Gold Medal Hair Products warning letter
This article was originally published in The Rose Sheet
Executive Summary
Firm says it plans to change the claims for several of its products following receipt of a March 30 FDA warning letter. The letter states that Carbonoel Skin Ointment, Medicated Scalp Ointment and Medicated Liquid Shampoo, Australian Tea Tree Oil, Power Gro Scalp Therapy Oil and Pollen d'Abeilles bee pollen supplements are unapproved new drugs due to labeling suggesting that the products are "useful in treating or preventing various diseases." Labeling claims include "Australian Tea Tree Oil... Ideal for skin problems such as pimples" and "Carbonoel Medicated Skin Ointment for acne and skin problems...Dermatologists have prescribed this medicated cream...to dry away pimples and acne.