On the 10th, Global Standard Certification Agency (GSC Korea) announced a strengthened initiative to assist Korean cosmetics and personal care companies in overcoming one of their most significant barriers to entry in the U.S. market: the FDA's OTC (Over-The-Counter) drug facility registration. The program will continuously recruit 25 companies and offers financial support of 60 million won per company to facilitate this complex process.

The U.S. regulatory landscape presents unique challenges, as many products commonly classified in Korea as general or functional cosmetics fall under stringent OTC regulations in the U.S. Notable examples include sunscreens, acne treatment products (containing salicylic acid or benzoyl peroxide), dandruff shampoos, fluoride toothpaste, and hand sanitizers. To export these categories, companies must register their manufacturing facilities as OTC drug establishments and list their products according to FDA guidelines, distinct from the existing Cosmetics Modernization Act (MoCRA) requirements.

The intricacies involved in the registration process, compounded by high annual costs and strict compliance reviews, pose considerable challenges for small and medium-sized enterprises. Among these are requirements for DUNS and FEI numbers, the designation of a U.S. agent, electronic registration via the eDRLS system, and annual renewals between October and December. The facility fee can be a significant barrier, particularly for SMEs, with costs set for FY2026 at $19,188 for general establishments and $12,792 for contract manufacturing facilities, due by June 1, 2026. However, facilities producing only active pharmaceutical ingredients (APIs) are exempt from this fee.

Moreover, compliance with current Good Manufacturing Practices (CGMP) as defined by 21 CFR Part 211 after registration requires thorough preparation for FDA inspections. Any deficiencies identified during inspections could lead to severe export complications, such as customs holds or import alerts. In response to these considerable risks, GSC has crafted this support initiative to assist companies in navigating these regulatory complexities more effectively.

Companies participating in the program will receive tailored support aligned with their stage of market entry. For those preparing to enter the U.S. market for the first time, guidance on OTC product registration and preparation for initial inspections will be provided. Existing entrants can benefit from gap analyses based on 21 CFR Part 211 and mock inspections led by former FDA inspectors, allowing them to identify and address deficiencies in advance.

This initiative is anticipated to be particularly beneficial for companies holding and developing OTC items such as sunscreens, acne care products, and hand sanitizers, as well as those preparing for facility inspections and addressing challenges post-FDA reviews. A representative from GSC noted that companies, even those producing cosmetics, often face the bewildering reality of stringent drug-level regulations based on their product categories. GSC is committed to helping K-beauty firms navigate the complex registration and inspection processes so they can successfully penetrate the U.S. market without setbacks.

The financial support offered under this initiative amounts to 60 million won per participating company, with a company contribution of 25%. The program is open for ongoing registration until further notice, allowing interested firms to apply online through the Cosmetics Industry Information Portal (allcos). For further details, companies can reach out to GSC (02-899-4265 / operation@gsckorea.co.kr).