HT042, Korea’s First Height-Growth Ingredient, Receives U.S. FDA New Dietary Ingredient Notification

Neumed Inc.’s 15-Year Scientific Journey Brings K-Functional Ingredient to the Global Stage

SEOUL, South Korea, Oct. 16, 2025 — Neumed Inc., a natural product R&D company led by Dr. Hocheol Kim, announced today that its proprietary ingredient HT042, a complex herbal extract containing Astragalus and other botanicals, has been officially recognized through the New Dietary Ingredient Notification (NDIN) process by the U.S. Food and Drug Administration (FDA).
 

[Image by Neumed Inc.]

This marks the first time a height-growth ingredient developed by a South Korean company has been acknowledged through the FDA’s NDIN process. The NDIN serves as a rigorous safety evaluation required for any new dietary ingredient to enter the U.S. market. It involves comprehensive reviews of the ingredient’s composition, manufacturing process, toxicity data, and human consumption history.
 
The notification details will be published on the FDA’s official portal, Regulations.gov, on October 28 (local time) / October 29 (KST), as New Dietary Ingredient Notification Report No. 1428, under the name “Astragalus extract mixture (HT042), aka Grow HT042.”
 
Korea’s First Height-Growth Ingredient, Developed Through 15 Years of Research
HT042 is a scientifically formulated complex of Astragalus (traditionally known as the “Crown Prince’s tonic”), Siberian Ginseng (Acanthopanax senticosus), and Phlomis (Phlomis umbrosa).

 
After 15 years of research beginning in 1999, the ingredient was officially recognized in 2014 by the Korea Ministry of Food and Drug Safety (MFDS) for its functionality: “May help with children’s height enhancement.” It became Korea’s first individually approved functional ingredient for child growth.
 
The height-growth promoting effect of HT042 was demonstrated in two randomized, double-blind, placebo-controlled clinical trials conducted on growing children. Its mechanism of action has been validated through 12 studies published in SCI(E)-indexed international journals.
 
Recently, a clinical trial on immune function was successfully completed, expanding HT042’s scope beyond growth to immune health. In preclinical studies, the ingredient showed the ability to enhance immune defense by activating NK and T cells, with the results published in May 2025 in an SCI(E)-indexed international journal.
 
Global Recognition for K-Science Innovation  
HT042’s scientific achievements are drawing international attention. In September 2025, it was showcased as a landmark example of translating traditional Korean medical wisdom into scientifically validated innovation at the Shanghai Cooperation Organization (SCO) Forum of Traditional Medicine held in Nanchang, Jiangxi Province, China.
 
Delegates and policymakers from multiple countries recognized HT042 as a pioneering case of modernizing and industrializing traditional Korean herbal science.
 
Proven Safety and Market Success
Currently, HT042 is the core ingredient in several leading children’s height-growth health supplements, achieving cumulative sales exceeding USD 248 million (approximately KRW 340 billion).
 
It has been trusted by parents for over a decade, being used in products such as: KeyCleo042 (Neumed L&B), Iker (CKD Health), KidsTen042 (Yonsei Life Health), KeyLab (Kyowon), and Grow Up Vital (Rotbexen).
 
A New Global Standard for Growth and Immune Health
A Neumed Inc. official stated, “This FDA notification is a major milestone that recognizes over 15 years of scientific research by our team. HT042 has now been acknowledged as a safe, scientifically validated functional ingredient by one of the most rigorous regulatory bodies in the world. Moving forward, we aim to position HT042 as a global benchmark functional ingredient for both growth and immune health, representing the next evolution of K-functional science.”
 
 
 
About Neumed Inc.
Neumed Inc. is a Korea-based R&D company specializing in the scientific development of natural product–based functional ingredients and herbal pharmaceuticals. Founded in 2003 by Dr. Hocheol Kim, Neumed has focused on integrating traditional Korean medicine with modern scientific validation, developing internationally recognized ingredients such as HT042 (child growth), HP426 (liver health), HT074 (gastric health), and HT009 (brain health).
For more information, visit www.neumed.co.kr
  

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