FDA Needs Industry Work Plan Before Granting Sunscreen Ingredient Rulemaking Deferrals

02 Aug 2019

Industry must provide the agency with a draft plan by 3 Sept. describing the work it intends to conduct to support the generally recognized safety and effectiveness of eight chemical UV filters commonly used on today’s market. Without rulemaking deferrals, the active ingredients’ fate is uncertain as the 26 Nov. statutory deadline for a final OTC sunscreen drug monograph draws near.

The US Food and Drug Administration is giving industry until 3 Sept. to submit a draft work plan for sunscreen active ingredients whose generally recognized as safe and effective (GRASE) status is in question under the agency’s proposed rule issued in February.

“FDA’s agreement to defer further rulemaking for each ingredient depends on receiving satisfactory commitments to fill the data gaps in...