Statement by Farah Ahmed, Chair, Sunscreen Committee Personal Care Products Council In Response to FDA Announcement on New Sunscreen Ingredient Applications
“We are very disappointed with the U.S. Food and Drug Administration’s (FDA) preliminary decision on the last two pending sunscreen ingredients, ecamsule and enzacamene. On February 24, 2015, the Agency announced that it needed additional data before it could approve these ingredients – ingredients that have been approved and used safely by millions of consumers worldwide.
“Reducing the rate of skin cancer is a priority for personal care products companies. 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. FDA must keep up with technology in order for us to offer Americans new and innovative sunscreens.
“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 framework that is science-based, flexible to advances in toxicological and medical science, and used by regulators and authoritative scientific bodies around the world.
“Having a wide range of FDA approved sunscreen ingredients allows our industry to provide American families with a greater variety of safe and effective sunscreens. We believe that this greater choice will encourage sunscreen use and further protect the public from the damaging effects of the sun, including premature skin aging and skin cancer.
“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.”