The ingredients in question are ecamsule and enzacamene; the former has been approved for use in the US since 2006, but only at a specific concentration and only in a few products, while the latter has been under review at the Agency since 2002.
The FDA says that enzacamene is not generally recognized as safe and effective (GRASE) and is misbranded when used in over-the-counter (OTC) 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.”
The decision, which was put in the FDA’s proposal in the Federal Register, has not been received well by some industry organisations and has been dubbed ‘disappointing’, as many feel it is limiting innovative sunscreen development.
‘Disappointing’
“We are very disappointed with the US Food and Drug Administration’s preliminary decision on the last two pending sunscreen ingredients, ecamsule and enzacamene,” says Farah Ahmed, Chair, Sunscreen Committee Personal Care Products Council, after the Agency announced that it needed additional data before it could approve these ingredients.
“[These are] ingredients that have been approved and used safely by millions of consumers worldwide.”
Sunscreen development is an ongoing process in the industry as companies strive to reduce the rate of skin cancer, with advances in sunscreen formulation technology a top priority; and Ahmed urges regulators to keep up.
“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,” she says.
“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.”
Ahmed says that having a wide range of FDA-approved sunscreen ingredients allows the industry to provide American families with a greater variety of safe and effective sunscreens, and that this greater choice will encourage sunscreen use.
PASS Coalition
Michael Werner, policy advisor to the PASS Coalition, which aims to work with the FDA and others to develop safe and effective sunscreens, agrees that innovation in sunscreen is limited with this decision, particularly as products like the ones now outlawed have been used around the world, for years.
“Ecamsule is unique among pending sunscreen ingredients because it has already been approved by FDA through the New Drug Application (NDA) process since 2006,” says Werner.
“Last year, Congress unanimously enacted the Sunscreen Innovation Act to get these products to the market quickly and respond to the public health crisis from growing rates of skin cancer and melanoma. We look forward to working Members of Congress and FDA to ensure the legislation is implemented to achieve that objective.”