Leader Co.
This article was originally published in The Tan Sheet
Executive Summary
In April 21 warning letter, FDA states the company's aloe vera gel is an unapproved new drug because it is marketed with claims that refer to disease including "irritable bowel syndrome, antibacterial, anti-pruritic, arthritis, athlete's foot, boils, chicken pox, cold sores, colitis, ear infection, eczema, fever blisters, fungicidal, gastritis, hemorrhoids, psoriasis, skin rashes, tonsilitis, ulcers, vaginitis, virucidal." Based in North Canton, Ohio, the company markets the product through mail order. Leader Co. is developing its response to the letter