Thailand's FDA reclassified 5,000 ppm fluoride toothpaste as a controlled medicine (not a cosmetic) to clarify consumer confusion after a recent government gazette announcement. Standard toothpaste (≤1,500 ppm) remains unaffected and safe for daily use; high-concentration 5,000 ppm formulations are reserved for high-risk patients (oral cancer radiotherapy survivors, elderly) and require dental professional supervision. The move addresses Thailand's high cavity prevalence (49.7% in 12-year-olds, 80.9% in working-age adults) and enables better prevention options, but users under 12 should avoid the stronger formula due to swallowing risk.