Prostatic hypertrophy treatment claims for saw palmetto draw FDA "courtesy" letters.
This article was originally published in The Tan Sheet
Executive Summary
BPH TREATMENT CLAIMS DRAW FDA "COURTESY" LETTERS for structure/function claims that suggest the dietary supplements are "intended to treat, mitigate, or pre-vent a disease, namely benign prostatic hypertrophy," FDA says. One letter was sent to Celestial Seasonings, which had notified the agency in January it was using the structure/function claims "Helps maintain healthy, comfortable urinary flow and frequency" and "Natural support for men over age 40" for its Celestial Seasonings Saw Palmetto Standardized Herbal Extract. The firm has not decided whether it will change the claims.