Zhejiang Hisun Pharmaceutical Co Ltd recently announced that its core dietary ingredient, SAMe-1,4-butanedisulfonate, has passed the Generally Recognized as Safe (GRAS) Self-Affirmation under the United States Food and Drug Administration, giving it access to the US market.

SAMe-1,4-butanedisulfonate is a high-value nutritional enhancer widely used in dietary supplements and food processing for its role in regulating physiological functions. With the certification, Hisun's ingredient can now be used as a dietary material in the US for specific foods and meal replacement products, meeting growing global demand for nutrition and health.

Based in Taizhou, East China's Zhejiang province, Hisun has developed a complete industrial chain in this field, from active pharmaceutical ingredients to finished formulations. Since 2010, the company has launched both injectable and oral versions of the compound in China, reducing reliance on imports. By 2024, sales of its key product, liver care ademetionine 1, 4-butanedisulfonate enteric-coated tablets, had reached 145 million yuan ($20.31 million) domestically.

The latest certification confirms that the ingredient has passed a rigorous scientific evaluation, allowing it to be sold and used in the US and other markets recognizing the GRAS standard.