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Hair regrowth warning letter

This article was originally published in The Tan Sheet

Executive Summary

GemKen Pelocell shampoo claims as a hair regrowth product cause it to be cited as a new drug by FDA in an Aug. 23 warning letter. Claims on labeling and on the San Antonio-based company's Web site include "Nature's Stimulant for Thinning Hair" and "Once Pelocell stops or slows your hair loss, you can expect to see new hair growth." The shampoo contains saw palmetto, tea tree oil, panthenol, vitamin B6 and other ingredients. Minoxidil in 2% and 5% formulas is the only FDA-approved OTC ingredient for hair regrowth products

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