Comments on sunscreen ingredients' environmental impact
This article was originally published in The Tan Sheet
FDA requests comments on the potential environmental impact of sunscreen ingredients and other substances the agency may add to OTC monographs. In a 1notice prepared for the Feb. 22 Federal Register, the Center for Drug Evaluation and Research says environmental regulations require it to estimate the substances' expected introductory concentration in the aquatic environment. The notice lists ingredients not currently approved for use including: amiloxate, bemotrizinol, bisoctrizole, diethylhexyl butamido triazone, enzacamene and octyl triazone for sunscreen; climbazole, piroctone olamine and sodium shale oil sulfonate for dandruff; laxative ingredient sodium picosulfate; and triclosan for acne treatment. The notice also lists ingredients currently marketed in the U.S. through new drug applications as possible OTC monograph additions, ecamsule for sunscreen and triclosan for oral care. The sunscreen ingredients would be part of the first final monograph published for the indication. A final monograph emerged in 1999, but its publication was consistently stayed due to industry pressure, which continued since FDA issued a draft rule in August 2007 (2"The Tan Sheet" Nov. 30, 2009, In Brief). CDER will accept environmental impact comments concerning these ingredients for three months
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The Personal Care Products Council requests a meeting with FDA to discuss the sunscreen ingredient monograph proposed in 2007. In a Nov. 3 1letter to Principal Deputy Commissioner Josh Sharfstein, the council urges the agency "to finalize the sunscreen regulations in a way that allows for labeling that educates and helps consumers protect themselves from the dangers of sun exposure." A council spokeswoman said the trade group has not heard back from FDA. Johnson & Johnson and its subsidiary Neutrogena sent a subsequent 2letter Nov. 5 voicing the company's concerns about the monograph's proposal to cap sunscreen label claims at SPF 50, unless adequate supporting data are submitted (3"The Tan Sheet" Aug. 27, 2007). "Any proposed cap on SPF labeling is not necessary and will significantly contribute to reduced innovation and likely reduced communication spends within our industry," J&J says