U.S. FDA Drugs: Establishment Registration, Drug Listing, and Labeling Review
U.S. FDA drug compliance should not be reduced to one registration number. A company should first confirm whether the product is a drug, then review establishment registration, drug listing, NDC, labeling files, manufacturing-quality records, and import records according to the applicable prescription, OTC, generic, new-drug, or other pathway.
Pre-Export Checklist
| Item | Review focus | Common risk |
|---|---|---|
| Product status | Confirm whether ingredients, intended use, or listing claims make the product a drug | Functional wording is written as disease treatment or prevention wording |
| Establishment registration | Review roles such as manufacturer, repacker, and relabeler | Actual manufacturer, brand owner, and listing records do not match |
| Drug listing and NDC | Confirm listing data, package sizes, label version, and NDC records | Listing data covers an old package or old formula instead of the current SKU |
| Market pathway | Assess records by prescription, OTC, generic, new-drug, or other applicable pathway | Establishment registration or drug listing is presented as FDA approval |
| Labels and advertising wording | Review indications, directions, warnings, ingredients, and claim boundaries | E-commerce claims exceed label and pathway records |
Claim Boundaries
- Establishment registration and drug listing should not be presented as official endorsement of product efficacy, safety, or quality.
- After formula, label, package size, manufacturing site, or brand-relationship changes, drug listing records should be reviewed again.
- OTC drugs should be reviewed against the applicable monograph or other pathway; prescription and new-drug pathways need separate assessment.
- Customer-facing pages should avoid wording that could be misunderstood as official endorsement.
Green Ark's Recommendation
Green Ark (Shenzhen) Certification Co., Ltd. recommends building a matrix that links product status, establishment role, drug listing, label version, market pathway, and import records. FDA-related information is suitable for customer-facing materials only when pathway, label, and sales version are consistent.
