The Natural Products Association (NPA) in two recent public filings with the U.S. Food and Drug Administration (FDA) encouraged the adoption of standards that would result in the availability of more natural ingredients in sunscreen for consumers. NPA called on the FDA to clarify what it considers an active ingredient in sun protection products and to also amend the approval process to allow more applications for new products.
“Changing the process by which new sunscreen products are approved will greatly serve the American consumer, giving them access to more effective natural products and support the important goal of reducing skin cancer in the United States," said Corey Hilmas, M.D., Ph.D., senior vice president of scientific and regulatory affairs of NPA.
NPA encouraged FDA to take these specific steps to benefit consumers:
Nonprescription Sunscreen Drug Products—Content and Format of Data Submissions
NPA supports FDA’s clarification on the content and format of Generally Recognized as Safe and Effective (GRASE) submissions and the timeline for GRASE submission and determination. However, NPA requested the Agency specify the time frame which sponsors are allowed to submit additional information after an initial refusal of the 586A request. NPA also requested that FDA list both the technical specifications required and technical specifications that should be omitted from the Common Technical Document (CTD) to be considered a complete GRASE submission. Lastly, NPA requested clarity on whether or not combination active ingredients are required to submit multiple GRASE submissions and how this would affect the submission of safety and toxicity data.
Advisory Committee Process
The Nonprescription Drug Advisory Committee (NDAC) is an important component of FDA drug review and an important piece of the 586A review and SIA process. NPA urged FDA to reconsider the frequency which NDAC meets in regards to 586A request as well as the number of pending 586A requests reviewed by the committee. In addition, NPA recommended the Agency allow for an NDAC request to be made only when a request is no longer pending. NPA believes this will expedite the process which sunscreen active ingredients are reviewed and will greatly serve the American consumer, giving them access to new efficacious sunscreen products which will support the important goal of reducing instances of skin cancer in the United States.