Ginesis Natural Products
This article was originally published in The Tan Sheet
Executive Summary
Company's "All Natural Ginesis Exclusive Formula Shampoo," which carries claims for dandruff and hair loss, "Progesterone 950 mg Natural Woman Essential Body Cream," carrying cancer and osteoporosis claims, and "Pregnenolone Natural Aura Arthritis Joint Relief" products are new drugs requiring approved NDAs, FDA states in an Oct. 20 warning letter. Moreover, since the latter two products contain the hormones progesterone and pregnenolone, they are subject to the final monograph for OTC hormone drugs