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Industry Groups To Request FDA Rulemaking Deferrals For Sunscreen Ingredients In Question

Executive Summary

Trade groups PCPC and CHPA say they likely will request that FDA defer further rulemaking on sunscreen ingredients that require additional data to retain their GRASE designations under the agency’s proposed rule for a final OTC sunscreen drug monograph, issued in February. For now, the associations are asking for an extension of the allotted comment period beyond May 28, 2019.

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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.

FDA Sunscreen MUsT’s ‘Real World’ Applicability Under Debate, Which Could Hold Up Testing

Spaulding Clinical, which the FDA contracted for its sunscreen maximal usage trial published in May, is in discussions with a handful of sunscreen industry players about doing more MUsTs to fulfill data needs identified by the agency. Meanwhile, leading trade groups are interested in talking to the FDA about developing sunscreen study protocols that more accurately reflect real-world consumer usage.

EWG Casts FDA’s Proposed Sunscreen Rule As Validation Of Longstanding Concerns

The Environmental Working Group has long favored mineral over chemical sunscreens in its annual ratings and buying guide, with particular concerns about oxybenzone, one of 12 active ingredients that FDA says need additional safety data to support GRASE determinations.

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