GSC to Host FDA OTC Manufacturing Registration Seminar on June 1
The Global Standard Certification Institute (GSC), led by CEO Jeon Jae-geum, announced on June 1 that it will host the "US FDA OTC Manufacturing Registration Support Seminar" at Maison D'Ivre (T Tower, Room 1512) in Gwangmyeong, Gyeonggi Province, from 3:00 PM to 4:30 PM. This event targets companies that have been selected for the 2026 FDA OTC program, providing essential insights for domestic beauty and health product companies planning to enter the US market.
During the seminar, GSC will comprehensively cover the fundamentals of the FDA OTC support program and detail specific benefits offered to the selected enterprises along with a timeline for the program's implementation. This proactive engagement is particularly relevant as companies often encounter hurdles in navigating U.S. regulatory frameworks.
Furthermore, an in-depth Q&A session will address real-world challenges faced by participants, facilitating clarity regarding the complexities involved in market entry. The event will conclude with networking opportunities among attendees, allowing for information exchange and tailored consultations to foster stronger industry connections.
OTC, or Over the Counter drugs, refers to medications that can be purchased legally without a doctor's prescription at pharmacies or supermarkets. In the U.S. market, products such as sunscreens, BB creams, and creams with whitening and anti-wrinkle properties, along with anti-dandruff and anti-hair loss shampoos, acne treatment cosmetics, hand sanitizers, toothpaste, and topical ointments, are categorized as OTC items, subject to stringent management standards.
Registration as an OTC manufacturing facility stands as a critical requirement for Korean companies aspiring to penetrate the U.S. cosmetic and health product market. GSC boasts a structured OTC registration system aimed at businesses looking to expand into the U.S., providing comprehensive solutions from expert consulting to navigating complex regulatory requirements.
With a robust infrastructure built around local FDA agents, GSC distinguishes itself through its specialized expertise, swiftly relaying the latest FDA OTC regulations and market trends to the domestic beauty industry. This proactive approach is essential for amplifying K-beauty’s global footprint.
CEO Jeon Jae-geum noted, “While the U.S. represents the largest beauty and healthcare market globally, inadequate understanding of FDA OTC regulations can make market entry difficult. Through this seminar, we are committed to equipping selected companies to minimize trial and error, preparing thoroughly to secure substantial competitive advantages in the U.S. market.”
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