Sunscreen approval delays prompt push for high-throughput tests

Sunscreen manufacturers are urging the U.S. FDA to relax testing requirements for new active ingredients, claiming the tests are too costly, animal intensive, and slow. Companies want instead to use high-throughput, nonanimal methods. Animal welfare groups and some members of Congress support the idea. In a Jan. 17 letter to the director of the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods, Rep. Robert Pittenger (R-N.C.) asked what the center is doing “to facilitate the regulatory acceptance of alternatives to animal testing for sunscreen ingredients.” The Sunscreen Innovation Act, enacted in 2014, set deadlines for FDA to review new sunscreen active ingredients, but it did not eliminate the need for FDA to determine that each substance is “generally recognized as safe and effective.” Eight ingredients—amiloxate, bemotrizinol, bisoctrizole, drometrizole trisiloxane, ecamsule, enzacamene, iscotrizinol, and octyl triazone—were under review when the law was enacted, and they still are. FDA requested additional toxicity data for all of them, but manufacturers have yet to comply. The deadline clock starts after FDA receives the data.