CHPA Consulting With OTC Antiseptic Advocates As Sunscreen GRASE Push Begins
Executive Summary
Following FDA’s proposed sunscreen rule in February, the Consumer Healthcare Products Association has opened a line of communication with the American Cleaning Institute to gain insight into the GRASE data delivery process that kicked off for consumer antiseptic products in September 2016.
You may also be interested in...
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’s Final Rule On OTC Antiseptic Rubs Affects Just 3% Of Market; Alcohol Rulemaking Deferred
The majority of over-the-counter hand sanitizers and wipes on the US market rely on ethyl alcohol, one of three active ingredients for which final rulemaking has been deferred to allow industry to generate additional safety and effectiveness data. FDA's final rule, released April 11, completes a series of related actions pertaining to OTC antiseptic drug products.
Industry Groups To Request FDA Rulemaking Deferrals For Sunscreen Ingredients In Question
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.