FDA Tempers Benzoyl Peroxide's GRASE Status With Additional Warnings
This article was originally published in The Rose Sheet
Executive Summary
FDA deems benzoyl peroxide an ingredient generally recognized as safe and effective (GRASE) for OTC topical acne drug products, providing that manufacturers add warnings and directions to product cartons
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FDA deems benzoyl peroxide an ingredient generally recognized as safe and effective (GRASE) for OTC topical acne drug products, providing that manufacturers add warnings and directions to product cartons. Benzoyl peroxide is safe in concentrations of 2.5 percent to 10 percent based on safety data that shows the organic peroxide compound is not carcinogenic or photocarcinogenic, according to a final rule in the March 4 Federal Register. The safety data is new since FDA published a proposed rule on the ingredient in 1995. However, cartons for products that use the ingredient - such as Neutrogena Clear Pore Cleanser/Mask and PanOxyl Acne Spot Treatment - must include extra warnings because benzoyl peroxide is a skin irritant and sensitizer, FDA adds. Specifically, OTC products with the ingredient must warn consumers not to use a product if they have very sensitive skin; to keep it away from eyes, lips and mouth; to avoid contact with hair and dyed fabrics; and to discontinue use and contact a physician if severe irritation occurs. The packaging also must direct consumers to apply sunscreen after using the product and before going outside. FDA requires the extra warnings and directions only on product cartons. Firms also must include warnings currently required for other acne active ingredients, such as "for external use only." Manufacturers of benzoyl peroxide products with annual sales of less than $25,000 must comply with the package changes by March 2, 2012, while those whose annual sales exceed $25,000 must comply by March 4, 2011, according to the final rule. FDA also has revised labeling requirements for OTC topical acne products containing resorcinol, resorcinol monoacetate, salicyclic acid and/or sulfur to reflect current OTC drug labeling format and content requirements. The changes are "minimal" but necessary because FDA implemented the Drug Facts format and content requirements after the agency deemed the ingredients GRASE in a 1991 final rule, according to the March 4 notice. Firms have until March 2015 to comply. A Long Time Coming The addition of benzoyl peroxide to the list of GRASE ingredients for OTC acne products comes almost 19 years after FDA added the four other acne actives to the list in a final rule in 1991. Even though an advisory review panel on OTC antimicrobial drug products determined in 1982 that benzoyl peroxide was safe and effective for OTC topical use to treat acne, FDA held off on including the ingredient in the 1991 rule because studies on the ingredient's carcinogenicity and photocarcinogenicity were not available or were inconclusive. The agency issued a call for additional studies in a same-day proposed rule classifying the ingredient as category III - or as needing more data before GRASE status could be determined. A second advisory committee in 1992 recommended that the ingredient remain on the market while FDA gathered and evaluated additional studies, but it also recommended a warning about the "tumor-promoting potential" of the ingredient on a package insert, which FDA included in the 1995 proposed rule. The final rule drops the insert requirement. FDA says it worked with the Consumer Healthcare Products Association to conduct photocarniongenicity and carcinogenicity studies, which convinced it that the ingredient is not photocarcinogenic or carcinogenic. The results of the studies are "more meaningful" than conflicting studies that show benzoyl peroxide could be a tumor promoter and therefore "justify a GRASE determination," the agency says. - Elizabeth Crawford ( 1 [email protected] ) |