The Korean Cosmetic Industry Research Institute, led by Director Jo Shin-haeng, announced on the 10th that it is recruiting participants for its '2026 U.S. OTC Manufacturing Site Registration Pre-Consulting Support Project'. This initiative aims to enhance the capability of domestic cosmetics companies to navigate FDA regulations and establish a stable entry pathway into the U.S. market.

In the U.S., certain products like sunscreens, acne treatments, and dandruff treatments fall under the category of over-the-counter (OTC) drugs. Companies exporting these products must comply with rigorous FDA facility registration and quality management standards. The support initiative is tailored for domestic manufacturers and raw material suppliers keen on exporting to the U.S., helping them develop a comprehensive understanding of U.S. FDA regulations.

This program targets a total of 25 domestic cosmetics and raw materials manufacturers. Selected companies will receive comprehensive consulting services, which include document reviews for U.S. OTC registration, mock facility inspections, and practical recommendations for compliance. The presence of experts with prior FDA inspection experience ensures that each participating company can assess its manufacturing environment and quality control systems effectively.

The Research Institute anticipates that this project will empower domestic cosmetics manufacturers to better navigate U.S. OTC regulations, thereby enhancing their production and quality foundations essential for successful exports and entry into global supply chains.

Interested companies can apply through the Korean Cosmetic Industry Research Institute's official website (www.allcos.biz), under the education/seminar section for the 2026 U.S. OTC Manufacturing Site Registration Pre-Consulting (ongoing recruitment). Registration will be processed on a first-come, first-served basis until the capacity is filled. The total project cost for each company can reach up to 600 million KRW, with government subsidies varying based on company size—75% for small enterprises and 70% for medium-sized enterprises.

Park Sang-hoon, head of the Korean Cosmetic Industry Research Institute, highlighted that the U.S. is the largest cosmetics market globally. OTC products require a different regulatory approach compared to regular cosmetics. He affirmed the Institute's commitment to enabling domestic cosmetics firms to proactively address U.S. OTC regulations and build a stable export foundation through this initiative.