Lifewe’s CitiCogni Citicoline and Citicoline Sodium were Granted SELF-GRAS

Mar. 05, 2024

On January 24, 2024, the GRAS panel evaluated the safety of Lifewe's main nucleoside products Citicoline and Citicoline Sodium, and unanimously concluded that they are safe under the conditions of intended use as food ingredients. The process was conducted in accordance with the GRAS guidelines outlined in the US FDA. The team unanimously recognized and approved it, and it was successfully approved by SELF-GRAS in the U.S.

Lifewe’s CitiCogni Citicoline and Citicoline Sodium were Granted SELF-GRAS

"Generally Recognized As Safe" (GRAS) is a designation within U.S. food regulation introduced in 1958. This term signifies that a particular substance, often a food ingredient, is widely acknowledged as safe for consumption based on the consensus of qualified experts. Unlike specific food additives, substances classified as GRAS are exempt from certain regulatory requirements. GRAS status is a result of expert evaluation, indicating that, under defined conditions, the substance is considered safe for use in food.

The successful attainment of SELF GRAS certification serves as a crucial basis for Lifewe's citicoline and citicoline sodium products to enter the U.S. market. This achievement lays the foundation for the promotion of these products in the United States and international markets. Throughout the Self-GRAS process, close collaboration between Lifewe's research and production teams and our agent, Anchor Center of Certification (ACC), facilitated a swift and efficient acquisition of SELF-GRAS recognition. This underscores the alignment of Lifewe's production standards, quality control, cGMP, HACCP, and other management aspects with international standards. The safety and production compliance of the products received unanimous approval from the U.S. expert panel.

Lifewe bioengineering is a company that integrates R&D, production, sales and service. It uses synthetic biology technology to produce ingredients used in nutriceutical and dietary supplement industry. With the beautiful vision of "Enabling the Microbes, Powering the Nature", and using the green biosynthesis manufacturing way to make the world a better place. The company has been researching the development of nucleoside products since 2019, and has made key breakthroughs in bacterial strain construction, fermentation technology, enzyme technology and product application fields. The company has formulated and improved corporate standards and strictly controlled product quality. This time Citicoline / Citicoline Sodium has passed the SELF GRAS safety certification, which provides a strong guarantee for the lifewe’s Citicoline products to sell well overseas.

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