Permitted and Prohibited Promotional Claims
Permitted claimsβ
- 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 claimsβ
| Claim type | Reason |
|---|---|
| Claims beyond approved indications | Exceeds νλͺ©νκ° scope |
| Curative claims for unapproved conditions | Misleading |
| Testimonials implying guaranteed outcomes | Misleading |
| Comparative claims without evidence | Misleading |
| Claims device is "safe" without qualification | Misleading |
Enforcement consequencesβ
- Warning letters
- Required withdrawal of advertisement
- Administrative fines
- In serious cases, suspension of the νλͺ©νκ°