GSC Offers Comprehensive Support for FDA OTC Registration to Enhance U.S. Market Entry

Global Standard Certification (GSC Korea) announced on the 10th that it is reinforcing support for Korean beauty and consumer goods companies preparing to enter the U.S. market through its 'FDA OTC Establishment Registration Consulting Support Project.' The initiative is designed to assist 25 companies in overcoming the significant barrier of registering manufacturing facilities with the FDA, a critical step for exporting products classified under Over-The-Counter (OTC) regulations in the U.S.

The U.S. has stringent regulations that classify many products, typically marketed as cosmetics in Korea, as OTC drugs. Notable examples include sunscreens, acne treatments containing salicylic acid or benzoyl peroxide, anti-dandruff shampoos, fluoride toothpaste, and hand sanitizers. To export these items, companies must register their manufacturing facilities with the FDA as OTC drug establishments and ensure proper drug listing, which is mandated separately from the Cosmetics Modernization Act (MoCRA).

The FDA registration process presents several complexities, including navigating an elaborate English electronic system, incurring substantial annual costs, and undergoing rigorous site inspections. Companies need to acquire DUNS and FEI numbers, designate a U.S. Agent, complete electronic registration through the eDRLS system, and renew registrations annually between October and December. Small businesses, in particular, struggle with the recurring OMUFA facility fees, which for FY2026 stand at $19,188 for general manufacturers and $12,792 for contract manufacturers, due by June 1, 2026, with exceptions for facilities that produce only active ingredients (API).

Moreover, once registered, companies must adhere to the Current Good Manufacturing Practice (CGMP) standards outlined in 21 CFR Part 211, which subjects them to FDA inspections. Failure to pass these inspections could result in severe export disruptions, including customs holds or import alerts. GSC Korea, known for its impartial evaluations as a third-party certification body, has launched this support initiative specifically to mitigate these risks faced by enterprises.

Participating companies will receive systematic assistance tailored to their readiness for U.S. market entry. Firms planning to register for the first time will be guided through OTC product registration and site inspection preparations. In contrast, companies with prior experience will benefit from gap analysis based on 21 CFR Part 211, as well as mock inspections conducted by former FDA inspectors to identify and address any deficiencies beforehand.

Industries developing or holding OTC products, such as sunscreens, acne care solutions, and hand sanitizers, are expected to gain significant advantages from this initiative. Furthermore, companies preparing for site inspections following registration, and those experiencing challenges post-FDA inspections, will find this support invaluable.

A representative from GSC Korea highlighted the confusion faced by companies when products they manufacture are subjected to drug-level regulations, noting, “We aim to assist K-beauty brands in navigating the complex registration procedures and inspection readiness through our expert pre-diagnostic programs, ensuring they successfully pass the initial hurdle of U.S. exports.” Moreover, this project offers individual support up to ₩60 million ($50,000) per company, with a 25% co-payment requirement from the participating company. Applications are being accepted on an ongoing basis until further notice for 25 companies, with details available via the Korean Cosmetics Industry Information Portal (allcos). Interested businesses can inquire further through GSC Korea at 02-899-4265 or .