Details

FDA (Food & Cosmetics)

Purpose of Certification

U.S. FDA certification supervises and approves production, distribution, and sale of products that meet safety standards to protect public health and monitor product safety throughout consumer use. It aims to verify essential requirements for Korean food and cosmetics manufacturers entering the U.S. market.

Certification Overview

The FDA regulates all food and cosmetics imported into the United States. Before products may be sold in the U.S., requirements include facility registration, prior notice for imported food and cosmetics, and labeling rules. Facility registration applies to domestic and foreign manufacturers; all information must be registered, and certification under FDA regulations is required from hygienic production and distribution through U.S. customs clearance.

Target Products

Food products

General foods: processed foods, canned foods, frozen foods, snacks, beverages, natural foods, etc.
Dietary supplements and functional foods
Low-acid canned foods (pH ≥ 4.6, water activity > 0.85) and acidified foods (pH ≤ 4.6, water activity > 0.85): bottled/canned foods, juices, retort pouch foods, etc.

Cosmetic products

General cosmetics: cleansing, beautifying, promoting attractiveness, altering appearance — registered via Voluntary Cosmetic Registration Program (VCRP)
Functional cosmetics: products intended to affect body structure or function (efficacy/treatment) — classified as OTC drugs and registered accordingly

Required Documents

Food registration documents

Application form
Business registration certificate (English)
Unique Facility Identifier (UFI)
Facility information (name, address, phone, representative, contact person, etc.)
All trade names used by the facility
Applicable food categories on the registration form
U.S. agent information (agent service available if none)
Certification that submitted information is true, accurate, and authorized
Assurance allowing FDA facility inspection as permitted under the FD&C Act
(If required) Other documents as requested

General cosmetics — VCRP documents

Application form
Business registration certificate
Cosmetic establishment registration information (FDA 2511)
Product ingredient statement information (FDA 2512 CPIS and FDA 2512a)
(If required) Other documents as requested

Functional cosmetics — OTC registration documents

Application form
Business registration certificate
D-U-N-S number (assistance available if not held)
Cosmetic manufacturer registration information
Product specification
Full ingredient list
Label
(If required) Other documents as requested

Remarks

Food

Validity Period

Valid for one year after registration; annual renewal fee payment (Oct 1–Dec 31) maintains certification.

Facility Inspection

For OTC registration of functional cosmetics, FDA may conduct a manufacturing facility inspection within six months after registration completion. ※ GMP-level review

Labeling

General Cosmetics

Product type and category
Product name
Directions for use
Full ingredient listing
Manufacturer and country of origin
Importer or manufacturer name and address
Net weight or volume
Warnings
Manufacturing and expiration dates
Cautions