PCPC Formally Responds to EWG's 'Unscientific' Sunscreen Report

Posted: July 2, 2009

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"Consumers can be confident in the safety of the sunscreens they buy for themselves and their families because all sunscreens sold in the U.S. are regulated as over-the-counter (OTC) drugs by the US Food and Drug Administration (FDA), which requires them to go through a rigorous scientific assessment and approval process that includes safety and performance testing before marketing. The OTC review program, through which FDA requires significant safety and efficacy data on every active ingredient that is used in a sunscreen product, is the most rigorous in the world for ensuring the safety and efficacy of sunscreen products and is conducted in an open, transparent manner. The law gives the agency broad authority to inspect manufacturing facilities, to require adherence to strict good manufacturing practices, and to enforce the stringent, science-based regulations that ensure sunscreen products are safe and effective for consumers. FDA also relies on independent experts in the science of sun protection to help advise them in their assessment of safety and efficacy.

"Allegations made in the EWG report about the safety and efficacy of sunscreens conflict with FDA assessments of sunscreen products and their ingredients as well as with the safety assessments and approvals of regulatory and scientific experts in the European Union, Canada and numerous other countries.

"For example, EWG has specifically questioned the safety of the common active ingredient in sunscreens called oxybenzone. However, oxybenzone is approved by the FDA, the European Union and Canada as a safe and effective sunscreen ingredient. It has also been reviewed by the Cosmetic Ingredient Review (CIR) program, an independent panel of leading scientific and medical experts who assess the safety of cosmetic ingredients used in the United States, and determined it to be safe for use as a photostabilizer (to protect the formulation) in cosmetic products.

 "These reviews, based on the most current science available and conducted in a public forum, provide clear support for the safety of this important ingredient. In contrast, EWG’s assertions about the safety of oxybenzone lack the rigor and reliability of formal, expert evaluation, are not peer-reviewed, and could unnecessarily confuse or alarm consumers and even cause them to alter their safe sun habits.

“Although the report tries to credit activist pressure on manufacturers for changes in product formulations, it is well-known that the personal care products industry is dynamic and innovative and constantly employs cutting-edge science to introduce new, better and more effective products for consumers.