Global First! Shandong Weiyan’s β-carotene Secured FDA GRAS Notification and No Questions Letter

On September 10, 2026, under the professional support of CIRS Group, Shandong Weiyan’s β-carotene successfully passed the review by the U.S. FDA, obtaining the FDA GRAS Notice (No. GRN 1328) and the FDA “No Questions Letter”. Relying on a solid, comprehensive scientific dossier and professional, efficient application support, this project took only about six months from submission to receiving the FDA No Questions Letter. Consequently, Shandong Weiyan Biotechnology Co., Ltd. has become the first company globally to achieve official FDA recognition for β-carotene produced via synthetic biology technology. 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.

Both FDA GRAS Notification and Self-GRAS can be used to demonstrate the safety of food ingredients, but they differ in authority and market communication value. Self-GRAS typically involves a company completing a safety assessment based on existing scientific evidence, with conclusions formed by qualified experts, allowing the company to proceed with compliance planning. In contrast, FDA GRAS Notification involves formally submitting a complete scientific dossier to the U.S. FDA for review; if no safety concerns arise, the FDA issues a “No Questions Letter”. Compared to Self-GRAS, FDA GRAS Notification provides an official-level review feedback and a no-questions conclusion from the U.S. authorities. This offers customers, brand owners, and overseas partners a more credible compliance basis, helps reduce market access communication costs, enhances international product recognition, and fully demonstrates the comprehensive advantages of Shandong Weiyan’s synthetic biology β-carotene in production processes, safety assessments, and quality control.

Rigorous Safety Assessment Safeguarding Global Market Layout

The successful completion of this evaluation signifies that Shandong Weiyan’s biofermentation β-carotene meets the safety and quality standards required for entry into the U.S. food market. It can be widely applied in dietary supplements, functional foods, regular foods, and related fields, providing safe and high-quality biobased raw material solutions for compliant market customers in the U.S. and abroad.

β-carotene possesses excellent physiological activity and antioxidant properties, efficiently converting into vitamin A in the body, playing a vital role in maintaining visual health and mucosal integrity. As a natural colorant combining nutritional value and stable performance, β-carotene is already widely used in dietary supplements, functional foods, and regular foods. It is a core active ingredien with both health attributes and commercial application potential. Biofermentation-derived β-carotene helps brands build product differentiation competitiveness, aligning with the global market trend toward natural, stable, and biobased active ingredients.

Synthetic Biology Empowers Efficient Manufacturing Systems

Shandong Weiyan has long been deeply engaged in the field of biosynthesis. Leveraging cutting-edge synthetic biology technologies, it has established an integrated production system combining low carbon-green practices, high-density fermentation, and advanced purification processes. The company focuses on the research, development, and large-scale production of carotenoid series products, building a complete technical system covering high-yield strain construction, fermentation and separation/purification R&D, new dosage form development, product applications, and full-process refined quality control. Possessing multiple independent core patents, the company ranks among the industry leaders in industrialization strength.

Expanding Application Fields to Enable Value Realization Across Multiple Sectors

As an innovative enterprise deeply rooted in bio-synthesized active carotenoid raw materials, Shandong Weiyan focuses on fermentation process development and low carbon-green production, strictly adhering to domestic and international quality and safety management regulations while upholding sustainable development principles. Utilizing advanced technologies such as synthetic biology and enzymatic conversion, the company has successfully broken foreign technological monopolies in the high-end natural pigment sector. It has pioneered green, efficient, and high-quality industrialized production of products like β-carotene, astaxanthin, and canthaxanthin using synthetic biology technology. These products are widely applied in livestock, aquaculture, crop protection, and food sectors, exported to overseas markets, and highly recognized by the industry and customers.

In the future, the company will leverage its authoritative safety assessment results and qualification advantages to continuously expand domestic and overseas market channels, empowering the global dietary nutrition and functional food industries. It aims to showcase the technological innovation capabilities and social responsibility of Chinese biomanufacturing enterprises. Meanwhile, Shandong Weiyan will continue to promote the application of synthetic biology technology in feed additives, food additives, novel food ingredients, health supplements, cosmetics, and pharmaceutical-related products, breaking through key synthetic biology technologies to achieve innovation in product development and process technology.

Introduction to Shandong Weiyan Biotechnology Co., Ltd.

Shandong Weiyansyn Biotechnology Co., Ltd. was established in April 2014, located in Binzhou High-tech Zone, Shandong, with a registered capital of 118.88 million RMB and a land area of 200 mu. It is a wholly-owned subsidiary of Shanghai Weimu Biotechnology Co., Ltd., focusing on the research, development, and industrialization of synthetic biology technologies.

The company has made substantial investments in the synthetic biology field, introducing a technical team with backgrounds in synthetic biology R&D and industrialization. With rich product and technical reserves, it has obtained 8 authorized invention patents, filed 10 invention patent applications, and secured 24 utility model patents.

The company focuses on applying synthetic biology technology to feed additives, food additives, food ingredients, health supplements, cosmetics, and pharmaceutical-related products. Relying on decades of R&D innovation platforms built by the enterprise, it breaks through key synthetic biology technologies to achieve innovation in product development and process technology. It aims to become a top-tier domestic demonstration base for synthetic biology R&D and manufacturing, fully leveraging its leading and exemplary effects to drive the advancement of synthetic biomanufacturing and industrial upgrading.

CIRS Group - Professional Regulatory Services to Help Raw Material Enterprises Go Global

The successful completion of Shandong Weiyan’s precision fermentation β-carotene project—from submission to receiving the FDA No Questions Letter—in approximately six months is attributed to CIRS Group’s systematic control over the project pathway, scientific evidence, and application dossiers. CIRS Group’s U.S. office is equipped with full-time experts possessing over 20 years of practical experience in GRAS/NDI matters. Leveraging coordinated efforts between U.S. and China teams, the group provides one-stop services ranging from dossier quality assessment and scientific evidence supplementation to official submission, review communication, and subsequent compliance support.

For different product uses and market targets, CIRS Group assists companies in making scientific judgments among various U.S. food and feed regulatory pathways, including GRAS, NDI, FAP, CAP, SRIS, AFIC, and others, avoiding delays in market entry due to inappropriate pathway selection. Simultaneously, through collaboration between U.S. and Chinese regulatory experts and continuous follow-up on official communication milestones, the group helps companies more efficiently resolve overseas market access issues for novel food ingredients, food additives, dietary supplement ingredients, and animal feed ingredients.

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