Lianyungang, China, September 10, 2026 — Lianyungang Jinkang Hexion Pharmaceutical Co., Ltd. announced that its flagship product, Magnafolate^® (chemical name: calcium 6S-5-methyltetrahydrofolate), received an independent GRAS conclusion issued by a panel of independent U.S. experts on September 4, 2026.

According to the panel's conclusion, Magnafolate^® may be used as an alternative folate source in U.S. infant and toddler formula, provided it replaces the current folate dosage on a molar-equivalent basis.

1. Magnafolate^® Approved for Use in U.S. Infant and Toddler Formula

On September 4, 2026, a GRAS expert panel convened by CIRS Group USA Inc. issued its independent conclusion, determining that Magnafolate^® meets the standard of being "reasonably certain to be safe" when used in infant and toddler formula as a molar-equivalent replacement for the current folate dosage.

Three experts participated in the review:

• Dr. Katrina Emmel, toxicology expert;
• Dr. Ronald E. Kleinman, pediatric gastroenterology and nutrition expert;
• Dr. Xiaopeng Zhang, D.A.B.T., food safety and toxicology expert.

The panel reviewed human and animal safety data and evaluated the product's synthetic process, quality control requirements, and intended use levels. After multiple rounds of review, the panel reached this independent conclusion.

2. From Conventional Foods to Infant Formula: A Decade of Work

Jinkang Hexion spent ten years advancing its GRAS compliance efforts in the United States.

On March 24, 2016, the company completed its first self-affirmed GRAS review. The reviewing experts unanimously concluded that Magnafolate^® could be used in selected conventional food categories — including ready-to-eat cereals, nutrition bars, nutritional beverages, protein and nutrition powders, and yeast extract spreads — in compliance with applicable U.S. requirements. Meat and poultry products, however, as well as infant and toddler formula, were not included in the scope of that recognition.

That same year, Magnafolate^® also completed the U.S. FDA New Dietary Ingredient (NDI) notification process, entering the dietary supplement market. Ten years later, Jinkang Hexion submitted a new application for an independent GRAS conclusion, completing the pathway for use in infant and toddler formula.

3. Turning Active Folate into Product Standards

Magnafolate^® is a C-crystal form of calcium 6S-5-methyltetrahydrofolate. Around product safety, stability, and human bioavailability, Jinkang Hexion has accumulated substantial research and quality-control data.

Manufacturing and impurity control

The Magnafolate^® manufacturing process does not use formaldehyde, p-toluenesulfonic acid, or heavy metals, and controls for compounds such as JK12A and 5-methyltetrahydrofolate. According to toxicology testing by the Shanghai Municipal Center for Disease Control and Prevention, Magnafolate^® reaches the "practically non-toxic" level. Publicly available information shows that the specification for the key harmful impurity JK12A is controlled to within one-tenth of the relevant United States Pharmacopeia standard, product purity exceeds 99.5%, and the C-crystal form remains stable for 36 months at room temperature.

Human bioavailability

Magnafolate^® uses calcium 6S-5-methyltetrahydrofolate, an active folate form with a structure similar to endogenous folate in the human body, allowing it to participate in folate metabolism without first undergoing multiple conversion steps in the body. In China, the carrier rate of MTHFR gene mutations is approximately 78.4%. For some individuals, the body's ability to metabolically convert conventional synthetic folic acid may be affected. Magnafolate^® requires no conversion and is absorbed directly, reducing reliance on this conversion step.

Since the project's launch in 2007, Jinkang Hexion has filed more than 100 invention patent applications worldwide, holds 43 granted invention patents globally along with 7 PCT international patents, has published 14 academic papers in China and abroad, and has driven the implementation of five domestic application-regulation upgrades.

4. Continued Expansion of Applications in China and Overseas

While advancing its U.S. GRAS compliance, Magnafolate^® continues to expand its approved applications in China.

In 2017, Magnafolate^® was approved as a new food nutrient fortifier, usable in formulated milk powder and powdered beverages. In 2020, its scope expanded to formulated milk, formulated milk powder, and milk powder for children and pregnant/lactating women, as well as ready-to-eat cereals, fruit and vegetable juice beverages, and foods for special medical purposes. In 2021, Magnafolate^® was approved for maternal and lactating-women nutritional supplements and sports nutrition foods. In 2025, Magnafolate^® was approved for use in wheat flour. In 2026, it was approved for complementary food supplements for infants and young children, covering infants aged 6–36 months and children aged 37–60 months.

Magnafolate^® now covers a wide range of active folate food applications. Going forward, Jinkang Hexion will continue to advance active folate R&D and quality management, and conduct further application research on Magnafolate^® in foods, health supplements, and pharmaceutical products.

About Jinkang Hexion Pharmaceutical

Lianyungang Jinkang Hexion Pharmaceutical Co., Ltd. has focused on the R&D, production, and sales of active (naturalized) folate for 20 years. It is the principal driver of domestic active folate application-regulation upgrades in China, holds one of the world's largest active folate patent portfolios, and is a globally leading provider of active folate application solutions.

Reference：

[1] Yang et al. PLoS ONE, 2013;8(3):e57917.

[2] Lian Zenglin et al. China Food Additives, 2022(2):279-286.

[3] China Food News, 2023-12-26. https://www.cnfood.cn/article/281124.html

[4] China Food News. Jinkang Hexin Supports Health Throughout the Life Cycle With Naturalization Folate. 2026-04-27. https://www.cnfood.cn/article/285767.html

[5] Xinhua News App. Integrating Nutritional Fortification Into Everyday Meals: "Policy + Technology" Drives Faster Growth in Food Fortification. 2026-04-21. https://app.xinhuanet.com/news/article.html?articleId=20260421b6c54036c6ad4c12934a893bef452fe5

[6] Lian Z, Chen H, Liu K, et al. Improved Stability of a Stable Crystal Form C of 6S-5-Methyltetrahydrofolate Calcium Salt, Method Development and Validation of an LC-MS/MS Method for Rat Pharmacokinetic Comparison. Molecules, 2021, 26, 6011.

[7] Xu T, Wang K, Zhang J, et al. Study on the Characterization of 6S-5-Methyltetrahydrofolate Calcium Salt Crystal Form C and its Stability Improvement by Ascorbic Acid and Cysteine. LWT - Food Science and Technology, 2024, 198: 115984.