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

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).   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    정현식 기자ingredient notification growth ingredient proprietary ingredient new dietary

2025.10.15. 23:15

Mixsoon Enters Amazon's Premium Beauty Store, Strengthening Trust with Ingredient-Based High-Performance Skincare

Eco-friendly skincare brand Mixsoon has officially launched in Amazon's Premium Beauty Store as of January 3. Amazon's Premium Beauty Store is a curated section where brands are selected directly by Amazon based on product performance and ingredient verification. This selective approach ensures that only trusted brands are featured. Mixsoon's entry into this premium beauty store marks a significant turning point in the brand's global expansion and is expected to further enhance its credibility.   As a skincare brand focused on ingredient-based efficacy, Mixsoon has gained trust from many consumers by offering high-performance products that are gentle on sensitive skin, using natural ingredients. Particularly in international markets, Mixsoon has established itself as a luxurious yet effective skincare brand with its slogan, "Premium Korean Skincare Brand for Glass Skin." As a result, the brand has seen a steady increase in demand, particularly in the U.S. and other overseas markets.   Additionally, Mixsoon's flagship product, the Bean Essence, has gained significant popularity, ranking No. 2 in Amazon's serum category. Recently, the brand's response has become even more enthusiastic following the appointment of globally popular K-pop group ENHYPEN as its brand ambassadors.   Mixsoon spokespersons shared, "We will strengthen our presence and credibility in the U.S. market through Amazon’s Premium Beauty Store." They also added, "We will continue to introduce a variety of products on Amazon and work to lead the K-beauty trend." As the Amazon Premium Beauty Store selectively features only trusted brands, Mixsoon is expected to meet the demands of U.S. consumers who prefer 'clean beauty' and 'efficacy-driven' skincare, helping the brand expand its customer base. Furthermore, leveraging Amazon's extensive distribution network and global customer base, Mixsoon is expected to expand more its brand recognition and establish itself as a strong icon in the K-beauty industry.    최지원 기자performance ingredient amazons premium beauty store performance products

2025.02.24. 18:45