US Regulations Update: FDA Issues Final Monograph for Skin Protectants

On June 4, 2003, the FDA published the Final Monograph (FM) for Skin Protectant Drugs for Human Use.¹ The Proposed Rules (PR) were issued August 4, 1978,² and the first Tentative Final Monograph (TFM) was published on February 15, 1983.³ The TFM was amended on October 3, 19894 to include the treatment of poison ivy, oak, sumac and the treatment of insect bites.

As with all PRs, TFMs and FMs, the document consists of three major sections. The first is a review of the comments and the FDA’s position on these comments. The second is the economic impact statement and details, which I will not cover. Finally, the important third section is the new Code of Federal Regulations (CFR) to reflect these new regulations. A complete and exact copy of the FM is available on the Weba.

Significant Comments and their Page Numbers One comment requested the definition of skin protectant be reworded to include other words, which the FDA agreed to (p. 33363). There were several comments concerning cosmetic claims for these products. The FDA reiterated their position that, with the exception of the ingredient declarations of OTC drugs that also make cosmetic claims (and therefore must follow cosmetic ingredient labeling), they would not allow any cosmetic claims within the “Drug Facts” box. Cosmetic claims are permitted outside this area (p. 33363). This is very important to producers, who should view this very seriously, as penalties can range from warning letters to fines to the seizing of products.