FDA’s Announcement on Ecamsule and Enzacamene Applications Demonstrates Clear Disregard for Increased Rates of Melanoma, Public’s Demand for Latest Sunscreen Technology.

Like the Six previously Pending Ingredients

Ecamsule and Enzacamene Will Continue to be Held Hostage by the FDA

Today, the Public Access to SunScreens (PASS) Coalition released a statement regarding FDA’s recent announcement of two sunscreen ingredient applications, ecamsule and enzacamene.

Michael Werner, policy advisor to the PASS Coalition stated, “Today’s action taken by the FDA regarding ecamsule and enzacamene means that Americans will not have access to innovative products that have been used safely all over the world– in some cases for more than a decade. With skin cancer and melanoma rates increasing dramatically, Americans need more options to protect themselves from the sun’s harmful UV rays. Last fall, the US Surgeon General issued a Call to Action on skin cancer urging the federal government to work with the private sector and take necessary steps to respond to this public health crisis. FDA’s latest action is inconsistent with this approach.

Werner stated, “Ecamsule is unique among pending sunscreen ingredients because it has already been approved by FDA through the New Drug Application (NDA) process since 2006. The application was submitted for approval under the Time and Extent Application (TEA) for broader use in the OTC space, but prior to today, and despite its approval as an NDA, the application languished for almost 8 years at FDA without a decision. Like with the other products FDA has not approved under the TEA process, the agency’s message today is that manufacturers must submit data through a process with requirements that mimic the NDA process. This is not tenable for sunscreen and will result in delayed access to new products for Americans.”

Werner concluded, “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.”

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