Happi Staff11.27.19
It's not happening...yet. The Sunscreen Innovation Act (SIA) was scheduled to go into effect yesterday, per passage of the Act back in 2014. But according to industry sources, the US Food and Drug Administration is postponing implementation.
"Our understanding is that the FDA has indicated a delay until September 2020 to finalize the sunscreen monograph," explained Lisa Powers, EVP-public affairs & communications, Personal Care Products Council. "Apparently, the Agency received a significant amount of public comments and is still going through them."
The Act was enacted on November 26, 2014 to provide an alternative process for the review of safety and effectiveness of nonprescription sunscreen active ingredients.
The SIA supplements the FDA’s Time and Extent Application (TEA) regulation with new statutory procedures. The SIA also requires FDA to establish timeframes for review of TEAs for OTC drugs other than sunscreen active ingredients.
"Our understanding is that the FDA has indicated a delay until September 2020 to finalize the sunscreen monograph," explained Lisa Powers, EVP-public affairs & communications, Personal Care Products Council. "Apparently, the Agency received a significant amount of public comments and is still going through them."
The Act was enacted on November 26, 2014 to provide an alternative process for the review of safety and effectiveness of nonprescription sunscreen active ingredients.
The SIA supplements the FDA’s Time and Extent Application (TEA) regulation with new statutory procedures. The SIA also requires FDA to establish timeframes for review of TEAs for OTC drugs other than sunscreen active ingredients.