self-GRAS notification. This milestone signifies the product’s approval as a safe food ingredient for sale and use in the American market, providing crucial support for VDK’s global expansion strategy. This notification was fully supported by CIRS Group.
United States
Food and Food Related Products
GRAS
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CIRS Assists VDK in Securing GRAS Status for β-carotene
United States
Food and Food Related Products
GRAS
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CIRS Helps Tianjin Hesheng Successfully Obtain US GRAS Notice and China New Food Additive Registration for Its 2’-FL
On December 8, 2025, Tianjin Hesheng Biotechnology Co., Ltd. (HS SynBio) (Tianjin) received “FDA has no questions” letter. This marks the official recognition of its HMO 2'-Fucosyllactose (2'-FL) as GRAS.
China
United States
Food Additives
Food and Food Related Products
GRAS
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CIRS Helps Tianjin Hesheng Successfully Obtain US GRAS Notice and China New Food Additive Registration for Its 2’-FL
China
United States
Food Additives
Food and Food Related Products
GRAS
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US FDA GRAS Notice
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Genetically Modified Microorganism Food Additive Registration in China
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US FDA Dietary Supplement Structure/Function Claim Notification
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US FDA Registration of Food Facilities
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US Food Label/Advertisement Information Review
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EU Novel Food Application
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GACC Overseas Manufacturers Registration of Imported Food (GACC Decree No.248)
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MARA Imported Feed and Pet Food Registration
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US FDA GRAS Notice
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Genetically Modified Microorganism Food Additive Registration in China
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US FDA Dietary Supplement Structure/Function Claim Notification
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US FDA Registration of Food Facilities
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US Food Label/Advertisement Information Review
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EU Novel Food Application
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GACC Overseas Manufacturers Registration of Imported Food (GACC Decree No.248)
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MARA Imported Feed and Pet Food Registration
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