Permitted and Prohibited Promotional Claims
Permitted claims
- Accurate descriptions of the approved intended use
- Performance claims supported by data in the approved STED
- Fair, accurate, evidence-supported comparative claims
- Statements about regulatory status (e.g., "MFDS approved")
Prohibited claims
| Claim type | Reason |
|---|---|
| Claims beyond approved indications | Exceeds 품목허가 scope |
| Curative claims for unapproved conditions | Misleading |
| Testimonials implying guaranteed outcomes | Misleading |
| Comparative claims without evidence | Misleading |
| Unqualified safety claims (e.g., "completely safe", "risk-free") without reference to specific conditions or risk profile | Misleading |
Enforcement consequences
- Warning letters
- Required withdrawal of advertisement
- Administrative fines
- In serious cases, suspension of the 품목허가