FDA denies acne petition
This article was originally published in The Rose Sheet
Executive Summary
D'Arcy Skincare petition requesting 10% sulfur and 2% salicylic acid combination be recognized as safe and effective under the OTC topical acne drug products monograph is denied by FDA. Agency says it is "unaware of any clinical studies demonstrating that both sulfur and salicylic acid contribute to the overall effectiveness of the combination" and notes D'Arcy did not submit effectiveness data to support its position. Although 3%-10% sulfur and .5%-2% salicylic acid are permitted under the monograph, they are not allowed at those levels in combination. D'Arcy includes 2% salicylic acid and 10% sulfur in combination in its Drying Lotion acne treatment and argued it has seen no adverse effects during more than 20 years of marketing the product. The company also submitted repeat insult patch test to FDA to support safety and consumer testimonials to prove efficacy (1"The Rose Sheet" July 19, 2004, p. 8)...