GeneChem Inc., a biotechnology company specializing in AI-powered enzyme engineering and the development of high-value biomaterials, today announced that the U.S. Food and Drug Administration (FDA) issued an acknowledgment letter stating that it has no objection to the company's New Dietary Ingredient Notification (NDIN) for its novel ingredient 6'-Sialyllactose (6'-SL) Sodium Salt, marketed under the trade name Siallac6®. The notification was prepared and submitted on GeneChem's behalf by REJIMUS, INC., a U.S.-based FDA regulatory management consultancy with expertise in GRAS and NDI Notifications.
NORTH RICHLAND HILLS, Texas, Aug. 7, 2026 /PRNewswire-PRWeb/ -- GeneChem Inc., a biotechnology company specializing in AI-powered enzyme engineering and the development of high-value biomaterials, today announced that the U.S. Food and Drug Administration (FDA) issued an acknowledgment letter stating that it has no objection to the company's New Dietary Ingredient Notification (NDIN) for its novel ingredient 6'-Sialyllactose (6'-SL) Sodium Salt, marketed under the trade name Siallac6®. The notification was prepared and submitted on GeneChem's behalf by REJIMUS, INC., a U.S.-based FDA regulatory management consultancy with expertise in GRAS and NDI Notifications.
The FDA's July 30, 2026 letter concerns New Dietary Ingredient notification report number 1471. Under the notified conditions of use, Siallac6® is intended for daily use in dietary supplements at up to 6 grams per day in adults 18 years of age and older. FDA issued the acknowledgment after review of the original notification and substantive supplemental information provided during the review period. The acknowledgement provides dietary supplement brands with greater confidence in sourcing Siallac6® for use in adult products marketed in the U.S. under the conditions described in the notification.
This milestone reflects a close collaboration between GeneChem and REJIMUS, INC. REJIMUS guided the regulatory strategy, preparation and electronic submission of the NDIN, integration of the scientific and safety evidence, and responses to FDA's requests for additional information. The successful outcome reinforces the value of combining GeneChem's ingredient science and manufacturing expertise with REJIMUS' specialized experience in novel-ingredient notifications and U.S. market-entry strategy.
6'-SL is a sialylated human milk oligosaccharide (HMO) that has attracted scientific and commercial interest for applications ranging from early-life nutrition to adult wellness. GeneChem applies its proprietary AI-powered enzyme engineering platform and enzymatic biosynthesis technologies to the development and commercial-scale production of sialyllactose and other high-value biomolecules. The acknowledgment without objection creates an important pathway for Siallac6® to be supplied for appropriately labeled adult dietary supplements in the United States under the conditions described in the notification.
"This FDA acknowledgment is an important step in expanding the Siallac® platform for the U.S. adult dietary supplement market," said Dr. Nam Huh, CEO of GeneChem. "It reflects our commitment to responsible innovation, rigorous science, and the scalable production of high-quality HMO ingredients. We sincerely appreciate the REJIMUS team for its strategic guidance and disciplined support throughout the notification and review process."
GeneChem's successful NDI notification demonstrates the company's serious commitment to transparency and safety of ingredients intended for U.S. market access," said Brandon Griffin, CEO of REJIMUS, INC. "We are proud to have been entrusted by GeneChem throughout this process from strategy outline and master file development through to FDA's review, and we look forward to seeing Siallac6® support responsible innovation in adult dietary supplements."
About GeneChem Inc.
GeneChem Inc. is a Republic of Korea-based biotechnology company specializing in AI-powered enzyme engineering and production optimization. Through its proprietary enzyme-engineering platform and one-pot enzymatic biosynthesis technology, GeneChem designs, scales, and commercializes high-value biomolecules found in nature, including sialyllactose HMOs and other advanced materials for food, health, biopharmaceutical, and cosmetic applications. For more information, visit https://genechem.co.kr.
About REJIMUS, INC.
REJIMUS, INC. is a preeminent FDA regulatory management consultancy and regulatory SaaS provider enabling companies in the Food & Beverage, Dietary Supplement, Cosmetic, and OTC industries to achieve and maintain cost-efficient compliance operations and supply chains while mitigating quality and regulatory risks and accelerating responsible time-to-market. REJIMUS specializes in FDA, FTC, and USDA matters, including electronic NDI and GRAS notifications, regulatory due diligence, quality-system optimization, labeling, claims substantiation, and enforcement-response support. For more information, visit https://www.rejimus.com.
Media Contact
Brandon Griffin, REJIMUS, INC., 1 6822671203, [email protected], https://www.rejimus.com
SOURCE REJIMUS, INC.
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