Statement by Personal Care Products Council and Consumer Healthcare Products Association In Response to FDA’s Draft Guidance on New Sunscreen Ingredient Data Requirements
“Today, the Personal Care Products Council and the Consumer Healthcare Products Association submitted comments in response to the U.S. Food and Drug Administration’s (FDA) Over-the-Counter Sunscreens: Safety and Effectiveness Data Draft Guidance for Industry (Draft Guidance).
“The science of ingredient safety evaluation is a highly technical, multifaceted, and rapidly evolving field. The Draft Guidance outlines FDA’s current thinking on the kinds of data it needs before the Agency can approve a new sunscreen ingredient. However, with few exceptions, FDA’s thinking is not reflective of the current state-of-the-art ingredient safety assessment framework recognized and used by the majority of health authorities worldwide.
“It is because of these significant differences, and the importance of providing consumers with a wide variety of sunscreen ingredients, that we have asked FDA to hold public meetings or workshops to allow further discussion to attempt to reconcile these differences.
“Every day our industry’s research and development scientists strive to advance sunscreen formulation technology to create sunscreens that families enjoy and trust to help protect them against the harmful effects of the sun, including skin cancer and premature skin aging. FDA must keep up with technology in order for companies to offer Americans new and innovative sunscreen products. We believe that this greater choice will encourage sunscreen use and further protect the public.
“The goal of the Sunscreen Innovation Act, passed in late 2014, is to modernize and streamline FDA’s process for reviewing sunscreen ingredients that have already been on the market in other countries for at least five years. However, the manner in which FDA reviews sunscreen ingredient safety needs updating. FDA should use a state-of-the-art safety assessment framework that is science-based, flexible to advances in toxicological and medical science, and used by regulators and authoritative scientific bodies around the world.
“The Centers for Disease Control and Prevention (CDC), the American Academy of Dermatology (AAD), the Skin Cancer Foundation and health care professionals worldwide all emphasize that using sunscreens is a critical part of a safe sun regimen. The dangers of sun exposure are clear and universally recognized by public health professionals and dermatologists. The National Institutes of Health Report on Carcinogens identifies solar UV radiation as a ‘known human carcinogen.’ A single bad burn in childhood doubles the risk of developing skin cancer later in life.
“Our goal is to provide Americans with access to a wide variety of safe and innovative sunscreens to use as an important part of an overall safe sun program. Our hope is that in finalizing the Draft Guidance, FDA revises its position to reflect the current science of ingredient safety assessments.”