FDA Needs Industry Work Plan Before Granting Sunscreen Ingredient Rulemaking Deferrals
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.
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The US FDA’s deferral of final GRASE rulemaking on UV filters identified in its February proposed rule as lacking data hinges on its acceptance of industry’s work plan. In October, the agency expressed concerns about the plan submitted by the Personal Care Products Council, but granted the group’s request for a meeting – slated for 13 November – to discuss the issues further.
Industry and the FDA agree that the OTC drug monograph system is direly in need of reform, but innovating with noncompliant dosage forms and indications, without approved new drug applications, is a risk companies need to weigh seriously, says Arnall Golden Gregory partner Alan Minsk. The FDA offers perspective on its OTC monographs for acne and antiperspirant products.
“CVS Pharmacy is highly attuned to our customers’ evolving needs and their desire for products that are more sustainable while still being efficacious,” says CVS Health’s George Coleman, senior vice president of merchandising. The retailer is committed to eliminating oxybenzone and octinoxate from CVS-branded sunscreens with SPFs less than 50 by the end of 2020.