The U.S. Food and Drug Administration (FDA) recently announced a preliminary decision to prevent ecamsule and enzacamene — two sunscreen ingredients — from entering the U.S. market, unless companies using them can prove they’re safe and effective. Ecamsule was approved for use in the U.S. in 2006 at a specific concentration and only in limited products. Enzacamene has been under review at the FDA since 2002.
According to the FDA, enzacamene is not generally recognized as safe and effective (GRASE) and is misbranded in over-the-counter sunscreen products, because “the currently available data are insufficient to classify it as GRASE and not misbranded, and additional information is needed to allow us to determine otherwise.”
FDA’s Decision Not Well Received
Many industry organizations are disappointed in the FDA’s ruling, as they feel it is restricting innovation in sunscreen development.
“We are very disappointed with the U.S. Food and Drug Administration’s preliminary decision on the last two pending sunscreen ingredients, ecamsule and enzacamene,” says Chair of the Sunscreen Committee Personal Care Products Council Farah Ahmed, in a statement.
“(These are) ingredients that have been approved and used safely by millions of consumers worldwide,” continued Ahmed.
Companies are striving to advance the current sunscreen formulation technology, making reducing the rate of skin cancer a top priority.
“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,” Ahmed says.
“However, the manner in which FDA reviews sunscreen ingredient safety needs updating,” she continues.” “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.”
“The Centers for Disease Control and Prevention (CDC), the American Academy of Dermatology (AAD), the Skin Cancer Foundation and healthcare professionals worldwide all emphasize that using sunscreens is a critical part of a safe sun regimen,” Ahmed says. “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.”
Having a wide-variety of FDA-approved sunscreen ingredients allows the industry to give consumers a larger selection of safe and effective sunscreens to use, effectively encouraging sunscreen use, Ahmed says.
Ecamsule and Enzacamene Legal in Other Countries
Michael Werner, policy advisor to the PASS Coalition — which strives to work with the FDA and others to develop safe and effective sunscreen products — also believes this decision limits innovation in sunscreen product development, especially as the two outlawed ingredients have been used worldwide for years.
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