Pukyong National University Faculty Startup Registers Lime Peel Extract as Functional Ingredient with U.S. FDA

Nutright Accelerates Entry into U.S. Market
Paving the Way for Globalization of K-Health Functional Foods

Pukyong National University (President Bae Sanghoon) announced on September 24 that Nutright Co., Ltd., a faculty startup led by CEO and Professor Cho Seungmok (Department of Food Engineering), has had its exclusive functional ingredient, lime peel extract (BENESOMNOTM), registered as a New Dietary Ingredient (NDI) with the U.S. Food and Drug Administration (FDA).

Nutright previously received recognition from the Ministry of Food and Drug Safety in May for this extract as a functional ingredient for health functional foods. Building on this, the company has now achieved validation in the United States, which is at the center of the global health functional food market.

For a new functional ingredient to be sold in the U.S. market, it must undergo a pre-market NDI notification and verification process with the FDA. The U.S. FDA rigorously reviews the safety and standard specifications of the proposed functional ingredient before listing it as an NDI. With this registration, Nutright’s lime peel extract has been confirmed as an outstanding functional ingredient that meets the high international standards required globally.

The lime peel extract developed by Nutright has been scientifically proven to improve sleep through cell, animal, and human clinical trials. It is a functional ingredient for health functional foods that enhances sleep quality by activating GABA receptors in the central nervous system, thereby increasing deep sleep.

In clinical trials based on polysomnography, the extract showed significant improvements in key sleep indicators, including an 8.5% increase in sleep efficiency, reduced sleep onset latency, increased total sleep time, decreased wake time after sleep onset, and an increase in deep sleep during Stage 2.

Thanks to the excellent sleep improvement effects of the lime peel extract, Nutright has entered into non-disclosure agreements with renowned international health functional food companies this year and is actively negotiating exports. Accordingly, this NDI registration is expected to serve as a foundation and a significant turning point for the export and globalization of the lime peel extract in the United States and beyond.

Kim Seonghee, Director of the Research Institute, stated, "Lime peel extract not only improves sleep but is also effective in relieving stress and easing tension, giving it excellent growth potential as a mental care functional ingredient. Nutright will continue to grow as a global leader in the field of nutritional neuroscience."

Choi Yoonjin, Principal Researcher, emphasized, "Through the NDI registration in the United States and export negotiations with global health functional food companies, we are establishing a world-class quality management system and hope to contribute to the globalization of K-health functional foods."

Professor Seungmok Cho, CEO of Nutright Co., Ltd. (third from the left), and employees.