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

 
• By Ryan Nelson

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.

Sand running through the bulbs of an hourglass measuring the passing time in a countdown to a deadline, on a dark background with copy space.

Industry needs more time to draft comments on FDA’s proposed rule to establish a final OTC sunscreen drug monograph and likely will request rulemaking deferrals for at least some of the 12 sunscreen active ingredients that, according to FDA, require additional data to show general recognition of safety and effectiveness.

The Personal Care Products Council and Consumer Healthcare Products Association submitted a joint request to the agency March 4...

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