Last month, President Barack Obama signed into law the Sunscreen Innovation Act. The Act is intended to reform FDA’s process to expedite the review and approval of all TEA products and in particular products containing new sunscreen ingredients.
The law is geared toward ensuring manufactures receive timely and predictable responses. For example, FDA will be required to notify manufactures within 60 days of the submission of an application as to whether the application is sufficiently complete to support a review by regulators.
The law requires the FDA to speed up its publication of its responses and tasked with acting on most applications within the next three months, create a guidance document to clarify how brands can have their sunscreen products approved by FDA and the data FDA will require prior to an approval decision, and pressures the FDA to issue a new sunscreen monograph within 5 years of the legislation’s passage. Such a monograph would clear the way for new sunscreen products by declaring their base ingredients GRASE, allowing them to skip FDA’s arduous approvals process so long as they conform to the monograph.
- Michael Werner of the Public Access to Sun Screens (PASS) Coalition highlighted that “the signing of the Sunscreen Innovation Act by President Barack Obama is the culmination of persistent, bipartisan work by Congress and stakeholders to provide Americans with access to the latest sunscreen products to help curb future cases of skin cancer, particularly melanoma…The President’s approval of the Sunscreen Innovation Act demonstrates that the White House and Congress agree that FDA should ensure all sunscreens receive a transparent review within a predictable time frame. With this law, Congress has helped answer the U.S. Surgeon General’s Call to Action to Prevent Skin Cancer. The PASS Coalition and other stakeholders will now focus on working with FDA to guarantee the new law is implemented as quickly as possible.”
- In advance of the President’s signing, Kristina Schake, Chief Communications Officer at L’Oréal USA, a founding member of the PASS Coalition reported that “L’Oréal USA commends the House of Representatives for its unanimous passage of the Senate version of the Sunscreen Innovation Act (S.2141), which will provide American consumers greater access and choice when it comes to the latest and effective sunscreen products available. L’Oréal has been a pioneer in sunscreen innovation since the company’s founder invented the first sunscreen in 1936, and the company continues to invest deeply in the science of sun protection. The creation of a predictable, transparent and timely review process for sunscreen ingredients will not only help tackle a growing public health concern, but also continue to incentivize American sunscreen innovation.”
- Another member of the (PASS) Coalition, BASF stated that they highly welcome the Sunscreen Innovation Act. Passage of the bill represents a significant step towards ensuring the timely review of new sun protection ingredients by the FDA, that will ultimately provide US consumers with a wider array of safe and effective sunscreen products,” said Dirk Buengel, Senior Vice President Care Chemicals for BASF in North America.
Given the amount of legislative and public support of the bill from public health groups, dermatologists, sunscreen ingredient manufacturers, key opinion leaders, skin cancer advocates, and Congress the FDA should move quickly to implement the new requirements.
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