In a statement, the Personal Care Products Council and The Consumer Healthcare Products Association noted that industry has worked collaboratively, via public comments and dialogues, with the US Food and Drug Administration (FDA) on its Over-the-Counter (OTC) Sunscreens: Safety and Effectiveness Data Draft Guidance to ensure it reflects the best science and latest available research.
“We appreciate FDA’s willingness to seek input from the industry and other stakeholders on this effort. However, we were disappointed to see that FDA’s Final Guidance did not take the industry’s comments into account, specifically around current approaches to toxicological risk assessments. Current approaches have the potential to save significant time and resources while meeting our shared goal of protecting the public health.
“Nothing is more important than ensuring the safety of our products that are trusted and used by millions of families every day. That is why our member companies continue to invest significant time and resources to provide Americans with access to a wide variety of safe and innovative sunscreens, which is a crucial step in the fight against skin cancer and premature skin aging.”
The Public Access to SunScreens (PASS) Coalition issued the following statement in response to the FDA’s final guidance:
“The PASS Coalition’s mission is to work collaboratively with FDA, Congress and stakeholders to ensure Americans have access to the latest sunscreen technology. We are pleased the FDA met the statutory deadline under the bipartisan Sunscreen Innovation Act to publish a final guidance on sunscreen ingredient testing. We support the changes from the earlier draft—especially changes to the formulations and the body surface area to be tested. However, we were disappointed that the agency’s approach remains inconsistent with the recommendations made by independent scientific reviewers that were published in peer-reviewed literature. We look forward to continuing to work with FDA and the new Administration.”