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Could Gottlieb Bring Red-Tape Scissors To FDA Sunscreen Review?

This article was originally published in The Rose Sheet

Executive Summary

FDA Commissioner nominee Scott Gottlieb has been a vocal critic of FDA bureaucracy and excessive data demands that in his view have slowed access to life-saving drugs and medical devices in the US. His expected confirmation as FDA head could offer a new glimmer of hope to sponsors seeking GRASE status for next-generation UV filters, a process that has all but ground to a halt, according to industry advocates.

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According to industry, available scientific evidence regarding oxybenzone’s and octinoxate’s effects on coral does not support their removal from the OTC sunscreen drug monograph’s list of permitted UV filters, and FDA is fully compliant with federal environmental laws, contrary to the Center for Biological Diversity’s suggestions. FDA says the petition raises complex issues requiring extensive review.

EWG Remains Concerned About SPF Boosting With Anti-Inflammatories

Without an FDA cap on SPF claims, companies continue to answer consumer demand for lofty SPFs using the limited active ingredients cleared for OTC use in the US. The Environmental Working Group says manufacturers also are spiking sunscreen formulas with anti-inflammatory ingredients to boost SPF scores, but some such ingredients may only "mask" signs of UV-induced skin damage.

Consumer Reports Blasts SPF Claims Again, But Industry's Problems May Be Bigger

The annual bad marks given to sunscreen brands from Consumer Reports for their SPF claims could be due to CR's nonconformity with FDA-prescribed test guidelines or could signal testing failures or other compliance problems in the industry. In any event, companies are hurrying to retest sunscreen formulas and validate their claims.

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